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Study flow | Five pharmacies participated in this study. However, one of them withdrew before the start of the study because the prescribing practitioners did not consent to provide assistance to this study. The remaining four pharmacies were allocated to the intervention and control groups at a 1-to-1 ratio. During the study, 6 patients in the intervention group and 2 in the control group dropped out. Results were obtained from 19 intervention-group and 12 control-group patients (Fig.
Flow of the study | PMC9951417 | ||
Patient attributes | Table
Patient attributesIG: Intervention group, CG: Controlled group, | PMC9951417 | ||
Changes in outcomes in patients | Table
Changes in Outcome scores#: Difference between 6months and baseline, DAI-10: Drug Attitude Inventory-10, PHR-9:Patient Health Questionnaire-9, EQ-5D-5 L: Euro Qual 5 Dimensions 5 Level | PMC9951417 | ||
Effect of each variable on the amount of change in the DAI-10 | REGRESSION | A multiple regression analysis was performed using a stepwise method with the change in DAI-10 as the dependent variable and PHQ-9, EQ-5D, patient satisfaction, as independent variables. As a result, only the change in patient satisfaction (standardized coefficient β: 0.450, p = 0.024) was included in the model. The adjusted R-squared value was 0.203. A list of the excluded variables and their variable correlation coefficients and significance probabilities is provided as a supplemental document. | PMC9951417 | |
Pharmacist attributes | Five pharmacists in IG and three pharmacists in CG provided patient care in this study and responded to the questionnaire for pharmacists. 60.0% of the IG and 33.3% of the CG were female. The mean years of experience as a pharmacist was 10.1 for the intervention group and 3.3 for the control group (p = 0.20). | PMC9951417 | ||
Changes in outcomes in pharmacists | depression, Depression | Post-baseline changes in the participating pharmacists’ self-reported confidence in interacting with patients with depression were analyzed, and the results are summarized in Table
Changes in Study Pharmacists’ Self-Reported Confidence in Interacting With Patients With Depression (PCMCD Score)#: Difference between 6months and baseline | PMC9951417 | |
Discussion | panic disorder, insomnia, depressed, unipolar depression, depressive symptoms, depression | RECURRENCE, DISEASE, DISORDERS, SECONDARY, REGRESSION | This study suggested the possibility that community pharmacists can help improve the medication adherence of patients with unipolar depression by providing CBT-based medication support. This possibility is probably associated with intervention-induced changes in the patients’ perceptions of medication and health care professionals. This parallel-group study to evaluate the impact of CBT-based medication support on antidepressant adherence was the first of its kind in Japan. The intervention-group patients of our study showed improvements in clinical symptoms, and this positive finding contradicted the results of the systematic meta-analysis that reviewed the effects of pharmacist intervention on antidepressant adherence and symptomatology [Given that CBT-based counseling support can improve medication adherence and symptoms, this approach will provide better healthcare opportunities than information-focused patient education. One of the major challenges for CBT-based medication support is to elicit unspoken (and often biased) assumptions and thoughts from the patients during the contact. Building trust, therefore, is the foundation for the community pharmacist to provide CBT-based medication support to their patients. The intervention-group patients also exhibited increased patient satisfaction. Moreover, the intervention-group pharmacists demonstrated an increase in the self-confidence in interacting with patients with depression. Intervention-group pharmacists commented that their patient assignment helped them build trusting relationships because it allowed them to have a stronger commitment to their study patients. Specifically, the study setting enabled them to gather information on their patients’ background, medical history, and other personal matters. Effective interventions based on these pieces of information contributed to the patients’ satisfaction and the pharmacists’ sense of competence.Several methodological limitations of this study must be pointed out. First, this was not a randomized trial, although the distributions of the demographic and baseline characteristics of the study patients were not significantly biased. The proportion of patients with employment was slightly higher in the intervention group. This probably reflected the differences in the geographic location, with the intervention-group pharmacies being placed in a more urban area than their counterparts. Second, the sample size of this study was small. This warranted a larger study in the future. Third, the primary and secondary endpoints were subjective. However, the instruments used in this study have been thoroughly tested for validity and reliability, and are commonly used in research. Fourth, patient selection bias may have occurred. Fifth, this study included both newly and previously diagnosed patients. As a result, the study patients had varying lengths of disease duration. However, our multiple regression analysis showed a poor correlation between the post-baseline DAI-10 score change and disease duration (Supplemental Table 1), and these results suggested the positive effects of the CBT-based medication support were independent of the time from diagnosis. Patients with depression tend to have negatively biased thinking styles regardless of the duration of disease. CBT can help patients learn effective self-help skills, thereby contributing to preventing the recurrence of depression. Sixth, some control group pharmacists attended the training. The control group was asked not to use CBT-A during the intervention period and to treat patients as usual, but it cannot be denied that this may have been weakened the intervention effect of this study. This study did not collect data on the relapse or recurrence of depressive symptoms. Seventh, the intervention group had telephone follow-up as needed, which may have increased patient contact. It is undeniable that this may have affected medication adherence and patient satisfaction. However, telephone follow-up of patients in intervention trials has been conducted in previous studies [Despite the above limitations, this interventional study demonstrated that CBT-based interventions by community pharmacists improved the medication adherence of patients with depression. This also suggests that it might be possible to shorten the duration of treatment for depressed patients and thus reduce health care costs. We hope that similar initiatives will be pursued in pharmacies in the future for patients with panic disorder, insomnia, addiction, and other disorders.We believe that it would be beneficial to provide basic education on CBT to pharmacy students at universities so that medication support based on CBT can be practiced more widely in the community. It would be also desirable to establish an organization, led by a pharmacist association, to support pharmacists in clinical settings to continue learning about CBT and to monitor the adequacy of the support provided. | PMC9951417 |
Acknowledgements | The authors thank the pharmacists at the Apis Pharmacy Corporation, Osaka, Japan, for their contributions to this study. | PMC9951417 | ||
Authors’ contributions | MS was responsible for the planning, designing, and management of the study and drafting the manuscript. HM, KT, and FW conducted the training course for the study pharmacists, provided advice and guidance regarding the study design, and reviewed the manuscript. AF and YI selected the study pharmacies, supported the conduct of the training course, and allocated the pharmacies to intervention and control groups. AS provided assistance to the study management, and was assigned the task of data input, management, and analysis. MO supervised the study, and reviewed the manuscript. | PMC9951417 | ||
Funding | This study was financially supported by the Health Care Science Institute, Tokyo, Japan. | PMC9951417 | ||
Data availability | The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. | PMC9951417 | ||
Declarations | PMC9951417 | |||
Competing interests | The authors have no conflicts of interest to declare. | PMC9951417 | ||
Ethics approval and consent to participate | This study was approved prior to initiation by the Research Ethics Committee of the Osaka University of Pharmaceutical Sciences (Currently, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University; The approval ID: 0063). All methods were carried out in according with the Ethical Guidelines for Medical and Health Research Involving Human Subjects. | PMC9951417 | ||
Informed consent | We obtained informed consent from all participants or, if the participants were under 20, from a parent or legal guardian. | PMC9951417 | ||
Consent for publication | Not applicable. | PMC9951417 | ||
References | PMC9951417 | |||
Objective | T2DM | TYPE 2 DIABETES | Basal insulin glargine has a neutral effect on cardiovascular risk in type 2 diabetes (T2DM). In practice, basal insulin is often paired with a glucagon-like peptide-1 receptor agonist (GLP1-RA) or meal insulin; however, the cardiovascular implications of these combinations have not been fully elucidated. In this context, we sought to evaluate the vascular function effects of adding the GLP1-RA exenatide or meal insulin lispro to basal glargine therapy in early T2DM. | PMC9998007 |
Methods | T2DM | REACTIVE HYPEREMIA | In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout. At baseline, 8-weeks, and washout, fasting endothelial function was assessed with reactive hyperemia index (RHI) measurement by peripheral arterial tonometry. | PMC9998007 |
Results | SE | At baseline, there were no differences in blood pressure (BP), heart rate (HR) or RHI between participants randomized to Glar (n = 24), Glar/Lispro (n = 24), and Glar/Exenatide (n = 25). At 8-weeks, Glar/Exenatide decreased systolic BP (mean − 8.1 mmHg [95%CI − 13.9 to − 2.4], p = 0.008) and diastolic BP (mean − 5.1 mmHg [− 9.0 to − 1.3], p = 0.012) compared to baseline, with no significant changes in HR or RHI. Notably, baseline-adjusted RHI (mean ± SE) did not differ between the groups at 8-weeks (Glar 2.07 ± 0.10; Glar/Lispro 2.00 ± 0.10; Glar/Exenatide 1.81 ± 0.10; p = 0.19), nor did baseline-adjusted BP or HR. There were no differences between the groups in baseline-adjusted RHI, BP or HR after 12-weeks washout. | PMC9998007 | |
Keywords | PMC9998007 | |||
Introduction | diabetes | TYPE 2 DIABETES, TYPE 2 DIABETES, REMISSION, DIABETES | The 2008 Food and Drug Administration (FDA) guidance requiring ascertainment of the cardiovascular safety of new glucose-lowering medications has launched an era in which the vascular implications of diabetes therapies are fundamental considerations in the management of type 2 diabetes (T2DM)[In the recently-reported PREserVing Beta-cell Function in Type 2 Diabetes with Exenatide And InsuLin (PREVAIL) Trial, we demonstrated that 3 glargine-based regimens (glargine alone, glargine with thrice daily meal insulin lispro, and glargine with twice daily administration of the GLP1-RA exenatide) had similar effects on both pancreatic beta-cell function after 8 weeks of treatment (primary outcome) and rates of diabetes remission after 12-weeks washout [ | PMC9998007 |
Methods | T2DM | PREVAIL was a 20-week, open-label, parallel-arm trial wherein patients aged 30–80 years with T2DM of ≤ 7 years duration were randomized (1:1:1) to 8-weeks treatment with insulin glargine, glargine + thrice-daily lispro, or glargine + twice-daily exenatide, followed by 12-weeks washout. The study protocol and primary outcome have been described in detail previously [ | PMC9998007 | |
Intervention | T2DM | The study intervention has been described in detail [Glargine, administered at bedtime, with doses titrated to target fasting glucose ≤ 5.3 mmol/l;Glargine at bedtime with thrice-daily pre-meal lispro, with doses titrated to target fasting glucose ≤ 5.3 mmol/l and 2-h postprandial glucose < 8 mmol/l;Glargine at bedtime with twice-daily exenatide before breakfast and dinner at doses of 5 ug twice daily for the first 4 weeks, followed by 10ug twice daily for the next 4 weeks (glargine titrated to target fasting glucose ≤ 5.3 mmol/l).The assigned intervention was stopped at 8-weeks, after which participants entered a 12-week washout during which they were advised to follow healthy lifestyle practices for managing T2DM [ | PMC9998007 | |
Vascular measures | PAT | At each of the study visits at baseline, 4-weeks, 8-weeks and washout, heart rate and blood pressure were measured in a seated position, after 10 min of rest, with an automated blood pressure monitor. Two measurements were performed 10 min apart, with the average recorded. At the study visits at baseline, 8-weeks and washout, endothelial function was assessed by peripheral arterial tonometry (PAT) with the Endo-PAT2000 device (Itamar Medical Inc, Framingham, MA). This assessment was performed after overnight fasting (with glargine held that night). On the morning of the testing, meal insulin and exenatide were not administered because of the intention to assess the primary outcome of the trial (beta-cell function) on oral glucose tolerance test (OGTT) in the absence of these medications [The COVID-19 pandemic prevented completion of the Endo-PAT portion of the protocol in the full study population of 102 participants, first by preventing some in-person visits and later because of unavailability of the PAT finger probes. Accordingly, Endo-PAT assessment was completed in 73 participants, yielding the study population for the current analysis. | PMC9998007 | |
Statistical analyses | SE | Statistical analyses were conducted with R 4.2.1 and on an intention-to-treat basis. Two-tailed Baseline characteristics of the 3 treatment groups: (i) glargine, (ii) glargine + lispro, and (iii) glargine + exenatideContinuous variables are presented as mean followed by standard deviation in parentheses (if normal distribution) or median followed by interquartile range (if skewed distribution). Categorical variables are presented as proportionsChanges in vascular measures from baseline to 8-weeks in response to the interventionsP-values reflect comparison between measurement at 8-weeks and measurement at baselineBaseline-adjusted vascular outcomes after intervention and after 3-month washoutData are presented as adjusted mean (SE) | PMC9998007 | |
Results | Table Figure Mean fasting capillary glucose on self-monitoring during each week of therapy in the 3 treatment arms (data are presented as mean with standard error)Vascular measures in each of the treatment arms during the trial: | PMC9998007 | ||
Discussion | stroke, vascular disease, T2DM | STROKE, EVENTS, VASCULAR DISEASE, DYSFUNCTION | In this study, 8-weeks of glargine/exenatide combination therapy decreased BP in patients with T2DM of modest duration, without inducing significant changes in heart rate or RHI. Notably, there were no differences in baseline-adjusted RHI between glargine alone, glargine + lispro and glargine + exenatide after the 8-week intervention or after subsequent 12-weeks washout. These data thus suggest that adding either exenatide or lispro to basal insulin therapy does not affect endothelial function in early T2DM.For determining the cardiovascular risk implications of a glucose-lowering regimen, the optimal evaluation would be provided by a dedicated cardiovascular outcome trial. Though such trials have shown neutral effects of both glargine [To date, there has been limited investigation of this question. In a recent study of 34 glargine-treated patients with T2DM with mean A1c ~ 8.0% at baseline, the addition of either once daily lixisenatide or insulin glulisine (administered only before breakfast) for 8-weeks was found to yield similar effects on systemic hemodynamic measures in the fasted state (including BP, HR, stroke volume, cardiac index, systemic vascular resistance index, and normalized augmentation index) [Our data suggest that, in the setting of basal insulin therapy, the postprandial metabolic coverage provided by exenatide and lispro does not improve endothelial function. However, this interpretation should be coupled with certain caveats. First, with well-controlled T2DM of modest duration and relatively high rates of adoption of cardioprotective medications (renin-angiotensin system blockers, statins), it is possible that this study population may not have had sufficiently advanced vascular disease for demonstration of a therapeutic effect on endothelial function or had insufficient dysfunction for such a demonstration at this sample size. Indeed, at baseline, the mean RHI values in each group (ranging from 1.83 to 1.88) exceeded the threshold that typically reflects abnormal function (< 1.67). Second, since RHI was assessed in only 73 of the 102 participants, it is possible that there was insufficient statistical power to detect differences in this measure. Third, the absence of differences in RHI under fasting conditions (as measured herein) may not exclude differences in endothelial function in the postprandial state. Of note, previous studies have shown that a single dose of exenatide can improve RHI when the latter is measured after a meal challenge [Another consideration is that, in current practice, long-acting GLP1-RAs have surpassed short-acting formulations in popularity (both with and without basal insulin). Interestingly, a recent study in 112 individuals with T2DM showed that the long-acting GLP1-RA dulaglutide (which has been previously shown to reduce the risk of major adverse cardiovascular events in T2DM [In conclusion, 8-weeks of glargine/exenatide combination therapy decreased BP, without significant changes in heart rate or RHI. Importantly, RHI at fasting did not differ between glargine alone, glargine + lispro, and glargine + exenatide either after 8-weeks of treatment or after subsequent washout. These data thus suggest that the prandial metabolic coverage provided by adding either exenatide or lispro to basal insulin therapy does not appear to affect fasting endothelial function in early T2DM. | PMC9998007 |
Acknowledgements | RR holds the Boehringer Ingelheim Chair in Beta-cell Preservation, Function and Regeneration at Mount Sinai Hospital. RR is guarantor and had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. | PMC9998007 | ||
Author contributions | JP | RR and BZ designed the study. RR, AE, CKK and BZ implemented the study and acquired the data. RR led study implementation. AE oversaw research coordination. JP and CY performed the statistical analyses. RR wrote the manuscript. All authors contributed to interpretation of the data and critical revision of the manuscript. All authors read and approved the manuscript. | PMC9998007 | |
Funding | Diabetes | HEART, BEST, DIABETES | This study was supported by the Canadian Institutes of Health Research (CIHR) (MOP 136938) and the University of Toronto Faculty of Medicine, Banting and Best Diabetes Centre and Heart & Stroke/Richard Lewar Centre of Excellence in Cardiovascular Research. | PMC9998007 |
Availability of data and materials | De-identified data can be made available under restricted access from the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the Mount Sinai Hospital Research Ethics Board. | PMC9998007 | ||
Declarations | PMC9998007 | |||
Ethics approval and consent to participate | The study was approved by the Mount Sinai Hospital Research Ethics Board and registered at ClinicalTrials.Gov (NCT02194595). All participants provided written informed consent. | PMC9998007 | ||
Competing interests | RR reports grants from Boehringer Ingelheim, grants and personal fees from Novo Nordisk, personal fees from Sanofi, personal fees from Eli Lilly, outside the submitted work. CKK reports research support from Boehringer Ingelheim, outside the submitted work. All other authors declare no competing interests. | PMC9998007 | ||
References | PMC9998007 | |||
Background | hypertension | HYPERTENSION | Telemedicine is becoming integral in primary care hypertension management, and is associated with improved blood pressure control, self-management and cost-effectiveness. This study explored the experiences of patients and healthcare professionals and their perceived barriers and facilitators in implementing and using a technology-enabled blood pressure monitoring intervention with teleconsultation in the Singapore primary care setting. | PMC10018584 |
Methods | Hypertension | HYPERTENSION | This was a qualitative study embedded within the Primary Technology-Enhanced Care Hypertension pilot trial. Patients were selected purposively and invited to participate by telephone; healthcare professionals involved in the trial were invited to participate by email. Individual semi-structured interviews were conducted in English or Mandarin with thirteen patients and eight healthcare professionals. Each interview was audio-recorded and transcribed verbatim. Data were analyzed inductively to identify emergent themes which were then grouped into the dimensions of the socio-technical systems model to study the interactions between the technical, individual and organizational factors involved in the process. | PMC10018584 |
Results | anxiety | Several emergent themes were identified. The factors involved in the implementation and use of the intervention are complex and interdependent. Patients and healthcare professionals liked the convenience resulting from the intervention and saw an improvement in the patient-provider relationship. Patients appreciated that the intervention helped form a habit of regular blood pressure monitoring, improved their self-management, and provided reassurance that they were being monitored by the care team. Healthcare professionals found that the intervention helped to manage workload by freeing up time for other urgent matters. Nevertheless, participants highlighted challenges with usability of the equipment and management portal, data access, and some expressed technology anxiety. Participants suggested patient segmentation for the intervention to be more targeted, wished for a more user-friendly equipment and proposed allocating more resources to the intervention. | PMC10018584 | |
Conclusions | hypertension | HYPERTENSION | The implementation and use of telemedicine for hypertension management can engender various benefits and challenges to patients, healthcare professionals and the healthcare system. Stakeholder feedback gathered on the sociotechnical aspects of the technology should be taken into consideration to guide the design, implementation and evaluation of future telemedicine interventions in primary care. | PMC10018584 |
Trial registration | This study was registered on ClinicalTrials.gov on October 9, 2018. ID: NCT03698890. | PMC10018584 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12875-023-02014-8. | PMC10018584 | ||
Keywords | PMC10018584 | |||
Background | hypertension, Hypertension, chronic disease | CARDIOVASCULAR DISEASES, CHRONIC DISEASES, HYPERTENSION, HYPERTENSION, CHRONIC DISEASE | Hypertension is one of the most prevalent chronic diseases in Singapore, affecting 35.5% of adults aged between 18 and 74 years old [Besides lifestyle modifications and pharmacological treatment if indicated, telemedicine has increasingly been considered as an integral part of hypertension management in primary care to improve access to services, quality of care, productivity and prevention of cardiovascular diseases [The most well-received telemedicine application for hypertension management is BP telemonitoring, which allows BP readings to be transmitted remotely from the patient’s home to the physician [Singapore is a multi-ethnic and urbanized country in Asia, with a small population size of 5.7 million people and high mobile phone and internet penetration rates [The Primary Technology-Enhanced Care – Hypertension (PTEC-HT) pilot trial showed that there is an opportunity for telemedicine to improve clinical outcomes and cost-effectiveness of chronic disease management programs in Singapore’s primary care. PTEC-HT was a quasi-experimental trial conducted in a polyclinic in central Singapore with patients recruited from September 2018 to March 2019. The study methodology and main results have been reported elsewhere [The current qualitative study, embedded within the PTEC-HT trial, explored the experiences and perspectives of patients and HCPs on the barriers and facilitators to the implementation and use of the intervention in the Singapore primary care setting. | PMC10018584 |
Methods | PMC10018584 | |||
Recruitment of interview participants | To capture a range of experiences of implementing and using the intervention, the research team identified HCPs who were involved in the implementation and patients who had remained in the trial to participate in the current study. Twenty patients were selected purposively and invited by telephone, and a maximum variation sample was sought based on age and sex characteristics. Ten HCPs were identified and invited via email. Due to the scope of the ethical approval, patients who withdrew from the trial could not be recruited into the current qualitative study. | PMC10018584 | ||
Data collection | Individual semi-structured interviews were chosen to elicit participant thoughts and feelings about the implementation of the BP telemonitoring intervention [All participants provided written consent for this study. The interviews were conducted face-to-face with each participant between March and September 2019, each interview lasted 20–60 minutes. Two investigators (SHT and EALC) who are trained in qualitative methods conducted the interviews in English or Mandarin in an enclosed room in the polyclinic. Each interview was audio-recorded and transcribed verbatim. Repeat interviews were not carried out. Transcripts were anonymized to ensure data confidentiality.Ethical approval was received from the National Healthcare Group Domain Specific Review Board. | PMC10018584 | ||
Analysis | SHT | STS | Each transcript was checked for accuracy against the recording. Data analysis was conducted following the framework method [Two investigators (SHT and EALC) read and re-read the transcripts independently to familiarize with the data and independently coded the data. SHT is a research fellow with a master’s degree in public health and EALC is a research fellow with PhD in Communications. Data were analyzed inductively to examine the perspectives of different participants, highlighting similarities and differences, and generating unanticipated insights [The themes were further mapped to the dimensions of the socio-technical systems (STS) model to understand the relationships between the sociotechnical aspects of the intervention [(1) Hardware and software – This dimension focuses on the technical aspects required to run the applications, including the physical equipment and software.(2) Clinical content – This dimension considers the data collected that are useful for patients and HCPs to manage patient care and inform clinical decisions.(3) Human-computer interface – This dimension includes aspects of the system that users can see, touch or hear as they interact with the application.(4) People – This dimension represents the patients and HCPs who are involved in the implementation and use of the intervention, and how the intervention helps them think and makes them feel.(5) Workflow and communication – This dimension focuses on the interaction between the patients and HCPs to accomplish patient care as well as the impact of the intervention on the HCP workflows.(6) Internal organizational policies, procedures, and culture – This dimension can affect every other dimension in the model, as organizational policies and procedures can affect the availability of hardware and software and clinical workflows related to the intervention.(7) External rules and regulations – This dimension focuses on the external regulations and priorities that can facilitate or impede the implementation and use of the intervention.(8) System measurement and monitoring – This dimension focuses on measuring and monitoring the availability, usage, effectiveness and outcomes of the intervention regularly.Socio-technical systems (STS) model by Sittig and SinghThe latter two dimensions were omitted from this study as the analysis did not find any relevance of the data to these dimensions.NVivo 12 (QSR International Pty Ltd) was used for data management and analysis. This study is reported according to the Consolidated criteria for Reporting Qualitative research (COREQ) checklist [ | PMC10018584 |
Results | STS | Thirteen patients and eight HCPs were enrolled into the current study. Participant characteristics are shown in Tables Participant characteristics: Patients (Participant characteristics: Staff (We reported our key findings classified into themes presented by the applicable STS dimensions. The emergent codes, categories, and themes were represented in a coding tree chart (Fig. Coding tree of patient and provider perspectives on the intervention, mapped to the STS dimensionsStudy findings mapped to the socio-technical systems model. Green boxes represent emergent themes and subthemes, green arrows represent additional relationships identified from the study | PMC10018584 | |
Hardware and software | PMC10018584 | |||
Usability and functionality | INTERACTION | Six patients commented that the devices were fast and easy to use, with clear indications and instructions by the care team. Four patients were below 50 years old, two were above 60 years old, and all were in full-time or part-time employment.Nevertheless, patients encountered technical challenges with the devices. Four patients were frustrated that the cuff did not fit them well. F035 (male, 67 years old) lamented that it was “really big, stiff!”, and F009 (female, 47 years old) was frustrated as “it keeps dropping down…By the time I can take the measurement, I think my blood pressure shoot up already.” S003 (care manager) acknowledged the issue, “So the first batch they were all quite stiff, very hard to apply. So no matter how you do it, it’s always quite loose…” Cuffs were subsequently replaced for some patients during the initial stage of the trial to prevent inaccurate readings and loss of motivation from patients.Many patients also experienced challenges with the gateway, which they referred to as “phone”. They described the connection issues and that it would switch to flight mode unknowingly as the option was close to the power button, thereby affecting the transmission of readings. Some found the gateway cumbersome as it added to the number of devices they had to manage. The care coordinators, whom patients usually approached for troubleshooting, recalled that some patients withdrew from the trial due to the gateway issues. S001 escalated some issues to the vendor, while S007 was concerned that these performance issues might affect patients’ confidence in the intervention and relationship with the care team “like they lose trust in our treatment because the devices don’t work well or not as accurate as how they expect it to be.”When asked about how the issues could be ameliorated, most patients, care managers and care coordinators expressed preference for a more user-friendly machine that could integrate BP measurement and data transmission more seamlessly. Patients who provided suggestions were all professionals with tertiary education, including IT professionals, managers, and teachers. F022 who was working in senior management, remarked that the intervention was outdated and advised the team to obtain user experience feedback as the intervention was being implemented and enhanced.User experience is something that’s very important…put on a hat of a profile of the client, whether it’s a particular age group, then you try to empathize how that person feels…Maybe some of them are not so technologically-savvy…go through with them…and make it simpler. Interaction can be just a one-touch button, to make it more user-friendly. Things should be intuitive. (F022, male, 64 years old) | PMC10018584 | |
Clinical content | PMC10018584 | |||
Availability of records | The transmitted BP readings were only accessible through the web-based clinical management portal by the HCPs, and patients did not know how to retrieve the history from the BP monitor. Therefore, F096 and F099 kept their own record through methods such as taking a video or photo of the readings displayed on the monitor, or manually in a book.Three patients expressed desire to have access to their readings, so that they could share with other healthcare providers, or monitor the BP trends and motivate themselves to adopt a healthier lifestyle.I think it’ll be good if you can aggregate the readings over a month and say…I think you’re doing very well or not doing too well, and maybe nudge you, you may like to exercise or you might want to control your diet, less salt…I think it is a behavioral thing that can nudge you to a more healthy lifestyle…I think every participant would benefit. (F022, male, 64 years old)They also suggested having an integrated mobile application where patients could readily communicate with the care team or access their BP data and other useful information, such as contact numbers of the care team and frequently asked questions. HCPs interviewed concurred as patients could feel empowered and a sense of ownership when they have access to their own data.A concern arising from having data access, and with consultation and medication titration being done over the phone, was data confidentiality as unauthorized personnel may impersonate as HCPs. Patients proposed verification methods, such as two-factor authentication or using the device serial number, to ensure that the call is genuinely from the polyclinic. | PMC10018584 | ||
Human–computer interface | PMC10018584 | |||
Usability of clinical management portal | WASTED | The care coordinators and care managers who regularly used the portal for enrolling patients and monitoring patients’ BP noted that its functions and interface were manual and not user-friendly. This slowed their work down and they took some time to adapt to it, affecting the feasibility of the intervention.
Not the easiest to navigate… it’s not very neat and tidy. The buttons are like everywhere… So not the most intuitive to use, took me awhile to get used to it. (S003, female, care manager)
It’s not that bad but it’s not very straight-forward…But of course can improve much more… the speed is not very fast... Due to PDPA [Personal Data Protection Act], it keeps logging us out halfway… It feels like you wasted all your documents. A little bit complicated... A lot of info. (S007, female, care coordinator) | PMC10018584 | |
People | PMC10018584 | |||
Impact on users | The participants described the emotional to physical to behavioral impact that they experienced since they started using the intervention. | PMC10018584 | ||
Caused technology anxiety | anxiety | Three patients, who were above 60 years old and were retired or working part-time, described how they became more anxious since participating in the trial. Their concerns were—afraid to see high BP readings, errors with transmission of readings, unable to reach polyclinic hotline, and found it a chore to remember to measure BP. Two of these three patients had uncontrolled BP (≥ 140/90 mmHg) after 6 months of trial participation. Staff also recalled encountering anxious patients, some of whom even withdrew from the trial.
[It is] okay but also sometimes gives you anxiety. Like if high, you [get] scared… Sometimes it could be a chore, you have to remember to measure. (F099, female, 64 years old)
Sometimes the hotline can be very busy, and if you are very urgent, you can’t get through, you can get panicked. (F122, female, 73 years old)Three patients also feared losing or damaging the BP monitor, as they perceived it to belong to the government and compensation would be a consequence. Due to this, F007 (male, 47 years old) kept the devices in the box after each measurement, which became a barrier and “makes it more cumbersome” to take regular BP readings since it was kept out of sight. | PMC10018584 | |
Personal schedules | Most patients and HCPs appreciated the convenience brought about by the intervention. It saved patients’ clinic visits, travelling and waiting time, especially for the working individuals. They could also monitor at a time that suited their schedules. Patients recounted that they no longer had to record BP readings manually on a monitoring sheet, and HCPs could monitor the readings from the portal easily without having to wait for the patients to bring the physical copy at their next clinic visit.One thing is because I can easily monitor it at home, only one week once, out of my own convenience, how I want to check it. Sometimes I do it after I came back from work, after I have a wash, relax myself… You just have to press a button, it got transmitted... for you. Rather than you have to jot down…the timing… (F096, female, 46 years old)During the intervention period, patients received scheduled and unscheduled teleconsultations from the clinic to follow up on their BP readings. While F029 (male, 49 years old) liked that the timing was flexible as “at that time [when they called] I was busy so I rescheduled…”, three other patients described how scheduled calls were not punctual despite having made appointments, or that the calls did not match their work schedules, resulting in rejected or missed calls.Office hours and sometimes, you are in the midst of doing something, and then the call come in. So, it’s like a lot of interruption…Your care team, they have a job to do. They follow up and all. I mean that’s good. But for people working, I think it’s a little bit inconvenient. Especially the few times when they called me, I was in the meeting with my boss. So, I have to say, “No, I’m busy now. I cannot talk to you." (F119, male, 58 years old)The care managers, who usually made the calls, mentioned that calls to most patients were completed smoothly. However, there were instances of unfriendly remarks from patients or unresponsiveness and they had to make multiple calls to patients which added to their workload.Sometimes they work same times as us…they will need to keep the hand phones [aside] so they can’t answer… It’s not that they don’t want to [answer]. (S003, female, care manager) | PMC10018584 | ||
Behavior change | hypertension | HYPERTENSION | Six patients, mostly working individuals, reported that the intervention had helped instill a habit, routine and discipline of measuring BP regularly, which would otherwise not be possible even if they had owned a BP monitor.Even though you can buy [a BP monitor], you don't have the discipline to check, but with this thing, you know that you have to check one week once, so there is no excuse that you don't have to check…that is one thing good about it... The responsibility is there... (F096, female, 46 years old)Patients became more motivated and improved their self-management and health literacy of hypertension from the advice provided by the care team. They grew more aware of their own triggers of BP fluctuations and ways to maintain a healthy BP in terms of diet, exercise and emotions. F022 felt that participation in the trial allowed patients to have “more ownership of managing their own healthcare”. S003 noted that patients had shown “good outcomes”, and S007 found that whether patients were new to home BP monitoring or not, the intervention “gives them an exposure to start monitoring themselves…Empowered, maybe.” | PMC10018584 |
Patient profile | stroke, hearing difficulties | STROKE | The participants identified the patient profiles that are more suitable for the intervention than others. These include personal schedules, adaptability, age and digital literacy, health literacy and social support, and physical condition. They felt that the intervention would be more appropriate for certain individuals – busy, retired, adaptable or accepting of technology, possess some level of health and digital literacy regardless of age, or have social support if they are unable to self-manage. Participants also highlighted that the intervention would benefit those with poor BP control and had a risk or history of stroke to keep them motivated and prevent their condition from worsening.Among the study participants, those who were younger and received tertiary education were more accepting of teleconsultation and phone medication titration. Contrastingly, the older patients preferred traditional face-to-face mode of care for better communication or when discussions involved medications. F035 preferred physical consultations as he could obtain the test reports from the clinic and that “through the phone, maybe communication breakdown” as the elderly may have hearing difficulties. HCPs agreed that physical consultations might be more useful for elderly patients, or for those who required monitoring of medication compliance. S003 felt that “patients may feel more confident to have a face-to-face [consultation] especially those like elderly patients” and that people in Singapore are generally “not used to talk to a person over the phone asking many health-related questions”. | PMC10018584 |
Workflow and communication | PMC10018584 | |||
Communication process | The participants discussed several aspects of the intervention relating to internal workflows and engagement between patients and HCPs. | PMC10018584 | ||
Workload management | Through the intervention, HCPs could receive patients’ BP readings remotely and conduct phone medication titration quickly if warranted. This raised conflicting views from HCPs about the impact on their workload.In the initial stages of the trial, S005 (female, care manager) had to “find pockets of time” to check each patient’s BP readings monthly for fluctuations through the portal and phone calls, “whether it is urgent or not”. Subsequently, a Jobstack function was created and helped the healthcare team prioritize certain patients for closer monitoring and unscheduled teleconsultations. This freed up some time for them to focus on other tasks. Since then, S005, S006 and S007 saw better workload management as they could spend their clinic time attending to patients with more complex needs, while conducting phone medication titration and teleconsultation for patients with stable BP.At individual level, the time that I usually spend for my patient [usual consult] compared to now for this [intervention], it has reduced a little. But overall, if I see it as a whole, for the 120 patients, it does help to ease out the appointment for other patients. If I get a lot of them to be on teleconsult, so I free up some of the appointments for other more complex cases. (S006, male, family physician)On the contrary, the intervention become overwhelming for some HCPs. S002 found an increase in workload as she had to manage patients with clinic appointments and phone follow-up with the trial participants concurrently.It’s quite packed every day… Sometimes [the time] I spend [on] the call is very long, so the patient actually in the clinic was waiting. These are the difficulties. (S002, female, care manager)One family physician felt that the effort involved in teleconsultation and phone medication titration in this pilot trial was not acknowledged but was hopeful that the workload might improve in future.All [done] remotely, [patients] don’t have to come back. So in a way, [they] save time, right? Because they don’t come in and take our slot. But the bad thing is that it is not accounted for, it’s just extra work... Maybe in the initial phase, there will be increased workload, but in the long run once everyone is optimized… there may be a decrease in the workload. (S004, female, family physician) | PMC10018584 | ||
Patient-provider engagement | The patients and HCPs reflected on the engagement between each other relating to the relationship built and support provided during the intervention.Patients reported a sense of security, as they knew that they were being monitored closely by the healthcare team, who would alert them of any irregular or missing BP readings. F035 (male, 67 years old) even exclaimed “I feel happy!” when he received an unscheduled teleconsultation for a rise in BP. This also motivated him to measure BP regularly and look out for triggers. HCPs concurred that issues with patients’ BP could be addressed in a timelier manner through this intervention as the healthcare team could intervene quickly, if needed, through a teleconsultation or phone medication titration. HCPs felt that their relationship with patients improved, as the ready technical support rendered by the care coordinators, frequent phone calls and encouragement by the doctors and care managers, and BP improvements contributed to the building of rapport and between patient and HCPs.Conversely, four patients were expecting to receive feedback on their BP readings from the healthcare team during the trial, but they did not seem to have received any phone calls. Two were aged 47–49 years old and two were aged 64–73 years old. This affected their confidence in the patient-provider engagement, as F007 wondered “if someone is looking at my records or just for the sake of collecting data”. They preferred more regular interaction with the healthcare team to understand HCP workflows in relation to monitoring BP readings, provide feedback on the process and receive advice on their BP readings and lifestyle management.F029 (male, 49 years old) recounted that she had to return to the clinic to refill her medications as the doctor increased the dosage over phone medication titration. However, the pharmacy was not informed and she “had to wait for quite some time because I guess they need to clarify with the doctor… So if that link is there, it’s more convenient.” This also highlighted that the healthcare teams need to work with other clinic staff who might not be part of but still support the core team, such as the pharmacist. | PMC10018584 | ||
Organizational policies and culture | PMC10018584 | |||
Internal policy | RECRUITMENT | HCPs interviewed, especially the care managers and care coordinators, were concerned about the limited manpower and time available, which would also affect the workload of the intervention. They wondered whether adjustments to internal allocation of resources would be possible in order for the intervention to sustain.
If we have a mobile phone to call the patients, if patients keep on texting or messaging, then the nurse will be very stressed also. So I don’t know whether in the future [there] will be a coordinator [who] have some nursing background [and] able to man the phone… (S002, female, care manager)
Maybe give us a bit of extra time every day to just handle things like this. I would say, minimum maybe 15 minutes a day? If not, half an hour would be better, to go through the cases. (S004, female, family physician)
During the initial recruitment stage, like on standby, we can have more care coordinators and care managers in the same area to prepare to recruit patients. Because sometimes when it’s just one care coordinator, it gets piled up more and more. Then every recruitment could get very long, half an hour to an hour... But at the same time, it’s quite hard because the doctors and care managers also have to see other patients… So that part in workflow, it’s more on team communication also. (S007, female, care coordinator) | PMC10018584 | |
Discussion | STS | The purpose of this study was to assess the barriers and facilitators to the implementation and use of the PTEC-HT BP telemonitoring system with teleconsultation, to inform future expansion of the intervention. Our analysis showed that the technical, human, workflow and organizational factors involved were complex and interdependent, and the STS model provided a comprehensive framework to understand the relationship between these dimensions.Our study findings further substantiated the patient satisfaction survey results of the PTEC-HT pilot trial, in which patients agreed that it was convenient to record and share BP measurements with the healthcare team, were motivated to monitor BP weekly and were satisfied with the advice provided through teleconsultations [ | PMC10018584 | |
Comparison with prior work | The themes that emerged from the current study were largely consistent with the literature which reported that technological usability, reduction of in-office visits, positive impact on self-management and improved patient-provider relationship were the most frequently reported facilitators for adoption of telemedicine [ | PMC10018584 | ||
Hardware and software, human–computer interface, people | diabetes | HYPERTENSION, DIABETES | Our study participants found the intervention easy-to-use, and patients could save time travelling to and waiting in the hectic polyclinic setting, or recording BP readings manually. HCPs also had quicker access to BP readings and could conduct teleconsultation, if necessary, thereby improving their efficiency. Fletcher et al. reported that patients liked the ability to be able to monitor BP whenever they wanted as they were more relaxed outside the clinic environment [Patients in our study saw changes in their attitudes and behaviors in managing hypertension, like previous studies conducted in the US and UK [Participants experienced technical challenges with using the equipment and clinical management portal. Firstly, issues with the cuff and gateway and having to handle multiple cumbersome devices caused frustration and affected patients’ motivation to continue the intervention. They preferred the functions of measuring, recording and transmission of BP readings to be integrated in one machine. Similar to interventions targeting home blood glucose and BP telemonitoring for patients with diabetes, the equipment was not “plug and play” for some patients and higher digital literacy and frequent assistance from the care team was needed to overcome these obstacles [Patients and clinicians were found to be uncomfortable with the interpretation of self-monitoring measurements due to the difference between home and office readings [ | PMC10018584 |
Clinical content, people | Patients in the current study wished to have access to their data for sharing with other HCPs or self-management, and some form of feedback or advice even if their readings were satisfactory. These could encourage them to become more engaged as active managers of their healthcare thereby facilitating self-management.However, while most patients were comfortable with data being shared between patients and HCPs, some were concerned about data privacy and security especially when the intervention involved medication titration. This is a common concern reported in the literature, and it was expected due to the health data security breaches previously reported in Singapore [ | PMC10018584 | ||
People | anxiety | There was variability in the use of the intervention by certain populations in this study. Older patients experienced technology anxiety as they were afraid to see abnormal readings or were worried that the readings did not get transmitted. They also preferred face-to-face consultations possibly for the human connection [Participants also proposed higher utility of the intervention by specific populations, and this suggests the need for patient segmentation to craft and target strategies to assist patients with various needs to achieve maximum benefit. The personae proposed by Low et al. or the Bloem-Stalpers model could be considered to segment patients according to their socioeconomic and sociodemographic characteristics, acceptance of technology, or acceptance and perceived control of their condition [ | PMC10018584 | |
Workflow and communication, people, organizational policies and culture | confusion, anxiety | WEST | Whereas patients and HCPs were reported to be concerned about telemedicine hindering the patient-provider relationship [While other studies mainly focused on the doctor as the provider of the intervention, team-based care was provided at the polyclinic as teamlets. However, one patient experienced confusion as there was a lack of communication with the pharmacists, who usually supported the teamlets. Coordinating workflows with other support staff ensures patient safety in the form of timely supply of patients’ medications and can also help to maintain patients’ motivation for the intervention.Although there was divergence of HCPs’ opinions on whether the intervention helped with workload management, they agreed on the need to allocate more resources to prevent burnout, and for the intervention to be sustainable in the long run. Although geographical barrier is less of a concern in Singapore than in other countries where healthcare may not readily accessible, the COVID-19 pandemic has created an invisible barrier between HCPs and patients in the form of safe distancing and reallocation of clinic manpower to support COVID-19 operations and other priorities. Telemedicine, with adequate planning of resources and workflows, can bridge this barrier by sustaining BP management and providing care to patients even in times when physical visits are not possible [The study populations of previous studies were mainly from the West and may not be translated to the Singapore or Asian context. The interventions in these studies included monitoring, medication titration and contact initiated by patients. However, the PTEC-HT intervention required HCPs to initiate contact with patients through scheduled or unscheduled teleconsultation, which was not available in the referenced studies. This provided sufficient support right from the start, especially for patients with technology anxiety or low health or digital literacy. Teleconsultation can provide reassurance, improve patient education and health communication and contribute to behavior change, addressing the areas for future research raised by Fletcher et al. [As we focus on patient-centredness in the implementation and use of telemedicine interventions, we can incorporate principles of service design and human factor approaches to achieve greater impact and better experience for our patients and HCPs [ | PMC10018584 |
Strengths and limitations | STS | This study was conducted within a quasi-experimental trial using qualitative methodologies. It provided insights into the views of patients and HCPs on the implementation and use of BP telemonitoring system with teleconsultation in a real-world setting. Integration with routine clinical practice and the ability to adapt features of the intervention encouraged uptake by both patients and HCPs. Using semi-structured interviews allowed us to build rapport with the participants and obtain rich data about their experiences. We interviewed patients and HCPs to obtain a diversity of views as they played different roles in the process.Applying the STS model in the analysis allowed us to study the intervention on a more holistic level and identified some complexities and important considerations as we plan and improve the implementation and use of telemedicine interventions in primary care. The dimensions of “external rules, regulations and pressures” and “system measurement and monitoring” were not addressed in this study as participants did not express any related views. Future research could consider interviews with developers of the intervention and healthcare administrators to understand the impact of any external forces and the expected outcomes of the intervention.There have been several other models developed to study health technologies [Notwithstanding the efforts to obtain a representative sample of patients to reflect demographics of the clinic, ethnic diversity was limited. Self-selection might also have occurred from voluntary participation. Compared to other participants in the PTEC-HT pilot trial, patients in this study were younger (mean age 50.5 vs 56.3 years) and a larger proportion attained tertiary education qualification (53.8% vs 25.2%), and they might have been more willing and able to share their views.The patient interviews were conducted when the patients had completed the 6-month trial in hope to maximize their experience and elucidate their perspectives of what did or did not work. However, there was a possibility that some patients could not recall details from the early months of their participation accurately. Future research may also involve views from patients who rejected participation or withdrew from the trial to understand their reasons and concerns. As the HCPs were part of the teamlet tasked to implement the intervention, they might have been supporters of the intervention so their views might not be representative of other primary care HCPs.As this was a qualitative study conducted in one public primary care clinic in Singapore before the COVID-19 pandemic, transferability of findings to other primary care clinics or non-primary care settings is limited as operational procedures may differ between institutions. However, the challenges identified from this study, such as digital literacy and data security, are still largely relevant even as we are adapting our healthcare services since the pandemic happened [ | PMC10018584 | |
Conclusions | Our study provides comprehensive perspectives on the barriers and facilitators to the implementation and use of a BP telemedicine intervention in a complex fast-paced primary care setting. It can engender various benefits and challenges to patients, healthcare professionals and the healthcare system. An intervention that is well-designed and successfully implemented can be an enabler to improve healthcare delivery, patient journey and safety, as well as avoid unplanned hospital admissions and visits. It is hoped that the insights gleaned can help to guide various stakeholders understand the importance of the various dimensions as they embark on telemedicine program design and implementation. | PMC10018584 | ||
Acknowledgements | RECRUITMENT | The research team are very grateful to the staff who helped with patient recruitment and study logistics, particularly Ms Nur Atiqah Binte Surya Akmaja. We would also like to thank all patients and healthcare professionals who participated in this study, and Dr Tam Chen Hee for his guidance. | PMC10018584 | |
Authors’ contributions | All authors contributed to the study design and data interpretation. SHT and EALC conducted the interviews and analyzed the qualitative data. SHT wrote the first draft of the manuscript and revisions based on comments from other authors. EALC made substantial contributions to revisions of the manuscript. VHYT, DWLN, WET and GCHK made editorial contributions to the manuscript. All authors read and approved the final version to be published. | PMC10018584 | ||
Funding | TRANSFORMATION | The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Ministry of Health Office for Healthcare Transformation, and the Ministry of Health's National Medical Research Council under the Centre Grant Programme (Ref No: NMRC/CG/C019/2017); and National Medical Research Council under the Centre Grant Programme—Singapore Population Health Improvement Centre (NMRC/CG/C026/2017_NUHS). | PMC10018584 | |
Availability of data and materials | The data generated and/or analyzed are available upon reasonable request. The data request can be sent to Clinical Research Unit, National Healthcare Group Polyclinics, Singapore; Email address: NHGP_CRU@nhgp.com.sg. | PMC10018584 | ||
Declarations | PMC10018584 | |||
Ethics approval and consent to participate | This study was approved by the National Healthcare Group Domain Specific Review Board (Reference number: 2018/00785). All participants provided informed consent to participate in the interviews. | PMC10018584 | ||
Consent for publication | This is not applicable as this manuscript does not contain data from any individual person. All participants in this study were de-identified and given participant ID. | PMC10018584 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10018584 | ||
References | PMC10018584 | |||
Background | Comprehensive Geriatric Assessment (CGA)is a widely accepted intervention for frailty and can be cost-effective within a primary care setting. | PMC10463370 | ||
Objective | To explore the feasibility of identifying older adults with frailty and assess the subsequent implementation of a tailored CGA with care and support plan by Advanced Nursing Practitioners (ANPs). | PMC10463370 | ||
Methods | A mixed-method parallel randomised controlled trial was conducted. Participants were recruited from two General Practice (GP) centres between January and June 2019. Older adults with confirmed frailty, as assessed by practice nurses, were randomised, using a web service, to the intervention or treatment-as-usual (TAU) groups for six months with an interim and a final review. Data were collected on feasibility, health service usage, function, quality of life, loneliness, and participants' experience and perception of the intervention. Non-parametric tests were used to analyse within and between-group differences. | PMC10463370 | ||
Results | One hundred sixty four older adults were invited to participate, of which 44.5% ( | PMC10463370 | ||
Discussion | Frailty | Frailty identification and intervention delivery in the community by ANPs were feasible. The study shows that older adults with frailty living in the community might benefit from intervention delivered by ANPs. It is suggested to examine the cost-effectiveness of the intervention in sufficiently powered future research. | PMC10463370 | |
Trial registrations | The protocol is available at clinicaltirals.gov, ID: NCT03394534; 09/01/2018. | PMC10463370 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12877-023-04218-0. | PMC10463370 | ||
Keywords | PMC10463370 | |||
Background | Frailty | RECRUITMENT, EMERGENCY | The number of people over the age of 85 has nearly doubled in the past three decades and it is estimated that by 2030 one in five people in England will be over the age of 65 [Comprehensive Geriatric Assessment (CGA) offers holistic multidisciplinary care for older adults with frailty. CGA takes into account various aspects of a person's health, such as their physical medical condition, mental health, functioning, social circumstances, and environment. This approach is used to create a personalised care plan that involves multiple agencies and disciplines, with specific goals aimed at facilitating discharge planning and minimising unnecessary hospital admissions [Furthermore, accurate and economical screening and identifying suitable candidates for CGA is the first step to avoiding over-or under-prescription. The electronic Frailty Index (eFI) [Once the older adults with frailty are identified, a CGA and subsequent care and support plan could be effectively delivered in the community or patient’s home. However, coordination of multidisciplinary team assessment and care and support plan formulation is impractical because of busy General Practice (GP) Centres; therefore, it is not feasible for anyone with frailty to undergo a full multidisciplinary CGA [This study aimed to explore the feasibility of identifying frail older adults who benefit most from CGA and subsequent implementation of a tailored CGA with care and support plan (CGA & CSP) for older adults with frailty by ANPs. Additionally, it aimed to measure key health-related outcomes, estimate healthcare resource usage, and evaluate patients’ perception of the intervention. In line with this, the objectives were:To assess the feasibility of the study, which includes reporting the study invitation response rate, the eligibility rate (i.e. the number of frail older adults confirmed by nurse’s assessment and clinical judgement), the recruitment rate (i.e. the number of participants who were eligible and randomised), the retention rate (i.e. the number of participants available for interim and final CGA & CSP review) and the dropout rate (i.e. participants not available for post-intervention outcome assessment).To explore whether the intervention (i.e. CGA & CSP) improves key health-related outcome domains such as function, quality of life, and loneliness (see Deviation from protocol).To estimate the utilisation of health care resource usage and expenses related to CGA & CSP delivery. This includes time ANPs spend on CGA & CSP, as well as hospital and nursing home admission, 999 calls, Accident and Emergency department (A&E) attendance, GP Centre, or GP Centre out-of-hour attendance and calls.To evaluate older adults’ perceptions of the CGA & CSP intervention and delivery. | PMC10463370 |
Methods | PMC10463370 | |||
Design | BLIND, STILL | A mixed-methods parallel randomised controlled trial design with an equal randomisation ratio, stratified based on level of frailty, was conducted. No sample size calculation was performed for this trial. Still, it was estimated that 160 people with frailty would be included based on the resource available and the number of registered patients at two participating GP centres. Those eligible completed the study outcome assessment form and subsequently were randomised to either CGA & CSP or treatment as usual (TAU) care using a web-based randomiser available at randomizer.org by a research assistant. The intervention group received the CGA & CSP for six months, which included an interim (3 months) and a final (6 months) review. Data were collected 2–3 weeks prior to the start of the intervention and again 2–3 weeks after final review. Professionals delivering the intervention to participants were masked to baseline and follow-up measurements. Outcome assessors were also blind to group allocation. A protocol was published a priori at clinicaltirals.gov ID: NCT03394534 on 09/01/2018. To ensure the quality of reporting, the Consolidated Standards of Reporting Trials (CONSORT), an extension to randomised pilot and feasibility trials (2010), was followed. | PMC10463370 | |
Participants’ screening and eligibility | To be included in the study, patients had to be assessed by a practice nurse and show mild, moderate, or severe levels of frailty. Between January and June 2019, administrative staff at two GP centres in Belper, UK, screened patients’ health records to identify potential eligible candidates for assessment. They invited all registered patients over 65 with an eFI score of at least 0.12. [Study flow diagram | PMC10463370 | ||
Intervention | Two ANPs, specialising in the health and care of older adults, adopted a holistic, biopsychosocial approach to assessing participants at their homes or the GP centres depending on individual participants’ convenience. A CGA proforma with sections on detailed assessment strategy, matters important to participants, referrals, and care and support plan protocol, was developed based on available literature and expert opinion (see Additional file CGA & CSP flow diagram | PMC10463370 | ||
Data collection | RS | SECONDARY | Data were collected at baseline and six months post-intervention from both CGA & CSP and TAU groups. Baseline data collection was conducted by practice nurses at participants' homes. A research nurse collected Post-intervention data over the phone (please see section ‘Deviation from protocol’). A data collection form containing all data items was developed before the start of the study following discussion amongst the team members. Data items and variables included sociodemographic variables, eFI, physical frailty test results, frailty diagnosis, and study outcomes (see secondary outcomes). Individuals responsible for screening and inviting patients were trained to identify and invite eligible participants and systematically record the observations, including reasons for non-participation. The training was also given to nurses at participating GP centres by the lead researcher (RS) about frailty assessment and data collection. | PMC10463370 |
Feasibility, retention, and dropouts | RECRUITMENT |
Response rate: percentage of the participants willing to participate who were eligible based on the eFI score.Eligibility rate: percentage of consented participants eligible who entered the study based on nurses’ clinical frailty diagnosis.Recruitment rate: percentage of invited participants who were eligible and randomised.Retention rate: percentage of randomised participants available for interim and follow-up reviews.Dropout rate: percentage of randomised participants not completing the post-intervention outcome measure tools. | PMC10463370 | |
Secondary outcomes | SECONDARY | The secondary outcomes included:Hospital and nursing home admissions during the past six months recalled by the study participants. This outcome was considered the proposed primary outcome of a future trial.Participants reported numbers of 999 calls, A&E attendances, GP Centre or GP Centre out-of-office calls and attendance during the past six months.ANPs’ time on CGA & CSP delivery and interim and final reviews, taken from completed CGA proforma.Function assessed by Functional Independence Measure (FIM) [Quality of life assessed by Health-Related Quality of Life- Short form (SF36) [Loneliness assessed by De Jong-Gierveld loneliness scale [ | PMC10463370 |
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