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Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams.

ABSTRACT: Background:Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of "Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management" (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial. Methods:Four-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants-patients of an interprofessional primary care team-were over age 18?years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes. Results:Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers (n?=?20) met 28 clients in 234 client encounters (home visits, phone calls, electronic messages); 27 reports were sent to the interprofessional team. At 4 months, controlling for baseline, most outcomes were better in the intervention compared to control group; physical activity notably better. The most common goal domains set were physical activity, diet/nutrition, and social connection. Clients felt the biggest impact was motivation toward goal achievement. They struggled with some of the technologies. Several participants perceived that the program was not a good fit, mostly those that felt they were already well-managing their diabetes. Conclusions:Health TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others. Trial registration:ClinicalTrials.gov, NCT02715791. Registered 22 March 2016-retrospectively registered.

SUBMITTER: Agarwal G

PROVIDER: S-EPMC6815451 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams.

Agarwal Gina G Gaber Jessica J Richardson Julie J Mangin Dee D Ploeg Jenny J Valaitis Ruta R Reid Graham J GJ Lamarche Larkin L Parascandalo Fiona F Javadi Dena D O'Reilly Daria D Dolovich Lisa L

Pilot and feasibility studies 20191027

<h4>Background</h4>Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of "Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management" (Health TAPESTRY-HC-DM) ...[more]

PMID: 31673398

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Project description:AimThe aim of the study was to describe practices that support collaboration in interprofessional primary health care teams, and identify performance indicators perceived to measure the impact of this collaboration from the perspective of interprofessional health providers.BackgroundDespite the surge of interprofessional primary health care models implemented across Canada, there is little evidence as to whether or not the intended outcomes of primary health care teams have been achieved. Part of the challenge is determining the most appropriate measures that can demonstrate the value of collaborative care. To date, little remains known about performance measurement from the providers contributing to the collaborative care process in interprofessional primary care teams. Having providers from a range of disciplinary backgrounds assist in the development of performance measures can help identify measures most relevant to demonstrate the value of collaborative care on the intended outcomes of interprofessional primary care models.MethodsA qualitative study; part of a larger mixed methods developmental evaluation to examine performance measurement in interprofessional primary health care teams. A stakeholder workshop was conducted at an annual association meeting of interprofessional primary health care teams in the province of Ontario, Canada. Six questions guided the workshop groups and participant responses were documented on worksheets and flip charts. All responses were collected and entered verbatim into a word document. Qualitative analytic strategies were applied to each question.FindingsA total of 283 primary health care providers from 14 health professions working in interprofessional primary health care teams participated. Top three elements of interprofessional collaboration (total n = 628) were communication (n = 146), co-treatment (n = 112) and patient-based conferences (n = 81). Top three performance indicators currently used to demonstrate the value of interprofessional collaboration (total n = 241) were patient experience (n = 71), patient health status (n = 35) and within team referrals (n = 30).

Project description:Effective delivery of healthcare is highly interdependent within and between interprofessional (IP) care teams and the patients they serve. This is particularly true for complex health conditions such as advanced heart failure (AHF). Our Academic Practice Partnership received funding to carry out IP workforce development with inpatient AHF care teams. Our objectives were to (a) identify challenges in team functioning that affected communication and relationships among the AHF care teams, (b) collaboratively identify a focal work process in need of improvement, and (c) test whether facilitated the implementation of team training and work process changes would lead to improvements in team communication, relationships, and process outcomes. The health-care team identified implementation of structured IP bedside rounds (SIBR) as the preferred approach to improving collaborative care. Utilizing a cross-sectional pre/post design, changes in team communication and relationships before and after a team intervention that included TeamSTEPPS training and SIBR implementation, were assessed using a validated Relational Coordination (RC) survey. The study population included AHF care team members (n ~ 100) representing seven workgroups (e.g., nurses, pharmacists) from two inpatient cardiology units at a 450-bed academic medical center in the Pacific Northwest during 2015-2016. Improvements in RC scores were demonstrated across all seven RC dimensions from baseline (Year 1) to follow-up (Year 2). Percent change on each of the seven dimensions ranged from 3.57% to 9.85%. Changes were statistically significant for improvements between baseline and follow-up on all but one of the seven RC dimensions (shared knowledge). The IP team intervention was associated with improvements in RC from baseline to follow-up. Additional research is needed to assess patient perspectives and outcomes of the IP team intervention. Findings of this study are consistent with the growing body of RC and SIBR research and provide a useful model of an IP team-based intervention in clinical practice.

Project description:BackgroundThe use of clinical performance feedback to support quality improvement (QI) activities is based on the sound rationale that measurement is necessary to improve quality of care. However, concerns persist about the reliability of this strategy, known as Audit and Feedback (A&F) to support QI. If successfully implemented, A&F should reflect an iterative, self-regulating QI process. Whether and how real-world A&F initiatives result in this type of feedback loop are scarcely reported. This study aimed to identify barriers or facilitators to implementation in a team-based primary care context.MethodsSemi-structured interviews were conducted with key informants from team-based primary care practices in Ontario, Canada. At the time of data collection, practices could have received up to three iterations of the voluntary A&F initiative. Interviews explored whether, how, and why practices used the feedback to guide their QI activities. The Consolidated Framework for Implementation Research was used to code transcripts and the resulting frameworks were analyzed inductively to generate key themes.ResultsTwenty-five individuals representing 18 primary care teams participated in the study. Analysis of how the A&F intervention was used revealed that implementation reflected an incomplete feedback loop. Participation was facilitated by the reliance on an external resource to facilitate the practice audit. The frequency of feedback, concerns with data validity, the design of the feedback report, the resource requirements to participate, and the team relationship were all identified as barriers to implementation of A&F.ConclusionsThe implementation of a real-world, voluntary A&F initiative did not lead to desired QI activities despite substantial investments in performance measurement. In small primary care teams, it may take long periods of time to develop capacity for QI and future evaluations may reveal shifts in the implementation state of the initiative. Findings from the present study demonstrate that the potential mechanism of action of A&F may be deceptively clear; in practice, moving from measurement to action can be complex.

Project description:BackgroundA documented gap in support exists for service users following discharge from acute mental health services, and structured interventions to reduce relapse are rarely provided. Peer-facilitated self-management interventions have potential to meet this need, but evidence for their effectiveness is limited. This paper describes the development of a peer-provided self-management intervention for mental health service users following discharge from crisis resolution teams (CRTs).MethodsA five-stage iterative mixed-methods approach of sequential data collection and intervention development was adopted, following the development and piloting stages of the MRC framework for developing and evaluating complex interventions. Evidence review (stage 1) included systematic reviews of both peer support and self-management literature. Interviews with CRT service users (n = 41) regarding needs and priorities for support following CRT discharge were conducted (stage 2). Focus group consultations (n = 12) were held with CRT service-users, staff and carers to assess the acceptability and feasibility of a proposed intervention, and to refine intervention organisation and content (stage 3). Qualitative evaluation of a refined, peer-provided, self-management intervention involved qualitative interviews with CRT service user participants (n = 9; n = 18) in feasibility testing (stage 4) and a pilot trial (stage 5), and a focus group at each stage with the peer worker providers (n = 4).ResultsExisting evidence suggests self-management interventions can reduce relapse and improve recovery. Initial interviews and focus groups indicated support for the overall purpose and planned content of a recovery-focused self-management intervention for people leaving CRT care adapted from an existing resource: The personal recovery plan (developed by Repper and Perkins), and for peer support workers (PSWs) as providers. Participant feedback after feasibility testing was positive regarding facilitation of the intervention by PSWs; however, the structured self-management booklet was underutilised. Modifications to the self-management intervention manual and PSWs' training were made before piloting, which confirmed the acceptability and feasibility of the intervention for testing in a future, definitive trial.ConclusionsA manualised intervention and operating procedures, focusing on the needs and priorities of the target client group, have been developed through iterative stages of intervention development and feedback for testing in a trial context. Trial Registration ISRCTN01027104 date of registration: 11/10/2012.

Project description:BACKGROUND:Many countries are engaged in primary care reforms to support older adults who are living longer in the community. Health Teams Advancing Patient Experience: Strengthening Quality [Health TAPESTRY] is a primary care intervention aimed at supporting older adults that involves trained volunteers, interprofessional teams, technology, and system navigation. This paper examines implementation of Health TAPESTRY in relation to interprofessional teamwork including volunteers. METHODS:This study applied Normalization Process Theory (NPT) and used a descriptive qualitative approach [1] embedded in a mixed-methods, pragmatic randomized controlled trial. It was situated in two primary care practice sites in a large urban setting in Ontario, Canada. Focus groups and interviews were conducted with primary care providers, clinical managers, administrative assistants, volunteers, and a volunteer coordinator. Data was collected at 4?months (June-July 2015) and 12?months (February-March 2016) after intervention start-up. Patients were interviewed at the end of the six-month intervention. Field notes were taken at weekly huddle meetings. RESULTS:Overall, 84 participants were included in 17 focus groups and 13 interviews; 24 field notes were collected. Themes were organized under four NPT constructs of implementation: 1) Coherence- (making sense/understanding of the program's purpose/value) generating comprehensive assessments of older adults; strengthening health promotion, disease prevention, and self-management; enhancing patient-focused care; strengthening interprofessional care delivery; improving coordination of health and community services. 2) Cognitive Participation- (enrolment/buy-in) tackling new ways of working; attaining role clarity. 3) Collective Action- (enactment/operationalizing) changing team processes; reconfiguring resources. 4) Reflective Monitoring- (appraisal) improving teamwork and collaboration; reconfiguring roles and processes. CONCLUSIONS:This study contributes key strategies for effective implementation of interventions involving interprofessional primary care teams. Findings indicate that regular communication among all team members, the development of procedures and/or protocols to support team processes, and ongoing review and feedback are critical to implementation of innovations involving primary care teams. TRIAL REGISTRATION:ClinicalTrials.gov, no. NCT02283723 November 5, 2014. Prospectively registered.

Project description:IntroductionChronic obstructive pulmonary disease (COPD) is associated with substantial functional morbidity, including activity-limiting symptoms such as dyspnea and fatigue. Self-management interventions aid in symptomatic management of COPD and have been shown to produce positive outcomes on quality of life (QOL) and reduce hospital admissions.PurposeThe purpose of this randomized controlled longitudinal pilot study was to assess feasibility of the combined Respiratory Fitness (RESP-FIT) + Smartphone Airway Management System (SAMS) program, a 6-week, self-management, technology-enhanced respiratory muscle strength training (RMST) mHealth intervention.Patients and methodsFeasibility was assessed by evaluating recruitment, retention, acceptability, adherence, and safety data. Data were collected from 30 participants (15 in intervention group, 15 in control) at 3 time points (baseline, 6 weeks, and 14 weeks). The intervention group was requested to perform RMST at regular intervals during the week (5 breaths, 5 times a day, 5 days a week). Bluetooth enabled tracking was used to track training sessions. Data were analyzed using descriptive statistics.ResultsRecruitment was staggered for device usage and was completed in 57 weeks, with near 90% retention from baseline to end-of-intervention. Mobile application rating scale scores and interview data indicated moderate satisfaction. Participants completed 14,388 actions in the app. The most commonly used features were recording of daily symptoms via ecological momentary assessment (EMA) and tracking RMST if assigned to training sessions. Training days were successfully captured using EMA, but Bluetooth enabled training tracking was found to be not feasible. Overall, participants reported satisfaction with the RESP-FIT + SAMS mHealth intervention and found it acceptable.ConclusionRESP-FIT is feasible and enables real-time COPD symptom assessment in the home environment, but additional work is needed to integrate Bluetooth technology into the platform. Ongoing investigations focus on the accuracy of symptom perception, self-efficacy, and momentary factors that impact adherence behaviors.

Project description:BackgroundStress management interventions combining technology with human involvement have the potential to improve the cost-effectiveness of solely human-delivered interventions, but few randomized controlled trials exist for assessing the cost-effectiveness of technology-assisted human interventions.ObjectiveThe aim of this study was to investigate whether a technology-assisted telephone intervention for stress management is feasible for increasing mental well-being or decreasing the time use of coaches (as an approximation of intervention cost) while maintaining participants' adherence and satisfaction compared with traditional telephone coaching.MethodsA 2-arm, pilot randomized controlled trial of 9 months for stress management (4-month intensive and 5-month maintenance phases) was conducted. Participants were recruited on the web through a regional occupational health care provider and randomized equally to a research (technology-assisted telephone intervention) and a control (traditional telephone intervention) group. The coaching methodology was based on habit formation, motivational interviewing, and the transtheoretical model. For the research group, technology supported both coaches and participants in identifying behavior change targets, setting the initial coaching plan, monitoring progress, and communication. The pilot outcome was intervention feasibility, measured primarily by self-assessed mental well-being (WorkOptimum index) and self-reported time use of coaches and secondarily by participants' adherence and satisfaction.ResultsA total of 49 eligible participants were randomized to the research (n=24) and control (n=25) groups. Most participants were middle-aged (mean 46.26, SD 9.74 years) and female (47/49, 96%). Mental well-being improved significantly in both groups (WorkOptimum from "at risk" to "good" Â>0.85; P<.001), and no between-group differences were observed in the end (Â=0.56, 95% CI 0.37-0.74; P=.56). The total time use of coaches did not differ significantly between the groups (366.0 vs 343.0 minutes, Â=0.60, 95% CI 0.33-0.85; P=.48). Regarding adherence, the dropout rate was 13% (3/24) and 24% (6/25), and the mean adherence rate to coaching calls was 92% and 86% for the research and control groups, respectively; the frequency of performing coaching tasks was similar for both groups after both phases; and the diligence in performing the tasks during the intensive phase was better for the research group (5.0 vs 4.0, Â=0.58, 95% CI 0.51-0.65; P=.03), but no difference was observed during the maintenance phase. Satisfaction was higher in the research group during the intensive phase (5.0 vs 4.0, Â=0.66, 95% CI 0.58-0.73; P<.001) but not during the maintenance phase.ConclusionsThe technology-assisted telephone intervention is feasible with some modifications, as it had similar preliminary effectiveness as the traditional telephone intervention, and the participants had better satisfaction with and similar or better adherence to the intervention, but it did not reduce the time use of coaches. The technology should be improved to provide more digested information for action planning and templates for messaging.Trial registrationClinicalTrials.gov NCT02445950; https://www.clinicaltrials.gov/ct2/show/study/NCT02445950.

Project description:To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (Living Well with Asthma) to support self-management.Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care.Adults (age≥16 years) with physician diagnosed, symptomatic asthma (Asthma Control Questionnaire (ACQ) score ≥1). People with unstable asthma or other lung disease were excluded.'Living Well with Asthma' is a desktop/laptop compatible interactive website designed with input from asthma/ behaviour change specialists, and adults with asthma. It aims to support optimal medication management, promote use of action plans, encourage attendance at asthma reviews and increase physical activity.Primary outcomes were recruitment/retention, website use, ACQ and mini-Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included patient activation, prescribing, adherence, spirometry, lung inflammation and health service contacts after 12 weeks. Blinding postrandomisation was not possible.Recruitment target met. 51 participants randomised (25 intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. 45/51 (88%; 20 intervention group) followed up. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 0.89; p=0.136). No adverse events.Recruitment and retention confirmed feasibility; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a phase 3 trial.ISRCTN78556552; Results.

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Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams.

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Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams.

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