Clinical and patient-centered implementation outcomes of mHealth interventions for type 2 diabetes in low-and-middle income countries: a systematic review

Background The prevalence of Type 2 Diabetes is rising in Low- and Middle-Income Countries (LMICs), affecting all age categories and resulting in huge socioeconomic implications. Mobile health (mHealth) is a potential high-impact approach to improve clinical and patient-centered outcomes despite the barriers of cost, language, literacy, and internet connectivity. Therefore, it is valuable to examine the clinical and implementation outcomes of mHealth interventions for Type 2 Diabetes in LMICs. Methods The Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) guidelines were applied in framing and reporting the review criteria. A systematic search of Cochrane Library, Web of Science, PubMed, Scopus, and Ovid databases was performed through a combination of search terms. Randomized Controlled Trials (RCTs) and cohort studies published in English between January 2010 and August 2021 were included. Risk of bias for missing results in the included studies was assessed using the Cochrane risk-of-bias tool for randomized trials (RoB 2). Quantitative and qualitative methods were used to synthesize the results. Results The search identified a total of 1161 articles. Thirty studies from 14 LMICs met the eligibility criteria. On clinical outcomes, 12 and 9 studies reported on glycated hemoglobin (HbA1c )and fasting blood glucose (FBG) respectively. Text messages was the most commonly applied mHealth approach, used in 19 out of the 30 studies. Ten out of the 12 studies (83.3%) that reported on HbA1c had a percentage difference of <0.3% between the mHealth intervention and the comparison group. Additionally, studies with longer intervention periods had higher effect size and percentage difference on HbA1c (1.52 to 2.92%). Patient-centred implementation outcomes were reported variedly, where feasibility was reported in all studies. Acceptability was reported in nine studies, appropriateness in six studies and cost in four studies. mHealth evidence reporting and assessment (mERA) guidelines were not applied in all the studies in this review. Conclusion mHealth interventions in LMICs are associated with clinically significant effectiveness on HbA1 but have low effectiveness on FBG. The application of mERA guidelines may standardize reporting of patient-centered implementation outcomes in LMICs. Trial registration PROSPERO: Registration ID 154209.

Understanding key implementation determinants for a school-based universal prevention intervention: a qualitative study

This study examined how teachers discuss various factors as impacting their ability to execute with fidelity the Michigan Model for Health (MMH), an evidence-based health universal prevention curriculum widely adopted throughout Michigan. Researchers have found a robust relationship between fidelity and participant outcomes, including in schools. While previous studies have identified barriers that inhibit fidelity, few have focused on identifying key barriers and deepening our understanding of how these factors influence intervention fidelity. We conducted a thematic analysis using the reflexive thematic approach to identify key barriers and facilitators and deepen our understanding of how these factors influence MMH implementation. Guided by the Consolidated Framework for Implementation Research (CFIR) and the Implementation Outcomes Framework, we conducted semistructured interviews with 23 high school health teachers across Michigan. Teachers identified intervention characteristics (e.g., design quality, packaging, and program adaptability), student needs (e.g., trauma exposure, substances), and the fit between the intervention and the context as factors that contributed to acceptability. They also discussed the curriculum and its alignment with their teaching style and/or experiences as contributing to fidelity. Teachers shared how they would often go “off protocol” to improve intervention-context fit and meet students’ needs. Our results identified acceptability, a perceptual implementation outcome, as demonstrating an important role in shaping the relationship between CFIR factors and fidelity. Results provide guidance for systematically designing implementation strategies that address key barriers to improve acceptability, enhance fidelity, and ultimately achieve desired public health objectives.

Process evaluation of a pre-adolescent transdisciplinary health intervention for inter-generational outcomes

Background The CIrCLE of Life Initiative was implemented to 537 grade 6 learners and their parents, in five Government-run South African primary schools. The transdisciplinary intervention was intended to increase knowledge and skills on HIV and obesity. The study aim was to assess and report on the implementation process. Methods Data was collected on an adapted Proctor’s taxonomy of implementation outcomes, and to assess participants’ experiences. Qualitative and quantitative data were collected through educator logbooks, researcher observations, and learner-parent workbooks. Results Differentiations between the various school contexts were observed. The process evaluation revealed high learner penetration (97.2%), but lower learner and parent exposure (44.3% and 55.5%, respectively). All educators thought that the intervention was a fit for both rural and urban schools, different socio-economic groups, and people of different ethnic and cultural backgrounds. The intervention was perceived to be sustainable, and there were recommendations for adoption into the school curriculum and scale-up if found to be effective. Conclusion The process evaluation facilitated the assessment of the implementation outcomes, described its processes, and acknowledged fundamental characteristics that could justify variability in the intervention impact and outcomes. The value of process evaluations and their benefit to the science of implementation were demonstrated.

Remote Follow-up of Self-isolating COVID-19 Patients with a Patient Portal: Protocol for a Mixed-method Pilot Study (The Opal-COVID Study) (Preprint)

BACKGROUND Individuals diagnosed with COVID-19 are instructed to self-isolate at home. However, during self-isolation, they may experience anxiety and insufficient care. Some patient portals can allow patients to self-monitor and share their health status with healthcare professionals for remote follow-up, but little data is available on the feasibility of their use. OBJECTIVE This manuscript presents the protocol of the Opal-COVID Study which has four objectives: 1) assess the implementation of using the Opal patient portal for distance monitoring of COVID-19 patients self-isolating at home; 2) identify influences on the intervention’s implementation; and describe 3) service and 4) patient outcomes of this intervention. METHODS This mixed-method pilot study aims to recruit 50 COVID-19 patient participants tested at the McGill University Health Centre (MUHC, Montreal, Canada) for 14 days of remote follow-up. With access to questionnaires through the Opal patient portal smartphone app, configured for this study, patients will complete a daily self-assessment of symptoms, vital signs, and mental health, monitored by a nurse, and receive subsequent teleconsultations, as needed. Study questionnaires will be administered to collect data on sociodemographic characteristics, medical background, implementation outcomes (acceptability, usability, and respondent burden) and patient satisfaction. Coordinator logbook entries will inform on feasibility outcomes, namely, recruitment/retention rates and fidelity, as well as on the frequency and nature of contacts with healthcare professionals via Opal. The statistical analyses for Objectives 1 (implementation outcomes), 3 (service outcomes), and 4 (patient outcomes) will evaluate the effects of time and sociodemographic characteristics on the outcomes. For Objectives 1 (implementation outcomes) and 4 (patient outcomes), the statistical analyses will also examine the attainment of predefined success thresholds. As to the qualitative analyses, for Objective 2 (influences on implementation), semi-structured qualitative interviews will be conducted with four groups of stakeholders (i.e., patient participants, healthcare professionals, technology developers and study administrators) and submitted to content analysis, guided by the Consolidated Framework for Implementation Research to help identify barriers and facilitators of implementation. For Objective 3 (service outcomes), reasons for contacting healthcare professionals through Opal will also be submitted to content analysis. RESULTS Between December 2020 and March 2021, 51 patient-participants were recruited. Qualitative interviews were conducted with 39 involved stakeholders, from April to September 2021. Delays in the study process were experienced due to implemented measures at the MUHC to address COVID-19 but the quantitative and qualitative analyses are currently underway. CONCLUSIONS This protocol is designed to generate multidisciplinary knowledge on the implementation of a patient portal-based COVID-19 care intervention and will lead to a comprehensive understanding of feasibility, stakeholder experience, and influences on implementation that may prove useful for scaling up similar interventions. CLINICALTRIAL ClinicalTrials.gov identifier NCT04978233.

Implementation strategies and outcomes for occupational therapy in adult stroke rehabilitation: a scoping review

Background Stroke survivors often encounter occupational therapy practitioners in rehabilitation practice settings. Occupational therapy researchers have recently begun to examine the implementation strategies that promote the use of evidence-based occupational therapy practices in stroke rehabilitation; however, the heterogeneity in how occupational therapy research is reported has led to confusion about the types of implementation strategies used in occupational therapy and their association with implementation outcomes. This review presents these strategies and corresponding outcomes using uniform language and identifies the extent to which strategy selection has been guided by theories, models, and frameworks (TMFs). Methods A scoping review protocol was developed to assess the breadth and depth of occupational therapy literature examining implementation strategies, outcomes, and TMFs in the stroke rehabilitation field. Five electronic databases and two peer-reviewed implementation science journals were searched to identify studies meeting the inclusion criteria. Two reviewers applied the inclusion parameters and consulted with a third reviewer to achieve consensus. The 73-item Expert Recommendations for Implementing Change (ERIC) implementation strategy taxonomy guided the synthesis of implementation strategies. The Implementation Outcomes Framework guided the analysis of measured outcomes. Results The initial search yielded 1219 studies, and 26 were included in the final review. A total of 48 out of 73 discrete implementation strategies were described in the included studies. The most used implementation strategies were “distribute educational materials” (n = 11), “assess for readiness and identify barriers and facilitators” (n = 11), and “conduct educational outreach visits” (n = 10). “Adoption” was the most frequently measured implementation outcome, while “cost” was not measured in any included studies. Eleven studies reported findings supporting the effectiveness of their implementation strategy or strategies; eleven reported inconclusive findings, and four found that their strategies did not lead to improved implementation outcomes. In twelve studies, at least partially beneficial outcomes were reported, corresponding with researchers using TMFs to guide implementation strategies. Conclusions This scoping review synthesized implementation strategies and outcomes that have been examined in occupational therapy and stroke rehabilitation. With the growth of the stroke survivor population, the occupational therapy profession must identify effective strategies that promote the use of evidence-based practices in routine stroke care and describe those strategies, as well as associated outcomes, using uniform nomenclature. Doing so could advance the occupational therapy field’s ability to draw conclusions about effective implementation strategies across diverse practice settings.

Using Implementation Science Strategy Mapping on the Age-Friendly Health System's 4Ms Journey

Background Implementation science is the study of methods to promote the adoption and integration of evidence-based practices into routine health care to improve the quality of care. The purpose of this study was to use Implementation Mapping to guide the implementation of The John A. Hartford evidence-based Age-Friendly Health Systems (AFHS) 4Ms Framework: What Matters, Medications, Mentation, and Mobility. Methods Implementation Mapping, a systematic process for planning implementation strategies, guided the 9-month integration of the 4Ms Framework in the 1,100 MinuteClinics across the US. Implementation Mapping includes five tasks: (1) conduct an implementation needs assessment and identify program adopters and implementers; (2) state adoption and implementation outcomes and performance objectives, identify determinants, and create matrices of change objectives; (3) choose theoretical methods (mechanisms of change) and select or design implementation strategies; (4) produce implementation protocols and materials; and (5) evaluate implementation outcomes. Results The implementation plan, developed by the implementation mapping method, was carried out over 9-months. Seven implementation strategies were identified from the Expert Recommendations for Implementing Change (ERIC) project including the provision of education, electronic health record integration, internal champion facilitation, cues to action, and a dashboard to monitor progress. To date, the implementation mapping has resulted in the adoption of the 4Ms by 1145 providers (37%). Monitoring of the adoption of the 4Ms Framework and consideration of future implementation strategies is ongoing. Conclusions Implementation Mapping provided a systematic process to develop strategies to improve the adoption, implementation, sustainment, and scale-up of the evidence-based 4Ms Framework.

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial

Background This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45–75 years compared to usual care; and b) an implementation strategy. Methods A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. Results 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. Conclusions Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness. Trial registration ClinicalTrials.gov, NCT03136211. Registered 2 May 2017, “retrospectively registered”.