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Addressing Diabetes in Primary Care: Hybrid Effectiveness-Implementation Study of Lifestyle Redesign® Occupational Therapy.

ABSTRACT: IMPORTANCE:Primary health care is rapidly developing as an occupational therapy practice area. Yet, to date, little evidence supports occupational therapy's feasibility and efficacy in primary care settings. OBJECTIVE:To report on the implementation and preliminary clinical outcomes of a Lifestyle Redesign® (LR)-occupational therapy (LR-OT) diabetes management intervention in a primary care clinic. DESIGN:Patients were randomized to be offered LR-OT or to a no-contact comparison group (data not reported). We assessed implementation outcomes using mixed methods. SETTING:Safety-net primary care clinic. PARTICIPANTS:Clinic providers and staff; English- or Spanish-speaking clinic patients ages 18-75 yr with diabetes and a current hemoglobin A1c (HbA1c) ? 9.0%. INTERVENTION:Eight 1-hr individual sessions of LR-OT focused on diabetes management. OUTCOMES AND MEASURES:Clinical and health behavior outcomes were assessed via electronic medical record (EMR) review and self-report surveys of patients receiving LR-OT at initial evaluation and discharge. We assessed implementation outcomes (acceptability, appropriateness, feasibility, fidelity, efficiency, and timeliness) using patient and staff surveys, interviews, focus groups, and observations. RESULTS:Seventy-three patients were offered LR-OT: 51 completed one or more sessions, and 38 completed the program. Clinical outcomes among program completers indicate beneficial changes in HbA1c, diabetes self-care, and health status. Implementation challenges included a need for patient and staff education, securing adequate workspace, and establishing a referral process. Factors contributing to implementation success included strong buy-in from clinic leadership, colocation, and shared EMR documentation. CONCLUSIONS AND RELEVANCE:LR-OT is a feasible approach to enhancing service delivery and clinical outcomes in primary care. WHAT THIS ARTICLE ADDS:This study provides insight into factors that may create challenges or contribute to the success of implementing occupational therapy services within primary health care settings. In addition, this study provides preliminary evidence of occupational therapy's effectiveness in improving clinical outcomes among ethnically diverse, low-income patients with diabetes in a safety-net primary care setting.

SUBMITTER: Pyatak E

PROVIDER: S-EPMC6813504 | biostudies-literature | 2019 Sep/Oct

REPOSITORIES: biostudies-literature

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Addressing Diabetes in Primary Care: Hybrid Effectiveness-Implementation Study of Lifestyle Redesign<sup>®</sup> Occupational Therapy.

Pyatak Elizabeth E King Maggie M Vigen Cheryl L P CLP Salazar Elia E Diaz Jesus J Schepens Niemiec Stacey L SL Blanchard Jeanine J Jordan Katie K Banerjee Josh J Shukla Jagruti J

The American journal of occupational therapy : official publication of the American Occupational Therapy Association 20190901 5

<h4>Importance</h4>Primary health care is rapidly developing as an occupational therapy practice area. Yet, to date, little evidence supports occupational therapy's feasibility and efficacy in primary care settings.<h4>Objective</h4>To report on the implementation and preliminary clinical outcomes of a Lifestyle Redesign<sup>®</sup> (LR)-occupational therapy (LR-OT) diabetes management intervention in a primary care clinic.<h4>Design</h4>Patients were randomized to be offered LR-OT or to a no-co ...[more]

PMID: 31484021

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Project description:IntroductionPromoting healthy eating and active play in early life is critical, however few interventions have been delivered or sustained at scale. The evaluation of interventions at scale is a crucial, yet under-researched aspect of modifying population-level health behaviours. INFANT is an evidence-based early childhood healthy lifestyle intervention that aims to improve parents' knowledge and skills around promoting optimal energy balance-related behaviours that, in turn, influence children's diet, activity and adiposity. It consists of: 1) Four group sessions delivered via first time parent groups across the first 12 months of life; 2) access to the My Baby Now app from birth to 18 months of age. This research aims to assess real-world implementation, effectiveness and cost-effectiveness of INFANT when delivered at scale across Victoria, Australia.Methods and analysisA hybrid type II implementation-effectiveness trial applying a mixed methods design will be conducted. INFANT will be implemented in collaboration with practice and policy partners including maternal and child health services, population health and Aboriginal health, targeting all local government areas (n=79) in Victoria, Australia. Evaluation is based on criteria from the 'Outcomes for Implementation Research' and 'RE-AIM' frameworks. Implementation outcomes will be assessed using descriptive quantitative surveys and qualitative interviews with those involved in implementation, and include intervention reach, organisational acceptability, adoption, appropriateness, cost, feasibility, penetration and sustainability. Process measures include organizational readiness, fidelity, and adaptation. Effectiveness outcomes will be assessed using a sample of INFANT participants and a non-randomized comparison group receiving usual care (1,500 infants in each group), recruited within the same communities. Eligible participants will be first time primary caregivers of an infant aged 0-3 months, owning a personal mobile phone and able to communicate in English. Effectiveness outcomes include infant lifestyle behaviours and BMIz at 12 and 18 months of age.ImpactThis is the first known study to evaluate the scale up of an evidence based early childhood obesity prevention intervention under real world conditions. This study has the potential to provide generalisable implementation, effectiveness and cost-effectiveness evidence to inform the future scale up of public health interventions both in Australia and internationally.Clinical trial registrationAustralian and New Zealand Clinical Trial Registry https://www.anzctr.org.au/, identifier ACTRN12620000670976.

Project description:IMPORTANCE:Developed in California to enable community-dwelling older adults to maintain healthy and meaningful activities, Lifestyle Redesign® is a well-known cost-effective preventive occupational therapy intervention. The impact of a newly adapted French version on older French-Canadians was, however, unknown. OBJECTIVE:To explore the influence of Lifestyle Redesign on older French-Canadians' health, social participation, leisure, and mobility. DESIGN:A mixed-methods design included a preexperimental component (questionnaires administered before and after the intervention and 3 and 6 mo postintervention) and an exploratory descriptive qualitative clinical study. Individual semidirected interviews were digitally audiotaped and transcribed, then underwent thematic content analysis using mix extraction grids. SETTING:Community. PARTICIPANTS:Sixteen volunteers (10 women) aged 65-90 yr (mean = 76.4, standard deviation = 7.6), 10 without and 6 with disabilities. Inclusion criteria were age ?65 yr, normal cognitive functions, residence in a conventional or senior home, and French speaking. INTERVENTION:French-Canadian 6-mo version of Lifestyle Redesign. OUTCOMES AND MEASURES:Health, social participation, leisure, and mobility were measured using the 36-item Short Form Health Survey, Social Participation Scale, Leisure Profile, and Life-Space Assessment, as well as a semistructured interview guide. RESULTS:The French-Canadian Lifestyle Redesign had a beneficial effect on participants' mental health (p = .02) and interest in leisure (p = .02) and, in those with disabilities, social participation (p = .03) and attitudes toward leisure (p = .04). Participants reported positive effects on their mental health, leisure, mobility, and social participation, including frequency and quality of social interactions, and indicated that having an occupational routine fostered better health. None of the participants reported no effect. CONCLUSION AND RELEVANCE:The translated and culturally adapted Lifestyle Redesign is a promising occupational therapy intervention for community-dwelling older French-Canadians. WHAT THIS ARTICLE ADDS:This study sheds light on the influence of the French-Canadian version of the intervention not only on older adults' health and social participation but also on their leisure activities and life-space mobility, two important outcomes not addressed in previous Lifestyle Redesign studies. Moreover, this study provides an in-depth understanding of the Lifestyle Redesign experience of French-Canadian older adults with and without disabilities, including participants with significant communication and mobility disabilities.

Project description:BackgroundLifestyle interventions can improve health-related outcomes for people with severe mental illness (SMI), but few studies evaluate this potential in everyday settings. After a successful approach in routine inpatient mental healthcare (MULTI), we sought to replicate this multidisciplinary lifestyle-enhancing support in people with SMI living in sheltered housing (MULTI_sh).AimsTo evaluate the effectiveness and implementation of MULTI_sh (trial registration: NCT03157557).MethodIn an effectiveness-implementation hybrid cluster-randomised controlled trial, six municipalities with sheltered housing facilities in The Netherlands were randomly assigned to MULTI_sh (n = 3) or treatment as usual (TAU, n = 3). After 12 months, we evaluated effects on metabolic health, sedentary behaviour/physical activity (ActiGraph GT3X+), quality of life (EuroQol 5D, WHOQoL-Bref) and psychopathology (Brief Psychiatric Rating Scale Expanded Version) using multiple regression, adjusting for baseline values and municipalities (intention to treat and per protocol). In addition, implementation fidelity and barriers/facilitators were evaluated (Measurement Instrument for Determinants of Innovation).ResultsOf 177 eligible patients, 74 (42%) could be included in the analyses. Health outcomes did not substantially improve with MULTI_sh (n = 45) compared with TAU (n = 29). MULTI_sh was not implemented as intended. Most patients and all healthcare professionals believed that patients' lifestyle should be part of treatment, but implementation was primarily (in)directly hindered by organisational factors (e.g. staff shortages, complexity of participation, lack of time and difficulty getting patients involved).ConclusionsMULTI_sh was not implemented as intended and no clinical health improvements were found. Organisations are decisive in the success or failure of the implementation of lifestyle interventions for people with SMI. More intensive implementation strategies on this level are warranted in sheltered housing.

Project description:INTRODUCTION:Two of the most acute and feared complications in type 1 diabetes (T1D) are hypoglycaemia and severe hypoglycaemia (SH). While impaired awareness of hypoglycaemia (IAH) can lead to SH with cognitive and motivational barriers implicated, the available education does not integrate behavioural change techniques to address these. A novel Hypoglycaemia Awareness Restoration Programme despite optimised care (HARPdoc) is currently being tested against an established blood glucose awareness training (BGAT) within a parallel, two-arm, group randomised, blinded trial (with its own protocol; NCT02940873) with adults with T1D whose problems with hypoglycaemia and SH have persisted despite otherwise optimised insulin management. While both programmes are aimed at reducing hypoglycaemia, SH and IAH, it is the former that integrates behavioural change techniques.The aim of the current (implementation) study is to evaluate delivery of both HARPdoc and BGAT and explore associations between implementation outcomes and trial endpoints; as well as to develop an evidence-based implementation blueprint to guide implementation, sustainment and scale-up of the effective programmes. METHODS AND ANALYSIS:Guided by the implementation science tools, frameworks, methods and principles, the current study was designed through a series of focus groups (n=11) with the key intervention stakeholders (n=28)-including (1) individuals with lived experience of T1D, IAH and a pilot version of the HARPdoc (n=6) and (2) diabetes healthcare professionals (n=22). A mixed-methods approach will be used throughout. Stakeholder engagement has underpinned study design and materials to maximise relevance, feasibility and impact. ETHICS AND DISSEMINATION:The protocol has been reviewed and received ethical approval by the Harrow Research Ethics Committee (18/LO/1020; 240752) on 1 October 2018. The findings will be submitted to a peer-reviewed journal and presented at scientific meetings. TRIAL REGISTRATION NUMBER:NCT02940873; Pre-results.

Project description:BACKGROUND: Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices. METHODS: This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n?=?200) or usual care (n?=?120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients and providers). Patient-effectiveness outcomes include measures of depression, anxiety, and physical health functioning using blinded independent evaluators. Implementation outcomes include patient engagement and adherence and clinician brief cognitive behavioral therapy adoption and fidelity. CONCLUSIONS: Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in primary care. Although trade-offs exist between scientific control and external validity, hybrid designs are part of an emerging approach that has the potential to rapidly advance both science and practice. TRIAL REGISTRATION: NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT01149772.

Project description:IntroductionThe Veterans Health Administration initiated implementation facilitation to integrate intimate partner screening programs in primary care. This study investigates implementation facilitation's impact on implementation and clinical effectiveness outcomes.Study designA cluster randomized, stepped-wedge, hybrid-II implementation-effectiveness trial (January 2021-April 2022) was conducted amidst the COVID-19 pandemic.Setting/participantsImplementation facilitation was applied at 9 Veterans Health Administration facilities, staged across 2 waves. Participants were all women receiving care at participating primary care clinics 3 months before (pre-implementation facilitation n=2,272) and 9 months after initiation of implementation facilitation (implementation facilitation n=5,149).InterventionImplementation facilitation included an operations-funded external facilitator working for 6 months with a facility-funded internal facilitator from participating clinics. The pre-implementation facilitation period comprised implementation as usual in the Veterans Health Administration.Main outcome measuresPrimary outcomes were changes in (1) reach of intimate partner violence (IPV) screening programs among eligible women (i.e., those seen within participating clinics during the assessment period; implementation outcome) and (2) disclosure rates among screened women (effectiveness outcome). Secondary outcomes included disclosure rates among all eligible women and post-screening psychosocial service use. Administrative data were analyzed.ResultsFor primary outcomes, women seen during the implementation facilitation period were nearly 3 times more likely to be screened for IPV than women seen during the pre-implementation facilitation period (OR=2.70, 95% CI=2.46, 2.97). Women screened during the implementation facilitation period were not more likely to disclose IPV than those screened during the pre-implementation facilitation period (OR=1.14, 95% CI=0.86, 1.51). For secondary outcomes, owing to increased reach of screening during implementation facilitation, women seen during the implementation facilitation period were more likely to disclose IPV than those seen during the pre-implementation facilitation period (OR=2.09, 95% CI=1.52, 2.86). Women screened during implementation facilitation were more likely to use post-screening psychosocial services than those screened during pre-implementation facilitation (OR=1.29, 95% CI=1.06, 1.57).ConclusionsFindings indicate that implementation facilitation may be a promising strategy for increasing the reach of IPV screening programs in primary care, thereby increasing IPV detection and strengthening connections to support services among the patient population.Trial registrationThis study is registered at www.Clinicaltrialsgov NCT04106193.

Project description:IntroductionIn Canada, as in most Organisation for Economic Co-operation and Development countries, healthcare systems face significant challenges in ensuring better access to primary care. A regional healthcare organisation in Quebec (Canada) serving a population of approximately 755 459 citizens has implemented a standardised access approach to primary care services for this population. The objective of this new clinical and organisational practice is to ensure that users benefit from the same referral process, regardless of the entry point, in order to be directed to the right services. This new practice integrates a shared decision-making process between the user and the professional, and a collaborative process between different health professionals within and between services. The objective of our research is to identify and characterise the conditions of implementation of this practice.MethodsThis effectiveness-implementation hybrid investigation will use an embedded single-case study, defined in this case as the process of implementing a clinical and organisational practice within a healthcare organisation. Further to an evaluation conducted during a preliminary phase of the project, this study consists of evaluating the implementation of this new practice in four medical clinics (family medicine groups). A qualitative analysis of the data and a quantitative preimplementation and postimplementation analysis based on performance indicators will be conducted. This study is ultimately situated within a participatory organisational approach that involves various stakeholders and users at each step of the implementation and evaluation process.Ethics and disseminationThis study was approved by the Ethics Committee of the Sectoral Research in Population Health and Primary Care of the Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale (#2020-1800). The results of the investigation will be presented to the stakeholders involved in the advisory committees and at several scientific conferences. Manuscripts will be submitted to peer-reviewed journals.

Dataset Information

Addressing Diabetes in Primary Care: Hybrid Effectiveness-Implementation Study of Lifestyle Redesign® Occupational Therapy.

Publications

Addressing Diabetes in Primary Care: Hybrid Effectiveness-Implementation Study of Lifestyle Redesign<sup>®</sup> Occupational Therapy.

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