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Testing an implementation strategy bundle on adoption and sustainability of evidence to optimize physical function in community-dwelling disabled and older adults in a Medicaid waiver: a multi-site pragmatic hybrid type III protocol.

ABSTRACT: BACKGROUND:In partnership with a state Medicaid home and community-based waiver program, this study tests implementation strategies for adoption and sustainability of an evidence-based intervention to support disabled and older adults who have difficulty with physical function and daily living tasks. A multi-level implementation strategy bundle will be directed at relationship, coalition, and team building; readiness to implement, leadership, and clinician attitude toward evidence assessments; intervention and facilitation training; interdisciplinary coordination; facilitation; and audit and feedback to support practice change. METHODS:Knowledge-to-Action model underpins this 2-arm, 3-year pragmatic mixed method randomized hybrid type III trial in 18 waiver program sites in Michigan. Data will be collected on sites, 775 clinicians (registered nurses, occupational therapists, social workers), and 15,000 disabled and older adults. Consolidated Framework for Implementation Research guides examination of site, clinician, and beneficiary characteristics; clinician attitude and self-efficacy; leadership and readiness to implement; and intervention impact on beneficiary outcomes. Sites will be randomized to either usual waiver care with internal facilitation of the bundle of implementation strategies or usual waiver care with both internal and external facilitation of the bundle. Primary outcomes are site-level adoption and sustainability over 12?months, and intervention effects on these outcomes are hypothesized to be mediated by clinicians' attitude and self-efficacy. At the beneficiary level, by addressing the individual's capabilities and home environment, the intervention is hypothesized to improve secondary outcomes of activities of daily living, pain, depression, falls, emergency department visits, and hospitalizations. Baseline site readiness and leadership and stages of implementation at 6?months will be explored as potential moderators. Linear mixed effects models will be used to test intervention effects on primary outcomes, with bias-correcting analytic strategy in mediation analyses. Generalized linear mixed effects modeling will be employed for the analysis of intervention effects on secondary outcomes. DISCUSSION:Synthesizing findings within and across the sites, we will specify how leadership, readiness for change, and level of facilitation enhance capacity for adoption and sustainability of an evidence-based intervention in an under-resourced Medicaid setting that cares for disabled and older adults. TRIAL REGISTRATION:ClinitalTrials.gov , NCT03634033 . Registered 16 August 2018.

SUBMITTER: Spoelstra SL

PROVIDER: S-EPMC6567613 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Testing an implementation strategy bundle on adoption and sustainability of evidence to optimize physical function in community-dwelling disabled and older adults in a Medicaid waiver: a multi-site pragmatic hybrid type III protocol.

Spoelstra Sandra L SL Schueller Monica M Sikorskii Alla A

Implementation science : IS 20190613 1

<h4>Background</h4>In partnership with a state Medicaid home and community-based waiver program, this study tests implementation strategies for adoption and sustainability of an evidence-based intervention to support disabled and older adults who have difficulty with physical function and daily living tasks. A multi-level implementation strategy bundle will be directed at relationship, coalition, and team building; readiness to implement, leadership, and clinician attitude toward evidence assess ...[more]

PMID: 31196137

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Project description:BackgroundEvidence-based interventions that optimize physical function for disabled and older adults living in the community who have difficulty with daily living tasks are available. However, uptake has been limited, particularly in resource-constrained (Medicaid) settings. Facilitation may be an effective implementation strategy. This study's aim was to compare internal facilitation (IF) versus IF and external facilitation (EF) on adoption and sustainability of an intervention in a Medicaid home and community-based waiver.MethodsIn a hybrid type 3 trial, waiver sites (N = 18) were randomly assigned to implement the intervention using a bundle of strategies with either IF or IF and EF. Adoption and sustainability were assessed via Stages of Implementation Completion (SIC) for each site. Clinician attitudes toward evidence-based practice and self-efficacy were evaluated among 539 registered nurses, social workers, and occupational therapists. Medicaid beneficiary outcomes of activities of daily living, depression, pain, falls, emergency department visits, and hospitalizations were evaluated in a sample of N = 7030 as reflected by electronic health records data of the Medicaid waiver program. Linear mixed-effects models were used to compare outcomes between trial arms while accounting for cluster-randomized design.ResultsThe mean SIC scores were 72.22 (standard deviation [SD] = 16.98) in the IF arm (9 sites) and 61.33 (SD = 19.29) in the IF + EF arm (9 sites). The difference was not statistically significant but corresponded to the medium clinically important effect size Cohen's d = 0.60. Clinician implementation outcomes of attitudes and self-efficacy did not differ by trial arm. Beneficiary depression was reduced significantly in the IF + EF arm compared to the IF arm (p = .04, 95% confidence interval for the difference [0.01, 0.24]). No differences between trial arms were found for other beneficiary outcomes.ConclusionsLevel of facilitation did not enhance capacity for adoption and sustainability of an evidence-based intervention in a Medicaid setting that cares for disabled and older adults. Improved beneficiary depression favored use of IF and EF compared to IF alone, and no differences were found for other outcomes. These findings also suggest level of facilitation may not have impacted beneficiary outcomes.Trial registrationClinicalTrials.gov , NCT03634033 ; date registered August 16, 2018.

Project description:BACKGROUND:Understanding the many factors that influence implementation of new programs, in addition to their success or failure, is extraordinarily complex. This qualitative study examines the implementation and adaptation process of two linked clinical programs within Primary Care, diabetes shared medical appointments (SMAs) and a reciprocal Peer-to-Peer (P2P) support program for patients with poorly controlled diabetes, through the lens of the Consolidated Framework for Implementation Research (CFIR). We illustrate the role and importance of pre-implementation interviews for guiding ongoing adaptations to improve implementation of a clinical program, achieve optimal change, and avoid type III errors. METHODS:We conducted 28 semi-structured phone interviews between September of 2013 and May of 2016, four to seven interviewees at each site. The interviewees were physician champions, chiefs of primary care, pharmacists, dieticians, nurses, health psychologists, peer facilitators, and research coordinators. Modifiable barriers and facilitators to implementation were identified and adaptations documented. Data analysis started with immersion in the data to obtain a sense of the whole and then by cataloging principal themes per CFIR constructs. An iterative consensus-building process was used to code. CFIR constructs were then ranked and compared by the researchers. RESULTS:We identified a subset of CFIR constructs that are most likely to play a role in the effectiveness of the diabetes SMAs and P2P program based on our work with the participating sites to date. Through the identification of barriers and facilitators, a subset of CFIR constructs arose, including evidence strength and quality, relative advantage, adaptability, complexity, patient needs and resources, compatibility, leadership engagement, available resources, knowledge and beliefs, and champions. CONCLUSIONS:We described our method for identification of contextual factors that influenced implementation of complex diabetes clinical programs - SMAs and P2P. The qualitative phone interviews aided implementation through the identification of modifiable barriers or conversely, actionable findings. Implementation projects, and certainly clinical programs, do not have unlimited resources and these interviews allowed us to determine which facets to target and act on for each site. As the study progresses, these findings will be compared and correlated to outcome measures. This comprehensive adaptation data collection will also facilitate and enhance understanding of the future success or lack of success of implementation and inform potential for translation and public health impact. The approach of using the CFIR to guide us to actionable findings and help us better understand barriers and facilitators has broad applicability and can be used by other projects to guide, adapt, and improve implementation of research into practice. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT02132676 .

Project description:BackgroundGlobally, many children fail to meet the World Health Organization's physical activity and sedentary behaviour guidelines. Schools are an ideal setting to intervene, yet despite many interventions in this setting, success when delivered under real-world conditions or at scale is limited. This systematic review aims to i) identify which implementation models are used in school-based physical activity effectiveness, dissemination, and/or implementation trials, and ii) identify factors associated with the adoption, implementation and sustainability of school-based physical activity interventions in real-world settings.MethodsThe review followed PRISMA guidelines and included a systematic search of seven databases from January 1st, 2000 to July 31st, 2018: MEDLINE, EMBASE, CINAHL, SPORTDiscus, PsycINFO, CENTRAL, and ERIC. A forward citation search of included studies using Google Scholar was performed on the 21st of January 2019 including articles published until the end of 2018. Study inclusion criteria: (i) a primary outcome to increase physical activity and/or decrease sedentary behaviour among school-aged children and/or adolescents; (ii) intervention delivery within school settings, (iii) use of implementation models to plan or interpret study results; and (iv) interventions delivered under real-world conditions.Exclusion criteria(i) efficacy trials; (ii) studies applying or testing school-based physical activity policies, and; (iii) studies targeting special schools or pre-school and/or kindergarten aged children.Results27 papers comprising 17 unique interventions were included. Fourteen implementation models (e.g., RE-AIM, Rogers' Diffusion of Innovations, Precede Proceed model), were applied across 27 papers. Implementation models were mostly used to interpret results (n?=?9), for planning evaluation and interpreting results (n?=?8), for planning evaluation (n?=?6), for intervention design (n?=?4), or for a combination of designing the intervention and interpreting results (n?=?3). We identified 269 factors related to barriers (n?=?93) and facilitators (n?=?176) for the adoption (n?=?7 studies), implementation (n?=?14 studies) and sustainability (n =?7 studies) of interventions.ConclusionsImplementation model use was predominately centered on the interpretation of results and analyses, with few examples of use across all study phases as a planning tool and to understand results. This lack of implementation models applied may explain the limited success of interventions when delivered under real-world conditions or at scale.Trial registrationPROSPERO (CRD42018099836).

Project description:BackgroundInstilling healthy dietary habits and active play in early childhood is an important public health focus. Interventions supporting the establishment of nutrition and active play behaviours in the first years of life have shown positive outcomes and long-term cost-effectiveness, however, most are research trials, with limited evidence regarding real-world application. Implementation science theories, models and frameworks (TMFs) can guide the process of research translation from trial to real-world intervention. The application of TMFs within nutrition and active play intervention studies in early childhood (< 5 years) is currently unknown. This systematic review identified the use of TMFs and barriers/ enablers associated with intervention adoption, implementation, and sustainability in early childhood nutrition and active play interventions implemented under real-world conditions.MethodsSix databases were searched for peer-reviewed publications between 2000-2021. Studies were included if primary outcomes reported improvement in diet, physical activity or sedentary behaviours amongst children aged < 5 years and interventions were delivered under real-world conditions within a community and/or healthcare setting. Two reviewers extracted and evaluated studies, cross checked by a third and verified by all authors. Quality assessment of included studies was completed by two authors using the Mixed Methods Appraisal Tool (MMAT).ResultsEleven studies comprising eleven unique interventions were included. Studies represented low, middle and high-income countries, and were conducted across a range of settings. Five TMFs were identified representing four of Nilsen's implementation model categories, predominantly 'evaluation models'. Ninety-nine barriers/facilitators were extracted across the three intervention phases-Implementation (n = 33 barriers; 33 facilitators), Sustainability (n = 19 barriers; n = 9 facilitators), Adoption (n = 2 barriers; n = 3 facilitators). Identified barriers/facilitators were mapped to the five domains of the Durlak and DuPre framework, with 'funding', 'compatibility' and 'integration of new programming' common across the three intervention phases.ConclusionsFindings demonstrate that there is no systematic application of TMFs in the planning, implementation and/or evaluation of early childhood nutrition and active play interventions in real-world settings, and selective and sporadic application of TMFs occurs across the intervention lifespan. This apparent limited uptake of TMFs is a missed opportunity to enhance real-world implementation success.Trial registrationPROSPERO (CRD42021243841).

Project description:BackgroundOpioid addiction and overdose is a public health problem in the United States and is expected to remain with substance use increasing due to the COVID-19 pandemic. Communities that approach this issue through multi-sector partnerships experience more positive health outcomes. Understanding motivation for stakeholder engagement in these efforts is essential to successful adoption, implementation, and sustainability particularly in the shifting landscape of needs and resources.MethodsA formative evaluation was conducted on the C.L.E.A.R. Program in Massachusetts, a state heavily impacted by the opioid epidemic. A stakeholder power analysis identified appropriate stakeholders for the study (n = 9). The Consolidated Framework for Implementation Research (CFIR) guided data collection and analysis. Surveys (n = 8) examined perception and attitudes on the program; motivations and communication for engagement; and, benefits and barriers to collaboration. Stakeholder interviews (n = 6) explored the quantitative findings in more detail. Surveys were analyzed using descriptive statistics and a content analysis with deductive approach was conducted for stakeholder interviews. The Diffusion of Innovation (DOI) Theory guided recommendations for communications to engage stakeholders.ResultsAgencies represented a range of sectors and the majority (n = 5) were familiar with the C.L.E.A.R.ProgramDespite the many strengths of the program and existing collaboration, based on the coding densities of each CFIR construct stakeholders identified crucial gaps in the services the program provided and noted that the overall infrastructure of the program could be enhanced. Opportunities for strategic communication to address the stages of DOI align with the gaps identified in the CFIR domains to result in increased agency collaboration and expansion of services into the surrounding communities to ensure sustainability of the C.L.E.A.R.ProgramConclusionsThis study explored factors necessary for ongoing multi-sector collaboration and sustainability of an existing community-based program especially given the changing context from COVID-19. Findings informed both program revisions and communication strategies to promote the program to new and existing collaborating agencies and the community served, and identify effective communication approaches across sectors. This is essential for successful implementation and sustainability of the program, especially as it is adapted and expanded to address post-pandemic times.Trial registrationThis study does not report results of a health care intervention on human participants, however it was reviewed and determined an exempt study with the Boston University Institutional Review Board (IRB #H-42107).

Dataset Information

Testing an implementation strategy bundle on adoption and sustainability of evidence to optimize physical function in community-dwelling disabled and older adults in a Medicaid waiver: a multi-site pragmatic hybrid type III protocol.

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Testing an implementation strategy bundle on adoption and sustainability of evidence to optimize physical function in community-dwelling disabled and older adults in a Medicaid waiver: a multi-site pragmatic hybrid type III protocol.

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