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
Open accessAbstract
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.
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To compare impact of implementation strategies, Spoelstra et al. randomized Medicaid home and community-based waiver sites to engage in the clinical intervention with the addition of the implementation bundle with internal facilitation or an enhanced version of the bundle with the addition of external facilitation.
“To compare the impact of implementation strategies, Spoelstra et al. randomized Medicaid home and community-based waiver sites to engage in the clinical intervention with the addition of the implementation bundle with internal facilitation or an enhanced version of the bundle with the addition of external facilitation.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Spoelstra et al. (2019)
The Abstract (Methods) describes the two arms as usual waiver care with the implementation-strategy bundle and internal facilitation, versus the same care with both internal and external facilitation. But it says sites “will be randomized,” and the Methods (Randomization) likewise describes a future procedure; this protocol does not establish that Spoelstra et al. had already randomized them. (LLM, conf=0.88)
Experimental — accuracy not yet measuredEach study site in Spoelstra et al. (2019) was randomized to receive varying bundles of implementation strategies to measure the impact on adoption and sustainability of the intervention.
“Each study site was then randomized to receive varying bundles of implementation strategies to measure the impact on adoption and sustainability of the intervention.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Spoelstra et al. (2019)
The Methods (Randomization; page unavailable) specify site-level randomization, and the Abstract (Methods; page unavailable) identifies adoption and sustainability as primary outcomes. But the protocol says sites *will be* randomized to internal facilitation or internal plus external facilitation of the same implementation-strategy bundle—not that they were randomized to varying bundles. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn Spoelstra et al. (2019), all sites conducted the same clinical intervention and clinical outcomes were gathered at the patient-level.
“In this study, all sites conducted the same clinical intervention and clinical outcomes were gathered at the patient-level (e.g. measures of pain, depression, falls).”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Spoelstra et al. (2019)
The Methods (Study design; page not available) describe the same underlying intervention in both arms, with additional external facilitation in arm 2. The Aims and measures table specify beneficiary-level outcomes including pain, depression, and falls. But this is a protocol: it says the intervention will be provided and assessment data will be obtained, not that all sites had conducted it or that outcomes had already been gathered. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSpoelstra, Schueller, and Sikorskii (2019) provide an example of a type 3 hybrid designed to examine the impact of a bundle of implementation strategies on adoption and sustainability of an intervention to improve physical function in community-dwelling disabled and older adults.
“Spoelstra, Schueller, and Sikorskii (2019) provide an example of a type 3 hybrid designed to examine the impact of a bundle of implementation strategies on adoption and sustainability of an intervention to improve physical function in community-dwelling disabled and older adults.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Spoelstra, Schueller, and Sikorskii (2019)
Spoelstra et al. (2019) study characterizes a type 3 design because the primary outcomes of interest are implementation-based rather than effectiveness-based.
“This study characterizes a type 3 design because the primary outcomes of interest are implementation-based rather than effectiveness-based.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Spoelstra et al. (2019)
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An introduction to effectiveness-implementation hybrid designs
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- Authors
- Spoelstra, S. L., Schueller, M., & Sikorskii, A.
- Affiliations
- Grand Valley State University (US)
- Michigan State University (US)
- Corresponding author
- Spoelstra, Sandra L.
- Venue
- Implementation Science
- Published
- 2019-06-13
- Volume
- 14
- Issue
- 1
- Pages
- 60-60
- ISSN
- 1748-5908 (ISSN-L)
- PMC
- PMC6567613
- OpenAlex
- W2949109548
- Cited by
- 21
- References
- 43
- Citations by year
- 2024: 3 · 2023: 7 · 2022: 7 · 2020: 2 · 2019: 2
- FWCI
- 3.74
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Implementation Science (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Language arts journal of Michigan (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Institute on Aging (1 R15 AG058193-01A1)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Health Professions › General Health Professions › Health Sciences Research and Education
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Medical Practices and Rehabilitation
- Keywords
- adults with disabilities, older adults, physical function, activities of daily living, clinician self-efficacy, clinician attitudes, audit and feedback, facilitation, knowledge to action, home and community-based services, multidisciplinary care, falls, depression, pain, emergency department visits, hospitalization
- MeSH terms
- Activities of Daily Living, Aged, Female, Persons with Disabilities, Health Plan Implementation, Health Promotion, Humans, Male, Medicaid, Michigan, Research Design, United States, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Models, Organizational, Clinical Trials, Phase III as Topic, Evidence-Based Medicine, Independent Living, Pragmatic Clinical Trials as Topic
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