Results of a multi-site pragmatic hybrid type 3 cluster randomized trial comparing level of facilitation while implementing an intervention in community-dwelling disabled and older adults in a Medicaid waiver

The aging population in the USA is growing rapidly [1], and nearly half report problems with physical function, which can lead to difficulty with daily tasks and often nursing home placement [2]. Evidence-based interventions that optimize physical function in settings that care for disabled and older adults are available yet rarely implemented, particularly in under-resourced settings. One such intervention is Community Aging in Place, Advancing Better Living for Elders (CAPABLE) [3‐5]. CAPABLE is delivered at home by occupational therapists (OT) and registered nurses (RN) over 16 weeks using assistive devices and home modifications by a handyman to improve function and factors that impact function (e.g., balance, pain, depression). CAPABLE addresses modifiable intrinsic and extrinsic risk factors and considers the psychological, environmental, and physical factors to enhance function of disabled adults and promote aging in place [3‐5].

A long-standing question in health care is how to incorporate knowledge generated from randomized controlled efficacy or effectiveness trials (like CAPABLE) into practice [6]. To close the gap, a need exists to evaluate solutions that are more effective at driving evidence into practice. Practice change and improved individual outcomes can occur with the use of proven implementation strategies [7]. Evidence on particular strategies has emerged in the literature [6]. Yet, limitations exist regarding specificity of strategies for replication. Thus, it is imperative that strategies that promote utilization of evidence be further evaluated.

One implementation strategy with demonstrated effectiveness is facilitation, a multifaceted process that involves problem-solving and supporting efforts to adopt and incorporate interventions into routine practice [8]. A facilitator acts as a “change agent” by building a supportive relationship with clinicians and providing information to enhance use of an evidence-based intervention [9, 10]. Facilitators use reflection, empathy, and counseling to deliver feedback on performance to change attitudes, skills, and behaviors of clinicians to improve practice [9, 10].

Internal facilitators are embedded in the organization or group (often a supervisor or manager), familiar with local structures, procedures, culture, and clinical processes, and perform problem-solving and support clinicians [11]. External facilitators are not a member of the organization or group, are experts in facilitation who are often linked with other facilitators, and provide guidance and support [11]. External facilitators often integrate facilitation with other implementation strategies [11]. Facilitation as both a role (a facilitator) and a process strengthens use of evidence-based interventions [12].

Several studies have shown facilitation to be an effective strategy for improving implementation of complex evidence-based practice changes and other clinical innovations, as well as improving patient and organizational level outcomes [13‐16]. More specifically, trials using external facilitation (EF) have been shown to improve intervention adoption and effectiveness [14, 15]. However, a recent review of multiple trials did not delineate whether internal facilitation (IF) or EF was used [16], making it challenging to replicate findings in practice. Furthermore, mixed results on the effectiveness of facilitation are evident in the literature [17], possibly due to the intensity or dose of the facilitation strategy provided or the context in which the study occurred. Although facilitation has been widely used to address implementation challenges, limited information is available about whether IF or EF or a combination of both is more effective at adopting and sustaining practice change within a clinical setting when implementing a multimodal intervention. Hence, examining IF and EF is a topic which is of import to the field of implementation science, particularly within clinical settings with the most challenging contexts.

We conducted a hybrid type 3 cluster-randomized controlled trial that used a bundle of strategies and compared levels of facilitation while implementing an intervention. The implementation strategy bundle included relationship, coalition, and team building; readiness to implement, leadership, and clinician attitude toward evidence assessments; training; interdisciplinary coordination; audit and feedback; and IF alone or IF plus EF (IF + EF). Arm 1 included usual waiver care and used the bundle of implementation strategies that included IF alone (IF arm), while arm 2 included all components of arm 1 plus EF (IF + EF arm).

The overarching goal was to examine implementation of an intervention to improve the ability of disabled or older adults (beneficiaries) to perform daily tasks. The study had three objectives: (1) to evaluate adoption and sustainability of the intervention for two facilitation strategies, IF and IF + EF, (2) to test clinician self-efficacy and attitude toward evidence-based practice and deployment of an implementation strategy bundle on adoption and sustainability of the intervention, and (3) to examine the effect of the intervention on beneficiary outcomes. We hypothesized use of more intensive facilitation (IF + EF) would increase adoption and sustainability and improve beneficiary outcomes compared to less intensive facilitation (IF alone). Beneficiary outcomes examined were activities of daily living (ADLs), instrumental activities of daily living (IADLs), pain, depression, falls, emergency department (ED) visits, and hospitalizations.

Study protocol is published elsewhere [18]. A brief description is as follows:

This trial sets an ambitious agenda to explore ways to adopt and sustain an evidence-based intervention across a Medicaid program. There was a significant amount of work that presented challenges and opportunities. First, implementation and evaluation with a hybrid 3 design in an under-resourced real-world setting forced a delicate balance of study design and voluntary participation. Our work with sites in a standardized manner encouraged local tailoring of the plan to optimize implementation. Similar to other studies, this trial was a success from a design perspective in that no sites dropped out [39]. Second, the selection of volunteer sites may limit heterogeneity in our sample. However, findings about stages of implementation will inform this intervention’s adoption and sustainability and may be generalizable to other settings or populations. Furthermore, findings from this trial are likely to generalize to other states and some community settings implementing the intervention because many challenges may be similar to our low-resource Medicaid setting. Third, this trial used 9 evidence-based implementation strategies; finding use of IF alone has less up-front cost and appears more sustainable. Like other trials, multiple strategies were needed to achieve adoption and sustainability [40, 41], and level of facilitation may or may not have impacted implementation [10, 14‐17]. Fourth, the measurement approach involved significant effort in data collection from sites, clinicians, and beneficiaries with surveys, interviews, and extraction of secondary administrative and clinical data across disparate clinician contexts. Despite the challenges of data collection and management, the findings generate a broader understanding in Medicaid settings and facilitate effective use of evidence in under-resourced, complex environments. Finally, past trials of the efficacy of CAPABLE with respect to beneficiary outcomes had similar results [3‐5, 42]. We expected to learn a great deal about beneficiary outcomes to further support efficacy of CAPABLE but were unable to collect intervention fidelity data due to difficulty extracting data from the EHR.

Similar to other studies, we believe that this methodological approach of measuring adoption and sustainability with the SIC, which is comprised of the three dimensions of quality, quantity, and timing, is appropriate for a wide range of implementation and translational studies [39]. We note that the Michigan Department of Health and Human Services Long-Term Care Division played a critical role in use of the intervention and implementation. Other states or settings may not have access to such an organization to support implementation.

In what may be the first randomized controlled trial examining implementation of the evidence-based CAPABLE intervention, the level of facilitation did not enhance the capacity for adoption and sustainability in an under-resourced Medicaid setting that cares for disabled and older adults. This may suggest that only internal facilitation may be warranted. These findings further support the merits of less intensive implementation approaches that ensure adequate training and ongoing facilitation to support clinicians attempting to implement a new intervention. Future studies should evaluate factors that predict optimal implementation, particularly internal facilitation.