Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices

Abstract

Background Poor adherence to antihypertensive medications is a significant contributor to the racial gap in rates of blood pressure (BP) control among Latino adults, as compared to Black and White adults. While multi-level interventions (e.g., those aiming to influence practice, providers, and patients) have been efficacious in improving medication adherence in underserved patients with uncontrolled hypertension, the translation of these interventions into routine practice within “real world” safety-net primary care settings has been inadequate and slow. This study will fill this evidence-to-practice gap by evaluating the effectiveness of practice facilitation (PF) as a practical and tailored strategy for implementing Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA), a multi-level approach to improving medication adherence and BP control in 10 safety-net practices in New York that serve Latino patients. Methods and design We will conduct this study in two phases: (1) a pre-implementation phase where we will refine the PF strategy, informed by the Consolidated Framework for Implementation Research, to facilitate the implementation of ALTA into routine care at the practices; and (2) an implementation phase during which we will evaluate, in a stepped-wedge cluster randomized controlled trial, the effect of the PF strategy on ALTA implementation fidelity (primary outcome), as well as on clinical outcomes (secondary outcomes) at 12 months. Implementation fidelity will be assessed using a mixed methods approach based on the five core dimensions outlined by Proctor’s Implementation Outcomes Framework. Clinical outcome measures include BP control (defined as BP< 130/80 mmHg) and medication adherence (assessed using the proportion of days covered via pharmacy records). Discussion The study protocol applies rigorous research methods to identify how implementation strategies such as PF may work to expedite the translation process for implementing evidence-based approaches into routine care at safety-net practices to improve health outcomes in Latino patients with hypertension, who suffer disproportionately from poor BP control. By examining the barriers and facilitators that affect implementation, this study will contribute knowledge that will increase the generalizability of its findings to other safety-net practices and guide effective scale-up across primary care practices nationally. Trial registration ClinicalTrials.gov NCT03713515, date of registration: October 19, 2018.

Application of the FRAME-IS to a Multifaceted Implementation Strategy

“…We are currently conducting a stepped-wedge cluster randomized controlled trial using a PF strategy to implement remote patient monitoring (RPM) supported by team-based care [herein called ALTA] in 700 patients with uncontrolled hypertension (HTN) receiving care at a large FQHC ( clinicaltrials.gov NCT03713515 ). ( 17 ) The FQHC where ALTA is being implemented provides healthcare services in southwest and central Brooklyn, capturing a diverse population of mostly Hispanic and Black immigrants (69.6%) facing poverty, and cultural, as well as language barriers (41% are best served in a language other than English).…”

“…( 19 ) The primary outcome of the trial is implementation fidelity, which is defined as the degree to which: (1) the implementors (in this case clinic providers and staff) adhere to the ALTA intervention protocol, (2) the dose of ALTA delivered, (3) quality of delivery by the implementors, (4) ALTA component differentiation (i.e., as compared to other practice initiatives), (5) patient exposure to ALTA, and (6) patient and FQHC responsiveness (i.e., satisfaction) to ALTA. ( 17 , 19 )…”

Integration of a task strengthening strategy for hypertension management into HIV care in Nigeria: a cluster randomized controlled trial study protocol

“…As previously noted, the study is guided by CFIR (for the pre-implementation phase) and RE-AIM (for the implementation and post-implementation phases). A robust framework for identifying and operationalizing context-relevant barriers and facilitators for intervention adaptation [ 41 ], the five domains of CFIR (i.e., intervention characteristics, outer setting, inner setting, characteristics of individuals, and the implementation process) provided pre-study data which informed the adaptation of the PF strategy for embedding the TASSH intervention within PHCs. Additional details on the use of CFIR for mapping the implementation readiness of the PHCs to integrate the TASSH intervention are published elsewhere [ 42 ].…”

Integration of a Task Strengthening Strategy for Hypertension Management into HIV Care in Nigeria: a Cluster Randomized Controlled Trial Study Protocol

“…As previously noted, the study is guided by CFIR (for the pre-implementation phase) and RE-AIM (for the implementation and post-implementation phases). A robust framework for identifying and operationalizing context-relevant barriers and facilitators for intervention adaptation (41), the ve domains of CFIR (i.e., intervention characteristics, outer setting, inner setting, characteristics of individuals, and the implementation process) provided pre-study data which informed the adaptation of the PF strategy for embedding the TASSH intervention within PHCs. Additional details on the use of CFIR for mapping the implementation readiness of the PHCs to integrate the TASSH intervention are published elsewhere (42) The RE-AIM framework will inform the evaluation of the effectiveness of the TASSH intervention on BP reduction as well as the adoption and sustainability of the intervention throughout the PHCs.…”