JMIR Publications

ABSTRACT

Background:

To enhance successful real-world uptake of effective telehealth-delivered behavioral health interventions among older adults with cardiovascular disease, incorporating implementation science (IS) methods at earlier stages of intervention development may be needed.

Objective:

Describe the rationale, design, and results of a Stage I study assessing the feasibility and implementation potential of a technology-delivered behavioral health intervention.

Methods:

Guided by translational research and implementation science frameworks, we created (Stage IA) and assessed the feasibility and implementation potential (Stage IB) of a 2-session, remotely-delivered, home-based, behavioral intervention comprised of psychoeducation, interoceptive exposure through low-to-moderate intensity walking, interoceptive counseling, and homework (Reducing Exercise Sensitivity with Exposure Training; RESET) among patients with recent acute coronary syndrome (ACS) and at least some fear of exercise. To assess feasibility of the intervention, we measured patient adherence to the protocol, fidelity of intervention delivery, and completion of intervention outcome assessments using direct observations, fidelity checklists, and surveys. To assess implementation potential, we measured Proctor’s implementation outcomes (feasibility, acceptability, and appropriateness) using 4-item measures, each rated from the patient perspective on a 1-5 Likert scale (1=completely disagree; 5=completely agree; criteria: ≥4= agree or completely agree), and patient-perceived implementation determinants and design feedback using survey and interview data. Interview data underwent thematic analysis to identify implementation determinant themes, which were then categorized into relevant Consolidated Framework for Implementation Research (CFIR) domains and constructs.

Results:

Out of 31 patients approached, 3 ACS patients (51.7±10.0 years, 67% male, 67% Black, 33% Hispanic) were enrolled and completed the study. The intervention was delivered with fidelity for all patients, and all patients completed the entire intervention protocol and outcome assessments. On average, participants agreed that the RESET intervention was feasible and acceptable, while appropriateness ratings did not meet implementation criteria (mean±SD: feasibility 4.2±0.4; acceptability 4.3±0.7; appropriateness 3.7±0.4). Key patient-perceived implementation determinants related to CFIR constructs in the innovation (design, adaptability, complexity), inner setting (available resources [physical space, funding, materials/equipment], access to knowledge and information), and innovation recipient characteristics (motivation, capability, opportunity, need) domains, with key barriers related to innovation design. Design feedback suggested that interoceptive exposure design and virtual delivery modality required the most revisions and reasons why (i.e., poor usability).

Conclusions:

The RESET intervention was feasible, but not implementable due to insufficient patient-perceived appropriateness. Our theory-informed, mixed-methods approach aided our understanding of what, how, and why RESET was not perceived as implementable; information that will guide future intervention refinement. Integrating IS methods at early stages of intervention development enabled simultaneous detection of intervention feasibility, implementation potential, and key implementation determinants and design feedback; each of which are essential elements to address at earlier stages of behavioral intervention development to maximize future effectiveness and real-world implementation of the intervention. Clinical Trial: The Reducing Exercise Sensitivity With Exposure Training (RESET) Study NCT05099926 https://clinicaltrials.gov/study/NCT05099926