Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program.

Area of Science:

• Health Services Research
• Clinical Trial Design
• Implementation Science

Background:

• Stepped wedge cluster randomized trials (SW-CRTs) are increasingly utilized for evaluating new clinical programs.
• Limited practical guidance exists for applying SW-CRT designs in real-world healthcare settings.
• This study reports on the initial implementation of a SW-CRT for the STRIDE inpatient mobility program within the Veterans Health Administration (VHA).

Purpose of the Study:

• To describe and assess the design and initial implementation stages of a SW-CRT.
• To provide practical recommendations for future research using SW-CRTs to evaluate clinical program rollouts.

Main Methods:

• A stepped wedge cluster randomized trial design was employed across 8 VHA hospitals.
• Hospitals were recruited and randomly assigned in two stratified blocks to staggered STRIDE program launch dates.
• Data were collected from study records and investigator reflections to assess the implementation process.

Main Results:

• Eight hospitals were successfully enrolled and launched the STRIDE program within their assigned timelines.
• Recruitment involved extensive outreach, with 8 of 22 interested VAs enrolled.
• Most sites initiated with modified or phased rollouts, highlighting the need for implementation flexibility.

Conclusions:

• Future SW-CRTs require adequate time for site recruitment and careful consideration of randomization blocking.
• Sufficient implementation support and planning for potential program 'ramp-up' periods are crucial for successful rollout.
• Effective SW-CRT execution balances rigorous design principles with practical logistical considerations for program implementation.