Overcoming challenges in real-world evidence generation: An example from an Adult Medical Care Coordination program

Area of Science:

• Health Services Research
• Clinical Trial Design
• Patient Self-Management

Background:

• The Adult Medical Care Coordination program aimed to enhance patient self-management and decrease 30-day unplanned hospital readmissions for high-risk individuals.
• A pragmatic, stepped wedge cluster randomized trial was designed to evaluate the program's effectiveness against usual care.

Purpose of the Study:

• To assess the impact of the Adult Medical Care Coordination program on patient outcomes.
• To identify and address implementation challenges in a pragmatic trial setting.
• To provide lessons learned for future learning health system research.

Main Methods:

• A pragmatic, stepped wedge cluster randomized trial was employed.
• Challenges including participant attrition and COVID-19 disruptions were encountered.
• Propensity score matching was adapted to address baseline patient population differences between study arms.

Main Results:

• Significant differences in patient demographics (e.g., mean age) were observed between the program and usual care groups.
• Methodological adaptations, such as propensity score matching, were necessary to mitigate bias.
• Implementation faced practical hurdles common in real-world healthcare settings.

Conclusions:

• Pragmatic trials require flexibility and adaptive designs to overcome unforeseen challenges.
• Careful consideration of design trade-offs is crucial for generating reliable evidence in healthcare research.
• Lessons learned can guide future studies aiming to translate research into practice effectively.