Recruitment and implementation of a behavioral economics randomized controlled trial

The Problem

The University of Southern California (USC) launched a National Institute on Aging-funded randomized, controlled trial to evaluate a novel incentive intervention that varies payment design based on the principles of behavioral economics. Studies have shown that financial incentives increase the adoption of healthy behaviors. Similarly, when financial incentives are removed, adherence of adopted behaviors is limited . Long-term adherence can be increased with the use of behavioral economics in place of simple cash incentives . This study tested different payment designs by randomizing patients who participated in disease management exercise classes into one of two study groups: incentive insurance or no incentive insurance. Payment for participation in the 12-week exercise program was dependent on frequency of attendance and study group. Recruitment required identification and communication with hundreds of patients. Additionally, implementation required collaboration with investigators and clinic partners to engage primary care providers, consent patients, and manage data.

The Solution

Engaging clinic partners
COPE Health Solutions collaborated with clinic partner, QueensCare Health Centers (QHC), to coordinate the implementation of multiple exercise classes at clinic sites throughout the Los Angeles area. By engaging QHC, COPE Health Solutions was able to reach hundreds of patients from seven clinic locations. Previously established relationships with clinic partners enabled COPE Health Solution to successfully launch a pilot study before full implementation.
Engaging primary care providers
To recruit and consent patients, the COPE Health Solutions team obtained medical clearance from patients’ primary care providers (PCPs) to ensure patient safety. COPE Health Solutions engaged PCPs during all staff meetings and provided training on proper documentation procedures for study items using the clinic’s electronic health record system (EHR). Project managers’ communication with PCPs garnered support for the project, increasing the number of patient referrals to the study.
Recruiting and consenting patients
The COPE Health Solutions team developed a recruitment strategy tailored to the specific needs of the study. Project managers utilized the following methods to recruit patients: referrals, in – clinic recruitment, and phone recruitment. Patients were individually screened for study eligibility using limited access to the clinic’s EHR. Once selected, the project manager, using the EHR, alerted PCPs and requested medical clearance.

While on site, the project manager approached patients to gage interest in participating in the study before or after scheduled appointments. The project manager worked closely with clinic staff to determine the best time to speak with patients, minimizing the impact to clinic workflow. Patients were approached while in the waiting area, after vitals were performed, before medication dispensation, or before laboratory tests were performed. PCPs also referred patients to attend exercise classes indicating referral in the EHR. The COPE Health Solutions teams provided follow – up phone calls to patient referrals. Patients who were given medical clearance, but did not have scheduled appointments, were contacted via phone. Using all these recruitment methods, the team was able to speak with over 900 potential study participants.
Cultural Competency
To effectively implement recruitment strategies, COPE Health Solutions utilized culturally competent project managers who were able to thoroughly explain the study and receive informed consent from participants in a manner that was both respectful and responsive to the health beliefs, practices, cultural, and linguistic needs of diverse patients. By strategically placing linguistically-fit project managers, COPE Health Solutions was able to reach a larger group of patients and prevent miscommunication due to language or cultural barriers. This expertise enhanced COPE Health Solutions’ ability to successfully implement the study design and build partnerships within the community.
Data management
COPE Health Solutions effectively communicated the data needs of the study to clinic leadership and created encounter codes designed to document participant attendance to exercise classes in the clinic’s EHR. This change allowed USC principal investigators to request data extracts from QHC containing all encounter codes indicating exercise class attendance along with de-identified patient medical information. Project managers recorded detailed information along various steps of the recruitment process to ensure the collection of sufficient data. Upon signing consent documents project managers administered questionnaires to patients to determine patients’ understanding of study design. All databases containing recruitment outcomes, incentive distribution, patient intervention assignments, and participant characteristics were maintained for a period of three years.

Outcomes

• Exercise classes were held at two clinic sites.
• There were six classes provided for study participants.
• A total of 152 patients consented to participate in the study.
• Completion of target number of patient understanding questionnaires.

“COPE project managers have a strong work-ethic and communicate effectively with community partners. I have been impressed by their ability to carry out complex recruiting tasks with great success.”

-Jason Doctor, PhD
Associate Professor,
Clinical Pharmacy and Pharmaceutical Economics & Policy
University of Southern California

For more information, please contact the COPE Health Solutions project principals:

Leslie Mendoza
Research Project Manager
lmendoza@copehealthsolutions.org

Alan F. Rothfeld, MD
Chief Medical Officer
arothfeld@copehealthsolutions.org