Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices

Abstract

Background: The decision aids for diabetes (DAD) trial explored the feasibility of testing the effectiveness of decision aids (DAs) about coronary prevention and diabetes medications in community-based primary care practices, including rural clinics that care for patients with type 2 diabetes.

Methods: As originally designed, we invited clinicians in eight practices to participate in the trial, reviewed the patient panel of clinicians who accepted our invitation for potentially eligible patients, and contacted these patients by phone, enrolling those who accepted our invitation. As enrollment failed to meet targets, we recruited four new practices. After discussing the study with the clinicians and receiving their support, we reviewed all clinic panels for potentially eligible patients. Clinicians were approached to confirm participation and patient eligibility, and patients were approached before their visit to provide written informed consent. This in-clinic approach required study coordinators to travel and stay longer at the clinics as well as to screen more patient records for eligibility. The in-clinic approach was associated with better recruitment rates, lower patient retention and outcome completion rates, and a better intervention effect.

Results: We drew four lessons: 1) difficulties identifying potentially eligible patients threaten the viability of practical trials of DAs; 2) to improve the recruitment yield, recruit clinicians and patients for the study at the clinic, just before their visit; 3) approaches that improve recruitment may be associated with reduced retention and survey response; and 4) procedures that involve working closely with the practice may improve recruitment and may also affect the quality of the implementation of the interventions.

Conclusion: Success in practice-based trials in usual primary care including rural clinics may require the smallest possible research footprint on the practice while implementing a streamlined protocol favoring in-clinic, in-person interactions with clinicians and patients.

Trial registration: ClinicalTrials.gov NCT01029288.

Figures

Figure 1

Enrollment flow associated with the recruitment approaches used during the DAD trial. Left, original design; right, in-clinic modified approach. DAD, decision aids for diabetes.

Figure 2

Eligibility and enrollment of patients over time in the DAD trial. Left, original design; right, in-clinic modified approach. DAD, decision aids for diabetes.