Impact of patient partnership in clinical trials

Impact of patient partnership in clinical trials: a pilot embedded cluster randomized trial

Context

Adherence to medication and study protocol is a core issue for clinical trials’ success, affecting treatment efficacy estimates, study validity and costs. Patient engagement in research is attracting considerable interest as a potential strategy to improve trials’ conduct, with a recent meta-analysis showing a significant improvement in study participants’ recruitment. Economic models suggest large potential savings derived from patient engagement in research. However, solid RCT-level evidence of impact is lacking. Pilot trials of complex interventions like patient partnerships can help ensure that the proposed studies are feasible, acceptable and appropriate before full-scale implementation.

Objective

Assess the feasibility of conducting an embedded cluster randomized trial of patient partnership in clinical trials. Specific objectives are to:

  1. Assess the acceptance of the patient partnership intervention at the study and patient levels;
  2. Determine measures of outcomes used in the definitive trial;
  3. Estimate effect size and intra-cluster correlation coefficient for the medication and protocol adherence outcomes (for definitive trial sample size calculation); and
  4. Estimate cost of the partnership intervention (for trial budget calculation).

Design

Pilot step-wedge cluster randomized trial, embedded in a host clinical trial of precision medicine anticoagulation treatment for prevention of cognitive decline in people with atrial fibrillation (BRAIN-AF).

The project is part of the Pharmacogenomics and Biomarkers substudy BRAIN-AF-PGx  of  the Double-Blinded Randomized trial of Anticoagulation to prevent Ischemic stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF) led by the Montreal Heart Institute.

In collaboration with: 

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