Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project

Abstract

Background: There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response.

Methods: This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment--addresses 10 domains of health behaviors and psychosocial issues--and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs.

Discussion: The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant.

Trial registration: Clinicaltrials.gov: NCT01825746.

Figures

Figure 1

MOHR study overview and timeline. The study started in January 2013. The approximate implementation date for the early implementation practices is March 2013 and July 2013 for the delayed implementation practices. (IRB = institutional review board, EIS = early implementation sites, DIS = delayed implementation sites).

Figure 2

MOHR study organization and coordination. The four general partners include funders, project coordination, local research teams, and study practices. The funders provide project coordinators general input into the study implementation and design. Overall project coordination includes the five working groups, MOHR planning committee, and the coordination center. The local research teams directly coordinate with the nine practice pairs to carry out and support the MOHR implementation and evaluation. (ACORN = Virginia Ambulatory Care Outcomes Research Network, UV = University of Vermont, UNC = University of North Carolina, UCLA = University of California, Los Angeles, and UTH = University of Texas Houston).

Figure 3

Patient summary and feedback from http://www.MyOwnHealthReport.org. The first page demonstrates the patient’s health behavior and psychosocial scores, level of concern, and whether the patient reported readiness to change and interest in talking with their doctor. The second page includes patient workspace for notes, creation of SMART health goals, and a follow-up plan.

Figure 4

MOHR study CONSORT flow diagram.

Figure 5

Depiction of the MOHR study PRECIS characteristics. The MOHR study design receives completely pragmatic scores for intervention flexibility, control flexibility, and practitioner expertise. The MOHR study design receives the next most pragmatic rating on the remaining seven dimensions.