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

Abstract

BackgroundThere 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.MethodsThis 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.DiscussionThe 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 registrationClinicaltrials.gov: NCT01825746

The impact of behavioral and mental health risk assessments on goal setting in primary care

“…Finally, it is unclear whether these findings can be generalized outside of a research setting. While the study design was highly ORIGINAL RESEARCH pragmatic to increase external validity [28,40], fielding MOHR required substantial resources and time from practices (an additional 28 min per patient) [30]. However, practice redesign efforts such as patientcentered medical homes, accountable care organizations, primary care and public health integrations, and primary care and mental health integrations are advancing team-based care models that can support all of the needed patient-centered HRA steps.…”

“…While the study methods, implementation findings, and frequency of unhealthy behaviors and mental health risks have been previously reported, the study design is detailed below [5,[28][29][30]. The study was approved by the Virginia Commonwealth University (VCU) (#HM12746), University of California, Los Angeles (#12-0017900), and five other participating institutional review boards.…”

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“…5,29 More sophisticated electronic health records (EHRs) have the potential to identify variations in service utilization across population groups. 39 iii. Distal Outcomes (of the decision to screen or not to screen) The longer-term consequences of the individualized decision will be best assessed by following patients over time, with standardized outcome measures to determine the patient, clinician and organizational factors that contribute across cancer organizations.…”

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“…All implementation studies involve design decisions, such as determinations about whether the identified research questions call for comparisons within-site, between-sites, or both; whether and how to incorporate randomization; as well as how to balance internal and external validity [6,8]. In implementation science, there is also growing emphasis on practical research designs that remain rigorous while incorporating the local context and stakeholder perspectives with the goal of accelerating and broadening the impact on policy and practice [9,10]. Design decisions often have clear implications for the selection of assessment approaches (e.g., identification of instruments, determinations about how resulting data will be compiled and analyzed), which are one of the most concrete manifestations of study design.…”