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Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project
- Source :
- Implementation Science : IS, Krist, Alex H; Glenn, Beth A; Glasgow, Russell E; Balasubramanian, Bijal A; Chambers, David A; Fernandez, Maria E; et al.(2013). Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project. Implementation Science, 8(1), 73. doi: http://dx.doi.org/10.1186/1748-5908-8-73. Retrieved from: http://www.escholarship.org/uc/item/16t161s9
- Publication Year :
- 2013
-
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
- Subjects :
- Patient-reported measures
Interprofessional Relations
Electronic health record
Health Behavior
Health Informatics
Pragmatic trial
Health administration
Nursing
Participatory design
Patient-Centered Care
Health care
Pragmatic Clinical Trials as Topic
Medicine
Cluster Analysis
Electronic Health Records
Humans
Health behaviors
Health policy
Chronic care
Medicine(all)
Primary Health Care
business.industry
Clinical study design
Health Policy
Data Collection
Health services research
Public Health, Environmental and Occupational Health
Methodology
General Medicine
Primary care
Mental Health
Costs and Cost Analysis
Feasibility Studies
Self Report
business
Psychosocial
Subjects
Details
- ISSN :
- 17485908
- Volume :
- 8
- Database :
- OpenAIRE
- Journal :
- Implementation science : IS
- Accession number :
- edsair.doi.dedup.....edb238717ca201af8dfd4cb1596b4c97