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

Alex H. Krist, Beth A. Glenn, Russell E. Glasgow, Bijal A. Balasubramanian, David A. Chambers, Maria E. Fernandez, Suzanne Heurtin-Roberts, Rodger Kessler, Marcia G. Ory, Siobhan M. Phillips, Debra P. Ritzwoller, Dylan H. Roby, Hector P. Rodriguez, Roy T. Sabo, Sherri N. Sheinfeld Gorin, Kurt C. Stange

Research output: Contribution to journalArticle

45 Citations (Scopus)

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.

Original languageEnglish (US)
Article number73
JournalImplementation Science
Volume8
Issue number1
DOIs
StatePublished - Jun 25 2013
Externally publishedYes

Fingerprint

Primary Health Care
Health
Health Behavior
Pragmatic Clinical Trials
Counseling
Outcome Assessment (Health Care)
Workflow
Administrative Personnel
Research Personnel
Delivery of Health Care
Costs and Cost Analysis
Research

Keywords

  • Electronic health record
  • Health behaviors
  • Mental health
  • Patient-reported measures
  • Pragmatic trial
  • Primary care

ASJC Scopus subject areas

  • Medicine(all)
  • Health Policy
  • Health Informatics
  • Public Health, Environmental and Occupational Health

Cite this

Krist, A. H., Glenn, B. A., Glasgow, R. E., Balasubramanian, B. A., Chambers, D. A., Fernandez, M. E., ... Stange, K. C. (2013). Designing a valid randomized pragmatic primary care implementation trial: The my own health report (MOHR) project. Implementation Science, 8(1), [73]. https://doi.org/10.1186/1748-5908-8-73

Designing a valid randomized pragmatic primary care implementation trial : The my own health report (MOHR) project. / Krist, Alex H.; Glenn, Beth A.; Glasgow, Russell E.; Balasubramanian, Bijal A.; Chambers, David A.; Fernandez, Maria E.; Heurtin-Roberts, Suzanne; Kessler, Rodger; Ory, Marcia G.; Phillips, Siobhan M.; Ritzwoller, Debra P.; Roby, Dylan H.; Rodriguez, Hector P.; Sabo, Roy T.; Sheinfeld Gorin, Sherri N.; Stange, Kurt C.

In: Implementation Science, Vol. 8, No. 1, 73, 25.06.2013.

Research output: Contribution to journalArticle

Krist, AH, Glenn, BA, Glasgow, RE, Balasubramanian, BA, Chambers, DA, Fernandez, ME, Heurtin-Roberts, S, Kessler, R, Ory, MG, Phillips, SM, Ritzwoller, DP, Roby, DH, Rodriguez, HP, Sabo, RT, Sheinfeld Gorin, SN & Stange, KC 2013, 'Designing a valid randomized pragmatic primary care implementation trial: The my own health report (MOHR) project', Implementation Science, vol. 8, no. 1, 73. https://doi.org/10.1186/1748-5908-8-73
Krist, Alex H. ; Glenn, Beth A. ; Glasgow, Russell E. ; Balasubramanian, Bijal A. ; Chambers, David A. ; Fernandez, Maria E. ; Heurtin-Roberts, Suzanne ; Kessler, Rodger ; Ory, Marcia G. ; Phillips, Siobhan M. ; Ritzwoller, Debra P. ; Roby, Dylan H. ; Rodriguez, Hector P. ; Sabo, Roy T. ; Sheinfeld Gorin, Sherri N. ; Stange, Kurt C. / Designing a valid randomized pragmatic primary care implementation trial : The my own health report (MOHR) project. In: Implementation Science. 2013 ; Vol. 8, No. 1.
@article{b1b204d0fa934aefb3627435c1ee6df8,
title = "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.",
keywords = "Electronic health record, Health behaviors, Mental health, Patient-reported measures, Pragmatic trial, Primary care",
author = "Krist, {Alex H.} and Glenn, {Beth A.} and Glasgow, {Russell E.} and Balasubramanian, {Bijal A.} and Chambers, {David A.} and Fernandez, {Maria E.} and Suzanne Heurtin-Roberts and Rodger Kessler and Ory, {Marcia G.} and Phillips, {Siobhan M.} and Ritzwoller, {Debra P.} and Roby, {Dylan H.} and Rodriguez, {Hector P.} and Sabo, {Roy T.} and {Sheinfeld Gorin}, {Sherri N.} and Stange, {Kurt C.}",
year = "2013",
month = "6",
day = "25",
doi = "10.1186/1748-5908-8-73",
language = "English (US)",
volume = "8",
journal = "Implementation Science",
issn = "1748-5908",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Designing a valid randomized pragmatic primary care implementation trial

T2 - The my own health report (MOHR) project

AU - Krist, Alex H.

AU - Glenn, Beth A.

AU - Glasgow, Russell E.

AU - Balasubramanian, Bijal A.

AU - Chambers, David A.

AU - Fernandez, Maria E.

AU - Heurtin-Roberts, Suzanne

AU - Kessler, Rodger

AU - Ory, Marcia G.

AU - Phillips, Siobhan M.

AU - Ritzwoller, Debra P.

AU - Roby, Dylan H.

AU - Rodriguez, Hector P.

AU - Sabo, Roy T.

AU - Sheinfeld Gorin, Sherri N.

AU - Stange, Kurt C.

PY - 2013/6/25

Y1 - 2013/6/25

N2 - 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.

AB - 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.

KW - Electronic health record

KW - Health behaviors

KW - Mental health

KW - Patient-reported measures

KW - Pragmatic trial

KW - Primary care

UR - http://www.scopus.com/inward/record.url?scp=84879227510&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84879227510&partnerID=8YFLogxK

U2 - 10.1186/1748-5908-8-73

DO - 10.1186/1748-5908-8-73

M3 - Article

C2 - 23799943

AN - SCOPUS:84879227510

VL - 8

JO - Implementation Science

JF - Implementation Science

SN - 1748-5908

IS - 1

M1 - 73

ER -