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Goal Setting for Health Behavior and Psychosocial Issues in Primary Care (MOHR)

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ClinicalTrials.gov Identifier: NCT01825746
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : May 13, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)
Office of Behavioral and Social Sciences Research (OBSSR)
University of California, Los Angeles
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE February 15, 2013
First Posted Date  ICMJE April 8, 2013
Last Update Posted Date May 13, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
  • Reach [ Time Frame: Entire 6 month early or delayed implementation phase ]
    The percent of eligible patients (e.g. those presenting for wellness or chronic care) who are offered the MOHR assessment and who complete the MOHR assessment
  • Effectiveness - Ask [ Time Frame: 6 month early implementation phase ]
    The percent of patients reporting that they were asked about health behavior and psychosocial topics in the early implementation (intervention) versus the delayed implementation (control) practices
  • Effectiveness - Goal Setting [ Time Frame: 6 month early implementation phase ]
    The percent of patients reporting that they set a goal about health behavior and psychosocial topics in the early implementation (intervention) versus the delayed implementation (control) practices
  • Effectiveness - Assistance [ Time Frame: 6 month early implementation phase ]
    The percent of patients reporting that received assistance for health behavior and psychosocial topic in the early implementation (intervention) versus the delayed implementation (control) practices
  • Effectiveness - Referred [ Time Frame: 6 month early implementation phase ]
    The percent of patients reporting that they were referred for health behavior and psychosocial counseling to a local program in the early implementation (intervention) versus the delayed implementation (control) practices
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
  • Cost [ Time Frame: 6 month early and delayed implementation phase ]
    The cost in terms of resources and time for practice to implement and field the MOHR assessment
  • Health behavior and psychosocial changes [ Time Frame: 4 months after completion of the initial MOHR assessment ]
    The change in patient responses to the 10 health behavior and psychosocial domains of the MOHR assessment with re-administration 4 months after initial completion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Goal Setting for Health Behavior and Psychosocial Issues in Primary Care
Official Title  ICMJE My Own Health Report (MOHR): A Pragmatic Evaluation to Enhance Primary Care Based Goal Setting and Evidence-Based Support for Health Behavior and Psychosocial Issues Through Meaningful Use of Patient-Centered Data and Tools
Brief Summary The purpose of this delayed cluster randomized intervention trial is to evaluate primary care strategies to increase goal setting, shared decision-making and evidence-based support and counseling for health behaviors and psychosocial issues through the implementation of a standard set of practical, patient-centered survey items and related decision support tools, called the My Own Health Report (MOHR) assessment. Nine pairs of diverse primary care practices will participate, four pairs of federally qualified health centers clinics and 5 pairs of practice based research network practices. Practice pairs are similar in size, patient and staff mix, culture, and level of EHR integration. Within pairs, practices will be randomized to early or delayed intervention (4 months later). The intervention consists of implementing the MOHR assessment and patient counseling into clinical care for all patients presenting for wellness or chronic care during a 6 month study period. Prior to implementation, practices will receive brief training about health behavior counseling, goal setting, and action planning. Practices will also be provided materials to support evidence-based counseling and referrals to local community resources. MOHR assessment implementation details will be determined by each practice pair but will generally include (1) asking patients to complete the MOHR assessment on the web prior to encounters (available at www.MyOwnHealthReport.org it addresses10 distinct health behaviors and psychosocial issues including physical activity, diet, alcohol consumption, tobacco use, drug use, sleep, stress, depression and anxiety), (2) provision, via the tool, immediate patient feedback that includes identification of unhealthy issues, assessment of readiness to change, prioritization of issues to change, and preparation for goal-setting and action planning, (3) feedback to the primary care team on the patient status and priorities for change, (4) provision of counseling, goal setting, and referrals to local resources by clinicians during the subsequent office visit, and (5) follow-up with the clinicians and local resources as agreed upon by the patient and clinician. Data sources will include patient responses to the MOHR assessment, practice appointment records, and a patient experience survey mailed to the first 300 patients offered the MOHR assessment two weeks after their office visit. Primary outcomes will include the Reach and Effectiveness of the intervention. Reach will be assessed in early and delayed intervention sites when they field the MOHR assessment. Effectiveness will compare early and delayed intervention sites during the early intervention phase, allowing the delayed intervention sites to serve as controls. Reach outcomes will include the percent of eligible patients receiving and completing the MOHR assessment. Effectiveness outcomes will include the percent of patients reporting that they were asked about health topics, set a change goal, received assistance for making a change, were referred for local counseling and support, and/or made any changes. Additional outcomes will include maintenance of the MOHR assessment implementation beyond 4 months, changes in patient reported health behavior and psychosocial measures by repeated administration of the MOHR assessment 4 months after initial completion, qualitative assessments on implementation factors and context that influence outcomes, and cost, in terms of time and resources required for practices to implement the MOHR assessment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Health Behaviors
  • Obesity
  • Substance Abuse
  • Anxiety
  • Depression
Intervention  ICMJE Other: Implementation of the MOHR assessment in primary care workflow
The MOHR assessment includes (1) asking patients to complete the MOHR assessment on the web prior to encounters (available at www.MyOwnHealthReport.org it addresses10 distinct health behaviors and psychosocial issues including physical activity, diet, alcohol consumption, tobacco use, drug use, sleep, stress, depression and anxiety), (2) provision, via the tool, immediate patient feedback that includes identification of unhealthy issues, assessment of readiness to change, prioritization of issues to change, and preparation for goal-setting and action planning, (3) feedback to the primary care team on the patient status and priorities for change, (4) provision of counseling, goal setting, and referrals to local resources by clinicians during the subsequent office visit, and (5) follow-up with the clinicians and local resources as agreed upon by the patient and clinician.
Study Arms  ICMJE
  • Active Comparator: Early implementation practices
    9 practices that will initially field the MOHR assessment for up to 6 months. These practices will serve as "intervention" sites for the effectiveness outcomes measured by the patient experience survey.
    Intervention: Other: Implementation of the MOHR assessment in primary care workflow
  • Delayed implementation practices
    9 practices that will field the MOHR assessment for up to 6 months but starting 4 months after the early implementation practices. These practices will serve as "control" sites for the effectiveness outcomes measured by the patient experience survey. However, they will provide intervention data with respect to Reach and cost during the delayed phase.
    Intervention: Other: Implementation of the MOHR assessment in primary care workflow
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2014)
3591
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2013)
2700
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all adult patients presenting for chronic or wellness care at the study practices

Exclusion Criteria:

  • Acute illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01825746
Other Study ID Numbers  ICMJE VCUFM0001
U58DP002759-01 ( U.S. NIH Grant/Contract )
R01CA140959 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Agency for Healthcare Research and Quality (AHRQ)
  • Office of Behavioral and Social Sciences Research (OBSSR)
  • University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Alex H Krist, MD MPH Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP