Goal Setting for Health Behavior and Psychosocial Issues in Primary Care

Obesity Clinical Trial

— MOHR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825746
• Other study ID #: VCUFM0001
• Secondary ID: U58DP002759-01R0
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: May 12, 2015
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3591
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Acute illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Depression
• Health Behaviors
• Obesity
• Substance Abuse

Intervention

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.

Locations

Country	Name	City	State
United States	Vermont College of Medicine	Burlington	Vermont
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Department of Health Promotion and Community Health Sciences, Texas A&M Health Sciences Center School of Rural Public Health	College Station	Texas
United States	University of Texas School of Public Health	Houston	Texas
United States	UCLA Fielding School of Public Health	Los Angeles	California
United States	OCHIN	Portland	Oregon
United States	Virginia Ambulatory Care Outcomes Research Network	Richmond	Virginia
United States	Carilion Health System	Roanoke	Virginia

Sponsors (5)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Agency for Healthcare Research and Quality (AHRQ), National Cancer Institute (NCI), Office of Behavioral and Social Sciences Research, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

Estabrooks PA, Boyle M, Emmons KM, Glasgow RE, Hesse BW, Kaplan RM, Krist AH, Moser RP, Taylor MV. Harmonized patient-reported data elements in the electronic health record: supporting meaningful use by primary care action on health behaviors and key psychosocial factors. J Am Med Inform Assoc. 2012 Jul-Aug;19(4):575-82. doi: 10.1136/amiajnl-2011-000576. Epub 2012 Apr 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach	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	Entire 6 month early or delayed implementation phase	No
Primary	Effectiveness - Ask	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	6 month early implementation phase	No
Primary	Effectiveness - Goal Setting	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	6 month early implementation phase	No
Primary	Effectiveness - Assistance	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	6 month early implementation phase	No
Primary	Effectiveness - Referred	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	6 month early implementation phase	No
Secondary	Cost	The cost in terms of resources and time for practice to implement and field the MOHR assessment	6 month early and delayed implementation phase	No
Secondary	Health behavior and psychosocial changes	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	4 months after completion of the initial MOHR assessment	No

External Links

•   Conference highlights for meeting to define the health behavior and psychosocial elements to be included on the MOHR assessment
•   Grid Enabled Measures Database used to help collect health behavior and psychosocial measures to consider for inclusion on the MOHR assessment