Goal Setting for Health Behavior and Psychosocial Issues in Primary Care

NCT ID: NCT01825746

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3591 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-02-28

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.

Conditions

Health Behaviors; Obesity; Substance Abuse; Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Implementation of the MOHR assessment in primary care workflow

Intervention Type: OTHER

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.

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.

Group Type: OTHER

Implementation of the MOHR assessment in primary care workflow

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Acute illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Office of Behavioral and Social Sciences Research (OBSSR)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex H Krist, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

UCLA Fielding School of Public Health

Los Angeles, California, United States

University of North Carolina

Chapel Hill, North Carolina, United States

OCHIN

Portland, Oregon, 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

Vermont College of Medicine

Burlington, Vermont, United States

Virginia Ambulatory Care Outcomes Research Network

Richmond, Virginia, United States

Carilion Health System

Roanoke, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22511015 (View on PubMed)

Krist AH, Glasgow RE, Heurtin-Roberts S, Sabo RT, Roby DH, Gorin SN, Balasubramanian BA, Estabrooks PA, Ory MG, Glenn BA, Phillips SM, Kessler R, Johnson SB, Rohweder CL, Fernandez ME; MOHR Study Group. The impact of behavioral and mental health risk assessments on goal setting in primary care. Transl Behav Med. 2016 Jun;6(2):212-9. doi: 10.1007/s13142-015-0384-2.

Reference Type: DERIVED

PMID: 27356991 (View on PubMed)

Krist AH, Phillips SM, Sabo RT, Balasubramanian BA, Heurtin-Roberts S, Ory MG, Johnson SB, Sheinfeld-Gorin SN, Estabrooks PA, Ritzwoller DP, Glasgow RE; MOHR Study Group. Adoption, reach, implementation, and maintenance of a behavioral and mental health assessment in primary care. Ann Fam Med. 2014 Nov-Dec;12(6):525-33. doi: 10.1370/afm.1710.

Reference Type: DERIVED

PMID: 25384814 (View on PubMed)

Phillips SM, Glasgow RE, Bello G, Ory MG, Glenn BA, Sheinfeld-Gorin SN, Sabo RT, Heurtin-Roberts S, Johnson SB, Krist AH; MOHR Study Group. Frequency and prioritization of patient health risks from a structured health risk assessment. Ann Fam Med. 2014 Nov-Dec;12(6):505-13. doi: 10.1370/afm.1717.

Reference Type: DERIVED

PMID: 25384812 (View on PubMed)

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; MOHR Study Group. Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project. Implement Sci. 2013 Jun 25;8:73. doi: 10.1186/1748-5908-8-73.

Reference Type: DERIVED

PMID: 23799943 (View on PubMed)

Related Links

https://www.gem-beta.org

Grid Enabled Measures Database used to help collect health behavior and psychosocial measures to consider for inclusion on the MOHR assessment

Other Identifiers

U58DP002759-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA140959

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VCUFM0001

Identifier Type: -

Identifier Source: org_study_id