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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Obesity; Depression; Anxiety; Substance Abuse; Health Behaviors

Treatments: Other: Implementation of the MOHR assessment in primary care workflow

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT01825746

U58DP002759-01 (U.S. NIH Grant/Contract)

R01CA140959 (U.S. NIH Grant/Contract)

VCUFM0001

Details and patient eligibility

About

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.

Enrollment: 3,591 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Acute illness

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,591 participants in 2 patient groups

Early implementation practices

Active Comparator group

Description:

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.

Treatment:

Other: Implementation of the MOHR assessment in primary care workflow

Delayed implementation practices

Other group

Description:

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.

Treatment:

Other: Implementation of the MOHR assessment in primary care workflow