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Completed

NCT Number: NCT01825746

Goal Setting for Health Behavior and Psychosocial Issues in Primary Care

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Fielding School of Public Health, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Acute illness

Treatment and study plan

Implementation of the MOHR assessment in primary care workflow

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • National Cancer Institute (NCI)
  • Office of Behavioral and Social Sciences Research (OBSSR)
  • University of California, Los Angeles

Registry information

Official study 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

Acronym: MOHR

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2013
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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