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

Primary Purpose

Health Behaviors, Obesity, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implementation of the MOHR assessment in primary care workflow
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Behaviors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute illness

Sites / Locations

  • UCLA Fielding School of Public Health
  • University of North Carolina
  • OCHIN
  • Department of Health Promotion and Community Health Sciences, Texas A&M Health Sciences Center School of Rural Public Health
  • University of Texas School of Public Health
  • Vermont College of Medicine
  • Virginia Ambulatory Care Outcomes Research Network
  • Carilion Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Early implementation practices

Delayed implementation practices

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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

Secondary Outcome Measures

Cost
The cost in terms of resources and time for practice to implement and field the MOHR assessment
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

Full Information

First Posted
February 15, 2013
Last Updated
May 12, 2015
Sponsor
Virginia Commonwealth University
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
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1. Study Identification

Unique Protocol Identification Number
NCT01825746
Brief Title
Goal Setting for Health Behavior and Psychosocial Issues in Primary Care
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behaviors, Obesity, Substance Abuse, Anxiety, Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3591 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early implementation practices
Arm Type
Active Comparator
Arm 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.
Arm Title
Delayed implementation practices
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Implementation of the MOHR assessment in primary care workflow
Intervention Description
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 Outcome Measure Information:
Title
Reach
Description
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
Time Frame
Entire 6 month early or delayed implementation phase
Title
Effectiveness - Ask
Description
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
Time Frame
6 month early implementation phase
Title
Effectiveness - Goal Setting
Description
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
Time Frame
6 month early implementation phase
Title
Effectiveness - Assistance
Description
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
Time Frame
6 month early implementation phase
Title
Effectiveness - Referred
Description
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
Time Frame
6 month early implementation phase
Secondary Outcome Measure Information:
Title
Cost
Description
The cost in terms of resources and time for practice to implement and field the MOHR assessment
Time Frame
6 month early and delayed implementation phase
Title
Health behavior and psychosocial changes
Description
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
Time Frame
4 months after completion of the initial MOHR assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all adult patients presenting for chronic or wellness care at the study practices Exclusion Criteria: Acute illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex H Krist, MD MPH
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Fielding School of Public Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
OCHIN
City
Portland
State/Province
Oregon
ZIP/Postal Code
92201-5195
Country
United States
Facility Name
Department of Health Promotion and Community Health Sciences, Texas A&M Health Sciences Center School of Rural Public Health
City
College Station
State/Province
Texas
ZIP/Postal Code
77483
Country
United States
Facility Name
University of Texas School of Public Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Vermont College of Medicine
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Virginia Ambulatory Care Outcomes Research Network
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Carilion Health System
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22511015
Citation
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.
Results Reference
background
PubMed Identifier
27356991
Citation
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.
Results Reference
derived
PubMed Identifier
25384814
Citation
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.
Results Reference
derived
PubMed Identifier
25384812
Citation
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.
Results Reference
derived
PubMed Identifier
23799943
Citation
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.
Results Reference
derived
Links:
URL
https://www.gem-beta.org
Description
Grid Enabled Measures Database used to help collect health behavior and psychosocial measures to consider for inclusion on the MOHR assessment

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Goal Setting for Health Behavior and Psychosocial Issues in Primary Care

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