NCT01825746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,591

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

February 15, 2013

Last Update Submit

May 12, 2015

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (2)

  • Cost

    6 month early and delayed implementation phase

  • Health behavior and psychosocial changes

    4 months after completion of the initial MOHR assessment

Study Arms (2)

Early implementation practices

ACTIVE COMPARATOR

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.

Other: Implementation of the MOHR assessment in primary care workflow

Delayed implementation practices

OTHER

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.

Other: Implementation of the MOHR assessment in primary care workflow

Interventions

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 practicesEarly implementation practices

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCLA Fielding School of Public Health

Los Angeles, California, 90095-1772, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

OCHIN

Portland, Oregon, 92201-5195, United States

Location

Department of Health Promotion and Community Health Sciences, Texas A&M Health Sciences Center School of Rural Public Health

College Station, Texas, 77483, United States

Location

University of Texas School of Public Health

Houston, Texas, 77030, United States

Location

Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Virginia Ambulatory Care Outcomes Research Network

Richmond, Virginia, 23298, United States

Location

Carilion Health System

Roanoke, Virginia, 24033, United States

Location

Related Publications (5)

  • 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.

    PMID: 22511015BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Health BehaviorObesitySubstance-Related DisordersAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental DisordersBehavioral Symptoms

Study Officials

  • Alex H Krist, MD MPH

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

April 8, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations