Health BehaviorsMOHRNCT01825746
Goal Setting for Health Behavior and Psychosocial Issues in Primary Care
A study testing Implementation of the MOHR assessment in primary care workflow in people with Health Behaviors and Obesity, run by Virginia Commonwealth University at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Health Behaviors, Obesity, Substance Abuse
- What is being tested?
- Implementation of the MOHR assessment in primary care workflow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,591 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all adult patients presenting for chronic or wellness care at the study practices
Who cannot join
- Acute illness
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Vermont College of Medicine
Burlington, Vermont, 05405
University of North Carolina
Chapel Hill, North Carolina, 27599
Department of Health Promotion and Community Health Sciences, Texas A&M Health Sciences Center School of Rural Public Health
College Station, Texas, 77483
University of Texas School of Public Health
Houston, Texas, 77030
UCLA Fielding School of Public Health
Los Angeles, California, 90095-1772
OCHIN
Portland, Oregon, 92201-5195
Virginia Ambulatory Care Outcomes Research Network
Richmond, Virginia, 23298
Carilion Health System
Roanoke, Virginia, 24033
About this study
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
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
- Being tested
- Implementation of the MOHR assessment in primary care workflow
- Medical subject headings
- Health Behavior, Obesity, Substance-Related Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of the MOHR assessment in primary care workflowOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Implementation of the MOHR assessment in primary care workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 month early implementation phase
Secondary outcomes (2)
Cost
The cost in terms of resources and time for practice to implement and field the MOHR assessment
Measured: 6 month early and delayed implementation phase
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
Measured: 4 months after completion of the initial MOHR assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Alex H Krist, MD MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825746
- Sponsor's protocol ID
- VCUFM0001
- Other IDs
- U58DP002759-01, R01CA140959
- Acronym
- MOHR
- Status last verified
- May 2015
- First submitted
- 15 Feb 2013
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22511015Krist 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.
PubMed 27356991Krist 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.
PubMed 25384814Phillips 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.
PubMed 25384812Krist 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.
PubMed 23799943
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01825746
- Acronym / sponsor ID
- MOHR / VCUFM0001
- Conditions
- Health Behaviors, Obesity, Substance Abuse, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,591 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- 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
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early implementation practices | Active comparator | Other: Implementation of the MOHR assessment in primary care workflow9 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. |
| Delayed implementation practices | Other | Other: Implementation of the MOHR assessment in primary care workflow9 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all adult patients presenting for chronic or wellness care at the study practices
Key exclusion criteria (1 listed)
- Acute illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of the MOHR assessment in primary care workflowThe 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. | Other | Delayed implementation practices, Early implementation practices |
Primary outcome
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
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
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
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
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
2 secondary outcomes
Cost
Time frame: 6 month early and delayed implementation phase
Health behavior and psychosocial changes
Time frame: 4 months after completion of the initial MOHR assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Background: PubMed 22511015Estabrooks 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.
- Derived from this study: PubMed 27356991Krist 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.
- Derived from this study: PubMed 25384814Krist 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.
- Derived from this study: PubMed 25384812Phillips 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.
- Derived from this study: PubMed 23799943Krist 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.
- Conference highlights for meeting to define the health behavior and psychosocial elements to be included on the MOHR assessmentLink provided by the sponsor.
- Grid Enabled Measures Database used to help collect health behavior and psychosocial measures to consider for inclusion on the MOHR assessmentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex H Krist, MD MPH principal investigator
Virginia Commonwealth University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of the MOHR assessment in primary care workflow in people with Health Behaviors and Obesity, run by Virginia Commonwealth University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: Entire 6 month early or delayed implementation phase). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01825746, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.