Integrating Behavioral Health and Primary Care for Comorbid Behavioral and Medical Problems
IBHPC
1 other identifier
interventional
4,025
1 country
1
Brief Summary
Behavioral problems are part of many of the chronic diseases that cause the majority of illness, disability and death. Tobacco, diet, physical inactivity, alcohol, drug abuse, failure to take treatment, sleep problems, anxiety, depression, and stress are major issues, especially when chronic medical problems such as heart disease, lung disease, diabetes, or kidney disease are also present. These behavioral problems can often be helped, but the current health care system doesn't do a good job of getting the right care to these patients. Behavioral health includes mental health care, substance abuse care, health behavior change, and attention to family and other psychological and social factors. Many people with behavioral health needs present to primary care and may be referred to mental health or substance abuse specialists, but this method is often unacceptable to patients. Two newer ways have been proposed for helping these patients. In co-location, a behavioral health clinician (such as a Psychologist or Social Worker) is located in or near the primary practice to increase the chance that the patient will make it to treatment. In Integrated Behavioral Health (IBH), a Behavioral Health Clinician is specially trained to work closely with the medical provider as a full member of the primary treatment team. The research question is: Does increased integration of evidence-supported behavioral health and primary care services, compared to simple co-location of providers, improve outcomes? The key decision affected by the research is at the practice level: whether and how to use behavioral health services. The investigators plan to do a randomized, parallel group clustered study of 3,000 subjects in 40 practices with co-located behavioral health services. Practices randomized to the active intervention will convert to IBH using a practice improvement method that has helped in other settings. The investigators will measure the health status of patients in each practice before and after they start using IBH. The investigators will compare the change in those outcomes to health status changes of patients in practices who have not yet started using IBH. The investigators plan to study adults who have both medical and behavioral problems, and get their care in Family Medicine clinics, General Internal Medicine practices, and Community Health Centers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedOctober 5, 2021
September 1, 2021
5.5 years
August 9, 2016
September 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
PROMIS-29 v2
Change in general health
24 months
Secondary Outcomes (12)
CAHPS 12-Month PCMH Adult Questionnaire 2.0
24 months
Consultation and Relational Empathy measure
24 months
Patient Activation Measure-13
24 months
Modified Self-reported Medication-taking Scale
24 months
Patient Report of Utilization
24 months
- +7 more secondary outcomes
Other Outcomes (6)
Staff Burnout
24 months
Practice Integration Profile
24 months
Costs of Implementation
24 months
- +3 more other outcomes
Study Arms (2)
Integration
EXPERIMENTALThe intervention consists of training for practice leaders, BHCs, PCPs, and office staff, a Protocolized Redesign Process support for practice redesign, and a toolkit of suggested tactics for implementing Tasks A through D: A. Identification B. Assessment C. Treatment D. Surveillance
Co-Location
NO INTERVENTIONA Behavioral Health Clinician (BHC) such as a psychologist or counselor is housed in or near the primary care practice.
Interventions
The intervention consists of training for practice leaders, BHCs, PCPs, and office staff, a Protocolized Redesign Process support for practice redesign, and a toolkit of suggested tactics for implementing Tasks A through D: A. Identification B. Assessment C. Treatment D. Surveillance
Eligibility Criteria
You may qualify if:
- Over 18 years of age
- At least one target chronic medical condition:
- arthritis
- asthma
- chronic obstructive lung disease
- diabetes
- heart failure
- or hypertension.
- Evidence of a behavioral problem or need:
- Diagnosis of:
- anxiety
- chronic pain including headache
- depression
- fibromyalgia
- insomnia
- +12 more criteria
You may not qualify if:
- Not seeking care at a participating practice
- Inability to consent due to cognitive and/or developmental impairment/delays
- Living in the same household as a previously enrolled study participant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Vermontlead
- Arizona State Universitycollaborator
- State University of New York at Buffalocollaborator
- Case Western Reserve Universitycollaborator
- DARTNetcollaborator
- National Committee for Quality Assurancecollaborator
- University of Massachusetts, Worcestercollaborator
- Patient Centered Outcomes Oriented Research Institutecollaborator
Study Sites (1)
University of Vermont
Burlington, Vermont, 05401, United States
Related Publications (8)
van Eeghen C, Soucie J, Clifton J, Hitt J, Mollis B, Rose GL, Scholle SH, Stephens KA, Zhou X, Baldwin LM. Implementation outcomes from a randomized, controlled trial of a strategy to improve integration of behavioral health and primary care services. BMC Health Serv Res. 2024 Nov 8;24(1):1361. doi: 10.1186/s12913-024-11801-7.
PMID: 39511571DERIVEDNagykaldi Z, Littenberg B, Bonnell L, Breshears R, Clifton J, Crocker A, Hitt J, Kessler R, Mollis B, Miyamoto RES, van Eeghen C. Econometric evaluation of implementing a behavioral health integration intervention in primary care settings. Transl Behav Med. 2023 Aug 11;13(8):571-580. doi: 10.1093/tbm/ibad013.
PMID: 37000706DERIVEDRose GL, Bonnell LN, Clifton J, Natkin LW, Hitt JR, O'Rourke-Lavoie J. Outcomes of Delay of Care After the Onset of COVID-19 for Patients Managing Multiple Chronic Conditions. J Am Board Fam Med. 2022 Dec 23;35(6):1081-1091. doi: 10.3122/jabfm.2022.220112R1. Epub 2022 Nov 17.
PMID: 36396416DERIVEDBonnell LN, Troy AR, Littenberg B. Exploring non-linear relationships between neighbourhood walkability and health: a cross-sectional study among US primary care patients with chronic conditions. BMJ Open. 2022 Aug 19;12(8):e061086. doi: 10.1136/bmjopen-2022-061086.
PMID: 35985786DERIVEDMa KPK, Mollis BL, Rolfes J, Au M, Crocker A, Scholle SH, Kessler R, Baldwin LM, Stephens KA. Payment strategies for behavioral health integration in hospital-affiliated and non-hospital-affiliated primary care practices. Transl Behav Med. 2022 Aug 17;12(8):878-883. doi: 10.1093/tbm/ibac053.
PMID: 35880768DERIVEDCross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.
PMID: 35514131DERIVEDvan Eeghen C, Hitt JR, Pomeroy DJ, Reynolds P, Rose GL, O'Rourke Lavoie J. Co-creating the Patient Partner Guide by a Multiple Chronic Conditions Team of Patients, Clinicians, and Researchers: Observational Report. J Gen Intern Med. 2022 Apr;37(Suppl 1):73-79. doi: 10.1007/s11606-021-07308-0. Epub 2022 Mar 29.
PMID: 35349025DERIVEDCrocker AM, Kessler R, van Eeghen C, Bonnell LN, Breshears RE, Callas P, Clifton J, Elder W, Fox C, Frisbie S, Hitt J, Jewiss J, Kathol R, Clark/Keefe K, O'Rourke-Lavoie J, Leibowitz GS, Macchi CR, McGovern M, Mollis B, Mullin DJ, Nagykaldi Z, Natkin LW, Pace W, Pinckney RG, Pomeroy D, Pond A, Postupack R, Reynolds P, Rose GL, Scholle SH, Sieber WJ, Stancin T, Stange KC, Stephens KA, Teng K, Waddell EN, Littenberg B. Integrating Behavioral Health and Primary Care (IBH-PC) to improve patient-centered outcomes in adults with multiple chronic medical and behavioral health conditions: study protocol for a pragmatic cluster-randomized control trial. Trials. 2021 Mar 10;22(1):200. doi: 10.1186/s13063-021-05133-8.
PMID: 33691772DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Littenberg, MD
University of Vermont
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 9, 2016
First Posted
August 16, 2016
Study Start
April 1, 2016
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
October 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- One year after study completion for at least one year.
- Access Criteria
- All requests will be reviewed by the project's Ancillary Studies committee to ensure scientific validity and lack of overlap with ongoing analyses.
A complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses will be made available within one year after the completion of the study. It will include a data dictionary with response and missing values defined as well as a complete set of survey instruments (excluding copyright protected material not licensed for transfer). The data will be available as an encrypted Stata data set or comma-separated file. The investigators will not make data from qualitative results available because of the potential for identifying individuals.