Mental HealthBHIP-CCMNCT05997836
Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0
A study testing Implementation Facilitation and Centralized Technical Assistance in people with Mental Health, run by VA Office of Research and Development at 17 sites in United States.
Trial summary
This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Implementation Facilitation and Centralized Technical Assistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81,424 participants
- Where
- 17 sitesUnited States
- Study dates
- 14 Jul 2023to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Note that treatment assignment will be at the facility level, and given the stepped wedge design, sites in Waves 2-4 will cross over from Centralized Technical Assistance to Implementation Facilitation.
- At the provider level (for completing the TDM), the primary inclusion criterion is clinicians working on BHIP Teams at the participating medical centers.
- At the patient level (for mental health hospitalizations, costs, and all-cause mortality), the primary inclusion criterion is Veterans treated by the BHIP teams at the participating medical centers.
- Note that, for mental health hospitalizations, separate sites have been identified as comparators using a balancing algorithm.
Who cannot join
- Patients with a diagnosis of dementia in the electronic medical record.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
West Texas VA Health Care System, Big Spring, TX
Big Spring, Texas, 79720
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV
Clarksburg, West Virginia, 26301-4155
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Fayetteville VA Medical Center, Fayetteville, NC
Fayetteville, North Carolina, 28301-3856
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Huntington VA Medical Center, Huntington, WV
Huntington, West Virginia, 25704-9300
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, 38104-2127
Jackson C. Montgomery VA Medical Center, Muskogee, OK
Muskogee, Oklahoma, 74401
Orlando VA Medical Center, Orlando, FL
Orlando, Florida, 32827
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Northern Arizona VA Health Care System, Prescott, AZ
Prescott, Arizona, 86313
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153-6404
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723-0001
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05001-3833
About this study
Official title: Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0 (QUE 20-026)
This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). The investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align BHIP teams' care practices more closely with the principles of the CCM.
Read the detailed description
This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). The investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align BHIP teams' care practices more closely with the principles of the CCM.
The two primary outcomes of this project are:
- BHIP team collaboration, as evidenced by improved scores in the Role Clarity and Team Primacy dimensions of the Team Development Measure (TDM)
- BHIP team clinical effectiveness, as evidenced by reduction in mental health hospitalizations among Veterans treated by the BHIP teams that have received the two types of implementation strategies described above.
- Conditions
- Mental Health
- Being tested
- Implementation Facilitation, Centralized Technical Assistance
- Keywords
- collaborative care
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation FacilitationOther
Also called IF
Implementation Facilitation involves and External Facilitator (from outside of the participating medical center) and an Internal Facilitator (from inside the participating medical center) working together to help BHIP teams within the site adopt care practices that are more consistent with the CCM
Centralized Technical AssistanceOther
Also called CTA
Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.
| Study group | Role | What they receive |
|---|---|---|
| Wave 1 | Other | Study design is a stepped wedge; Wave 1 begins by receiving Implementation Facilitation Receives: Other: Implementation Facilitation |
| Wave 2 | Other | Study design is a stepped wedge; Wave 2 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation Receives: Other: Implementation Facilitation; Other: Centralized Technical Assistance |
| Wave 3 | Other | Study design is a stepped wedge; Wave 3 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation Receives: Other: Implementation Facilitation; Other: Centralized Technical Assistance |
| Wave 4 | Other | Study design is a stepped wedge; Wave 4 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation Receives: Other: Implementation Facilitation; Other: Centralized Technical Assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role Clarity and Team Primacy subdomains of the Team Development Measure (TDM)
The TDM is a measure of team functioning, and the two listed subdomains represent the co-primary outcome for the study. Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance administration of the TDM. Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
Measured: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
Mental health hospitalization rate among Veterans treated within each BHIP team.
Mental health hospitalizations represent a measure of clinical effectiveness (co-primary outcome for the study). Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance calculation of the mental health hospitalization rate. Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
Measured: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
Secondary outcomes (3)
Treatment cost
The investigators will calculate estimated treatment costs for Veterans treated by participating BHIP teams. Note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
Measured: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
All-cause mortality
The investigators will calculate all-cause mortality for Veterans treated by participating BHIP teams. Note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
Measured: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
Treatment costs and hospitalization data compared to non-intervention sites
For mental health hospitalization and treatment costs, the investigators will compare results from intervention sites to other sites that did not undergo implementation facilitation (i.e. sites from outside the trial that are similar to intervention sites on variables like facility complexity and urban/rural location).
Measured: Post-facilitation (8 months after start of implementation facilitation) and post-sustainment (12 months after post-facilitation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start14 Jul 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This study will use a stepped wedge design, with participating medical centers assigned to one of four different waves. Wave 1 will begin the trial receiving implementation facilitation. Waves 2-4 will begin the trial receiving centralized technical assistance, and will then cross over to implementation facilitation.
- Masking
- None (open label)
- Enrolment
- 81,424 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs Office of Mental Health and Suicide Prevention
- Responsible party
- Sponsor
- Investigators
- Christopher J. Miller, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MASara J. Landes, PhD MA BA, Principal investigator, Central Arkansas Veterans Healthcare System , Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997836
- Sponsor's protocol ID
- QUX 23-002
- Acronym
- BHIP-CCM
- Status last verified
- Nov 2024
- First submitted
- 1 Aug 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller CJ, Sullivan JL, Stolzmann K, Raciborski RA, Brown M, Bailey HM, Connolly SL, Morena AL, Dougherty M, Henderson A, Rehmert A, Sippel LM, Kim B. Implementing the collaborative chronic care model for mental health: a nonrandomized clinical trial. Implement Sci Commun. 2026 Jun 22. doi: 10.1186/s43058-026-00995-y. Online ahead of print.
PubMed 42332779
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0 (QUE 20-026)
- ClinicalTrials.gov ID
- NCT05997836
- Acronym / sponsor ID
- BHIP-CCM / QUX 23-002
- Conditions
- Mental Health
- Keywords
- collaborative care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81,424 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- US Department of Veterans Affairs Office of Mental Health and Suicide Prevention
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 18 Aug 2023 (actual)
- 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.
This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). The investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align BHIP teams' care practices more closely with the principles of the CCM.
Detailed description
This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). The investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align BHIP teams' care practices more closely with the principles of the CCM.
The two primary outcomes of this project are:
- BHIP team collaboration, as evidenced by improved scores in the Role Clarity and Team Primacy dimensions of the Team Development Measure (TDM)
- BHIP team clinical effectiveness, as evidenced by reduction in mental health hospitalizations among Veterans treated by the BHIP teams that have received the two types of implementation strategies described above.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study will use a stepped wedge design, with participating medical centers assigned to one of four different waves. Wave 1 will begin the trial receiving implementation facilitation. Waves 2-4 will begin the trial receiving centralized technical assistance, and will then cross over to implementation facilitation.
| Arm | Type | Receives |
|---|---|---|
| Wave 1 | Other | Other: Implementation FacilitationStudy design is a stepped wedge; Wave 1 begins by receiving Implementation Facilitation |
| Wave 2 | Other | Other: Implementation Facilitation, Other: Centralized Technical AssistanceStudy design is a stepped wedge; Wave 2 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation |
| Wave 3 | Other | Other: Implementation Facilitation, Other: Centralized Technical AssistanceStudy design is a stepped wedge; Wave 3 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation |
| Wave 4 | Other | Other: Implementation Facilitation, Other: Centralized Technical AssistanceStudy design is a stepped wedge; Wave 4 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Note that treatment assignment will be at the facility level, and given the stepped wedge design, sites in Waves 2-4 will cross over from Centralized Technical Assistance to Implementation Facilitation.
- At the provider level (for completing the TDM), the primary inclusion criterion is clinicians working on BHIP Teams at the participating medical centers.
- At the patient level (for mental health hospitalizations, costs, and all-cause mortality), the primary inclusion criterion is Veterans treated by the BHIP teams at the participating medical centers.
- Note that, for mental health hospitalizations, separate sites have been identified as comparators using a balancing algorithm.
Key exclusion criteria (1 listed)
- Patients with a diagnosis of dementia in the electronic medical record.
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 FacilitationAlso: IFImplementation Facilitation involves and External Facilitator (from outside of the participating medical center) and an Internal Facilitator (from inside the participating medical center) working together to help BHIP teams within the site adopt care practices that are more consistent with the CCM | Other | Wave 1, Wave 2, Wave 3, Wave 4 |
| Centralized Technical AssistanceAlso: CTACentralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices. | Other | Wave 2, Wave 3, Wave 4 |
Primary outcome
Role Clarity and Team Primacy subdomains of the Team Development Measure (TDM)
Time frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
The TDM is a measure of team functioning, and the two listed subdomains represent the co-primary outcome for the study. Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance administration of the TDM. Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
Mental health hospitalization rate among Veterans treated within each BHIP team.
Time frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
Mental health hospitalizations represent a measure of clinical effectiveness (co-primary outcome for the study). Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance calculation of the mental health hospitalization rate. Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration). Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
3 secondary outcomes
Treatment cost
Time frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
All-cause mortality
Time frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
Treatment costs and hospitalization data compared to non-intervention sites
Time frame: Post-facilitation (8 months after start of implementation facilitation) and post-sustainment (12 months after post-facilitation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Derived from this study: PubMed 42332779Miller CJ, Sullivan JL, Stolzmann K, Raciborski RA, Brown M, Bailey HM, Connolly SL, Morena AL, Dougherty M, Henderson A, Rehmert A, Sippel LM, Kim B. Implementing the collaborative chronic care model for mental health: a nonrandomized clinical trial. Implement Sci Commun. 2026 Jun 22. doi: 10.1186/s43058-026-00995-y. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Christopher J. Miller, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Sara J. Landes, PhD MA BA principal investigator
Central Arkansas Veterans Healthcare System , Little Rock, AR
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Facilitation and Centralized Technical Assistance in people with Mental Health, run by VA Office of Research and Development at 17 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 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
This study is still under way. Results are not available in the source record yet.
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?
Role Clarity and Team Primacy subdomains of the Team Development Measure (TDM) (time frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).). The study lists 2 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 NCT05997836, which also lists 1 linked publication.
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 6 Nov 2024.