Substance Use DisordersRMC-PCNCT03746756
Recovery Management Checkups for Primary Care Experiment
A study testing SBIRT and SBIRT+RMC-PC in people with Substance Use Disorders, run by Chestnut Health Systems at 4 sites in United States.
Trial summary
National data show that only 8% of people with past-year substance use disorders (SUD) received any treatment for these disorders in the past year, resulting in high costs, both in terms of their own health and functioning and costs to society. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- SBIRT and SBIRT+RMC-PC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2017to 28 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scoring in the moderate to high range on the AUDIT or DAST
Who cannot join
- under 18
- a non-resident of Chicago or plan to move outside of Chicago within 12 months
- sentenced to a confined environment most of the next 12 months
- mandated to treatment because of a driving under the influence offense
- not fluent in English or Spanish
- cognitively unable to provide informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Friend Family Health Center
Chicago, Illinois, 60615
Heartland Alliance Health
Chicago, Illinois, 60640
Christian Community Health Center
Lansing, Illinois, 60438
PCC Wellness
Oak Park, Illinois, 60302
About this study
Official title: Recovery Management Checkups for Primary Care (RMC-PC) Experiment
National data show that only 8% of people with past-year substance use disorders (SUD) received any treatment for these disorders in the past year, resulting in high costs, both in terms of their own health and functioning and costs to society. Pilot work demonstrates that the proposed intervention has the potential to significantly increase SUD treatment engagement among patients with SUD within Federally Qualified Health Centers (FQHCs), and thereby reduce substance use and other related consequences. This project is being done in close collaboration with several FQHC providers to facilitate the potential for subsequent dissemination to other FQHCs and primary care settings.
Read the detailed description
Individuals with substance use disorders (SUDs) can be readily identified within primary care settings, but current interventions are not effective at linking them to SUD treatment. Patient and system level barriers present significant challenges and new, more robust, linkage models are needed that can successfully overcome the barriers. Identifying more effective linkage models is a priority within addiction health services, since untreated individuals with SUDs have poorer health and employment outcomes over time as well as use significantly more acute care services, resulting in substantially higher medical costs, compared with those who receive SUD treatment.
Results from three clinical trials conducted by the applicant team have demonstrated the effectiveness of Recovery Management Checkups (RMC) as a linkage model for individuals needing SUD treatment. Moreover, RMC participants were significantly more likely to enter treatment, enter sooner, and stay longer, having fewer days of use and fewer SUD symptoms. Outcomes were also associated with lower health care utilization, decreased criminal activity, and substantial savings to society, thereby offsetting the costs of additional treatment. RMC was modified for primary care (RMC-PC) and pilot results conducted in Federally Qualified Health Centers (FQHCs) indicated RMC-PC significantly increased the number of patients who agreed to go to treatment (72% vs. 97%; OR=12.6, p<.05) and who showed for treatment (12% vs. 75%, OR=22.0, p<.0001). Moreover, relative to patients in these same settings who received the usual referral condition, those who received RMC-PC had significantly greater reductions (post-pre) in their past-month days of any illicit drug use or misuse of prescription medications (-11.21 vs -22.11 days, d=-0.81, p<.001).
In this trial, investigators will: a) recruit 300 adult patients with SUD through SBIRT programs in 4 FQHC sites, b) randomly assign half to a referral as usual control and half to RMC-PC, and c) conduct quarterly follow-ups for 12-months post enrollment. Hypotheses include: H1 Relative to the control patients, patients receiving RMC-PC will be more likely to: a) initiate SUD treatment sooner, b) receive any SUD treatment, and c) receive more days of SUD treatment. H2. Relative to the control patients, patients receiving RMC-PC and those who receive more SUD treatment will report fewer days of: a) any alcohol use, b) use of illicit drugs or misuse of prescription medications, c) any substance use, and d) SUD problems. H3. The days of treatment will mediate the relationship between RMC-PC and changes in the pre and post measures of the dependent variables in H2.
- Conditions
- Substance Use Disorders
- Being tested
- SBIRT, SBIRT+RMC-PC
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRTBehavioural
As part of regular practice FQHC screen patients at least once a year with the Alcohol Use Disorders Identification Test (AUDIT) to identify alcohol problems and Drug Abuse Screening Test (DAST) to identify drug problems. Those who are the most severed and "referred to treatment" are approached about participating in the study.
SBIRT+RMC-PCBehavioural
In addition to SBIRT, those randomly assigned to the experimental condition will also receive Recovery Management Checkups for Primary Care (RMC-PC) at the time of referral/study enrollment and quarterly for 12 months. RMC-PC involves a linkage manager reviewing the assessment data and using motivational interviewing to encourage the person to go to treatment and identify barriers to entering or staying in treatment. It also involves problem solving on how to address common issues (e.g., transportation, scheduling), staying in regular contact for the first two weeks to make sure they stay in treatment, and checking in on continuing care compliance at later checkups.
| Study group | Role | What they receive |
|---|---|---|
| SBIRT as Usual | Experimental | The follow-up team will (a) contact participants within 24-48 hours to collect additional locator information and mailing a schedule card for the next interview, (b) receipt information in a management information system (MIS), (c) assign each case to a follow-up case tracker, (d) verify locator data, (e) conduct outreach for unverified cases and discussing them at weekly meetings, (f) mail thank-you cards to participants and collaterals, (g) schedule follow-up appointments, (h) mail 3 and 6 week post-enrollment flyers, (i) implement returned-mail procedures, (j) call participants 6 weeks before appointment to confirm date and location (phone vs. research office), (k) conduct outreach for unconfirmed cases and review them at weekly meetings, (l) complete follow-up interviews and scheduling next appointments, and (m) implement a no-show protocol. Receives: Behavioral: SBIRT |
| SBIRT + RMC-PC | Experimental | Patients will receive SBIRT plus the RMC protocol. The Linkage Manager (LM) will: 1) provide personalized feedback to participants about the status of their condition based on responses from the Global Appraisal of Individual Needs Quick version 3 (GAIN-Q3), 2) help participants resolve ambivalence about their dependence and moving them toward a commitment to change by accessing additional care, 3) address existing barriers to treatment, 4) schedule an assessment, and 5) facilitate reentry and engagement. The LM will stay in contact 2-3 times per week for two weeks to ensure that individuals both initiate and remain engaged in treatment. Receives: Behavioral: SBIRT; Behavioral: SBIRT+RMC-PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days from enrollment to first alcohol or other drug (AOD) treatment in the 12 months after enrollment
Days from enrollment to first alcohol or other drug (AOD) treatment in the 12 months after enrollment, measured with the Global Appraisal of Individual Needs Quick version 3 (GAIN-Q3)
Measured: 12 months post enrollment
Any alcohol or other drug (AOD) treatment in the 12 months after enrollment
Any alcohol or other drug (AOD) treatment in the 12 months after enrollment, dichotomized from days of treatment measured with the Global Appraisal of Individual Needs Quick version 3 (GAIN-Q3)
Measured: 12 months post treatment
Days of alcohol or other drug (AOD) treatment in the 12 months after enrollment
Days of alcohol or other drug (AOD) treatment in the 12 months after enrollment, measured with the Global Appraisal of Individual Needs Quick version 3 (GAIN-Q3)
Measured: 12 months post enrollment
Secondary outcomes (5)
Days of alcohol use
Days of any alcohol use each quarter and over the 12 months after study enrollment
Measured: 12 months post study enrollment
Days of heavy alcohol use
Days of any alcohol use each quarter and over the 12 months after study enrollment
Measured: 12 months post study enrollment
Days of other drug use
Days of any drug use each quarter and over the 12 month after study enrollment
Measured: 12 months post study enrollment
AOD related problems
a count of past quarter and past year symptoms of substance use disorders
Measured: 12 months post study enrollment
Health Care Utilization Costs
The number of units of 11 types of health care utilization (e.g., health, mental or substance related emergency room visits, nights in a hospital/residential program, outpatient, and outpatient surgery) times their unit costs as estimated by economists.
Measured: 12 months post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Oct 2017
- Primary completion31 May 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compares Screening, Brief Intervention and Referral to Treatment (SBIRT) as currently practiced at federal qualified health centers (FQHC) as a practice as usual comparison group vs. SBIRT+ Recovery Management Checkups for Primary Care at the time of referral and quarterly for 12 months.
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Dennis Watson, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746756
- Sponsor's protocol ID
- 1119-1216
- Other IDs
- R01AA024440
- Acronym
- RMC-PC
- Status last verified
- Jul 2024
- First submitted
- 15 Nov 2018
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scott CK, Grella CE, Dennis ML, Nicholson L. Linking Individuals with Substance Use Disorders (SUDs) in Primary Care to SUD Treatment: the Recovery Management Checkups-Primary Care (RMC-PC) Pilot Study. J Behav Health Serv Res. 2018 Apr;45(2):160-173. doi: 10.1007/s11414-017-9576-5.
PubMed 29181779Kahn JH, Hart MK, Watson DP, Allen CB, Singh RR, Grella CE, Dennis ML. Recent incarceration and minoritized racial status as barriers to the effectiveness of recovery management checkups. Subst Abuse Treat Prev Policy. 2025 Dec 29;20(1):53. doi: 10.1186/s13011-025-00684-4.
PubMed 41462312Scott CK, Dennis ML, Grella CE, Watson DP, Davis JP, Hart MK. Using recovery management checkups for primary care to improve linkage to alcohol and other drug use treatment: a randomized controlled trial three month findings. Addiction. 2023 Mar;118(3):520-532. doi: 10.1111/add.16064. Epub 2022 Oct 29.
PubMed 36208061
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Management Checkups for Primary Care (RMC-PC) Experiment
- ClinicalTrials.gov ID
- NCT03746756
- Acronym / sponsor ID
- RMC-PC / 1119-1216
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 20 Nov 2018 (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.
National data show that only 8% of people with past-year substance use disorders (SUD) received any treatment for these disorders in the past year, resulting in high costs, both in terms of their own health and functioning and costs to society. Pilot work demonstrates that the proposed intervention has the potential to significantly increase SUD treatment engagement among patients with SUD within Federally Qualified Health Centers (FQHCs), and thereby reduce substance use and other related consequences. This project is being done in close collaboration with several FQHC providers to facilitate the potential for subsequent dissemination to other FQHCs and primary care settings.
Detailed description
Individuals with substance use disorders (SUDs) can be readily identified within primary care settings, but current interventions are not effective at linking them to SUD treatment. Patient and system level barriers present significant challenges and new, more robust, linkage models are needed that can successfully overcome the barriers. Identifying more effective linkage models is a priority within addiction health services, since untreated individuals with SUDs have poorer health and employment outcomes over time as well as use significantly more acute care services, resulting in substantially higher medical costs, compared with those who receive SUD treatment.
Results from three clinical trials conducted by the applicant team have demonstrated the effectiveness of Recovery Management Checkups (RMC) as a linkage model for individuals needing SUD treatment. Moreover, RMC participants were significantly more likely to enter treatment, enter sooner, and stay longer, having fewer days of use and fewer SUD symptoms. Outcomes were also associated with lower health care utilization, decreased criminal activity, and substantial savings to society, thereby offsetting the costs of additional treatment. RMC was modified for primary care (RMC-PC) and pilot results conducted in Federally Qualified Health Centers (FQHCs) indicated RMC-PC significantly increased the number of patients who agreed to go to treatment (72% vs. 97%; OR=12.6, p<.05) and who showed for treatment (12% vs. 75%, OR=22.0, p<.0001). Moreover, relative to patients in these same settings who received the usual referral condition, those who received RMC-PC had significantly greater reductions (post-pre) in their past-month days of any illicit drug use or misuse of prescription medications (-11.21 vs -22.11 days, d=-0.81, p<.001).
In this trial, investigators will: a) recruit 300 adult patients with SUD through SBIRT programs in 4 FQHC sites, b) randomly assign half to a referral as usual control and half to RMC-PC, and c) conduct quarterly follow-ups for 12-months post enrollment. Hypotheses include: H1 Relative to the control patients, patients receiving RMC-PC will be more likely to: a) initiate SUD treatment sooner, b) receive any SUD treatment, and c) receive more days of SUD treatment. H2. Relative to the control patients, patients receiving RMC-PC and those who receive more SUD treatment will report fewer days of: a) any alcohol use, b) use of illicit drugs or misuse of prescription medications, c) any substance use, and d) SUD problems. H3. The days of treatment will mediate the relationship between RMC-PC and changes in the pre and post measures of the dependent variables in H2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Compares Screening, Brief Intervention and Referral to Treatment (SBIRT) as currently practiced at federal qualified health centers (FQHC) as a practice as usual comparison group vs. SBIRT+ Recovery Management Checkups for Primary Care at the time of referral and quarterly for 12 months.
| Arm | Type | Receives |
|---|---|---|
| SBIRT as Usual | Experimental | Behavioral: SBIRTThe follow-up team will (a) contact participants within 24-48 hours to collect additional locator information and mailing a schedule card for the next interview, (b) receipt information in a management information system (MIS), (c) assign each case to a follow-up case tracker, (d) verify locator data, (e) conduct outreach for unverified cases and discussing them at weekly meetings, (f) mail thank-you cards to participants and collaterals, (g) schedule follow-up appointments, (h) mail 3 and 6 week post-enrollment flyers, (i) implement returned-mail procedures, (j) call participants 6 weeks before appointment to confirm date and location (phone vs. research office), (k) conduct outreach for unconfirmed cases and review them at weekly meetings, (l) complete follow-up interviews and scheduling next appointments, and (m) implement a no-show protocol. |
| SBIRT + RMC-PC | Experimental | Behavioral: SBIRT, Behavioral: SBIRT+RMC-PCPatients will receive SBIRT plus the RMC protocol. The Linkage Manager (LM) will: 1) provide personalized feedback to participants about the status of their condition based on responses from the Global Appraisal of Individual Needs Quick version 3 (GAIN-Q3), 2) help participants resolve ambivalence about their dependence and moving them toward a commitment to change by accessing additional care, 3) address existing barriers to treatment, 4) schedule an assessment, and 5) facilitate reentry and engagement. The LM will stay in contact 2-3 times per week for two weeks to ensure that individuals both initiate and remain engaged in treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scoring in the moderate to high range on the AUDIT or DAST
Key exclusion criteria (6 listed)
- under 18
- a non-resident of Chicago or plan to move outside of Chicago within 12 months
- sentenced to a confined environment most of the next 12 months
- mandated to treatment because of a driving under the influence offense
- not fluent in English or Spanish
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 |
|---|---|---|
| SBIRTAs part of regular practice FQHC screen patients at least once a year with the Alcohol Use Disorders Identification Test (AUDIT) to identify alcohol problems and Drug Abuse Screening Test (DAST) to identify drug problems. Those who are the most severed and "referred to treatment" are approached about participating in the study. | Behavioural | SBIRT + RMC-PC, SBIRT as Usual |
| SBIRT+RMC-PCIn addition to SBIRT, those randomly assigned to the experimental condition will also receive Recovery Management Checkups for Primary Care (RMC-PC) at the time of referral/study enrollment and quarterly for 12 months. RMC-PC involves a linkage manager reviewing the assessment data and using motivational interviewing to encourage the person to go to treatment and identify barriers to entering or staying in treatment. It also involves problem solving on how to address common issues (e.g., transportation, scheduling), staying in regular contact for the first two weeks to make sure they stay in treatment, and checking in on continuing care compliance at later checkups. | Behavioural | SBIRT + RMC-PC |
Primary outcome
Days from enrollment to first alcohol or other drug (AOD) treatment in the 12 months after enrollment
Time frame: 12 months post enrollment
Days from enrollment to first alcohol or other drug (AOD) treatment in the 12 months after enrollment, measured with the Global Appraisal of Individual Needs Quick version 3 (GAIN-Q3)
Any alcohol or other drug (AOD) treatment in the 12 months after enrollment
Time frame: 12 months post treatment
Any alcohol or other drug (AOD) treatment in the 12 months after enrollment, dichotomized from days of treatment measured with the Global Appraisal of Individual Needs Quick version 3 (GAIN-Q3)
Days of alcohol or other drug (AOD) treatment in the 12 months after enrollment
Time frame: 12 months post enrollment
Days of alcohol or other drug (AOD) treatment in the 12 months after enrollment, measured with the Global Appraisal of Individual Needs Quick version 3 (GAIN-Q3)
5 secondary outcomes
Days of alcohol use
Time frame: 12 months post study enrollment
Days of heavy alcohol use
Time frame: 12 months post study enrollment
Days of other drug use
Time frame: 12 months post study enrollment
AOD related problems
Time frame: 12 months post study enrollment
Health Care Utilization Costs
Time frame: 12 months post study enrollment
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 15 Jul 2024.
- Background: PubMed 29181779Scott CK, Grella CE, Dennis ML, Nicholson L. Linking Individuals with Substance Use Disorders (SUDs) in Primary Care to SUD Treatment: the Recovery Management Checkups-Primary Care (RMC-PC) Pilot Study. J Behav Health Serv Res. 2018 Apr;45(2):160-173. doi: 10.1007/s11414-017-9576-5.
- Derived from this study: PubMed 41462312Kahn JH, Hart MK, Watson DP, Allen CB, Singh RR, Grella CE, Dennis ML. Recent incarceration and minoritized racial status as barriers to the effectiveness of recovery management checkups. Subst Abuse Treat Prev Policy. 2025 Dec 29;20(1):53. doi: 10.1186/s13011-025-00684-4.
- Derived from this study: PubMed 36208061Scott CK, Dennis ML, Grella CE, Watson DP, Davis JP, Hart MK. Using recovery management checkups for primary care to improve linkage to alcohol and other drug use treatment: a randomized controlled trial three month findings. Addiction. 2023 Mar;118(3):520-532. doi: 10.1111/add.16064. Epub 2022 Oct 29.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBIRT and SBIRT+RMC-PC in people with Substance Use Disorders, run by Chestnut Health Systems at 4 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 6 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 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Days from enrollment to first alcohol or other drug (AOD) treatment in the 12 months after enrollment (time frame: 12 months post enrollment). The study lists 3 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 NCT03746756, which also lists 3 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 15 Jul 2024.