Recovery Management Checkups for Primary Care Experiment

NCT03746756 | Completed DMC

• 2 other identifiers: 1119-1216R01AA024440
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  12 months post enrollment

Secondary Outcomes (5)

• Days of alcohol use

  12 months post study enrollment

• Days of heavy alcohol use

  12 months post study enrollment

• Days of other drug use

  12 months post study enrollment

• AOD related problems

  12 months post study enrollment

• Health Care Utilization Costs

  12 months post study enrollment

Study Arms (2)

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.

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.

Behavioral: SBIRT; Behavioral: SBIRT+RMC-PC

Interventions

SBIRT BEHAVIORAL

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-PC; SBIRT as Usual

SBIRT+RMC-PC BEHAVIORAL

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.

SBIRT + RMC-PC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scoring in the moderate to high range on the AUDIT or DAST

You may not qualify if:

• 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

Sponsors & Collaborators

• Chestnut Health Systems: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (4)

Friend Family Health Center

Chicago, Illinois, 60615, United States

Location

Heartland Alliance Health

Chicago, Illinois, 60640, United States

Location

Christian Community Health Center

Lansing, Illinois, 60438, United States

Location

PCC Wellness

Oak Park, Illinois, 60302, United States

Location

Related Publications (2)

• 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.

  PMID: 29181779 BACKGROUND

• Scott 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.

  PMID: 36208061 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 20, 2018
• Study Start: October 1, 2017
• Primary Completion: May 31, 2021
• Study Completion: February 28, 2022
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)