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Recovery Management Checkups for Primary Care Experiment (RMC-PC)

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ClinicalTrials.gov Identifier: NCT03746756
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Christy Scott, Chestnut Health Systems

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: SBIRT Behavioral: SBIRT+RMC-PC Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Recovery Management Checkups for Primary Care (RMC-PC) Experiment
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : February 28, 2022

Arm Intervention/treatment
Experimental: SBIRT as Usual
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
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.

Experimental: SBIRT + RMC-PC
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
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.

Behavioral: SBIRT+RMC-PC
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.




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. Days of alcohol use [ Time Frame: 12 months post study enrollment ]
    Days of any alcohol use each quarter and over the 12 months after study enrollment

  2. Days of heavy alcohol use [ Time Frame: 12 months post study enrollment ]
    Days of any alcohol use each quarter and over the 12 months after study enrollment

  3. Days of other drug use [ Time Frame: 12 months post study enrollment ]
    Days of any drug use each quarter and over the 12 month after study enrollment

  4. AOD related problems [ Time Frame: 12 months post study enrollment ]
    a count of past quarter and past year symptoms of substance use disorders

  5. Health Care Utilization Costs [ Time Frame: 12 months post study enrollment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746756


Contacts
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Contact: Christy K Scott, PhD 3122745306 cscott@chestnut.org
Contact: Michael L Dennis, PhD 3094517801 mdennis@chestnut.org

Locations
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United States, Illinois
Friend Family Health Center Recruiting
Chicago, Illinois, United States, 60615
Heartland Alliance Health Recruiting
Chicago, Illinois, United States, 60640
Christian Community Health Center Recruiting
Lansing, Illinois, United States, 60438
PCC Wellness Recruiting
Oak Park, Illinois, United States, 60302
Sponsors and Collaborators
Chestnut Health Systems
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications:
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Responsible Party: Christy Scott, Director of Research and Development, Chestnut Health Systems
ClinicalTrials.gov Identifier: NCT03746756     History of Changes
Other Study ID Numbers: 1119-1216
R01AA024440 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders