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Recovery Management Checkups for Primary Care Experiment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03746756
Acronym
RMC-PC
Enrollment
266
Registered
2018-11-20
Start date
2017-10-01
Completion date
2022-02-28
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

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.

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.

Interventions

BEHAVIORALSBIRT

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.

BEHAVIORALSBIRT+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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Chestnut Health Systems
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Days from enrollment to first alcohol or other drug (AOD) treatment in the 12 months after enrollment12 months post enrollmentDays 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 enrollment12 months post treatmentAny 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 enrollment12 months post enrollmentDays 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

MeasureTime frameDescription
AOD related problems12 months post study enrollmenta count of past quarter and past year symptoms of substance use disorders
Days of alcohol use12 months post study enrollmentDays of any alcohol use each quarter and over the 12 months after study enrollment
Health Care Utilization Costs12 months post study enrollmentThe 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.
Days of heavy alcohol use12 months post study enrollmentDays of any alcohol use each quarter and over the 12 months after study enrollment
Days of other drug use12 months post study enrollmentDays of any drug use each quarter and over the 12 month after study enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026