Recovery Management Checkups for Primary Care Experiment

Substance Use Disorders Clinical Trial

— RMC-PC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746756
• Other study ID #: 1119-1216
• Secondary ID: R01AA024440
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Chestnut Health Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: February 28, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Friend Family Health Center	Chicago	Illinois
United States	Heartland Alliance Health	Chicago	Illinois
United States	Christian Community Health Center	Lansing	Illinois
United States	PCC Wellness	Oak Park	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Chestnut Health Systems	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Days of alcohol use	Days of any alcohol use each quarter and over the 12 months after study enrollment	12 months post study enrollment
Secondary	Days of heavy alcohol use	Days of any alcohol use each quarter and over the 12 months after study enrollment	12 months post study enrollment
Secondary	Days of other drug use	Days of any drug use each quarter and over the 12 month after study enrollment	12 months post study enrollment
Secondary	AOD related problems	a count of past quarter and past year symptoms of substance use disorders	12 months post study enrollment
Secondary	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.	12 months post study enrollment