Clinical trial NCT03746756: Recovery Management Checkups for Primary Care Experiment
Official title: Recovery Management Checkups for Primary Care (RMC-PC) Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-11-20
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Days from enrollment to first alcohol or other drug (AOD) treatment in the 12 months after enrollment
timeFrame: 12 months post enrollment
measure: Any alcohol or other drug (AOD) treatment in the 12 months after enrollment
timeFrame: 12 months post treatment
measure: Days of alcohol or other drug (AOD) treatment in the 12 months after enrollment
timeFrame: 12 months post enrollment
Secondary outcomes:
measure: Days of alcohol use
timeFrame: 12 months post study enrollment
measure: Days of heavy alcohol use
timeFrame: 12 months post study enrollment
measure: Days of other drug use
timeFrame: 12 months post study enrollment
measure: AOD related problems
timeFrame: 12 months post study enrollment
measure: Health Care Utilization Costs
timeFrame: 12 months post study enrollment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Friend Family Health Center
state: Illinois
city: Chicago
country: United States
facility: Heartland Alliance Health
state: Illinois
city: Lansing
country: United States
facility: Christian Community Health Center
state: Illinois
city: Oak Park
country: United States
facility: PCC Wellness
state: Illinois
Study officials:
References:
citation: 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.