Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03746756
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2018-11-15
Brief Title:
Recovery Management Checkups for Primary Care Experiment
Sponsor:
Chestnut Health Systems
Organization:
Chestnut Health Systems
Study Overview
Official Title:
Recovery Management Checkups for Primary Care RMC-PC Experiment
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RMC-PC
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 OR126 p05 and who showed for treatment 12 vs 75 OR220 p0001 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 -1121 vs -2211 days d-081 p001
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
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 OR126 p05 and who showed for treatment 12 vs 75 OR220 p0001 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 -1121 vs -2211 days d-081 p001
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA024440 | NIH | None | httpsreporternihgovquickSearchR01AA024440 |