Clinical trial NCT04632238: Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid
Official title: Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Substance Use Disorders
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: New York State Office of Addiction Services and Supports
name: UConn Health
First posted: 2020-11-17
Enrollment: 7950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Cluster Randomized Trial (SW-RCT)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project will develop and test quality measures for and a facilitation model to help addictions treatment clinics increase use of medicines for opioid use disorders, retain clients longer in care, and help more people move into successful recovery. At the end of the project, we will have developed specific training and coaching protocols as well as electronic clinical support tools to guide quality improvement that can be disseminated within New York and the rest of the country.

The study will test a clinic-level intervention that uses external facilitators to provide guidance to addictions clinics and contain three key components: 1) training on data driven management; 2) training and guidance on patient-centered care and OUD medication; and 3) electronic tools for shared decision making and patient progress monitoring.

Detailed description: There will be 4 sources of data examined in this study: 3 at the patient level and 1 at the staff level. The sources of patient data include: 1) State administrative data from all clients receiving treatment at the enrolled clinics (\~7,950); 2) a subsample (1,200) who will be recruited directly from the clinics to complete patient-reported outcome assessments, and 3) treatment progress data for clients will also be collected.

For our administrative source of data, a final study population of approximately 7,950 individuals who are receiving treatment in the 30 enrolled outpatient treatment clinics for OUD is anticipated. Clinics will be located in the New York City metropolitan region (including Nassau, Westchester, and Rockland counties) and the Capital Region (including Albany, Rensselaer, Saratoga, Montgomery, Schenectady, and Schoharie counties). Staff at each enrolled clinic will also be interviewed and surveyed.

Eligibility criteria: Inclusion Criteria:

* Substance use disorder clinics in the regions surrounding New York City and the New York Capital Region with annual census of 50 or greater.
* All staff and patients from participating clinics will be eligible to participate in the study.
* Inclusion in the analyses using administrative data will be limited to those enrolled in Medicaid and not co-insured with Medicare (individuals ages greater than 64 and those with Federally determined disability).

Exclusion Criteria:

* Patients who are not working/being treated at substance use disorder clinics with less than 50 clients per year.

Primary outcomes:
measure: Change in clinic-level rates of initiation to OUD medications
timeFrame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
measure: Change in clinic-level rates of adherence to OUD medications
timeFrame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
measure: Retention in Care
timeFrame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
measure: Change in Incidence of Overdoses
timeFrame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
measure: Change in Incidence of Substance Use-Related Hepatitis C Infection
timeFrame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
measure: Change in Number of Emergency Room Visits
timeFrame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
measure: Change in Health Status
timeFrame: Assessed from the start of each clinic in the intervention to 1 year post-intervention
Secondary outcomes:
measure: Cost of treatment
timeFrame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
measure: Change in clinic-level rates of clients with Severe OUD
timeFrame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
measure: Change in clinic level-rates of clients identified as homeless
timeFrame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
measure: Change in clinic-rates of clients with co-existing psychiatric disorder as indicated in state administrative admission data
timeFrame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Other outcomes:
Locations:
city: Blauvelt
country: United States
facility: Samaritan Rockland - Outpatient Program
state: New York
city: Jamaica
country: United States
facility: Samaritan Queens - Jamaica IOP
state: New York
city: New York
country: United States
facility: Samaritan Daytop Village Harlem - Outpatient Program
state: New York
city: New York
country: United States
facility: Upper Manhattan Addiction Treatment Services Program
state: New York
Study officials:
affiliation: NYU Langone Health
name: Charles Neighbors, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Grady MA, Lincourt P, Greenfield B, Manseau MW, Hussain S, Genece KG, Neighbors CJ. A facilitation model for implementing quality improvement practices to enhance outpatient substance use disorder treatment outcomes: a stepped-wedge randomized controlled trial study protocol. Implement Sci. 2021 Jan 7;16(1):5. doi: 10.1186/s13012-020-01076-x.