Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid

Substance Use Disorders Clinical Trial

Official title:

Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04632238
• Other study ID #: 20-00776
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Charles Neighbors, PhD
• Phone: 646-501-3875
• Email: Charles.Neighbors[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7950
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Metrics-driven quality improvement (MDQI)
The intervention broadly consists of training and coaching to clinic staff and leadership on 1) clinical quality measure monitoring; 2) clinical practice process change management; and 3) use of tools for shared decision making and patient treatment progress monitoring.

Locations

Country	Name	City	State
United States	Samaritan Rockland - Outpatient Program	Blauvelt	New York
United States	Samaritan Queens - Jamaica IOP	Jamaica	New York
United States	Samaritan Daytop Village Harlem - Outpatient Program	New York	New York
United States	Upper Manhattan Addiction Treatment Services Program	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Drug Abuse (NIDA), New York State Office of Addiction Services and Supports, UConn Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinic-level rates of initiation to OUD medications		Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Primary	Change in clinic-level rates of adherence to OUD medications		Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Primary	Retention in Care	Clinic rates of 6-month client retention in care	Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Primary	Change in Incidence of Overdoses		Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Primary	Change in Incidence of Substance Use-Related Hepatitis C Infection		Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Primary	Change in Number of Emergency Room Visits		Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Primary	Change in Health Status	Change in health status is measured by the first item of the SF-12 Health Survey: "In general, would you say your health is: 1 - excellent, 2 - very good, 3 - good, 4 - fair, 5 - poor". Scores range from 1-5, with a higher score indicating worse health.	Assessed from the start of each clinic in the intervention to 1 year post-intervention
Secondary	Cost of treatment	Cost of the intervention to the clinic	Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Secondary	Change in clinic-level rates of clients with Severe OUD	As indicated by daily use and/or injection drug use as indicated in state administrative admission data	Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Secondary	Change in clinic level-rates of clients identified as homeless	As indicated in state administrative admission data	Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Secondary	Change in clinic-rates of clients with co-existing psychiatric disorder as indicated in state administrative admission data		Assessed from commencement of the intervention at each clinic to 1 year post-intervention