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

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04632238
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), New York State Office of Addiction Services and Supports (Other), UConn Health (Other)
7,950
4
2
48
1987.5
41.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Metrics-driven quality improvement (MDQI)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
7950 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Stepped Wedge Cluster Randomized Trial (SW-RCT)Stepped Wedge Cluster Randomized Trial (SW-RCT)
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Experimental: Metrics-driven quality improvement (MDQI) 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.

Outcome Measures

Primary Outcome Measures

  1. 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.]

  2. 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.]

  3. 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.]

    Clinic rates of 6-month client retention in care

  4. 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.]

  5. 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.]

  6. 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.]

  7. Change in Health Status [Assessed from the start of each clinic in the intervention to 1 year post-intervention]

    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.

Secondary Outcome Measures

  1. Cost of treatment [Assessed from commencement of the intervention at each clinic to 1 year post-intervention]

    Cost of the intervention to the clinic

  2. Change in clinic-level rates of clients with Severe OUD [Assessed from commencement of the intervention at each clinic to 1 year post-intervention]

    As indicated by daily use and/or injection drug use as indicated in state administrative admission data

  3. Change in clinic level-rates of clients identified as homeless [Assessed from commencement of the intervention at each clinic to 1 year post-intervention]

    As indicated in state administrative admission data

  4. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samaritan Rockland - Outpatient Program Blauvelt New York United States 10913
2 Samaritan Queens - Jamaica IOP Jamaica New York United States 11435
3 Samaritan Daytop Village Harlem - Outpatient Program New York New York United States 10027
4 Upper Manhattan Addiction Treatment Services Program New York New York United States 10031

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Charles Neighbors, PhD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04632238
Other Study ID Numbers:
  • 20-00776
First Posted:
Nov 17, 2020
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2022