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Completed

NCT Number: NCT04632238

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samaritan Rockland - Outpatient Program, Blauvelt, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metrics-driven quality improvement (MDQI)

Behavioral

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.

Primary outcomes

  1. Change in clinic-level rates of initiation to OUD medications

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Cost of treatment

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2020
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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