Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid
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| ClinicalTrials.gov Identifier: NCT04632238 |
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Recruitment Status :
Recruiting
First Posted : November 17, 2020
Last Update Posted : June 11, 2021
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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 |
|---|---|---|
| Opioid-use Disorder Substance Use Disorders | Behavioral: Metrics-driven quality improvement (MDQI) | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 7950 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | 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 : | July 1, 2020 |
| Estimated Primary Completion Date : | June 30, 2024 |
| Estimated Study Completion Date : | June 30, 2024 |
| 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. |
- 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. ]
- 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. ]
- 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
- 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. ]
- 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. ]
- 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. ]
- 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.
- 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
- 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
- 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
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632238
| Contact: Charles Neighbors, PhD | 646-501-3875 | Charles.Neighbors@nyulangone.org | |
| Contact: Megan O'Grady, PhD | 860-679-5483 | ogrady@uchc.edu |
| United States, New York | |
| Samaritan Rockland - Outpatient Program | Recruiting |
| Blauvelt, New York, United States, 10913 | |
| Contact: Carolann Slattery carolann.slattery@samaritanvillage.org | |
| Principal Investigator: Charles Neighbors, PhD | |
| Samaritan Queens - Jamaica IOP | Recruiting |
| Jamaica, New York, United States, 11435 | |
| Contact: Carolann Slattery carolann.slattery@samaritanvillage.org | |
| Principal Investigator: Charles Neighbors, PhD | |
| Samaritan Daytop Village Harlem - Outpatient Program | Recruiting |
| New York, New York, United States, 10027 | |
| Contact: Carolann Slattery carolann.slattery@samaritanvillage.org | |
| Principal Investigator: Charles Neighbors, PhD | |
| Upper Manhattan Addiction Treatment Services Program | Recruiting |
| New York, New York, United States, 10031 | |
| Contact: Kristy Rodriguez krodriguez@bowencsc.org | |
| Principal Investigator: Charles Neighbors, PhD | |
| Principal Investigator: | Charles Neighbors, PhD | NYU Langone Health |
| Responsible Party: | NYU Langone Health |
| ClinicalTrials.gov Identifier: | NCT04632238 |
| Other Study ID Numbers: |
20-00776 |
| First Posted: | November 17, 2020 Key Record Dates |
| Last Update Posted: | June 11, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Individual participant data that underlie the results reported in this article resulting from surveys only, after deidentification (text, tables, figures, and appendices), will be available. Client outcome data from State administrative data files will not be available for sharing due to the nature of the data security agreements. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. |
| Access Criteria: | The investigator who proposed to use the data upon reasonable request. Requests should be directed to Charles.Neighbors@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Disease Substance-Related Disorders Opioid-Related Disorders Pathologic Processes Chemically-Induced Disorders Mental Disorders |
Narcotic-Related Disorders Metronidazole Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents |