search
Back to results

Michigan SPARC Trial (MI-SPARC)

Primary Purpose

Alcohol, Drinking, Alcohol Use Disorder (AUD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Michigan SPARC Quality Improvement Intervention
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol focused on measuring Alcohol misuse, Unhealthy alcohol use, Alcoholism, Alcohol dependence, Alcohol abuse, Risky drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults age 18 years and older
  • Seen in primary care at a study practice during the practice's study period

Exclusion Criteria:

• None

Sites / Locations

  • Altarum Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Quality Improvement Intervention

Arm Description

Patients seen before the intervention launch date.

Patients seen after the intervention launch date.

Outcomes

Primary Outcome Measures

Prevention - Screening and brief intervention
The proportion of PC patients who screen positive for unhealthy alcohol use and have BI documented in their EHR.
Treatment - Prescription of AUD medications
The proportion of PC patients who are diagnosed with AUD at a visit who also receive a prescription for medications to treat AUD and are seen for follow-up within 14 days.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2021
Last Updated
March 23, 2023
Sponsor
Kaiser Permanente
Collaborators
Agency for Healthcare Research and Quality (AHRQ) - Funder, Altarum Institute, NORC at the University of Chicago
search

1. Study Identification

Unique Protocol Identification Number
NCT04861792
Brief Title
Michigan SPARC Trial
Acronym
MI-SPARC
Official Title
The Michigan Sustained Patient-centered Alcohol-Related Care (MI-SPARC) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
March 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Agency for Healthcare Research and Quality (AHRQ) - Funder, Altarum Institute, NORC at the University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Unhealthy alcohol use is a major contributor to morbidity and mortality in the US. Although effective prevention for unhealthy alcohol use and medication treatment for alcohol use disorders (AUDs) can be provided in primary care (PC), they have historically not been included in routine services. As a result, most patients do not receive evidence-based prevention or treatment for unhealthy alcohol use. Several efforts have successfully implemented alcohol-related preventive care-referred to as screening and brief intervention (SBI), but efforts to increase treatment of AUDs with medications have been less successful. Moreover, implementation efforts have usually neglected smaller PC practices, in which most PC is provided. The Michigan SPARC trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, bringing extensive expertise implementing evidence-based alcohol-related care, and Altarum Institute in Ann Arbor, Michigan, bringing demonstrated success engaging over 500 small to medium Michigan-based PC practices in effective quality improvement (QI) efforts. The project builds on Altarum's innovative approach to implementing new or improved clinical care using practice facilitators to provide continuing medical education and maintenance of certification (CME/MOC) programs to PC providers, along with ongoing support for QI using evidence-based implementation strategies. The KPWHRI team recently finished the highly successful AHRQ-funded Sustained Patient-centered Alcohol-Related Care (SPARC) trial using similar implementation strategies in KP Washington, including use of electronic health records and performance monitoring and feedback, and also developed a patient decision aid to support shared decision-making between patients with high-risk drinking and/or AUDs and their PC providers. The Michigan SPARC trial combines Altarum's expertise in QI in small-medium PC practices in Michigan with KPWHRI's expertise implementing evidence-based prevention and treatment of unhealthy alcohol use-specifically alcohol SBI and medication treatment for AUDs. Specific Aims of the Michigan SPARC trial had to be markedly modified due to the trial beginning in March 2020 at the same time as the COVID pandemic. A trial was not possible. The revised aims were to describe alcohol screening, brief intervention, AUD diagnosis and initiation of medication treatment for AUD, before and after the Michigan SPARC model was implemented, in small to medium PC practices in Michigan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol, Drinking, Alcohol Use Disorder (AUD)
Keywords
Alcohol misuse, Unhealthy alcohol use, Alcoholism, Alcohol dependence, Alcohol abuse, Risky drinking

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Originally the SPARC trial was a stepped-wedge cluster-randomized design to evaluate the Michigan SPARC quality improvement intervention compared to usual care. We converted the trial into a program evaluation due to COVID making randomization impossible (e.g., a randomly assigned, unpredictable time to implement was unacceptable in a pandemic, COVID markedly limited primary care practices interest in the trial, and some practices that enrolled closed during the project). The originally planned random assignment to receive the AUD decision aid was not possible due to the small number of participating practices during the pandemic and the need to provide all sites the decision aid to maximize engagement in the study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9590 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients seen before the intervention launch date.
Arm Title
Quality Improvement Intervention
Arm Type
Experimental
Arm Description
Patients seen after the intervention launch date.
Intervention Type
Behavioral
Intervention Name(s)
Michigan SPARC Quality Improvement Intervention
Intervention Description
Practice facilitation, electronic health record (EHR) support, performance monitoring and feedback combined with alcohol-related continuing medical education (CME) and maintenance of certification (MOC) and tools to support alcohol related care including a decision aid for shared decision making about alcohol use disorder (AUD).
Primary Outcome Measure Information:
Title
Prevention - Screening and brief intervention
Description
The proportion of PC patients who screen positive for unhealthy alcohol use and have BI documented in their EHR.
Time Frame
For Aim 1 the period up to 6 months before the launch date will be compared to the 6 month period after the launch date.
Title
Treatment - Prescription of AUD medications
Description
The proportion of PC patients who are diagnosed with AUD at a visit who also receive a prescription for medications to treat AUD and are seen for follow-up within 14 days.
Time Frame
For Aim 1 the period up to 6 months before the launch date will be compared to the 6 month period after the launch date.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults age 18 years and older Seen in primary care at a study practice during the practice's study period Exclusion Criteria: • None
Facility Information:
Facility Name
Altarum Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be shared in the following ways: External Evaluator. The Michigan SPARC investigators are committed to working with AHRQ's external evaluator (NORC) on the cross-grant evaluation. Other data sharing. We will also make de-identified data available, upon request, after Michigan SPARC trial results are completed and published. No PC practices will be identified in the dataset. Data will be available to investigators who propose a cogent analysis not already part of planned secondary analyses. Proposals must include a biosketch of the Investigator(s), as well as research question(s), sample, measures, methods and statistical issues. Proposals will be reviewed by the Multiple PIs and the leaders of the Michigan SPARC Data and Evaluation team. For approved projects, a data sharing agreement will be developed and subsequently data will be made available.

Learn more about this trial

Michigan SPARC Trial

We'll reach out to this number within 24 hrs