Michigan SPARC Trial (MI-SPARC)

March 23, 2023 updated by: Kaiser Permanente

The Michigan Sustained Patient-centered Alcohol-Related Care (MI-SPARC) Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9590

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Altarum Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Patients seen before the intervention launch date.
Experimental: Quality Improvement Intervention
Patients seen after the intervention launch date.
Behavioral: Michigan SPARC Quality Improvement Intervention
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention - Screening and brief intervention
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.
The proportion of PC patients who screen positive for unhealthy alcohol use and have BI documented in their EHR.
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.
Treatment - Prescription of AUD medications
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

NORC at the University of Chicago
Agency for Healthcare Research and Quality (AHRQ) - Funder
Altarum Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18HS027076 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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