Michigan SPARC Trial

NCT ID: NCT04861792

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-03-13

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Drinking Alcohol Use Disorder (AUD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

Patients seen before the intervention launch date.

Group Type NO_INTERVENTION

No interventions assigned to this group

Quality Improvement Intervention

Patients seen after the intervention launch date.

Group Type EXPERIMENTAL

Michigan SPARC Quality Improvement Intervention

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ) - Funder

UNKNOWN

Sponsor Role collaborator

Altarum Institute

UNKNOWN

Sponsor Role collaborator

NORC at the University of Chicago

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Altarum Institute

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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R18HS027076

Identifier Type: AHRQ

Identifier Source: org_study_id

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