An interventional study of Michigan SPARC Quality Improvement Intervention in Alcohol, Drinking and Alcohol Use Disorder (AUD), sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 9,590 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
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Exclusion Criteria:
Patients seen before the intervention launch date.
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).
Prevention - Screening and brief intervention
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.
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.
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.
Plan to share: Yes — 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.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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