MI-SPARC: Michigan SPARC Trial
Study Details
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 are to:
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Test whether the Michigan SPARC model increases (a) alcohol SBI and/or (b) initiation of medication treatment for AUDs, in small to medium PC practices in Michigan, in a stepped-wedge trial with 6 waves, and
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Test whether adding an innovative decision aid for AUDs to Michigan SPARC implementation increases rates of (a) SBI, and/or (b) initiation of medication treatment for AUDs, in a nested two-arm cluster randomized trial (with 1:1 randomization within each wave).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Usual Care Patients seen before the randomly assigned intervention launch date. |
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| Experimental: Quality Improvement Intervention Patients seen after the randomly assigned intervention launch date. |
Behavioral: Michigan SPARC Quality Improvement Intervention
Practice facilitation, electronic health record (EHR) support, and performance monitoring and feedback combined with alcohol-related continuing medical education (CME) and maintenance of certification (MOC).
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| Experimental: Quality Improvement Intervention Plus Decision Aid Patients at 50% of practices (nested within waves) that are randomized to receive the patient decision aid for AUD in addition to the Michigan SPARC intervention. |
Behavioral: Michigan SPARC Quality Improvement Intervention
Practice facilitation, electronic health record (EHR) support, and performance monitoring and feedback combined with alcohol-related continuing medical education (CME) and maintenance of certification (MOC).
Behavioral: Decision Aid for AUD
Decision aid for shared decision making about alcohol use disorder (AUD) is provided to primary care practices as part of CME. The decision aid for AUD will be available to give to patients with high risk drinking or AUD.
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Outcome Measures
Primary Outcome Measures
- Prevention - Screening and brief intervention [For Aim 1 the period up to 6 months before the randomly assigned launch date will be compared to the 6 month period after the launch date. For Aim 2 the two randomly assigned decision aid arms will be compared in the 6 months after the launch date.]
The proportion of PC patients who screen positive for unhealthy alcohol use and have BI documented in their EHR (the outcome for Aim 1a and Aim 2a).
- Treatment - Prescription of AUD medications [For Aim 1 the period up to 6 months before the randomly assigned launch date will be compared to the 6 month period after the launch date. For Aim 2 the two randomly assigned decision aid arms will be compared in the 6 months 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 (the outcome for Aim 1b and Aim 2b).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults age 18 years and older
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Seen in primary care at a study practice during the practice's study period
Exclusion Criteria:
• None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Altarum Institute | Ann Arbor | Michigan | United States | 48105 |
Sponsors and Collaborators
- Kaiser Permanente
- Agency for Healthcare Research and Quality (AHRQ) - Funder
- Altarum Institute
- NORC at the University of Chicago
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R18HS027076