Sustained Patient-centered Alcohol Related Care (SPARC) Trial and Future Michigan-SPARC Kathy Bradley, MD, MPH AHRQ Panel: Implementing PCOR Evidence PCORI Annual Meeting Washington DC, September, 19 2019 AHRQ R18 HS023173
Sustained Patient-centered Alcohol Related Care (SPARC) Trial Overview SPARC Trial – recently completed Michigan SPARC recently funded AHRQ R18 HS023173 2
SPARC Trial 3
Co-Investigators Amy Lee Ryan Caldeiro Jennifer Bobb Rebecca Parrish Julie Richards Joseph Glass Evette Ludman Emily Williams Carol Achtmeyer Paula Lozano Malia Oliver Chester Pabiniak Funding Sources: AHRQ – R18 HS023173 – SPARC Trial AHRQ – R18 HS027076– Michigan SPARC Trial K24AA022128 – support for secondary analyses NIAAA R21 AA023037 patient decision aid AHRQ R18 HS023173 4
Sustained Patient-centered Alcohol Related Care (SPARC) Trial Pragmatic implementation trial Kaiser Permanente Washington’s primary care clinics Two evidence-based practices implemented: Preventive alcohol screening & brief counseling Treatment of alcohol use disorders (AUD) Bobb IJERPH 2017; Glass Implementation Science 2018 USPSTF: Jonas Ann Intern Med 2012; Moyer Ann Intern Med 2013 Jonas JAMA 2014; Bradley & Kivlahan JAMA 2014 AHRQ R18 HS023173 5
Sustained Patient-centered Alcohol Related Care (SPARC) Trial Specific Aims 1. To increase the proportion of PC patients who have unhealthy alcohol use identified and who are offered brief preventive counseling 2. To increase the proportion of PC patients who have an AUD recognized and were engaged in alcohol-related treatment AHRQ R18 HS023173 6
Overview SPARC Trial & Implementation Intervention 7
SPARC Trial: Setting January 2015 - July 2018 Kaiser Permanente Washington All 25 primary care clinics: 3 pilot & 22 trial Stepped-wedge trial: 7 waves IRB: waivers of consent & HIPAA Bobb IJERPH 2017; Glass Implementation Science 2018 8
SPARC Implementation Intervention Alcohol-related clinical care 1. Alcohol screening 2. Preventive counseling: unhealthy alcohol use 3. DSM-5 symptom checklist (0-11): high risk 4. Shared decision-making re: options 5. Engagement in treatment Bobb IJERPH 2017; Glass Implementation Science 2018 A ReThink of the Way we Drink AHRQ R18 HS023173 9
SPARC Implementation Intervention Implementation Strategies 1. EHR tools 2. Performance monitoring and feedback 3. Practice facilitation (coaching) … Quality improvement by local team Stigma reduction: video & handout Improved knowledge & understanding Bobb IJERPH 2017; Glass Implementation Science 2018 A ReThink of the Way We Drink AHRQ R18 HS023173 10
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For BI AHRQ R18 HS023173
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Stigma Reduction AHRQ R18 HS023173
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SPARC Trial – 25 PC Clinics AHRQ R18 HS023173 16
SPARC What Happened? 17
SPARC Trial Primary care leader who partnered left Mental health leaders willing to support trial if … Depression and suicidality Alcohol cannabis and other drug use Implemented as Behavioral Health Integration 7-item paper screener – MA into EHR Assess on paper: depression, suicide, DSM-5 symptom checklists alcohol & other substance use Only pilot approved initially Bobb IJERPH 2017; Glass Implementation Science 2018 AHRQ R18 HS023173 18
SPARC: Lessons from Pilot Phase Health system financially stressed Decreased staffing Leadership changes Morale low No QI practices in primary care End of Pilot Year, acquisition announced Leaders only agreed to Year 1 of trial Bobb IJERPH 2017; Glass Implementation Science 2018 AHRQ R18 HS023173 19
Implementation: 4 Phases Each Site AHRQ R18 HS023173 20
Implementation: 4 Phases Each Site AHRQ R18 HS023173 21
Implementation: 4 Phases Each Site Usual Care AHRQ R18 HS023173 22
Implementation: 4 Phases Each Site Intervention AHRQ R18 HS023173 23
SPARC: Lessons from Pilot Phase Intensive Practice Coaching Weekly scheduled meetings required – 6 months Video and handout: big success DSM-5 Alcohol Symptom Checklists helpful Positive stories – huge positive impact But only 1 hour provider training Bobb IJERPH 2017; Glass Implementation Science 2018 AHRQ R18 HS023173 24
No, we can’t do this month. How about never? Is never good for you? AHRQ R18 HS023173 25
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SPARC Trial EHR tools Prevention: prompts for MA Screening and assessment Give provider alcohol handout No PCP prompt for brief alcohol counseling Alcohol treatment Best Practice Alert: need to initiate treatment No prompt for engagement visits AHRQ R18 HS023173 28
SPARC Trial Performance metrics Prevention: Weekly screening/assessment Not brief counseling Treatment: NCQA Alcohol and/or drug HEDIS measures Bobb IJERPH 2017; Glass Implementation Science 2018 AHRQ R18 HS023173 29
SPARC Trial Strong partnership with mental health service Social workers Transitioned to integrated MH clinicians Warm hand-offs key to success Number expanded during trial PC leaders not actively engaged Years 2-3: permission to randomize 1 month prior AHRQ R18 HS023173 30
SPARC Trial Methods 31
SPARC Trial Evaluation Methods Sample: all patients seen in primary care Measures: secondary electronic data Two main outcomes Prevention: brief alcohol counseling (NLP & codes) Alcohol treatment (ICD codes based on HEDIS) Assessed in entire PC sample GLMM: compares Usual Care vs Intervention Descriptive treatment cascades Consistent with consort requirements Bobb IJERPH 2017; Glass Implementation Science 2018 J. Bobb et. al. Designing to avoid identification bias, NIH Collaboratory ltextbook https://rethinkingclinicaltrials.org/chapters/design/experimental-designs-randomization- schemes-top/designing-to-avoid-identification-bias/ AHRQ R18 HS023173 32
SPARC Trial Results 33
Where we started We don’t have enough time or resources to do this. Whose idea was this? This is opening up Pandora’s box. This is a research project that others committed to … now we are being forced to prioritize it. 34 34
Where we ended I wouldn’t go back to providing care the way I used to if they asked me to. The best roll-out of any program I’ve experienced. I felt empowered to help this patient when she was in need. This is one of the best things that has happened to my primary care practice…this is just how we do primary care now. 35
What we achieved Alcohol screening rates: 22 primary care sites AHRQ R18 HS023173 36
Main Outcome: Prevention Prevention Usual Care vs Intervention per 10,000 PC patients UC Intervention p Screened* 2081 8319 < 0.0001 Most recent screen positive 502 1802 < 0.0001 High Positive 54 148 < 0.0001 Brief alcohol counseling 11 57 < 0.0001 37
Results: Prevention AHRQ R18 HS023173 38
Main Outcome: Treatment Alcohol Treatment Usual Care vs Intervention per 10,000 PC patients UC Intervention p New AUD diagnosis at visit 29 34 0.003 0.042 New AUD dx and initiated Tx 6.1 7.8 AUD treatment engagement 1.8 1.4 0.30 AHRQ R18 HS023173 39
Descriptive Results: Treatment AHRQ R18 HS023173 40
SPARC Trial Successful approaches Breadth of the effort: depression, suicidality, etc. Weekly scheduled practice coaching Using positive stories tipping point Bobb IJERPH 2017; Glass Implementation Science 2018 AHRQ R18 HS023173 41
SPARC Trial Challenges No performance feedback on main outcomes Inadequate PCP training for many Provider discomfort Bobb IJERPH 2017; Glass Implementation Science 2018 AHRQ R18 HS023173 42
Michigan- SPARC 43
AHRQ R18 RFA – Fall 2018 Alcohol-related prevention and treatment in… 125 PC practices (< 10 PCPs) Not in an integrated system Not already screening No collocated behavioral health clinicians High needs area 3 years: Lower resources and less time Due January 4 th … 44
AHRQ R18 RFA – Fall 2018 Cold Call from Altarum Anya Day (MPI/PD) Emily Erlich Tom Taylor Christine Stanik 45
Altarum 46
AHRQ R18 RFA – Fall 2018 Altarum Quality improvement with practice coaches Performance feedback (0, 3, & 5 months) EHR tech support MOC credit, CME and P4P Documented quality improvements 47
AHRQ R18 RFA – Fall 2018 SPARC Michigan 3 years 6 wave stepped wedge trial Practice coaches 2 in-person coaching sessions Then telephonic, biweekly 48
MI SPARC Figure 10. Timeline of MI-SPARC YEAR 1 YEAR 2 YEAR 3 Month of study 1 2 3 4 5 6 7 8 9 1 1 1 1 2 3 4 5 6 7 8 9 1 1 1 1 2 3 4 5 6 7 8 9 1 1 1 0 1 2 0 1 2 0 1 2 Start-up Pilot Period 1 recruitment Wave 1 implements Wave 2 implements Wave 3 implements Period 2 recruitment Wave 4 implements Wave 5 implements Wave 6 implements Formative Evaluation Data management Evaluation Dissemination 49
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