Background
Methods
Study setting
Study design
Year 1 (months) | Year 2 (months) | Year 3 (months) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Clusters | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | 27 | 30 | 33 | 36 |
Time period | ||||||||||||
1 (80 sites) | C | X | X | X | X | F | F | |||||
2 (70 sites) | C | C | X | X | X | X | F | F | ||||
3 (70 sites) | C | C | C | X | X | X | X | F | F | |||
4 (70 sites) | C | C | C | C | X | X | X | X | F | F |
Study site eligibility
Patient eligibility
Site recruitment
Conceptual framework
Intervention components
Practice facilitation protocol
Practice facilitator training and supervision
Evaluation
Outcome measures and data source
Domain | Measures | Data source | Administration |
---|---|---|---|
Primary outcomes | • Aspirin: percent of patients aged 18 years and older with ischemic vascular disease (IVD) with documented use of aspirin or other antithrombotic. • Blood pressure management: 1) Percent of patients aged 18–85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (<140/90). 2) Percent of patients aged 60–85 without diabetes (DM) or chronic kidney disease (CKD) with controlled BP (<150/90), 3) Percent aged 18–85 with DM or CKD with controlled BP (<140/90) • Cholesterol management: 1) Percentage of patients aged >21 diagnosed with ASCVD who are on statin therapy. 2) Percentage of patients aged >21 with history of LDL >190 mg/dL without ASCVD who are on statin therapy. 3) Percentage of patients aged 40–75 with diabetes without ASCVD and LDL 70–189 mg/dL who are on statin therapy • Smoking cessation support: Percentage of patients aged 18 years or older who were screened about tobacco use one or more times within 24 months and who received cessation counseling intervention if identified as a tobacco user. | EHR | Baseline, quarterly during intervention period, at the end of intervention (12 months), and 6 months post intervention |
Secondary outcome: practice change capacity | • Organizational change process capacity • Adaptive reserve | Provider and staff survey | Baseline, at the end of intervention (12 months) and 6 months post intervention |
Process evaluation measures and data collection methods
Domain | Measures | Data sources | Administration |
---|---|---|---|
Internal practice-level context | • Staffing/FTEs • Payer mix • Patient demographics • Baseline integration practice transformation components (population management) • PCMH certification | • Practice survey • Site visits and key informant (KI) interviews with sample of providers and staff | • Surveys at baseline, 12 and 18 months • Site visits and KI interviews baseline and 12 months |
External context | • Regulatory and financial environment (e.g., pay-for-performance, value based payment) | • Provider surveys • KI interviews with sample of practice site providers and staff | • Ongoing |
Implementation fidelity | • PF activities: dose, intensity and mode of delivery of PF intervention Practice change: Extent to which practice change components are implemented and in use | • PF activities: Web-based PF tracking system, Webinar registration and evaluation and collaborative call attendance • Practice change: practice change survey and site visits/KI interviews | • Ongoing PF tracking using saleforce.com • Practice change survey monthly |
Cost | • Implementation and intervention cost | • Cost data collection template embedded in PF tracking system | • Ongoing and reviewed monthly |