Kevin Fiscella1,2, Hua He3, Mechelle Sanders4, Andrea Cassells5, Jennifer K Carroll6, Stephen K Williams7, Jerry Cornell8, Tameir Holder3, Chamanara Khalida3, Jonathan N Tobin3,9. 1. University of Rochester, Rochester, NY, USA. Kevin_Fiscella@URMC.rochester.edu. 2. Family Medicine Research, 1381 South Ave, Rochester, NY, 14620, USA. Kevin_Fiscella@URMC.rochester.edu. 3. Tulane University, New Orleans, LA, USA. 4. University of Rochester, Rochester, NY, USA. 5. Clinical Directors Network (CDN), New York, NY, USA. 6. University of Colorado, Anschutz Medical Campus, Aurora, CO, USA. 7. NYU Langone Health, New York, NY, USA. 8. Family Medicine Research, 1381 South Ave, Rochester, NY, 14620, USA. 9. The Rockefeller University Center for Clinical and Translational Science, New York, NY, USA.
Abstract
BACKGROUND: Shortening time between office visits for patients with uncontrolled hypertension represents a potential strategy for improving blood pressure (BP). OBJECTIVE: We evaluated the impact of multimodal strategies on time between visits and on improvement in systolic BP (SBP) among patients with uncontrolled hypertension. DESIGN: We used a stepped-wedge cluster randomized controlled trial with three wedges involving 12 federally qualified health centers with three study periods: pre-intervention, intervention, and post-intervention. PARTICIPANTS: Adult patients with diagnosed hypertension and two BPs ≥ 140/90 pre-randomization and at least one visit during post-randomization control period (N = 4277). INTERVENTION: The core intervention included three, clinician hypertension group-based trainings, monthly clinician feedback reports, and monthly meetings with practice champions to facilitate implementation. MAIN MEASURES: The main measures were change in time between visits when BP was not controlled and change in SBP. A secondary planned outcome was changed in BP control among all hypertension patients in the practices. KEY RESULTS: Median follow-up times were 34, 32, and 32 days and the mean SBPs were 142.0, 139.5, and 139.8 mmHg, respectively. In adjusted analyses, the intervention did not improve time to the next visit compared with control periods, HR = 1.01 (95% CI: 0.98, 1.04). SBP was reduced by 1.13 mmHg (95% CI: -2.10, -0.16), but was not maintained during follow-up. Hypertension control (< 140/90) in the practices improved by 5% during intervention (95% CI: 2.6%, 7.3%) and was sustained post-intervention 5.4% (95% CI: 2.6%, 8.2%). CONCLUSIONS: The intervention failed to shorten follow-up time for patients with uncontrolled BP and showed very small, statistically significant improvements in SBP that were not sustained. However, the intervention showed statistically and clinically relevant improvement in hypertension control suggesting that the intervention affected clinician decision-making regarding BP control apart from visit frequency. Future practice initiatives should consider hypertension control as a primary outcome. CLINICAL TRIAL: www.ClinicalTrials.gov Identifier: NCT02164331.
BACKGROUND: Shortening time between office visits for patients with uncontrolled hypertension represents a potential strategy for improving blood pressure (BP). OBJECTIVE: We evaluated the impact of multimodal strategies on time between visits and on improvement in systolic BP (SBP) among patients with uncontrolled hypertension. DESIGN: We used a stepped-wedge cluster randomized controlled trial with three wedges involving 12 federally qualified health centers with three study periods: pre-intervention, intervention, and post-intervention. PARTICIPANTS: Adult patients with diagnosed hypertension and two BPs ≥ 140/90 pre-randomization and at least one visit during post-randomization control period (N = 4277). INTERVENTION: The core intervention included three, clinician hypertension group-based trainings, monthly clinician feedback reports, and monthly meetings with practice champions to facilitate implementation. MAIN MEASURES: The main measures were change in time between visits when BP was not controlled and change in SBP. A secondary planned outcome was changed in BP control among all hypertension patients in the practices. KEY RESULTS: Median follow-up times were 34, 32, and 32 days and the mean SBPs were 142.0, 139.5, and 139.8 mmHg, respectively. In adjusted analyses, the intervention did not improve time to the next visit compared with control periods, HR = 1.01 (95% CI: 0.98, 1.04). SBP was reduced by 1.13 mmHg (95% CI: -2.10, -0.16), but was not maintained during follow-up. Hypertension control (< 140/90) in the practices improved by 5% during intervention (95% CI: 2.6%, 7.3%) and was sustained post-intervention 5.4% (95% CI: 2.6%, 8.2%). CONCLUSIONS: The intervention failed to shorten follow-up time for patients with uncontrolled BP and showed very small, statistically significant improvements in SBP that were not sustained. However, the intervention showed statistically and clinically relevant improvement in hypertension control suggesting that the intervention affected clinician decision-making regarding BP control apart from visit frequency. Future practice initiatives should consider hypertension control as a primary outcome. CLINICAL TRIAL: www.ClinicalTrials.gov Identifier: NCT02164331.
Keywords:
Community Health Centers (CHCs); Federally Qualified Health Centers (FQHCs); Stepped Wedge Cluster Randomized Clinical Trial (SW-CRCT); blood pressure control; clinical practice guidelines; electronic health records (EHRs); hypertension; practice-based research networks (PBRNs); pragmatic trials
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