Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones

Carter, Barry L.; Ardery, Gail

doi:10.1161/jaha.116.004432

Cited by 13 publications

(6 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The trial was approved by institutional review boards at Cedars–Sinai Medical Center, Kaiser Permanente, and Westat (a survey company that conducted screening and enrollment and collected baseline and follow-up data), and the conduct of the trial was periodically reviewed by an independent data and safety monitoring board. 18 Participants provided written informed consent. The authors vouch for the completeness and accuracy of the data and analyses and for the fidelity of the trial to the protocol, available at NEJM.org.…”

Section: Methodsmentioning

confidence: 99%

A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops

et al. 2018

View full text Add to dashboard Cite

BACKGROUND Uncontrolled hypertension is a major problem among non-Hispanic black men, who are underrepresented in pharmacist intervention trials in traditional health care settings. METHODS We enrolled a cohort of 319 black male patrons with systolic blood pressure of 140 mm Hg or more from 52 black-owned barbershops (nontraditional health care setting) in a cluster-randomized trial in which barbershops were assigned to a pharmacist-led intervention (in which barbers encouraged meetings in barbershops with specialty-trained pharmacists who prescribed drug therapy under a collaborative practice agreement with the participants’ doctors) or to an active control approach (in which barbers encouraged lifestyle modification and doctor appointments). The primary outcome was reduction in systolic blood pressure at 6 months. RESULTS At baseline, the mean systolic blood pressure was 152.8 mm Hg in the intervention group and 154.6 mm Hg in the control group. At 6 months, the mean systolic blood pressure fell by 27.0 mm Hg (to 125.8 mm Hg) in the intervention group and by 9.3 mm Hg (to 145.4 mm Hg) in the control group; the mean reduction was 21.6 mm Hg greater with the intervention (95% confidence interval, 14.7 to 28.4; P<0.001). A blood-pressure level of less than 130/80 mm Hg was achieved among 63.6% of the participants in the intervention group versus 11.7% of the participants in the control group (P<0.001). In the intervention group, the rate of cohort retention was 95%, and there were few adverse events (three cases of acute kidney injury). CONCLUSIONS Among black male barbershop patrons with uncontrolled hypertension, health promotion by barbers resulted in larger blood-pressure reduction when coupled with medication management in barbershops by specialty-trained pharmacists. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT02321618.)

show abstract

Section: Methodsmentioning

confidence: 99%

A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops

et al. 2018

View full text Add to dashboard Cite

show abstract

“…17 We tracked enrollments and data quality. 18 Staffing shortages at two offices required that the research team provided support to perform the SC functions.…”

Section: Methodsmentioning

confidence: 99%

Cluster-Randomized Trial to Evaluate a Centralized Clinical Pharmacy Service in Private Family Medicine Offices

Carter

Levy²,

Gryzlak

et al. 2018

Circ: Cardiovascular Quality and Outcomes

Self Cite

View full text Add to dashboard Cite

show abstract

“…The study was approved by institutional review boards at Cedars-Sinai Medical Center, Kaiser-Permanente, and Westat (survey research company that conducted screening and enrollment and collected baseline and follow-up data), with an independent data safety and monitoring board. 9 All participants gave informed written consent.…”

Section: Methodsmentioning

confidence: 99%

Sustainability of Blood Pressure Reduction in Black Barbershops

Victor

Blyler

et al. 2019

Circulation

View full text Add to dashboard Cite

Background We developed a new model of hypertension (HTN) care for non-Hispanic black men that links health promotion by barbers to medication management by specialty-trained pharmacists and demonstrated efficacy in a 6-month randomized trial (Victor et al., NEJM, 2018). The marked reduction in systolic blood pressure (BP) seen at 6 months warranted continuing the trial through 12 months to test sustainability, a necessary precondition for subsequent implementation research. Methods We enrolled a cohort of 319 black male patrons with systolic BP ≥ 140 mm Hg at baseline, in a cluster-randomized trial. Fifty-two Los Angeles County barbershops were assigned to either a pharmacist-led intervention or an active control group. In the intervention group, barbers promoted follow-up with pharmacists who prescribed BP medication under a collaborative practice agreement with patrons’ primary care providers (PCPs). In the control group, barbers promoted follow-up with PCPs and lifestyle modification. After BP assessment at 6 months, the intervention continued with fewer in-person pharmacist visits to test if the intervention effect could be sustained safely for one year while reducing pharmacist travel time to and from barbershops. Final BP and safety outcomes were assessed in both groups at 12 months. Results At baseline, mean systolic BP was 152.4 mm Hg in the intervention group and 154.6 mm Hg in the control group. At 12 months, mean systolic BP fell by −28.6 mm Hg (to 123.8 mm Hg) in the intervention group and by −7.2 mm Hg (to 147.4 mm Hg) in the control group. The mean reduction was 20.8 mm Hg greater with the intervention (95% confidence interval, 13.9 to 27.7; p < 0.0001). A goal BP < 130/80 was achieved by 68.0% of the intervention group versus 11.0% of the control group (p < 0.02). These new 12-month efficacy data are statistically indistinguishable from our previously reported 6-month data. No treatment-related serious adverse events occurred in either group over 12 months. Cohort retention at 12 months was 90% in both groups. Conclusion Among black male barbershop patrons with uncontrolled HTN, health promotion by barbers resulted in large and sustained BP reduction when coupled with medication management by specialty-trained pharmacists. Broad-scale implementation research is both justified and warranted. Clinical Trial Registration ClinicalTrials.gov,

show abstract

Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones

Cited by 13 publications

References 34 publications

A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops

A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops

Cluster-Randomized Trial to Evaluate a Centralized Clinical Pharmacy Service in Private Family Medicine Offices

Sustainability of Blood Pressure Reduction in Black Barbershops

Contact Info

Product

Resources

About