TY - JOUR
T1 - Designing and evaluating health systems level hypertension control interventions for African-Americans
T2 - Lessons from a pooled analysis of three cluster randomized trials
AU - Pavlik, Valory N.
AU - Chan, Wenyaw
AU - Hyman, David J.
AU - Feldman, Penny
AU - Ogedegbe, Gbenga
AU - Schwartz, Joseph E.
AU - McDonald, Margaret
AU - Einhorn, Paula
AU - Tobin, Jonathan N.
N1 - Publisher Copyright:
© 2015 Bentham Science Publishers.
PY - 2015/8/1
Y1 - 2015/8/1
N2 - Objectives: African-Americans (AAs) have a high prevalence of hypertension and their blood pressure (BP) control on treatment still lags behind other groups. In 2004, NHLBI funded five projects that aimed to evaluate clinically feasible interventions to effect changes in medical care delivery leading to an increased proportion of AA patients with controlled BP. Three of the groups performed a pooled analysis of trial results to determine: 1) the magnitude of the combined intervention effect; and 2) how the pooled results could inform the methodology for future health-system level BP interventions. Methods: Using a cluster randomized design, the trials enrolled AAs with uncontrolled hypertension to test interventions targeting a combination of patient and clinician behaviors. The 12-month Systolic BP (SBP) and Diastolic BP (DBP) effects of intervention or control cluster assignment were assessed using mixed effects longitudinal regression modeling. Results: 2,015 patients representing 352 clusters participated across the three trials. Pooled BP slopes followed a quadratic pattern, with an initial decline, followed by a rise toward baseline, and did not differ significantly between intervention and control clusters: SBP linear coefficient = -2.60±0.21 mmHg per month, p<0.001; quadratic coefficient = 0.167± 0.02 mmHg/month, p<0.001; group by time interaction group by time group x linear time coefficient=0.145 ± 0.293, p=0.622; group x quadratic time coefficient= -0.017 ± 0.026, p=0.525). Results were similar for DBP. The individual sites did not have significant intervention effects when analyzed separately. Conclusion: Investigators planning behavioral trials to improve BP control in health systems serving AAs should plan for small effect sizes and employ a “run-in” period in which BP can be expected to improve in both experimental and control clusters.
AB - Objectives: African-Americans (AAs) have a high prevalence of hypertension and their blood pressure (BP) control on treatment still lags behind other groups. In 2004, NHLBI funded five projects that aimed to evaluate clinically feasible interventions to effect changes in medical care delivery leading to an increased proportion of AA patients with controlled BP. Three of the groups performed a pooled analysis of trial results to determine: 1) the magnitude of the combined intervention effect; and 2) how the pooled results could inform the methodology for future health-system level BP interventions. Methods: Using a cluster randomized design, the trials enrolled AAs with uncontrolled hypertension to test interventions targeting a combination of patient and clinician behaviors. The 12-month Systolic BP (SBP) and Diastolic BP (DBP) effects of intervention or control cluster assignment were assessed using mixed effects longitudinal regression modeling. Results: 2,015 patients representing 352 clusters participated across the three trials. Pooled BP slopes followed a quadratic pattern, with an initial decline, followed by a rise toward baseline, and did not differ significantly between intervention and control clusters: SBP linear coefficient = -2.60±0.21 mmHg per month, p<0.001; quadratic coefficient = 0.167± 0.02 mmHg/month, p<0.001; group by time interaction group by time group x linear time coefficient=0.145 ± 0.293, p=0.622; group x quadratic time coefficient= -0.017 ± 0.026, p=0.525). Results were similar for DBP. The individual sites did not have significant intervention effects when analyzed separately. Conclusion: Investigators planning behavioral trials to improve BP control in health systems serving AAs should plan for small effect sizes and employ a “run-in” period in which BP can be expected to improve in both experimental and control clusters.
KW - African-Americans
KW - Cluster randomized trial
KW - Effect size
KW - Health disparities
KW - Health systems interventions
KW - High blood pressure
KW - Hypertension control
KW - Minority health
KW - Practice-based research network (PBRNs)
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U2 - 10.2174/1573402111666150325234503
DO - 10.2174/1573402111666150325234503
M3 - Article
C2 - 25808682
AN - SCOPUS:84939797718
VL - 11
SP - 123
EP - 131
JO - Current Hypertension Reviews
JF - Current Hypertension Reviews
SN - 1573-4021
IS - 2
ER -