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Enhanced hypertension care through private clinics in Pakistan: a cluster randomised trial |
Khan MA, Khan N, Walley JD, Khan SE, Hicks J, Sheikh FI, Khan MA, Ali M, Ahmed M, Khan HJ, Zachariah R |
BJGP Open 2019 Apr;3(1):bjgpopen18X101617 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Hypertension in Pakistan affects 33% of people aged >= 45 years, and in urban areas around 70% of basic health care occurs in private facilities. AIM: To assess whether enhanced care at urban private clinics resulted in better control of hypertension, cardiovascular disease (CVD) risk factors, and treatment adherence. DESIGN AND SETTING: A two-arm cluster randomised controlled trial was conducted at 26 private clinics (in three districts of Punjab) between January 2015 to September 2016. Both arms had enhanced screening and diagnosis of hypertension and related conditions, and patient recording processes. Intervention facilities also had a clinical care guide, additional drugs for hypertension, a patient lifestyle education flipchart, associated training, and mobile phone follow-up. METHOD: Clinics were randomised in a 1:1 ratio (sealed envelope lottery method). A total of 574 intervention and 564 control patients in 13 clusters in each arm were recruited (male and female, aged >= 25 years, systolic blood pressure (SBP) > 140 mmHg, and/or diastolic blood pressure (DBP) > 90 mmHg). The primary outcome was change in SBP from baseline to 9-month follow-up. Staff and patients were not blinded, but outcome assessors were blinded. RESULTS: Nine-month primary outcomes were available for 522/574 (90.9%) intervention and 484/564 (85.8%) control participants (all clusters). The unadjusted cluster-level analysis results were as follows: mean intervention outcome was -25.2 mmHg (95% confidence intervals (CI) -29.9 to-20.6); mean control outcome was -9.4 mmHg (95% CI 21.2 to 2.2); and mean control-intervention difference was 15.8 (95% CI 3.6 to 28.0; p = 0.01). CONCLUSION: The findings and separate process evaluation support the scaling of an integrated CVD-hypertension care intervention in urban private clinics in areas lacking public primary care in Pakistan.
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