Stepwise treatment of uncontrolled HyperTensioN (Stepwise-HTN): Study design of a cluster randomised controlled trial in primary care.

BACKGROUND: Uncontrolled hypertension is a major health problem, and a key risk factor for cardiovascular disease. Most patients are detected and managed in primary care, but approximately 50% remains uncontrolled. Our aim is to assess whether a guided stepwise work-up management strategy for patients with uncontrolled hypertension in primary care would result in better blood pressure control in these patients compared to usual care. METHODS: A cluster randomised controlled trial aiming at randomizing 40 general practices to either "a protocolised stepwise work-up" or to "usual care". Uncontrolled hypertension is defined as an office blood pressure (BP) >140/90 mmHg while being prescribed three or more antihypertensive drugs simultaneously from different therapeutic classes for three or more months in an adequate dose. In the intervention arm, patients with uncontrolled hypertension will receive the stepwise approach, consisting of (i) excluding a white coat effect, (ii) re-evaluation of lifestyle, (iii) re-evaluation of drug adherence, (iv) optimalisation of antihypertensive treatment and (v) referral if the office BP is still >140/90 mmHg. The control group receives usual care in a regular program for cardiovascular risk management. The primary outcome is the absolute difference in the mean 24-h systolic BP between intervention and control arm after 8 months. Secondary outcomes include differences in the percentage of patients achieving a controlled BP, and time to reach a controlled BP. CONCLUSION: If stepwise treatment of uncontrolled hypertension is proven effective, the strategy could be implemented by blending the approach to the cardiovascular risk management already applied in general practice. Trial registration NTR7304, https://www.trialregister.nl/trial/7099.

Therapeutic inertia in the management of hypertension in primary care.

BACKGROUND: Therapeutic inertia is considered to be an obstacle to effective blood pressure (BP) control. AIMS: To identify patient characteristics associated with therapeutic inertia in patients with hypertension managed in primary care and to assess reasons not to intensify therapy. METHODS: A Dutch cohort study was conducted using electronic health record data of patients registered in the Julius General Practitioners' Network (n = 530 564). Patients with a diagnosis of hypertension, SBP at least 140 and/or DBP at least 90 mmHg, and one or two BP-lowering drug(s) were included. Therapeutic inertia was defined as not undertaking therapeutic action in follow-up despite uncontrolled BP. Multivariable logistic regression was used to identify characteristics associated with inertia. Furthermore, an exploratory survey was performed in which general practitioners of 114 patients were asked for reasons not to intensify treatment. RESULTS: We identified 6400 (10% of all patients with hypertension) uncontrolled patients on one or two BP-lowering drugs. Therapeutic inertia was 87%, similar in men and women. Older age, lower systolic, diastolic and near-target SBP, and diabetes were positively associated, while renal insufficiency and heart failure were inversely related to inertia. General practitioners did not intensify therapy because they first, considered office BP measurements as nonrepresentative (27%); second, waited for next BP readings (21%); third, wanted to optimize lifestyle first (19%). Eleven percent of patients explicitly did not want to change treatment. CONCLUSION: Therapeutic inertia is common in primary care patients with uncontrolled hypertension. Older age, and closer to target BP, but also concurrent diabetes were associated with inertia.