By Paul K. Whelton, MB, MD, MSc
An important new team-based care of hypertension trial was published in the March 2, 2023 issue of the Lancet (Effectiveness of a non-physician community healthcare provider-led intensive blood pressure intervention versus usual care on cardiovascular disease (CRHCP): an open-label, blinded-endpoint, cluster-randomised trial-based management of High BP. He J et al for the CRHCP Study Group. Lancet; doi: 10.1016/S0140-6736(22)02603-4. Online ahead of print.) The investigators recruited adults ≥ 40 years with an untreated systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg (≥130 mm Hg and ≥80 mm Hg for those at high risk for CVD or taking antihypertensive medication). Using an open-label, blinded-endpoint, cluster-design, they randomized assigned (1:1) 326 villages (clusters) to a non-physician community healthcare provider-led intervention or usual care. With supervision from primary care physicians, the non-physician community health-care providers used a simple stepped-care protocol to initiate and titrate antihypertensive medications to achieve an SBP/DBP < 130/80 mm Hg. They also delivered free or heavily discounted antihypertensive medications, provided health coaching, trained villagers to record home BPs and monitored progress through monthly visits. Over 36 months, the net group difference in SBP/DBP between the intervention and control villages was -21.3/-9.9 mm Hg and the hazard ratio (HR), 95% confidence interval (CI) for primary outcome (composite of myocardial infarction, stroke, hospitalized heart failure, and CVD death) was 0.67, 0.61 to 0.73. All four components of the primary outcome were significantly reduced, as was all-cause mortality (HR 0.85, 95% CI 0.76 to 0.95). Consistent intervention benefits were noted across pre-stated age, gender, education, antihypertensive medication use, and baseline CVD risk subgroups of interest.
This is an important publication that demonstrates the effectiveness of a non-physician healthcare provider-led simple team-based intervention aimed at the reduction of BP and prevention of CVD. The achieved separation in BP was greater than that reported in any other major trial, including the SPRINT, and the resultant prevention of CVD and all-cause mortality was remarkable. The intervention was conducted in a rural setting and led by community healthcare workers who lived in the community and used a simple algorithmic protocol for health coaching and antihypertensive drug treatment decisions, coupled with easy access to free or heavily discounted medications, and patient engagement by monthly visits and self-monitoring of BP. The trial provides a clear demonstration that a simple intervention that is well delivered is very effective and belies the need for individualization of antihypertensive therapy in most adults.
The CRHCP protocol has many similarities to the WHO HEARTS initiative and bodes well for the success of the latter when it is well delivered. It is the latest of many trials that have documented the efficacy of a team-based approach to antihypertensive care. Our traditional model of physician delivered care has failed miserably, with the result that BPs are measured badly in most clinical practice settings and both over and under treatment of hypertension is common. Further, hypertension control is woefully inadequate even to sub-standard levels of control (SBP/DBP <140/90 mm Hg) compared to what is recommended in most guidelines. We must employ a different model of care that reduces the burden on physicians and shifts responsibility to other trained care givers. The model that seems to work best has all or most of the following components: 1) a specific commitment by the provider, health system, or country to care goals, 2) health promotion, 3) convenient access to community care delivered using a team-based approach, 4) the use of simple evidence-based protocols for nonpharmacological (health coaching) and antihypertensive drug therapy, 5) reliable access to an affordable source of antihypertensive medications, preferably prescribed as a single-pill combination and available to patients at the point of care, and 6) information tracking (for example, using an electronic health record) and case-management, where feasible, to monitor success and identify those who need extra attention at an early stage when interventions are most likely to help them. CVD risk estimation is also desirable, but this is challenging in many middle- and low-income countries where risk estimating tools have not been validated and laboratory testing may be impracticable due to lack of access, cost and other considerations. The HEARTS model is a good example of a widely employed approach to achieve improved BP control. It will be important to determine the extent to which success is being achieved with the current approach to implementation of the HEARTS model worldwide and in individual countries. This is an exciting time, with an increasingly strong scientific basis for implementation approaches that are effective in community settings. The CRHCP provides a great example of what can be accomplished with strong leadership and attention to detail but use of a fairly simple intervention strategy that has components that are likely to be widely generalizable.