Nonphysician, Community Intervention Curbs CV Risk Factors: HOPE 4

PARIS, France—A comprehensive intervention led by nonphysician health workers (NPHW) and supported by family and community members resulted in a significant reduction in systolic blood pressure, LDL cholesterol levels, and cardiovascular disease risk among individuals with hypertension in multiple communities throughout Columbia and Malaysia, the HOPE 4 study showed.

The intervention translated into an 11.45-mm Hg reduction in systolic blood pressure and a 0.41-mmol/L (15.6-mg/dL) reduction in LDL cholesterol levels when compared with usual care, investigators reported today at a Hot Line session at the European Society of Cardiology Congress 2019. The study was published simultaneously in the Lancet.

In addition, the intervention lowered the absolute 10-year risk of cardiovascular disease by nearly 5%.

“There is clear evidence that lowering blood pressure will reduce cardiovascular disease and mortality,” said lead investigator Jon-David Schwalm, MD (Population Health Research Institute/McMaster University, Hamilton, Canada), during a press conference announcing the results. “Unfortunately, hypertension detection, treatment, and control are low globally.”

Statins, said Schwalm, have also been shown to reduce the risk of cardiovascular disease in those with hypertension, as in the HOPE-3 and ASCOT studies, but fewer than 5% take the medications. Combining hypertensive and lipid-lowering therapies has the potential to significantly reduce the risk of clinical events, but treatment access and adherence can be poor in those who would benefit most.

Thirty Communities in Malaysia and Colombia

Focusing on 30 communities in Columbia and Malaysia, Schwalm said their goal was to address the specific social barriers to effective management of hypertension in these two middle-income countries. The multifaceted intervention consisted of community screening, detection, treatment, and control of cardiovascular disease risk factors by NPHWs—a group consisting of newly hired and retrained community health workers and research staff—working in collaboration with local physicians. The NPHWs visited patients either in their home or at a local clinic and there was strong agreement between their treatment decisions with local physicians.

The program consisted of tablet-based, management algorithms, decision support, and counselling programs, as well as the free provision of antihypertensives (ACE inhibitor or angiotensin-receptor blocker coupled with a diuretic or calcium channel blocker) and statins (atorvastatin 20 mg or rosuvastatin 10 mg) administered by the NPHWs. Importantly, the intervention was designed to enlist the support of a friend or family member to improve adherence to medication and healthy lifestyle choices. In the usual-care group, individuals were provided with cardiovascular disease literature and recommended to see their local doctor.

In total, 1,371 participants 50 years and older with hypertension were randomly assigned to the intervention arm (n = 727) or usual care (n = 644). Systolic blood pressure at baseline was approximately 152 mm Hg in both treatment arms, and LDL cholesterol was 3.4 mmol/L (131.5 mg/dL). The average 10-year risk of cardiovascular disease assessed by the Framingham Risk Score (FRS) was 35.5% in the control arm and 32.6% in the intervention group.

The primary endpoint—the change in mean FRS 10-year risk score—was significantly better among patients randomized to the intervention arm. Secondary endpoints, including the change in systolic blood pressure and LDL cholesterol, were also significantly improved among those randomized to care from the NPHWs. At baseline, 17.2% and 11.5% of patients in the control and intervention arm had their systolic blood pressure under control (< 140 mm Hg). By 12 months, 48.0% of patients in the control arm and 80.0% of those treated by the NPHWs had systolic blood pressures less than 140 mm Hg, a difference that was statistically significant.

HOPE 4: Outcomes at 12 Months

Schwalm said the NPHW-based strategy was successful for several reasons. The intervention identified multiple barriers to care through extensive appraisals of the health system and addressed those roadblocks when developing their program. Importantly, the community-based program was specific to the local context.

“As part of the barrier analysis, we found that one of the biggest issues for patients was the distance they had to travel to get to a community clinic,” said Schwalm. The time required off work to travel to the clinic, as well as the cost of not working, were factors problematic for individuals in the community.

“Then, to dispense only a small amount of medication and to have to repeat the cycle for hypertension, which is a lifelong condition, is something this study tried to address,” he continued. “We were out in the community trying to facilitate communication between the participant in their home and the local healthcare clinics. Dispensation of medication was provided for longer periods of time, which varied depending on the country.”

Finally, the inclusion of friends and family who helped participants attend clinics, or ensured they were home for the NPHW visit, was critical. In between clinic/NPHW visits, the social support also helped with medication adherence, which was significantly better in the intervention arm than with usual care. Schwalm noted that belief in alternative therapies was an issue, particularly in Malaysia. “We worked with the training of the nonphysician health workers for counseling around this issue and to bring family members into that discussion,” he told TCTMD.

Importance of Primary Prevention

Natasja de Groot, MD, PhD (Erasmus Medical Center, Rotterdam, the Netherlands), who was not involved in the study, said HOPE 4 highlights the importance of primary prevention, particularly when the focus at large medical meetings can be on technological advances.

“You realize that in hospitals we do very complex procedures and we use very complex treatments, but sometimes the very simple things, like lowering blood pressure and paying attention to cholesterol levels as well as taking the entire community into account, are effective,” she told TCTMD. A primary prevention study like HOPE 4 is a reminder for physicians that “simple interventions can be implemented within society and achieve great outcomes,” she said.

Family support also is particularly important when addressing lifestyle changes to modify cardiovascular risk, she said. “I see it in the outpatient clinic,” she said. “If a couple comes in, and one is obese, a typical heart patient with diabetes and hypertension, and you explain their risk and the need to take medication, their partner is often concerned.” In many instances, the partner is equally, if not more, motivated to adopt lifestyle changes to lower the risk of cardiovascular disease, said de Groot.  

The Noncommunicable Disease (NCD) Countdown 2030 is a collaborative effort from the World Health Organization, NCD Alliance, Imperial College, and the Lancet aimed at reducing premature mortality from four major NCDs (cardiovascular disease, diabetes, cancer, and respiratory illnesses) by 30% in 2030. Schwalm said that given their results, there is no reason that global goal can’t be achieved. He added their group is currently planning a cost-effectiveness analysis of their intervention.

Eva Prescott, MD (University of Copenhagen, Denmark), the discussant following the late-breaking clinical trial’s presentation, praised the investigators but noted there are some issues still to work out. While there was a significant improvement in blood pressure and cholesterol levels, lifestyle changes were infrequent, she said. For example, some components of diet improved, but there was no change in weight and no difference in smoking cessation rates between the intervention and usual-care groups.

“We also don’t know which of the elements were effective,” said Prescott. “Was it the nonphysician health workers? Was it the free medication? Or was it the family support? Also, importantly, will these results be sustainable beyond the supervised period with frequent contact with the nonphysician health workers? So, hopefully these issues will be addressed in the future.”

Ina a Lancet editorial, Tazeen Jafar, MD, and Zainab Samad, MBBS (both from Aga Khan University, Karachi, Pakistan), and Gerald Bloomfield, MD, MPH (Duke University, Durham, NC), state that integrating a comprehensive intervention into an existing healthcare system will be a challenge but say there is precedent for scaling up programs for NCDs. Efforts are needed to make antihypertensive medications and statins accessible to all in low-to-middle-income countries, the editorialists advise, adding that the HOPE 4 study should “prompt the scientific and legislative communities to rethink the scale-up of large, evidence-based approaches to dramatically reduce the burden of uncontrolled hypertension and low cardiovascular risk—such bold strategies cannot be ignored.”