Researchers reported progress in innovating care delivery for patients with, or at risk of, heart disease at the American Heart Association (AHA) virtual meeting.
Simple digital materials successfully engaged heart failure patients to actively take part in shared decision-making for guideline-directed medical therapy (GDMT) titration, the EPIC-HF trial found, whereas the MyROAD group showed that sending hospitalized heart failure patients home with audio instructions for self-care resulted in better outcomes.
Additionally, patients may benefit from high-touch interventions away from traditional brick-and-mortar sites: a hypertension and high cholesterol management program was able to titrate medications remotely, and it was suggested in one study that group microfinance and medical visits may help women and people with low socioeconomic status in Kenya.
All four trials were reported during a late-breaking trial session at the AHA meeting, and session discussant Karen Joynt Maddox, MD, MPH, of Washington University School of Medicine in St. Louis, said the results of these implementation science studies are “encouraging but not definitive,” pending long-term data and more trials.
Heart failure (HF) patients sent instructional materials online had more productive clinic visits with optimized medication prescribing, according to a randomized trial.
People with chronic HF with reduced ejection fraction (HFrEF), none taking optimal medication doses, were sent links to a short video and a checklist encouraging them to understand their medication options, and ask questions at their upcoming visit to the doctor’s office.
GDMT intensification involving any change to improve therapy was observed in 49.0% of these patients at 30 days, compared with 29.7% of people going to a regularly scheduled cardiology clinic visit sans the digital tools, according to Larry Allen, MD, MHS, of University of Colorado School of Medicine in Aurora. Full results from the 290-person trial were published simultaneously in Circulation.
Allen noted that most changes involved increasing the dose of generic HFrEF medications already prescribed, not the addition of new medications. Most commonly uptitrated were beta blockers.
“Clinical inertia accounts for some portion of underuse of GDMT in HFrEF, and this can be partially overcome by engaging patients in prescribing decisions,” he concluded.
The intervention consisted of a 3-minute video and a one-page checklist delivered electronically by text or email. Patients received these materials at week 1, 3 days, and 24 hours prior to a cardiology clinic visit.
There were no significant safety signals with the novel patient engagement tool. The combined endpoint of death, hospitalization, or emergency department (ED) visit reached 10.3% of the intervention group versus 6.2% of controls (RR 1.6, 95% CI 0.7-3.6). There were zero deaths at 30 days.
The EPIC-HF trial was conducted within a single health system. Allen’s group screened 699 people to get 290 HFrEF patients for randomization. Average participant age was 65, and 29% women. About 10% were African American.
EPIC-HF’s limited follow-up period precluded analysis of further medication intensifications or subsequent de-escalations. The intervention’s effect on health outcomes also remains unclear because the trial was not powered for clinical outcomes, Allen added.
An audio-playing greeting card helped HF patients better understand their self-care expectations after discharge and prevent another trip to the hospital, according to a randomized trial.
ED visits were reduced by 27% at 1 month and 29% at 45 days comparing people randomized to a MyROAD card upon leaving the hospital versus controls getting the usual written discharge instructions, reported Nancy Albert, PhD, CCRN, of Cleveland Clinic.
“Brief, consistent, actionable messages that can be replayed help patients adjust during the transition from hospital to home and led to improvement in some clinical outcomes,” Albert concluded.
The composite endpoint of all-cause hospitalization, ED visits, or death was reduced by 25% at 30 days and 30% at 45 days. The intervention group was also 40% less likely to receive a heart assist device, undergo a heart transplant, or die at 3 months.
MyROAD has the appearance of a standard greeting card. An audio recording of a general statement is automatically triggered upon opening the card, which features one button each for audio segments about diet, physical activity, medication, and self-monitoring behaviors specific to HF.
“Patients may be tired, confused and worried about being able to follow provider orders and/or without family members at the time they are discharged, so they may lack the ability to carefully hear, understand and ask questions about instructions for self-care at home. Handing out more paperwork may not be the answer,” Albert said in a press release.
“In addition, some patients have health literacy issues, poor eyesight or they do not have access to the internet to get heart failure information. We needed a new way to provide this potentially life-saving information,” she continued.
The trial included 997 adults who had been hospitalized with HF at four sites in Ohio. Average age was 72.8 and 58.7% were men. Nearly a quarter of the cohort were African American.
More research is needed on how to optimize care to prevent post-discharge healthcare utilization, according to Albert.
Digital Care Transformation
A remote cholesterol and blood pressure (BP) management program had favorable interim results without a need for in-person visits, the Mass General Brigham health system found.
The program had patient navigators contact and educate patients remotely, while pharmacists prescribed and titrated GDMT according to an institutional software program with clinical decision support, according to Benjamin Scirica, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston.
Patients enrolled in the program were subsequently prescribed more lipid-lowering therapies (including statins, ezetimibe, and PCSK9 inhibitors) and antihypertensive medications from baseline, resulting in improvements in cholesterol and BP at 1 year, Scirica’s group showed in a large study published in Circulation.
LDL cholesterol was reduced by 52 mg/dL in those who completed the titration phase of the program (P<0.001) and was reduced by 24 mg/dL in the entire cohort (P<0.001). Significant LDL reductions were observed in people with established atherosclerotic cardiovascular disease, diabetes, severe hypercholesterolemia, or high-risk primary prevention.
Among people who conducted home BP monitoring, average BP fell from 138/78 mm Hg to 124/72 mm Hg (P<0.001).
“In addition to improved clinical outcomes, programs like this can improve quality metrics for value-based contracts, unburden the provider to focus on more complex care, and provide more patient education and longitudinal support,” Scirica said.
The remote management program saw recruitment improve by 25% during COVID-19, he noted.
The study included the first 5,000 patients across the Mass General Brigham health system enrolled in the program. These were individuals with uncontrolled LDL cholesterol and/or high BP identified from electronic health record and doctor referrals.
Study participants were over age 75 in 12% of cases. Women accounted for 55% of the cohort, and non-Hispanic Caucasians 71%.
Some people with diabetes or hypertension may benefit from communal medical visits and savings groups, a study in western Kenya suggested.
People randomized to usual care or an intervention group had systolic BP reduced to varying extents at 12 months:
- Usual care: -11.4 mm Hg
- Microfinance group: -14.8 mm Hg
- Group medical visits: -14.7 mm Hg
- Group medical visits plus microfinance group: -16.4 mm Hg
Upon adjustment, none of the three interventions were found to significantly improve systolic BP over usual care in the very poverty-stricken population, according to Rajesh Vedanthan, MD, MPH, of NYU Langone Health in New York City.
However, on subgroup analysis, women derived greater benefit from group medical visits and people with less wealth seemed to benefit more from microfinance.
“Incorporating social determinants of health into care delivery is important,” Vedanthan concluded from the BIGPIC trial. “Tailored interventions for subgroups might be particularly beneficial, especially women and those with low socioeconomic status.”
Group medical visits were monthly meetings in which members discussed a health topic and received one-on-one consultations with a clinician for an individualized treatment plan.
Community microfinance groups also met monthly. Each person contributed to group savings and was allowed to take interest-bearing loans for investment in business ventures and other expenses. There were no external funds given to the group from either the study or a third party.
These interventions took place in churches, schools, parks, and other community spaces.
Overall, the combination of group medical visits and microfinance did appear to result in a decrease in diastolic BP and QRISK3 score. People who underwent group medical visits fared better than usual care in their BP control, Vedanthan noted.
BIGPIC had people in western Kenya randomized at the health facility level to one of four groups: usual care, microfinance, group medical visits, group medical visits plus microfinance. Eligible patients were those with diabetes or hypertension with no acute illness.
In total, 2,890 people were randomized. Mean age was 60.7, and 70% were women. QRISK3 score was under 10% in 53.7% of the cohort at baseline. The level of poverty was illustrated by the lack of formal employment in 63.7% of people, with more than a quarter earning less than $46 per month.
Vedanthan cautioned that the trial may have limited generalizability and that there was a delay between trial enrollment and group formation.
EPIC-HF was funded by the AHA’s Strategically Focused Research Network. Allen disclosed support from the AHA, NIH, and the Patient-Centered Outcomes Research Institute, as well as relevant relationships with Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis.
MyROAD was funded by Cleveland Clinic. Albert disclosed no relevant relationships with industry.
Scirica disclosed support from Mass General Brigham and AllWays Health Partners.
Vedanthan disclosed support from the NIH.