LBS coverage (2020) | Clinical trials that are making strides in digital interventions to improve CV patient care


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Investigators in four trials shared creative and effective approaches for optimizing patient health at the Late-Breaking Scientific session “High Tech or High Touch: Creative Strategies to Optimize Patient Care” on Tuesday. They found:

  • Direct-to-consumer, pre-appointment tools led to guideline-directed medical therapy intensification for patients with HFrEF.  
  • Simple, recorded discharge instructions can improve outcomes for adults with heart failure after they transition from hospital to home.
  • A remote, algorithm-based cardiovascular risk management program is an efficient strategy to optimize guideline-directed therapy for lipid and hypertension control for previously undertreated adults.
  • Incorporating social determinants of health into care delivery for chronic diseases can improve outcomes. 

Prepping patients for HFrEF convo leads to better prescribing

Activating and empowering patients to talk with their physicians about prescriptions for their heart failure with reduced ejection fraction (HFrEF) resulted in better prescribing according to the EPIC-HF trial: An Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure With Reduced Ejection Fraction.

“A wide variety of guideline-directed medical therapies exist for patients with HFrEF,” said Larry A. Allen, MD, MHS, medical director of Advanced Heart Failure at the University of Colorado School of Medicine. “Yet, too often, people aren’t getting them, or their doses are too low.”

A 3-minute animated video and 1-page medication checklist were delivered electronically to 145 randomly selected, under-prescribed HFrEF patients. The tools were sent three times prior to a cardiology clinic visit. Their cardiologists also had access to the tools. A matched control group received routine care.

“The primary goal was to encourage patients to work collaboratively with their clinicians to initiate and intensify HFrEF prescribing. The practical video and checklist asked patients to try to identify at least one thing they might improve, challenging clinical inertia,” said Dr. Allen.

Within 30 days of the cardiology clinic visit, 49% of the intervention group experienced an initiation or intensification of their guideline-directed medical therapies (p=0.001). Most changes were increased dosages of generic beta-blocker drugs patients were already taking. Just 29.7% of the control group had initiation or up-titrations.

Optimizing medication management did not put patients at greater risk. At 30 days, there were no deaths in either group. And there were no significant differences in hospitalization or emergency department visits between the two groups.

A fairly simple tool sent to HFrEF patients prior to an appointment led to greater collaboration with their physicians and guideline-directed medical therapy intensification. “Without the generosity of the AHA and its contributors (many of whom are patients and loved ones), we could not do this work,” said Dr. Allen.

A sound approach to discharge reduces return visits

The MyROAD (My Recorded On-Demand Audio Discharge Instructions) Trial evaluated the effectiveness of a colorful, pre-recorded discharge instruction card on patients transitioning from hospital to home after heart failure admission. By helping patients and their family caregivers remember instructions and treatment plan expectations, the card improved several outcomes.

“Most patients with heart failure are older adults. We knew that too many bells and whistles would make them less inclined to use the card, so we used a ‘less is more’ philosophy,” said Nancy Albert, PhD, associate chief nursing officer of research and innovation at the Cleveland Clinic.

The MyRoad card was developed in collaboration with American Greetings. When the patient opens the card, a general overview message plays. Then, he or she can press one of four buttons to hear instructions about physical activity, diet, medications and self-monitoring. Each 35- to 40-second message can be played over and over.

The randomized trial analyzed 997 patients hospitalized with heart failure. All participants received usual care discharge education and printed discharge instructions. The study group of 506 also received the MyROAD audio card. Patients were encouraged to display the card and share it with family members.

At 30 days, the study group experienced a 27% decrease in the odds of all-cause emergency department visits. At 45 days, there was a 29% decrease in emergency department visits. And at 90 days, the MyROAD group showed a 47% decrease in the odds of heart failure related death, left ventricular assist device placement or cardiac transplantation.

Finally, the odds of experiencing the composite endpoint of all-cause emergency department care, rehospitalization or death were reduced by 25% at 30 days, and 30% at 45 days, compared to the usual care group. There were no significant differences in between-group morbidity and mortality outcomes at 180 days. 

“I hope providers and hospital administrators will recognize the cost-effectiveness and high value of this innovative intervention,” said Dr. Albert.

Closing CV risk gap through patient, provider and system

An interim report from an ongoing implementation project offered new hope for approximately 50% of patients not receiving optimal medical treatment established in practice guidelines for hypercholesterolemia and/or hypertension. Investigators for the Digital Care Transformation Trial revealed the results in the One-Year Report of the First 5,000 Patients Enrolled in a Remote Algorithm-Based CV Risk Management Program to Achieve Optimal Lipid and Hypertension Control.

“This study is set up like a ‘coumadin clinic’ for cholesterol and blood pressure management,” said lead investigator Benjamin M. Scirica, MD, MPH. He’s a cardiovascular medicine specialist and associate professor of medicine at Brigham and Women’s Hospital and Harvard Medical School. “We’re testing a remote care delivery program that leverages innovative digital tools and allows staff to work at the top of their license in order to reduce persistent gaps in care.”

Between Jan 1, 2018, and May 21, 2020, the Digital Care Transformation team enrolled 5,000 patients with uncontrolled low-density lipoprotein-cholesterol and/or blood pressure. Patients received a digitally enabled BP cuff for home use. Labs were measured at area lab centers with no additional in-person visits required.

Patient data was uploaded to CardioCompass, a custom-built software program. Using its algorithm-based CV risk management program, a pharmacist, under the supervision of physicians, initiated and titrated guideline-directed medications. A non-licensed patient navigator acted as the “face” of the program, providing assistance and education to all patients at preset intervals.

To date, the reduction in LDL-C was 24 mg/dl (18%) in all patients enrolled, including those who remained in active titration or dropped out, and 52 mg/dl (42%) in those who achieved maintenance after completed titration (each p<0.001). 

Significant LDL-C reductions occurred in all four cholesterol patient categories: atherosclerotic cardiovascular disease, diabetes, severe hypercholesterolemia (LDL-C >190 mg/dl) and high-risk primary prevention. Utilization of statins, ezetimibe and PCSK9i inhibitors increased significantly from baseline.

Mean home systolic/diastolic BP compared to program entry was reduced by 14/6mmHg (p<0.001). No serious adverse program-related outcomes occurred. 

“As an interesting side note, during the COVID-19 stay-at-home period, our enrollment increased by nearly 25%,” said Dr. Scirica. “The pandemic greatly shortened the implementation cycle and acceptance of remote care.”

Addressing social determinants of health improves outcomes

The results of the BIGPIC (Bridging Income Generation with Group Integrated Care) Trial demonstrated that tailoring health care interventions to address underlying social determinants of health is important, feasible and may impact patients in the fight against cardiovascular disease.

“In the BIGPIC trial, we integrated one social determinant of health — economic instability — with a clinical intervention to see if we could reduce cardiovascular disease risk,” said principal investigator Rajesh Vedanthan, MD, MPH, who is associate professor and director of the Section for Global Health at the NYU Grossman School of Medicine.

BIGPIC was a cluster randomized trial in poverty-stricken, rural, western Kenya with 2,890 participants. All had diabetes or hypertension.     

Participants were divided into usual care, or one of three intervention arms: usual care plus microfinance, group medical visits only and group medical visits plus microfinance. 

During monthly microfinance meetings, patients discussed their economic concerns and initiated a group-based financial savings program. At monthly group medical visits, a community health care worker led a discussion on a medical topic, then a clinician met with each patient to review blood pressure and diabetes prescriptions.

Over the course of a year, patients in the intervention arms achieved a substantial reduction in systolic blood pressure (SBP). However, the control arm also lowered SBP. This was likely due to the fact that the usual care arm was a multicomponent care program that was superior to the region’s usual standard of care.            

Secondary outcomes revealed a significant reduction of diastolic blood pressure and cardiovascular disease risk scores in patients who attended the group medical visit plus microfinance versus those in usual care. Further analysis suggests women tended to experience greater SBP reductions than men with group medical visits; and patients with lower socio-economic status tended to experience greater SBP reductions by engaging in group-based financial planning. 

“Addressing social determinants of health go “hand-in-glove” with clinical care delivery and can improve risk for cardiovascular disease. Hospitals and clinics can tailor and adapt programs to address locally relevant social determinants such as job training, literacy or housing.” said Dr. Vedanthan.