Rationale and Design of the mTECH-Rehab Randomized Controlled Trial: Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Health.

BACKGROUND: Cardiac rehabilitation (CR) is an evidence-based, guideline-recommended intervention for patients recovering from a cardiac event, surgery or procedure that improves morbidity, mortality, and functional status. CR is traditionally provided in-center, which limits access and engagement, most notably among underrepresented racial and ethnic groups due to barriers including cost, scheduling, and transportation access. This study is designed to evaluate the Corrie Hybrid CR, a technology-based, multicomponent health equity-focused intervention as an alternative to traditional in-center CR among patients recovering from a cardiac event, surgery, or procedure compared with usual care alone. METHODS: The mTECH-Rehab (Impact of a Mobile Technology Enabled Corrie CR Program) trial will randomize 200 patients who either have diagnosis of myocardial infarction or who undergo coronary artery bypass grafting surgery, percutaneous coronary intervention, heart valve repair, or replacement presenting to 4 hospitals in a large academic health system in Maryland, United States, to the Corrie Hybrid CR program combined with usual care CR (intervention group) or usual care CR alone (control group) in a parallel arm, randomized controlled trial. The Corrie Hybrid CR program leverages 5 components: (1) a patient-facing mobile application that encourages behavior change, patient empowerment, and engagement with guideline-directed therapy; (2) Food and Drug Administration-approved smart devices that collect health metrics; (3) 2 upfront in-center CR sessions to facilitate personalization, self-efficacy, and evaluation for the safety of home exercise, followed by a combination of in-center and home-based sessions per participant preference; (4) a clinician dashboard to track health data; and (5) weekly virtual coaching sessions delivered over 12 weeks for education, encouragement, and risk factor modification. The primary outcome is the mean difference between the intervention versus control groups in distance walked on the 6-minute walk test (ie, functional capacity) at 12 weeks post randomization. Key secondary and exploratory outcomes include improvement in a composite cardiovascular health metric, CR engagement, quality of life, health factors (including low-density lipoprotein-cholesterol, hemoglobin A1c, weight, diet, smoking cessation, blood pressure), and psychosocial factors. Approval for the study was granted by the local institutional review board. Results of the trial will be published once data collection and analysis have been completed. CONCLUSIONS: The Corrie Hybrid CR program has the potential to improve functional status, cardiovascular health, and CR engagement and advance equity in access to cardiac rehabilitation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05238103.

Use of Human-Centered Design Methodology to Develop a Digital Toolkit to Optimize Heart Failure Guideline-Directed Medical Therapy.

BACKGROUND: Guideline-directed medical therapies (GDMTs) improve quality of life and health outcomes for patients with heart failure (HF). However, GDMT utilization is suboptimal among patients with HF. OBJECTIVE: The aims of this study were to engage key stakeholders in semistructured, virtual human-centered design sessions to identify challenges in GDMT optimization posthospitalization and inform the development of a digital toolkit aimed at optimizing HF GDMTs. METHODS: For the human-centered design sessions, we recruited (a) clinicians who care for patients with HF across 3 hospital systems, (b) patients with HF with reduced ejection fraction (ejection fraction ≤ 40%) discharged from the hospital within 30 days of enrollment, and (c) caregivers. All participants were 18 years or older, English speaking, with Internet access. RESULTS: A total of 10 clinicians (median age, 37 years [interquartile range, 35-41], 12 years [interquartile range, 10-14] of experience caring for patients with HF, 80% women, 50% White, 50% nurse practitioners) and three patients and one caregiver (median age 57 years [IQR: 53-60], 75% men, 50% Black, 75% married) were included. Five themes emerged from the clinician sessions on challenges to GDMT optimization (eg, barriers to patient buy-in). Six themes on challenges (eg, managing medications), 4 themes on motivators (eg, regaining independence), and 3 themes on facilitators (eg, social support) to HF management arose from the patient and caregiver sessions. CONCLUSIONS: The clinician, patient, and caregiver insights identified through human-centered design will inform a digital toolkit aimed at optimizing HF GDMTs, including a patient-facing smartphone application and clinician dashboard. This digital toolkit will be evaluated in a multicenter, clinical trial.

AddREssing Social Determinants TO pRevent hypErtension (The RESTORE Network): Overview of the Health Equity Research Network to Prevent Hypertension.

BACKGROUND: The American Heart Association funded a Health Equity Research Network on the prevention of hypertension, the RESTORE Network, as part of its commitment to achieving health equity in all communities. This article provides an overview of the RESTORE Network. METHODS: The RESTORE Network includes five independent, randomized trials testing approaches to implement non-pharmacological interventions that have been proven to lower blood pressure (BP). The trials are community-based, taking place in churches in rural Alabama, mobile health units in Michigan, barbershops in New York, community health centers in Maryland, and food deserts in Massachusetts. Each trial employs a hybrid effectiveness-implementation research design to test scalable and sustainable strategies that mitigate social determinants of health (SDOH) that contribute to hypertension in Black communities. The primary outcome in each trial is change in systolic BP. The RESTORE Network Coordinating Center has five cores: BP measurement, statistics, intervention, community engagement, and training that support the trials. Standardized protocols, data elements and analysis plans were adopted in each trial to facilitate cross-trial comparisons of the implementation strategies, and application of a standard costing instrument for health economic evaluations, scale up, and policy analysis. Herein, we discuss future RESTORE Network research plans and policy outreach activities designed to advance health equity by preventing hypertension. CONCLUSIONS: The RESTORE Network was designed to promote health equity in the US by testing effective and sustainable implementation strategies focused on addressing SDOH to prevent hypertension among Black adults.

A Path Forward: COVID-19 Vaccine Equity Community Education and Outreach Initiative.

COVID-19 vaccines offer hope to end the COVID-19 pandemic. In this article, we document key lessons learned as we continue to confront COVID-19 variants and work to adapt our vaccine outreach strategies to best serve our community. In the fall of 2020, the Office of Diversity, Inclusion and Health Equity at Johns Hopkins Medicine, in collaboration with the Office of Government and Community Affairs for Johns Hopkins University and Medicine, established the COVID-19 Vaccine Equity Community Education and Outreach Initiative in partnership with faith and community leaders, local and state government representatives, and community-based organizations. Working with community and government partnerships established before COVID-19 enabled our team to quickly build infrastructure focused on COVID-19 vaccine education and equity. These partnerships resulted in the development and implementation of web-based educational content, major culturally adapted media campaigns (reaching more than 200,000 individuals), community and faith education outreach, youth-focused initiatives, and equity-focused mobile vaccine clinics. The community mobile vaccine clinics vaccinated over 3,000 people in the first 3 months. Of these, 90% identified as persons of color who have been disproportionately impacted during the COVID-19 pandemic. Academic-government-community partnerships are vital to ensure health equity. Community partnerships, education events, and open dialogues were conducted between the community and medical faculty. Using nontraditional multicultural media venues enabled us to reach many community members and facilitated informed decisionmaking. Additionally, an equitable COVID-19 vaccine policy requires attention to vaccine access as well as access to sound educational information. Our initiative has been thoughtful about using various types of vaccination sites, mobile vaccine units, and flexible hours of operation.

Addressing Hypertension Care in Africa (ADHINCRA): Study protocol for a cluster-randomized controlled pilot trial.

BACKGROUND: Uncontrolled hypertension is a major risk factor for cardiovascular disease. Evidence-based interventions to improve hypertension control in high-income countries have not been translated equally in sub-Saharan Africa (SSA). The objective of the Addressing Hypertension Care in Africa (ADHINCRA) Study was to test the feasibility and signal of efficacy of a multilevel, nurse-led, mobile health enhanced intervention in improving hypertension control in Ghana. METHODS: Using a cluster randomized controlled pilot trial design, four hospitals in Kumasi, Ghana, were randomized to the intervention arm (2 hospitals) and enhanced usual care arm (2 hospitals). A total of 240 patients with uncontrolled hypertension defined as systolic blood pressure (BP) ≥140 mmHg on their most recent visit were included (60 patients per hospital). Patients in the intervention arm received an intervention that consisted of nurse-led task-shifting and a mobile health application (Medtronic® Labs' Empower Health), and home BP monitoring. The enhanced usual care arm received usual care as determined by their providers, plus short text messages on health. The intervention was administered for six months, after which it was withdrawn, and patients were followed for six more months to assess outcomes. Feasibility measures included recruitment and dropout rates of study participants, protocol adherence in both arms. Clinical outcomes included changes in BP control status and systolic BP levels from baseline. Secondary outcomes included change in glycemic control, rates of hypertensive urgencies/emergencies, cardiovascular disease events, and medication adherence. DISCUSSION: Findings from this study will provide critical pilot data to inform the conduct of a larger scale trial and the development of scalable health system and policy interventions to improve hypertension control in low-resource settings. Trial registration NCT04010344. Registered on July 8, 2019 at ClinicalTrials.govhttps://clinicaltrials.gov/ct2/show/NCT04010344.

The Virtual Inclusive Digital Health Intervention Design to Promote Health Equity (iDesign) Framework for Atrial Fibrillation: Co-design and Development Study.

BACKGROUND: Smartphone ownership and mobile app use are steadily increasing in individuals of diverse racial and ethnic backgrounds living in the United States. Growing adoption of technology creates a perfect opportunity for digital health interventions to increase access to health care. To successfully implement digital health interventions and engage users, intervention development should be guided by user input, which is best achieved by the process of co-design. Digital health interventions co-designed with the active engagement of users have the potential to increase the uptake of guideline recommendations, which can reduce morbidity and mortality and advance health equity. OBJECTIVE: We aimed to co-design a digital health intervention for patients with atrial fibrillation, the most common cardiac arrhythmia, with patient, caregiver, and clinician feedback and to describe our approach to human-centered design for building digital health interventions. METHODS: We conducted virtual meetings with patients with atrial fibrillation (n=8), their caregivers, and clinicians (n=8). We used the following 7 steps in our co-design process: step 1, a virtual meeting focused on defining challenges and empathizing with problems that are faced in daily life by individuals with atrial fibrillation and clinicians; step 2, a virtual meeting focused on ideation and brainstorming the top challenges identified during the first meeting; step 3, individualized onboarding of patients with an existing minimally viable version of the atrial fibrillation app; step 4, virtual prototyping of the top 3 ideas generated during ideation; step 5, further ranking by the study investigators and engineers of the ideas that were generated during ideation but were not chosen as top-3 solutions to be prototyped in step 4; step 6, ongoing engineering work to incorporate top-priority features in the app; and step 7, obtaining further feedback from patients and testing the atrial fibrillation digital health intervention in a pilot clinical study. RESULTS: The top challenges identified by patients and caregivers included addressing risk factor modification, medication adherence, and guidance during atrial fibrillation episodes. Challenges identified by clinicians were complementary and included patient education, addressing modifiable atrial fibrillation risk factors, and remote atrial fibrillation episode management. Patients brainstormed more than 30 ideas to address the top challenges, and the clinicians generated more than 20 ideas. Ranking of the ideas informed several novel or modified features aligned with the Theory of Health Behavior Change, features that were geared toward risk factor modification; patient education; rhythm, symptom, and trigger correlation for remote atrial fibrillation management; and social support. CONCLUSIONS: We co-designed an atrial fibrillation digital health intervention in partnership with patients, caregivers, and clinicians by virtually engaging in collaborative creation through the design process. We summarize our experience and describe a flexible approach to human-centered design for digital health intervention development that can guide innovative clinical investigators.

The role of South-North partnerships in promoting shared learning and knowledge transfer.

While it is clear that hospitals in developing countries need to improve quality of health services and improve patient safety, hospitals in high resource countries need to do the same. Most often the focus on improvement through institutional health partnerships involves hospital teams from high resource settings attempting to aid and teach hospital staff in low resource settings, particularly in Africa. However these efforts to provide assistance may be more satisfying and sustainable if we understand that partnership learning is bi-directional whereby hospital teams from high resource settings also benefit. One particular partnership-based model that demonstrates this benefit to high resource partners is the World Health Organization African Partnerships for Patient Safety (APPS). Johns Hopkins Medicine Armstrong Institute for Patient Safety & Quality (AI) through the APPS model has co-created twinning partnerships with hospitals in Uganda, South Sudan & Liberia. This commentary aims to deconstruct specific learnings that have benefited the Johns Hopkins AI community through the APPS partnership.

The Armstrong Institute: An Academic Institute for Patient Safety and Quality Improvement, Research, Training, and Practice.

Academic medical centers (AMCs) could advance the science of health care delivery, improve patient safety and quality improvement, and enhance value, but many centers have fragmented efforts with little accountability. Johns Hopkins Medicine, the AMC under which the Johns Hopkins University School of Medicine and the Johns Hopkins Health System are organized, experienced similar challenges, with operational patient safety and quality leadership separate from safety and quality-related research efforts. To unite efforts and establish accountability, the Armstrong Institute for Patient Safety and Quality was created in 2011.The authors describe the development, purpose, governance, function, and challenges of the institute to help other AMCs replicate it and accelerate safety and quality improvement. The purpose is to partner with patients, their loved ones, and all interested parties to end preventable harm, continuously improve patient outcomes and experience, and eliminate waste in health care. A governance structure was created, with care mapped into seven categories, to oversee the quality and safety of all patients treated at a Johns Hopkins Medicine entity. The governance has a Patient Safety and Quality Board Committee that sets strategic goals, and the institute communicates these goals throughout the health system and supports personnel in meeting these goals. The institute is organized into 13 functional councils reflecting their behaviors and purpose. The institute works daily to build the capacity of clinicians trained in safety and quality through established programs, advance improvement science, and implement and evaluate interventions to improve the quality of care and safety of patients.