The investigators propose an intervention that leverages the success of Community Healthcare Workers (CHWs) and telehealth to connect patients with severe hypertension from Emergency Department (ED) to primary care resources and to coach them to adopt evidence-based, practical lifestyle solutions relevant to urban living. The investigators have proposed this intervention as "Coaching and Navigation by Community Health Workers (CHWs) through Telehealth for High-risk Hypertension: CONNECT-HTN intervention. The investigators hypothesize that participants receiving the CONNECT-HTN intervention will have a lower likelihood of experiencing a major cardiac event compared with those referred to clinic-based care.
Must be over the age of 18 years
Have an ED triage SBP ≥ 180 and/or DBP ≥ 110, with a repeat similar reading ≥30 minutes after triage
May have received treatment for elevated BP, but must have no evidence of end-organ damage (defined as dialysis dependence, acute stroke, acute coronary syndrome, acute kidney injury, or papilledema)
Have a functional status of either fully active (independent in daily activities) or mildly restricted but ambulatory and able to work (washing, toileting, dressing, feeding, mobility).
pregnant patients
terminally ill patients, as well as
those requiring admission to the hospital due to severe complications (other than deranged BP).
Parallel
CONNECT-HTN
BehavioralWe propose a multimodal intervention that leverages the success of CHWs and telehealth to connect patients with severe hypertension to primary care resources and coach them to adopt evidence-based, practical lifestyle solutions relevant to urban living. We call the intervention Coaching and Navigation by CHW through Telehealth for High-risk Hypertension or CONNECT-HTN. CONNECT HTN will add to the evidential basis for implementing many of the WHO Best Buys for Non-Communicable Disease (NCD) prevention and control, and will be the first study powered to measure substantive mortality and mortality outcomes in LMICs.
Standard ED management
Other interventionDuring the Emergency Department (ED) admission, the participants in the control group will be provided a blood pressure measurement device and training to calculate their blood pressure at home. Standard ED management will be provided to these patients, followed by either discharge or admission for the management of hypertension.
Rate of Major Adverse Cardiac Events (MACE)
Major Adverse Cardiovascular Events (MACE) is a composite outcome including heart attack (myocardial infarction), stroke, heart failure, and cardiovascular death. The primary outcome will be assessed by comparing the cumulative incidence of MACE events between participants randomized to the CONNECT-HTN intervention arm and those randomized to referral to clinic-based care. MACE events will be identified through participant interviews, hospital record review, death certificates during the outcome collection team visit and verbal autopsy when required, and adjudicated using standardized criteria.
Blood Pressure (SBP/DBP) Over Time
Change in systolic and diastolic blood pressure over time, measured during blinded home visits using standardized oscillometric assessment. At each visit, three blood pressure readings will be obtained five minutes apart and averaged. Longitudinal blood pressure trajectories will be compared between trial arms.
Outpatient Primary Care Follow-up
Proportion of participants who attend at least one outpatient primary care visit for hypertension management during the study period, assessed via participant report and/or available medical records during the outcome collection team visit
Medication Adherence (MMAS-8 Score)
Medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8), a validated self-report questionnaire commonly used in hypertension research. Scores range from 0 to 8, with higher scores indicating greater adherence. Adherence will be measured during blinded home visits and compared between study arms over time during the outcome collection team visit.
Proportion of outcome measurement team visits completed
Proportion of scheduled outcome measurement team home visits successfully completed over the study period. Outcome measurement team, blinded to the study arm, will visit all patients at 6 month intervals to get their in home BP monitoring and collect information on patient's medication adherence, self-efficacy, and quality of life
Assessment of Participant Satisfaction using Telehealth Usability Questionnaire (Intervention group only)
Participant satisfaction with the CONNECT-HTN intervention will be assessed using the Telehealth Usability Questionnaire (TUQ), a seven-point Likert-scale instrument consisting of 21 questions administered to participants randomized to the intervention arm.
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Weill Medical College of Cornell University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
