Purpose

CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years
  • Acute HF as a primary cause of hospitalization and a previous clinical diagnosis of HF
  • Hospitalizations for acute HF will be determined by local clinician-investigators but should include the following:
  • Symptoms (eg, dyspnea, fatigue), signs (eg, elevated jugular venous pressure, peripheral edema), or laboratory/imaging evidence of HF (eg, pulmonary congestion on chest x-ray, elevated natriuretic peptide levels) during the hospitalization and
  • Treatments aimed at acute HF (eg, intravenous diuretics, vasodilators, or inotropes)
  • LVEF ≤ 40% based on last local measurement using echocardiography, multigated acquisition scan, computed tomography (CT) scanning, magnetic resonance imaging, or ventricular angiography
  • Planned discharge to home or other supported care facility where patients are individually responsible for medication management

Exclusion Criteria

  • Prior heart transplant or current/planned left ventricular assistance device
  • Chronic kidney disease requiring dialysis
  • Terminal illness other than HF, such as malignancy, or with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
  • Unable to participate in longitudinal follow-up, such as plans to move outside the US in the following year

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Direct & Digital
Health system engagement to improve local QI programs and patient engagement to improve self-management/medication adherence
  • Other: Digital Engagement
    Patient engagement to improve self-management/medication adherence
  • Other: Direct Engagement
    Health system engagement to improve local QI programs
Other
Direct & Registry
Health system engagement to improve local QI programs and patient and control
  • Other: Direct Engagement
    Health system engagement to improve local QI programs
Other
Digital & Registry
Patient engagement to improve self-management/medication adherence and control
  • Other: Digital Engagement
    Patient engagement to improve self-management/medication adherence
No Intervention
Registry
Control

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Kairee Navarro

More Details

NCT ID
NCT03035474
Status
Recruiting
Sponsor
Duke University

Study Contact

Tracy Hofmann
919-668-7544
tracy.hofmann@duke.edu

Detailed Description

This trial will be a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics. Outcomes will be assessed in the year following discharge for participants hospitalized with acute HF and history of reduced left ventricular ejection fraction. All participants in the trial will be consented as part of the CONNECT-HF registry on clinical outcomes, medication use, and participant-centered outcomes, including quality-of-life (QOL) assessments, at 6 weeks and 3, 6, and 12 months after discharge, for longitudinal follow-up.

The health-system QI program will involve site visits and ongoing mentoring from teams of healthcare professionals with specialized training and field experience to help health systems and individual hospitals to design local QI plans.

A key substudy will assess a participant-engagement strategy (digital) of a mobile application utilizing behavioral tools to reinforce health behaviors, including self-monitoring/self-management and medication adherence.

Follow-up will occur via a centralized telephone interview by trained personnel via the DCRI Call Center. At each interview, participants will be asked to report current medications, rehospitalizations, and QOL assessments. Based on participant-reported events, medical billing data for rehospitalizations, emergency department visits, and procedures will be obtained.

Quality of life assessments will include the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQOL five dimensions questionnaire (EQ-5D).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.