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Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF)

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ClinicalTrials.gov Identifier: NCT03035474
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Duke University

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Other: Digital Engagement Other: Direct Engagement Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7040 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF)
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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



Primary Outcome Measures :
  1. Time-to-first HF rehospitalization or death during the 12-months after discharge [ Time Frame: 12-months after discharge ]
  2. Improvement in an opportunity-based composite score of adherence to quality metrics for HF. [ Time Frame: Baseline to 12 months post discharge ]

    The opportunity-based composite score will be created to grade the quality of care provided. The numerator will be the number of times that good care is provided; the denominator will be the number of opportunities available. The score will consist of the following quality metrics assessed at the time of hospital discharge and during outpatient follow-up:

    • Use of evidence-based specific β-blockers at ≥ 50% target dose
    • ACE-I, ARB, or sacubitril/valsartan use at ≥ 50% target dose
    • Aldosterone antagonist use
    • Anticoagulation use in participants with atrial fibrillation
    • In participants with an LVEF ≤ 35%, implantable cardioverter defibrillator placement including cardiac resynchronization therapy placement for participants with sinus rhythm, LBBB, and a QRS ≥ 150 ms
    • Attendance at 1 or more of the following: a multidisciplinary HF disease management program, a cardiac rehabilitation program, or HF group educational classes


Secondary Outcome Measures :
  1. Improvement in an opportunity-based composite score for adherence to site-level HF discharge quality measures [ Time Frame: Baseline through study completion, an average of 3 years ]

    The opportunity-based composite score will be created to grade the quality of care provided. The numerator will be adherence to medications; the denominator will be the number of opportunities available. The per-opportunity adherence rate will consist of the following quality metrics assessed at the time of hospital discharge:

    • ACE-I, ARB, or sacubitril/valsartan prescription at discharge
    • ß-blocker prescription at discharge
    • Discharge instructions addressing activity level, diet, discharge medications, follow-up appointment, weight monitoring, and how to respond to a change in symptoms
    • LVEF assessment
    • Smoking cessation counseling
    • Medication adherence

  2. Participant-level healthcare expenditures at 6 months and 1 year postdischarge [ Time Frame: 6 months and 1 year postdischarge ]
  3. Participant use of mobile applications in the study including impact of behavioral interventions on mobile application use [ Time Frame: Baseline through study completion, an average of 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035474


Contacts
Contact: Tracy Hofmann 919-668-7544 tracy.hofmann@duke.edu
Contact: Shannon Carr 919-668-8785 Shannon.M.Smith@duke.edu

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Sponsors and Collaborators
Duke University
Duke Clinical Research Institute
Investigators
Principal Investigator: Adam DeVore, MD, MHS Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03035474     History of Changes
Other Study ID Numbers: Pro00074513
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Heart Failure
Quality Improvement

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases