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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03035474
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : June 26, 2020
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE January 5, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date June 26, 2020
Actual Study Start Date  ICMJE April 21, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Time-to-first HF rehospitalization or death during the 12-months post-discharge [ Time Frame: 12-months after discharge ]
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Time-to-first HF rehospitalization or death during the 12-months after discharge [ Time Frame: 12-months after discharge ]
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Improvement in an opportunity-based composite score for adherence to 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
  • If there is a significant positive effect on at least one of the primary endpoints, then participant-level healthcare expenditures [ Time Frame: 6 months and 1 year postdischarge ]
  • Cumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations [ Time Frame: Baseline through study completion, an average of 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • 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
  • Participant-level healthcare expenditures at 6 months and 1 year postdischarge [ Time Frame: 6 months and 1 year postdischarge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
Official Title  ICMJE Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF)
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.
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 following discharge for participants hospitalized with acute HF and reduced left ventricular ejection fraction. All participants in the trial will be consented for follow-up as part of the CONNECT-HF registry on clinical outcomes, medication use, and participant-centered outcomes, including quality-of-life (QOL) assessments will be collected up to 12 months post-discharge at pre-specified intervals (6 weeks and 3, 6, and 12 months).

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Other: Digital Engagement
    Patient engagement to improve self-management/medication adherence
  • Other: Direct Engagement
    Health system engagement to improve local QI programs
Study Arms  ICMJE
  • Direct & Digital
    Health system engagement to improve local QI programs and patient engagement to improve self-management/medication adherence
    Interventions:
    • Other: Digital Engagement
    • Other: Direct Engagement
  • Direct & Registry
    Health system engagement to improve local QI programs and patient and control
    Intervention: Other: Direct Engagement
  • Digital & Registry
    Patient engagement to improve self-management/medication adherence and control
    Intervention: Other: Digital Engagement
  • No Intervention: Registry
    Control
Publications * DeVore AD, Granger BB, Fonarow GC, Al-Khalidi HR, Albert NM, Lewis EF, Butler J, Piña IL, Heidenreich PA, Allen LA, Yancy CW, Cooper LB, Felker GM, Kaltenbach LA, McRae AT, Lanfear DE, Harrison RW, Kociol RD, Disch M, Ariely D, Miller JM, Granger CB, Hernandez AF. Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure: Rationale and design of CONNECT-HF. Am Heart J. 2020 Feb;220:41-50. doi: 10.1016/j.ahj.2019.09.012. Epub 2019 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 25, 2020)
5749
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
8000
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • Acute HF as a primary cause of hospitalization

    • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035474
Other Study ID Numbers  ICMJE Pro00074513
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Duke Clinical Research Institute
Investigators  ICMJE
Principal Investigator: Adam DeVore, MD, MHS Duke University
PRS Account Duke University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP