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

January 22, 2021 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

5749

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Hospital
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Sparks Regional Medical Center
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital and Clinics
    • California
      • Banning, California, United States, 92220
        • San Gorgonio Memorial Hospital
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Redwood City, California, United States, 94062
        • Dignity Health Sequoia Hospital
      • Riverside, California, United States, 92501
        • Riverside Community Hospital
      • Sacramento, California, United States, 95816
        • Sutter Medical Center
      • Stanford, California, United States, 94305
        • Stanford University
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Colorado Springs, Colorado, United States, 80909
        • UC Health Memorial
      • Greeley, Colorado, United States, 80631
        • Northern Colorado Medical Center
    • Connecticut
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital
    • Florida
      • Atlantis, Florida, United States, 33462
        • JFK Medical Center
      • Bradenton, Florida, United States, 34208
        • Manatee Memorial Hospital
      • Bradenton, Florida, United States, 34209
        • Blake Medical Center
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Fort Lauderdale, Florida, United States, 33308
        • Broward Health Imperial Point
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health
      • Panama City, Florida, United States, 32401
        • Cardiovascular Institute of Northwest Florida
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital
      • Pensacola, Florida, United States, 32501
        • Baptist Hospital
      • Saint Petersburg, Florida, United States, 33709
        • Northside Hospital
      • Saint Petersburg, Florida, United States, 33701
        • Bayfront Health - St. Petersburg
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
      • South Miami, Florida, United States, 33143
        • South Miami Hospital
      • Tampa, Florida, United States, 33613
        • Florida Hospital Tampa
      • Tampa, Florida, United States, 33614
        • St. Joseph's Hospital
      • Winter Haven, Florida, United States, 33881
        • Winter Haven Hospital
    • Georgia
      • Athens, Georgia, United States, 30606
        • Piedmont Athens Regional Medical Center
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
      • Augusta, Georgia, United States, 30912
        • AU Medical Center
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Macon, Georgia, United States, 31201
        • Medical Center, Navicent Health (THE)
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queens Medical Center
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Copley Memorial Hospital
      • Aurora, Illinois, United States, 60506
        • Presence Mercy Medical Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital and Health Sciences System
      • Chicago, Illinois, United States, 60612
        • John H. Stroger Jr. Hospital of Cook County
      • Olympia Fields, Illinois, United States, 60461
        • Specialty Physicians of Illinois
      • Rockford, Illinois, United States, 61108
        • Saint Anthony Medical Center
      • Springfield, Illinois, United States, 62702
        • St Johns Hospital
      • Urbana, Illinois, United States, 61801
        • The Carle Foundation Hospital
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Indiana University Health Bloomington
      • Muncie, Indiana, United States, 47303
        • Indiana University Health Ball Memorial Hospital
      • Richmond, Indiana, United States, 47374
        • Reid Health
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center-Davenport
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • King's Daughters Medical Center
      • Lexington, Kentucky, United States, 40504
        • KentuckyOne Health - Saint Joseph Hospital
      • Louisville, Kentucky, United States, 40241
        • Norton Brownsboro Hospital
      • Louisville, Kentucky, United States, 40205
        • Norton Women and Children's Hospital
      • Madisonville, Kentucky, United States, 42431
        • Baptist Health Madisonville
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Rapides Regional Medical Center
      • Natchitoches, Louisiana, United States, 71457
        • Natchitoches Regional Medical Center
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University-Health Science Center- Shreveport
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Bethesda, Maryland, United States, 20814
        • Suburban Hospital
      • Clinton, Maryland, United States, 20735
        • MedStar Southern Maryland Hospital Center
      • Columbia, Maryland, United States, 21044
        • Johns Hopkins University
      • Rockville, Maryland, United States, 20850
        • Adventist HealthCare Shady Grove
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Hyannis, Massachusetts, United States, 02601
        • Cape Code Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • St. Joseph Mercy Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Detroit, Michigan, United States, 48236
        • St. John Hospital and Medical Center
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
      • Lansing, Michigan, United States, 48910
        • Mclaren Greater Lansing
      • Madison Heights, Michigan, United States, 48071
        • St. John Macomb-Oakland
      • Midland, Michigan, United States, 48670
        • MidMichigan Medical Center Midland
      • Mount Clemens, Michigan, United States, 48043
        • McLaren Macomb
      • Petoskey, Michigan, United States, 49770
        • McLaren - Northern Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Hospital
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St Lukes Hospital
    • Mississippi
      • Gulfport, Mississippi, United States, 39502
        • Memorial Hospital at Gulfport
    • Missouri
      • Blue Springs, Missouri, United States, 64014
        • St. Mary's Medical Center
      • Kansas City, Missouri, United States, 64114
        • St. Joseph Medical Center
      • North Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Springfield, Missouri, United States, 65807
        • Cox Medical Centers
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Hospital
      • Kalispell, Montana, United States, 59901
        • Glacier View Research Institute-Cardiology
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Southern NH Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Our Lady of Lourdes Medical Center
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center
      • Pomona, New Jersey, United States, 08240
        • Atlanticare Regional Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • Valley Hospital
      • Somerville, New Jersey, United States, 08876
        • Robert Wood Johnson University Hospital Somerset
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center Hospital
      • Albany, New York, United States, 12208
        • St. Peter's Hospital
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Huntington, New York, United States, 11743
        • Huntington Hospital
      • Johnson City, New York, United States, 13790
        • United Health Services Hospitals
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel
      • Schenectady, New York, United States, 12309
        • Ellis Hospital
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
      • Staten Island, New York, United States, 10310
        • Richmond University Medical Center
      • Stony Brook, New York, United States, 11794
        • University Hospital (Stony Brook)
      • Syracuse, New York, United States, 13203
        • St. Joseph's Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Charlotte-Mecklenburg Hospital Authority
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
      • Lumberton, North Carolina, United States, 28358
        • Duke Cardiology of Lumberton
      • Raleigh, North Carolina, United States, 27609
        • Duke Raleigh Hospital
      • Raleigh, North Carolina, United States, 27610
        • WakeMed
      • Wilmington, North Carolina, United States, 28402
        • New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health System
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Elyria, Ohio, United States, 44035
        • University Hospitals - Elyria Medical Center
      • Springfield, Ohio, United States, 45504
        • Springfield Regional Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Baptist Medical Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Health Science Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Hospital and Clinics
    • Pennsylvania
      • Johnstown, Pennsylvania, United States, 15905
        • Memorial Medical Center
      • Lebanon, Pennsylvania, United States, 17042
        • WellSpan Good Samaritan Hospital
    • South Carolina
      • Greenwood, South Carolina, United States, 29646
        • Self Regional Healthcare
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Jackson-Madison County General Hospital
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Fort Worth, Texas, United States, 76104
        • Plaza Medical Center of Fort Worth
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • Longview, Texas, United States, 75601
        • Christus Good Shepherd Medical Center
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
      • San Antonio, Texas, United States, 78229
        • Methodist Hospital
      • Seguin, Texas, United States, 78155
        • Guadalupe Regional Medical Center
      • Tyler, Texas, United States, 75708
        • University of Texas Health Science Center at Tyler
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Inova Alexandria Hospital
      • Newport News, Virginia, United States, 23601
        • Riverside Regional Medical Center
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, United States, 23235
        • CJW Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
        • Wheeling Hospital
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Mayo Clinic Health System Franciscan Medical Center
      • Milwaukee, Wisconsin, United States, 53211
        • Ascension Columbia St. Mary's Hospital
      • Racine, Wisconsin, United States, 53405
        • Ascension-All Saints
      • Waukesha, Wisconsin, United States, 53188
        • Waukesha Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-first HF rehospitalization or death during the 12-months post-discharge
Time Frame: 12-months after discharge
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
Baseline to 12 months post discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through study completion, an average of 3 years
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
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
Baseline through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Duke Clinical Research Institute

Investigators

  • Principal Investigator: Adam DeVore, MD, MHS, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 21, 2017

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (ESTIMATE)

January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00074513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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