Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
CONNECT-HF
1 other identifier
interventional
5,749
1 country
154
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Apr 2017
Typical duration for not_applicable heart-failure
154 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedStudy Start
First participant enrolled
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 25, 2021
December 1, 2020
3.7 years
January 5, 2017
January 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time-to-first HF rehospitalization or death during the 12-months post-discharge
12-months after discharge
Improvement in an opportunity-based composite score of adherence to quality metrics for HF.
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 Outcomes (3)
Improvement in an opportunity-based composite score for adherence to HF discharge quality measures
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
6 months and 1 year postdischarge
Cumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations
Baseline through study completion, an average of 3 years
Study Arms (4)
Direct & Digital
OTHERHealth system engagement to improve local QI programs and patient engagement to improve self-management/medication adherence
Direct & Registry
OTHERHealth system engagement to improve local QI programs and patient and control
Digital & Registry
OTHERPatient engagement to improve self-management/medication adherence and control
Registry
NO INTERVENTIONControl
Interventions
Patient engagement to improve self-management/medication adherence
Health system engagement to improve local QI programs
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Duke Clinical Research Institutecollaborator
Study Sites (154)
University of Alabama Hospital
Birmingham, Alabama, 35233, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901, United States
Arkansas Heart Hospital and Clinics
Little Rock, Arkansas, 72211, United States
San Gorgonio Memorial Hospital
Banning, California, 92220, United States
Memorial Medical Center
Modesto, California, 95355, United States
Dignity Health Sequoia Hospital
Redwood City, California, 94062, United States
Riverside Community Hospital
Riverside, California, 92501, United States
Sutter Medical Center
Sacramento, California, 95816, United States
Stanford University
Stanford, California, 94305, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
UC Health Memorial
Colorado Springs, Colorado, 80909, United States
Northern Colorado Medical Center
Greeley, Colorado, 80631, United States
Stamford Hospital
Stamford, Connecticut, 06904, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
Manatee Memorial Hospital
Bradenton, Florida, 34208, United States
Blake Medical Center
Bradenton, Florida, 34209, United States
Broward Health Imperial Point
Fort Lauderdale, Florida, 33308, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Orlando Health
Orlando, Florida, 32806, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32401, United States
Baptist Hospital
Pensacola, Florida, 32501, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
South Miami Hospital
South Miami, Florida, 33143, United States
Bayfront Health - St. Petersburg
St. Petersburg, Florida, 33701, United States
Northside Hospital
St. Petersburg, Florida, 33709, United States
Florida Hospital Tampa
Tampa, Florida, 33613, United States
St. Joseph's Hospital
Tampa, Florida, 33614, United States
Winter Haven Hospital
Winter Haven, Florida, 33881, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, 30606, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
AU Medical Center
Augusta, Georgia, 30912, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Medical Center, Navicent Health (THE)
Macon, Georgia, 31201, United States
The Queens Medical Center
Honolulu, Hawaii, 96813, United States
Copley Memorial Hospital
Aurora, Illinois, 60504, United States
Presence Mercy Medical Center
Aurora, Illinois, 60506, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612, United States
Specialty Physicians of Illinois
Olympia Fields, Illinois, 60461, United States
Saint Anthony Medical Center
Rockford, Illinois, 61108, United States
St Johns Hospital
Springfield, Illinois, 62702, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Indiana University Health Bloomington
Bloomington, Indiana, 47403, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Reid Health
Richmond, Indiana, 47374, United States
Genesis Medical Center-Davenport
Davenport, Iowa, 52803, United States
King's Daughters Medical Center
Ashland, Kentucky, 41101, United States
KentuckyOne Health - Saint Joseph Hospital
Lexington, Kentucky, 40504, United States
Norton Women and Children's Hospital
Louisville, Kentucky, 40205, United States
Norton Brownsboro Hospital
Louisville, Kentucky, 40241, United States
Baptist Health Madisonville
Madisonville, Kentucky, 42431, United States
Rapides Regional Medical Center
Alexandria, Louisiana, 71301, United States
Natchitoches Regional Medical Center
Natchitoches, Louisiana, 71457, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Louisiana State University-Health Science Center- Shreveport
Shreveport, Louisiana, 71103, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735, United States
Johns Hopkins University
Columbia, Maryland, 21044, United States
Adventist HealthCare Shady Grove
Rockville, Maryland, 20850, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Cape Code Hospital
Hyannis, Massachusetts, 02601, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Wayne State University
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
St. John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
McLaren Greater Lansing
Lansing, Michigan, 48910, United States
St. John Macomb-Oakland
Madison Heights, Michigan, 48071, United States
MidMichigan Medical Center Midland
Midland, Michigan, 48670, United States
McLaren Macomb
Mount Clemens, Michigan, 48043, United States
McLaren - Northern Michigan
Petoskey, Michigan, 49770, United States
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
St Lukes Hospital
Duluth, Minnesota, 55805, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39502, United States
St. Mary's Medical Center
Blue Springs, Missouri, 64014, United States
St. Joseph Medical Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
Cox Medical Centers
Springfield, Missouri, 65807, United States
Billings Clinic Hospital
Billings, Montana, 59101, United States
Glacier View Research Institute-Cardiology
Kalispell, Montana, 59901, United States
Bryan Medical Center
Lincoln, Nebraska, 68506, United States
University Medical Center
Las Vegas, Nevada, 89102, United States
Southern NH Medical Center
Nashua, New Hampshire, 03060, United States
Our Lady of Lourdes Medical Center
Camden, New Jersey, 08103, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, 08240, United States
Valley Hospital
Ridgewood, New Jersey, 07450, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
Albany Medical Center Hospital
Albany, New York, 12208, United States
St. Peter's Hospital
Albany, New York, 12208, United States
Huntington Hospital
Huntington, New York, 11743, United States
United Health Services Hospitals
Johnson City, New York, 13790, United States
Mount Sinai Beth Israel
New York, New York, 10003, United States
Ellis Hospital
Schenectady, New York, 12309, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
University Hospital (Stony Brook)
Stony Brook, New York, 11794, United States
St. Joseph's Hospital
Syracuse, New York, 13203, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Charlotte-Mecklenburg Hospital Authority
Charlotte, North Carolina, 28203, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Duke Cardiology of Lumberton
Lumberton, North Carolina, 28358, United States
Duke Raleigh Hospital
Raleigh, North Carolina, 27609, United States
WakeMed
Raleigh, North Carolina, 27610, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Altru Health System
Grand Forks, North Dakota, 58201, United States
Summa Health
Akron, Ohio, 44304, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
University Hospitals - Elyria Medical Center
Elyria, Ohio, 44035, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
OHSU Hospital and Clinics
Portland, Oregon, 97239, United States
Memorial Medical Center
Johnstown, Pennsylvania, 15905, United States
WellSpan Good Samaritan Hospital
Lebanon, Pennsylvania, 17042, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, 76104, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Christus Good Shepherd Medical Center
Longview, Texas, 75601, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
Guadalupe Regional Medical Center
Seguin, Texas, 78155, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304, United States
Riverside Regional Medical Center
Newport News, Virginia, 23601, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
CJW Medical Center
Richmond, Virginia, 23235, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Wheeling Hospital
Wheeling, West Virginia, 26003, United States
Mayo Clinic Health System Franciscan Medical Center
La Crosse, Wisconsin, 54601, United States
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, 53211, United States
Ascension-All Saints
Racine, Wisconsin, 53405, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Related Publications (3)
Rao VN, Kaltenbach LA, Granger BB, Fonarow GC, Al-Khalidi HR, Albert NM, Butler J, Allen LA, Lanfear DE, Ariely D, Miller JM, Brodsky MA, Lalonde TA, Lafferty JC, Granger CB, Hernandez AF, Devore AD; Durham, North Carolina; Los Angeles, California; Cleveland, Ohio; Jackson, Misssissippi, Aurora, Colorado; Detroit, Michigan; Ewa Beach, Hawaii; Staten Island, New York. The Association of Digital Health Application Use With Heart Failure Care and Outcomes: Insights From CONNECT-HF. J Card Fail. 2022 Oct;28(10):1487-1496. doi: 10.1016/j.cardfail.2022.07.050. Epub 2022 Jul 26.
PMID: 35905867DERIVEDDeVore AD, Granger BB, Fonarow GC, Al-Khalidi HR, Albert NM, Lewis EF, Butler J, Pina IL, Allen LA, Yancy CW, Cooper LB, Felker GM, Kaltenbach LA, McRae AT, Lanfear DE, Harrison RW, Disch M, Ariely D, Miller JM, Granger CB, Hernandez AF. Effect of a Hospital and Postdischarge Quality Improvement Intervention on Clinical Outcomes and Quality of Care for Patients With Heart Failure With Reduced Ejection Fraction: The CONNECT-HF Randomized Clinical Trial. JAMA. 2021 Jul 27;326(4):314-323. doi: 10.1001/jama.2021.8844.
PMID: 34313687DERIVEDDeVore AD, Granger BB, Fonarow GC, Al-Khalidi HR, Albert NM, Lewis EF, Butler J, Pina 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.
PMID: 31770656DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam DeVore, MD, MHS
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2017
First Posted
January 30, 2017
Study Start
April 21, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
January 25, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share