Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
- Conditions
- Heart Failure
- Interventions
- Other: Digital EngagementOther: Direct Engagement
- Registration Number
- NCT03035474
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5749
-
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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Direct & Digital Digital Engagement Health system engagement to improve local QI programs and patient engagement to improve self-management/medication adherence Direct & Digital Direct Engagement Health system engagement to improve local QI programs and patient engagement to improve self-management/medication adherence Direct & Registry Direct Engagement Health system engagement to improve local QI programs and patient and control Digital & Registry Digital Engagement Patient engagement to improve self-management/medication adherence and control
- Primary Outcome Measures
Name Time Method 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. 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
Name Time Method Improvement in an opportunity-based composite score for adherence to HF discharge quality measures 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 adherenceCumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations 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
Trial Locations
- Locations (152)
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Sparks Regional Medical Center
🇺🇸Fort Smith, Arkansas, United States
Memorial Medical Center
🇺🇸Johnstown, Pennsylvania, United States
San Gorgonio Memorial Hospital
🇺🇸Banning, California, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Stanford University
🇺🇸Stanford, California, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Blake Medical Center
🇺🇸Bradenton, Florida, United States
Broward Health Imperial Point
🇺🇸Fort Lauderdale, Florida, United States
Cardiovascular Institute of Northwest Florida
🇺🇸Panama City, Florida, United States
Baptist Hospital
🇺🇸Pensacola, Florida, United States
Northside Hospital
🇺🇸Saint Petersburg, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
South Miami Hospital
🇺🇸South Miami, Florida, United States
Winter Haven Hospital
🇺🇸Winter Haven, Florida, United States
Piedmont Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
AU Medical Center
🇺🇸Augusta, Georgia, United States
Medical Center, Navicent Health (THE)
🇺🇸Macon, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Copley Memorial Hospital
🇺🇸Aurora, Illinois, United States
Presence Mercy Medical Center
🇺🇸Aurora, Illinois, United States
John H. Stroger Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences System
🇺🇸Chicago, Illinois, United States
Specialty Physicians of Illinois
🇺🇸Olympia Fields, Illinois, United States
Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
Indiana University Health Bloomington
🇺🇸Bloomington, Indiana, United States
Indiana University Health Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
The Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Genesis Medical Center-Davenport
🇺🇸Davenport, Iowa, United States
Reid Health
🇺🇸Richmond, Indiana, United States
King's Daughters Medical Center
🇺🇸Ashland, Kentucky, United States
Natchitoches Regional Medical Center
🇺🇸Natchitoches, Louisiana, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
MedStar Southern Maryland Hospital Center
🇺🇸Clinton, Maryland, United States
Johns Hopkins University
🇺🇸Columbia, Maryland, United States
Adventist HealthCare Shady Grove
🇺🇸Rockville, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Cape Code Hospital
🇺🇸Hyannis, Massachusetts, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
McLaren Greater Lansing
🇺🇸Lansing, Michigan, United States
MidMichigan Medical Center Midland
🇺🇸Midland, Michigan, United States
St. John Macomb-Oakland
🇺🇸Madison Heights, Michigan, United States
McLaren - Northern Michigan
🇺🇸Petoskey, Michigan, United States
McLaren Macomb
🇺🇸Mount Clemens, Michigan, United States
Lakeland Hospital
🇺🇸Saint Joseph, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Memorial Hospital at Gulfport
🇺🇸Gulfport, Mississippi, United States
North Kansas City Hospital
🇺🇸North Kansas City, Missouri, United States
Cox Medical Centers
🇺🇸Springfield, Missouri, United States
Glacier View Research Institute-Cardiology
🇺🇸Kalispell, Montana, United States
Billings Clinic Hospital
🇺🇸Billings, Montana, United States
Bryan Medical Center
🇺🇸Lincoln, Nebraska, United States
Southern NH Medical Center
🇺🇸Nashua, New Hampshire, United States
Our Lady of Lourdes Medical Center
🇺🇸Camden, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Albany Medical Center Hospital
🇺🇸Albany, New York, United States
St. Peter's Hospital
🇺🇸Albany, New York, United States
Huntington Hospital
🇺🇸Huntington, New York, United States
United Health Services Hospitals
🇺🇸Johnson City, New York, United States
Mount Sinai Beth Israel
🇺🇸New York, New York, United States
Ellis Hospital
🇺🇸Schenectady, New York, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Charlotte-Mecklenburg Hospital Authority
🇺🇸Charlotte, North Carolina, United States
Richmond University Medical Center
🇺🇸Staten Island, New York, United States
University Hospital (Stony Brook)
🇺🇸Stony Brook, New York, United States
Duke Cardiology of Lumberton
🇺🇸Lumberton, North Carolina, United States
Duke Raleigh Hospital
🇺🇸Raleigh, North Carolina, United States
WakeMed
🇺🇸Raleigh, North Carolina, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Summa Health
🇺🇸Akron, Ohio, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
University Hospitals - Elyria Medical Center
🇺🇸Elyria, Ohio, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Plaza Medical Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Christus Good Shepherd Medical Center
🇺🇸Longview, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Guadalupe Regional Medical Center
🇺🇸Seguin, Texas, United States
Inova Alexandria Hospital
🇺🇸Alexandria, Virginia, United States
Riverside Regional Medical Center
🇺🇸Newport News, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Wheeling Hospital
🇺🇸Wheeling, West Virginia, United States
Mayo Clinic Health System Franciscan Medical Center
🇺🇸La Crosse, Wisconsin, United States
University Medical Center
🇺🇸Las Vegas, Nevada, United States
Dignity Health Sequoia Hospital
🇺🇸Redwood City, California, United States
Riverside Community Hospital
🇺🇸Riverside, California, United States
St. Joseph's Hospital
🇺🇸Syracuse, New York, United States
St Johns Hospital
🇺🇸Springfield, Illinois, United States
Springfield Regional Medical Center
🇺🇸Springfield, Ohio, United States
St. Mary's Medical Center
🇺🇸Blue Springs, Missouri, United States
WellSpan Good Samaritan Hospital
🇺🇸Lebanon, Pennsylvania, United States
University of Texas Health Science Center at Tyler
🇺🇸Tyler, Texas, United States
The Queens Medical Center
🇺🇸Honolulu, Hawaii, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
UC Health Memorial
🇺🇸Colorado Springs, Colorado, United States
Northern Colorado Medical Center
🇺🇸Greeley, Colorado, United States
St Lukes Hospital
🇺🇸Duluth, Minnesota, United States
Altru Health System
🇺🇸Grand Forks, North Dakota, United States
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Alabama Hospital
🇺🇸Birmingham, Alabama, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
OHSU Hospital and Clinics
🇺🇸Portland, Oregon, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Oklahoma University Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Florida Hospital Tampa
🇺🇸Tampa, Florida, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
Arkansas Heart Hospital and Clinics
🇺🇸Little Rock, Arkansas, United States
Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
AtlantiCare Regional Medical Center
🇺🇸Pomona, New Jersey, United States
Broward Health Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Bayfront Health - St. Petersburg
🇺🇸Saint Petersburg, Florida, United States
Louisiana State University-Health Science Center- Shreveport
🇺🇸Shreveport, Louisiana, United States
Rapides Regional Medical Center
🇺🇸Alexandria, Louisiana, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Ascension Columbia St. Mary's Hospital
🇺🇸Milwaukee, Wisconsin, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Self Regional Healthcare
🇺🇸Greenwood, South Carolina, United States
Robert Wood Johnson University Hospital Somerset
🇺🇸Somerville, New Jersey, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Ascension-All Saints
🇺🇸Racine, Wisconsin, United States
Sutter Medical Center
🇺🇸Sacramento, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Novant Health Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Norton Women and Children's Hospital
🇺🇸Louisville, Kentucky, United States
Norton Brownsboro Hospital
🇺🇸Louisville, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
St. Joseph Medical Center
🇺🇸Kansas City, Missouri, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
CJW Medical Center
🇺🇸Richmond, Virginia, United States
KentuckyOne Health - Saint Joseph Hospital
🇺🇸Lexington, Kentucky, United States
Baptist Health Madisonville
🇺🇸Madisonville, Kentucky, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States