Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure

Heart Failure Clinical Trial

— CONNECT-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035474
• Other study ID #: Pro00074513
• Status: Completed
• Phase: N/A
• Start date: April 21, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 5749
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Digital Engagement
Patient engagement to improve self-management/medication adherence
• Direct Engagement
Health system engagement to improve local QI programs

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-first HF rehospitalization or death during the 12-months post-discharge		12-months after discharge
Primary	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 ß-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	Improvement in an opportunity-based composite score for adherence to HF discharge quality measures	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
Secondary	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
Secondary	Cumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations		Baseline through study completion, an average of 3 years