Clinical trial NCT03035474: Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
Official title: Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Quality Improvement
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
First posted: 2017-01-30
Enrollment: 5749
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Time-to-first HF rehospitalization or death during the 12-months post-discharge
timeFrame: 12-months after discharge
measure: Improvement in an opportunity-based composite score of adherence to quality metrics for HF.
timeFrame: Baseline to 12 months post discharge
Secondary outcomes:
measure: Improvement in an opportunity-based composite score for adherence to HF discharge quality measures
timeFrame: Baseline through study completion, an average of 3 years
measure: If there is a significant positive effect on at least one of the primary endpoints, then participant-level healthcare expenditures
timeFrame: 6 months and 1 year postdischarge
measure: Cumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations
timeFrame: Baseline through study completion, an average of 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Fort Smith
country: United States
facility: Sparks Regional Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital and Clinics
state: Arkansas
city: Banning
country: United States
facility: San Gorgonio Memorial Hospital
state: California
city: Modesto
country: United States
facility: Memorial Medical Center
state: California
city: Redwood City
country: United States
facility: Dignity Health Sequoia Hospital
state: California
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: UC Health Memorial
state: Colorado
city: Greeley
country: United States
facility: Northern Colorado Medical Center
state: Colorado
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Bradenton
country: United States
facility: Blake Medical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Health Imperial Point
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Health - St. Petersburg
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: South Miami
country: United States
facility: South Miami Hospital
state: Florida
city: Tampa
country: United States
facility: Florida Hospital Tampa
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven Hospital
state: Florida
city: Athens
country: United States
facility: Piedmont Athens Regional Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Augusta
country: United States
facility: AU Medical Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Macon
country: United States
facility: Medical Center, Navicent Health (THE)
state: Georgia
city: Honolulu
country: United States
facility: The Queens Medical Center
state: Hawaii
city: Aurora
country: United States
facility: Copley Memorial Hospital
state: Illinois
city: Aurora
country: United States
facility: Presence Mercy Medical Center
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
city: Olympia Fields
country: United States
facility: Specialty Physicians of Illinois
state: Illinois
city: Rockford
country: United States
facility: Saint Anthony Medical Center
state: Illinois
city: Springfield
country: United States
facility: St Johns Hospital
state: Illinois
city: Urbana
country: United States
facility: The Carle Foundation Hospital
state: Illinois
city: Bloomington
country: United States
facility: Indiana University Health Bloomington
state: Indiana
city: Muncie
country: United States
facility: Indiana University Health Ball Memorial Hospital
state: Indiana
city: Richmond
country: United States
facility: Reid Health
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center-Davenport
state: Iowa
city: Ashland
country: United States
facility: King's Daughters Medical Center
state: Kentucky
city: Lexington
country: United States
facility: KentuckyOne Health - Saint Joseph Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Women and Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Brownsboro Hospital
state: Kentucky
city: Madisonville
country: United States
facility: Baptist Health Madisonville
state: Kentucky
city: Alexandria
country: United States
facility: Rapides Regional Medical Center
state: Louisiana
city: Natchitoches
country: United States
facility: Natchitoches Regional Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University-Health Science Center- Shreveport
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Clinton
country: United States
facility: MedStar Southern Maryland Hospital Center
state: Maryland
city: Columbia
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rockville
country: United States
facility: Adventist HealthCare Shady Grove
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Code Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Lansing
country: United States
facility: McLaren Greater Lansing
state: Michigan
city: Madison Heights
country: United States
facility: St. John Macomb-Oakland
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center Midland
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb
state: Michigan
city: Petoskey
country: United States
facility: McLaren - Northern Michigan
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland Hospital
state: Michigan
city: Warren
country: United States
facility: St. John Macomb Hospital
state: Michigan
city: Duluth
country: United States
facility: St Lukes Hospital
state: Minnesota
city: Gulfport
country: United States
facility: Memorial Hospital at Gulfport
state: Mississippi
city: Blue Springs
country: United States
facility: St. Mary's Medical Center
state: Missouri
city: Kansas City
country: United States
facility: St. Joseph Medical Center
state: Missouri
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Centers
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Hospital
state: Montana
city: Kalispell
country: United States
facility: Glacier View Research Institute-Cardiology
state: Montana
city: Lincoln
country: United States
facility: Bryan Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: University Medical Center
state: Nevada
city: Nashua
country: United States
facility: Southern NH Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Somerville
country: United States
facility: Robert Wood Johnson University Hospital Somerset
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center Hospital
state: New York
city: Albany
country: United States
facility: St. Peter's Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Johnson City
country: United States
facility: United Health Services Hospitals
state: New York
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: Schenectady
country: United States
facility: Ellis Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Stony Brook
country: United States
facility: University Hospital (Stony Brook)
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital
state: New York
city: Charlotte
country: United States
facility: Charlotte-Mecklenburg Hospital Authority
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Lumberton
country: United States
facility: Duke Cardiology of Lumberton
state: North Carolina
city: Raleigh
country: United States
facility: Duke Raleigh Hospital
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Elyria
country: United States
facility: University Hospitals - Elyria Medical Center
state: Ohio
city: Springfield
country: United States
facility: Springfield Regional Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Portland
country: United States
facility: OHSU Hospital and Clinics
state: Oregon
city: Johnstown
country: United States
facility: Memorial Medical Center
state: Pennsylvania
city: Lebanon
country: United States
facility: WellSpan Good Samaritan Hospital
state: Pennsylvania
city: Greenwood
country: United States
facility: Self Regional Healthcare
state: South Carolina
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Longview
country: United States
facility: Christus Good Shepherd Medical Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Seguin
country: United States
facility: Guadalupe Regional Medical Center
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
city: Alexandria
country: United States
facility: Inova Alexandria Hospital
state: Virginia
city: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: CJW Medical Center
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Wheeling
country: United States
facility: Wheeling Hospital
state: West Virginia
city: La Crosse
country: United States
facility: Mayo Clinic Health System Franciscan Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Ascension Columbia St. Mary's Hospital
state: Wisconsin
city: Racine
country: United States
facility: Ascension-All Saints
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
Study officials:
affiliation: Duke University
name: Adam DeVore, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: DeVore 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.
citation: DeVore 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.