CONNECT-HF: Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- 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
- 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 adherence
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Hospital | Birmingham | Alabama | United States | 35233 |
| 2 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 3 | Sparks Regional Medical Center | Fort Smith | Arkansas | United States | 72901 |
| 4 | Arkansas Heart Hospital and Clinics | Little Rock | Arkansas | United States | 72211 |
| 5 | San Gorgonio Memorial Hospital | Banning | California | United States | 92220 |
| 6 | Memorial Medical Center | Modesto | California | United States | 95355 |
| 7 | Dignity Health Sequoia Hospital | Redwood City | California | United States | 94062 |
| 8 | Riverside Community Hospital | Riverside | California | United States | 92501 |
| 9 | Sutter Medical Center | Sacramento | California | United States | 95816 |
| 10 | Stanford University | Stanford | California | United States | 94305 |
| 11 | Torrance Memorial Medical Center | Torrance | California | United States | 90505 |
| 12 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 13 | UC Health Memorial | Colorado Springs | Colorado | United States | 80909 |
| 14 | Northern Colorado Medical Center | Greeley | Colorado | United States | 80631 |
| 15 | Stamford Hospital | Stamford | Connecticut | United States | 06904 |
| 16 | JFK Medical Center | Atlantis | Florida | United States | 33462 |
| 17 | Manatee Memorial Hospital | Bradenton | Florida | United States | 34208 |
| 18 | Blake Medical Center | Bradenton | Florida | United States | 34209 |
| 19 | Broward Health Imperial Point | Fort Lauderdale | Florida | United States | 33308 |
| 20 | Holy Cross Hospital | Fort Lauderdale | Florida | United States | 33308 |
| 21 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 22 | Mayo Clinic Florida | Jacksonville | Florida | United States | 32224 |
| 23 | Orlando Health | Orlando | Florida | United States | 32806 |
| 24 | Cardiovascular Institute of Northwest Florida | Panama City | Florida | United States | 32401 |
| 25 | Baptist Hospital | Pensacola | Florida | United States | 32501 |
| 26 | Sacred Heart Hospital | Pensacola | Florida | United States | 32504 |
| 27 | Bayfront Health - St. Petersburg | Saint Petersburg | Florida | United States | 33701 |
| 28 | Northside Hospital | Saint Petersburg | Florida | United States | 33709 |
| 29 | Sarasota Memorial Hospital | Sarasota | Florida | United States | 34239 |
| 30 | South Miami Hospital | South Miami | Florida | United States | 33143 |
| 31 | Florida Hospital Tampa | Tampa | Florida | United States | 33613 |
| 32 | St. Joseph's Hospital | Tampa | Florida | United States | 33614 |
| 33 | Winter Haven Hospital | Winter Haven | Florida | United States | 33881 |
| 34 | Piedmont Athens Regional Medical Center | Athens | Georgia | United States | 30606 |
| 35 | Grady Memorial Hospital | Atlanta | Georgia | United States | 30303 |
| 36 | AU Medical Center | Augusta | Georgia | United States | 30912 |
| 37 | Northeast Georgia Medical Center | Gainesville | Georgia | United States | 30501 |
| 38 | Medical Center, Navicent Health (THE) | Macon | Georgia | United States | 31201 |
| 39 | The Queens Medical Center | Honolulu | Hawaii | United States | 96813 |
| 40 | Copley Memorial Hospital | Aurora | Illinois | United States | 60504 |
| 41 | Presence Mercy Medical Center | Aurora | Illinois | United States | 60506 |
| 42 | John H. Stroger Jr. Hospital of Cook County | Chicago | Illinois | United States | 60612 |
| 43 | University of Illinois Hospital and Health Sciences System | Chicago | Illinois | United States | 60612 |
| 44 | Specialty Physicians of Illinois | Olympia Fields | Illinois | United States | 60461 |
| 45 | Saint Anthony Medical Center | Rockford | Illinois | United States | 61108 |
| 46 | St Johns Hospital | Springfield | Illinois | United States | 62702 |
| 47 | The Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 48 | Indiana University Health Bloomington | Bloomington | Indiana | United States | 47403 |
| 49 | Indiana University Health Ball Memorial Hospital | Muncie | Indiana | United States | 47303 |
| 50 | Reid Health | Richmond | Indiana | United States | 47374 |
| 51 | Genesis Medical Center-Davenport | Davenport | Iowa | United States | 52803 |
| 52 | King's Daughters Medical Center | Ashland | Kentucky | United States | 41101 |
| 53 | KentuckyOne Health - Saint Joseph Hospital | Lexington | Kentucky | United States | 40504 |
| 54 | Norton Women and Children's Hospital | Louisville | Kentucky | United States | 40205 |
| 55 | Norton Brownsboro Hospital | Louisville | Kentucky | United States | 40241 |
| 56 | Baptist Health Madisonville | Madisonville | Kentucky | United States | 42431 |
| 57 | Rapides Regional Medical Center | Alexandria | Louisiana | United States | 71301 |
| 58 | Natchitoches Regional Medical Center | Natchitoches | Louisiana | United States | 71457 |
| 59 | Ochsner Medical Center | New Orleans | Louisiana | United States | 70121 |
| 60 | Louisiana State University-Health Science Center- Shreveport | Shreveport | Louisiana | United States | 71103 |
| 61 | Anne Arundel Medical Center | Annapolis | Maryland | United States | 21401 |
| 62 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 63 | Suburban Hospital | Bethesda | Maryland | United States | 20814 |
| 64 | MedStar Southern Maryland Hospital Center | Clinton | Maryland | United States | 20735 |
| 65 | Johns Hopkins University | Columbia | Maryland | United States | 21044 |
| 66 | Adventist HealthCare Shady Grove | Rockville | Maryland | United States | 20850 |
| 67 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 68 | Cape Code Hospital | Hyannis | Massachusetts | United States | 02601 |
| 69 | St. Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 70 | Wayne State University | Detroit | Michigan | United States | 48201 |
| 71 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 72 | St. John Hospital and Medical Center | Detroit | Michigan | United States | 48236 |
| 73 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 74 | Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
| 75 | McLaren Greater Lansing | Lansing | Michigan | United States | 48910 |
| 76 | St. John Macomb-Oakland | Madison Heights | Michigan | United States | 48071 |
| 77 | MidMichigan Medical Center Midland | Midland | Michigan | United States | 48670 |
| 78 | McLaren Macomb | Mount Clemens | Michigan | United States | 48043 |
| 79 | McLaren - Northern Michigan | Petoskey | Michigan | United States | 49770 |
| 80 | Lakeland Hospital | Saint Joseph | Michigan | United States | 49085 |
| 81 | St. John Macomb Hospital | Warren | Michigan | United States | 48093 |
| 82 | St Lukes Hospital | Duluth | Minnesota | United States | 55805 |
| 83 | Memorial Hospital at Gulfport | Gulfport | Mississippi | United States | 39502 |
| 84 | St. Mary's Medical Center | Blue Springs | Missouri | United States | 64014 |
| 85 | St. Joseph Medical Center | Kansas City | Missouri | United States | 64114 |
| 86 | North Kansas City Hospital | North Kansas City | Missouri | United States | 64116 |
| 87 | Cox Medical Centers | Springfield | Missouri | United States | 65807 |
| 88 | Billings Clinic Hospital | Billings | Montana | United States | 59101 |
| 89 | Glacier View Research Institute-Cardiology | Kalispell | Montana | United States | 59901 |
| 90 | Bryan Medical Center | Lincoln | Nebraska | United States | 68506 |
| 91 | University Medical Center | Las Vegas | Nevada | United States | 89102 |
| 92 | Southern NH Medical Center | Nashua | New Hampshire | United States | 03060 |
| 93 | Our Lady of Lourdes Medical Center | Camden | New Jersey | United States | 08103 |
| 94 | Englewood Hospital and Medical Center | Englewood | New Jersey | United States | 07631 |
| 95 | Monmouth Medical Center | Long Branch | New Jersey | United States | 07740 |
| 96 | Jersey Shore University Medical Center | Neptune | New Jersey | United States | 07753 |
| 97 | Saint Michael's Medical Center | Newark | New Jersey | United States | 07102 |
| 98 | AtlantiCare Regional Medical Center | Pomona | New Jersey | United States | 08240 |
| 99 | Valley Hospital | Ridgewood | New Jersey | United States | 07450 |
| 100 | Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | United States | 08876 |
| 101 | Holy Name Medical Center | Teaneck | New Jersey | United States | 07666 |
| 102 | University of New Mexico Health Sciences Center | Albuquerque | New Mexico | United States | 87131 |
| 103 | Albany Medical Center Hospital | Albany | New York | United States | 12208 |
| 104 | St. Peter's Hospital | Albany | New York | United States | 12208 |
| 105 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
| 106 | Huntington Hospital | Huntington | New York | United States | 11743 |
| 107 | United Health Services Hospitals | Johnson City | New York | United States | 13790 |
| 108 | Mount Sinai Beth Israel | New York | New York | United States | 10003 |
| 109 | Ellis Hospital | Schenectady | New York | United States | 12309 |
| 110 | Staten Island University Hospital | Staten Island | New York | United States | 10305 |
| 111 | Richmond University Medical Center | Staten Island | New York | United States | 10310 |
| 112 | University Hospital (Stony Brook) | Stony Brook | New York | United States | 11794 |
| 113 | St. Joseph's Hospital | Syracuse | New York | United States | 13203 |
| 114 | Charlotte-Mecklenburg Hospital Authority | Charlotte | North Carolina | United States | 28203 |
| 115 | Duke University Hospital | Durham | North Carolina | United States | 27710 |
| 116 | Duke Cardiology of Lumberton | Lumberton | North Carolina | United States | 28358 |
| 117 | Duke Raleigh Hospital | Raleigh | North Carolina | United States | 27609 |
| 118 | WakeMed | Raleigh | North Carolina | United States | 27610 |
| 119 | New Hanover Regional Medical Center | Wilmington | North Carolina | United States | 28402 |
| 120 | Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | United States | 27103 |
| 121 | Altru Health System | Grand Forks | North Dakota | United States | 58201 |
| 122 | Summa Health | Akron | Ohio | United States | 44304 |
| 123 | Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
| 124 | University Hospitals - Elyria Medical Center | Elyria | Ohio | United States | 44035 |
| 125 | Springfield Regional Medical Center | Springfield | Ohio | United States | 45504 |
| 126 | Oklahoma University Health Science Center | Oklahoma City | Oklahoma | United States | 73104 |
| 127 | Integris Baptist Medical Center | Oklahoma City | Oklahoma | United States | 73112 |
| 128 | OHSU Hospital and Clinics | Portland | Oregon | United States | 97239 |
| 129 | Memorial Medical Center | Johnstown | Pennsylvania | United States | 15905 |
| 130 | WellSpan Good Samaritan Hospital | Lebanon | Pennsylvania | United States | 17042 |
| 131 | Self Regional Healthcare | Greenwood | South Carolina | United States | 29646 |
| 132 | Jackson-Madison County General Hospital | Jackson | Tennessee | United States | 38301 |
| 133 | University of Tennessee Medical Center | Knoxville | Tennessee | United States | 37920 |
| 134 | Baptist Memorial Hospital | Memphis | Tennessee | United States | 38120 |
| 135 | Centennial Medical Center | Nashville | Tennessee | United States | 37203 |
| 136 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705 |
| 137 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 138 | Plaza Medical Center of Fort Worth | Fort Worth | Texas | United States | 76104 |
| 139 | Ben Taub General Hospital | Houston | Texas | United States | 77030 |
| 140 | Christus Good Shepherd Medical Center | Longview | Texas | United States | 75601 |
| 141 | The Heart Hospital Baylor Plano | Plano | Texas | United States | 75093 |
| 142 | Methodist Hospital | San Antonio | Texas | United States | 78229 |
| 143 | Guadalupe Regional Medical Center | Seguin | Texas | United States | 78155 |
| 144 | University of Texas Health Science Center at Tyler | Tyler | Texas | United States | 75708 |
| 145 | Inova Alexandria Hospital | Alexandria | Virginia | United States | 22304 |
| 146 | Riverside Regional Medical Center | Newport News | Virginia | United States | 23601 |
| 147 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
| 148 | CJW Medical Center | Richmond | Virginia | United States | 23235 |
| 149 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
| 150 | Wheeling Hospital | Wheeling | West Virginia | United States | 26003 |
| 151 | Mayo Clinic Health System Franciscan Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 152 | Ascension Columbia St. Mary's Hospital | Milwaukee | Wisconsin | United States | 53211 |
| 153 | Ascension-All Saints | Racine | Wisconsin | United States | 53405 |
| 154 | Waukesha Memorial Hospital | Waukesha | Wisconsin | United States | 53188 |
Sponsors and Collaborators
- Duke University
- Duke Clinical Research Institute
Investigators
- Principal Investigator: Adam DeVore, MD, MHS, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00074513