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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/8/2019
Start Date:April 21, 2017
End Date:July 2020
Contact:Tracy Hofmann
Email:tracy.hofmann@duke.edu
Phone:919-668-7544

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

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.

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).

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
We found this trial at
161
sites
Long Branch, New Jersey
Principal Investigator: Lynne Einbinder, MD, FACC
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43 New Scotland Avenue
Albany, New York 12208
Principal Investigator: Fran Cavanaugh, DNP, ACNP-BC, CCRN
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8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Principal Investigator: Gregory Kumkumian, MD
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Eli Gelfand, MD, FACC
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Ileana Pina, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Principal Investigator: Jacob Chemmalakuzh, MD
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Anupama Kottam, MD,FACC
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Principal Investigator: Syed Ahmed, MD
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: Joshua Larned, MD
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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860 South Columbia Road
Grand Forks, North Dakota 58201
701-780-1750
Principal Investigator: Rabeea Aboufakher, MD
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24 Sturtevant St
Orlando, Florida 32806
Principal Investigator: Deepak Vivek, MD
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Tampa, Florida 33607
Principal Investigator: Augustine Agocha, MD, PhD, MBA
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Akron, Ohio
Principal Investigator: Ottorino Costantini, MD
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Albany, New York 12208
Principal Investigator: Reid Muller, MD
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Albuquerque, New Mexico 87131
Principal Investigator: Mark Garcia, MD
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3316 U.S. 280
Alexander City, Alabama 35010
Principal Investigator: William Davis, MD
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211 4th Street
Alexandria, Louisiana 71301
Principal Investigator: Naseem Jaffrani, MD
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Alexandria, Virginia 22304
Principal Investigator: Narian Rajan, MD
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Anchorage, Alaska 99508
Principal Investigator: Ankie Amos, MD
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Ann Arbor, Michigan 48197
Principal Investigator: Ahmad Mizyed, MD
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Annapolis, Maryland 21401
Principal Investigator: James Welker, DO
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Ashland, Kentucky 41101
Principal Investigator: Faisal Hayat, MD
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1199 Prince Avenue
Athens, Georgia 30606
Principal Investigator: Catherine Marti, MD, MPH
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Adesoji Oderinde, MD
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Atlantis, Florida 33462
Principal Investigator: Waqas Ghumman, MD
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Augusta, Georgia 30909
Principal Investigator: Janaki Nadarajah, DPM
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Augusta, Georgia 30912
Principal Investigator: Neal Weintraub, MD
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Larry Allen, MD, MHS
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2972 Indian Trail Road
Aurora, Illinois 60504
Principal Investigator: Basharat Muneer, MD
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Aurora, Illinois 60506
Principal Investigator: Basharat Muneer, MD
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Austin, Texas 78758
Principal Investigator: John Dieck, MD
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Principal Investigator: Mauro Moscucci, MD, MBA
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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600 North Highland Springs Avenue
Banning, California 92220
Principal Investigator: Jeremy Cox, DO
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2800 10th Avenue North
Billings, Montana 59101
Principal Investigator: Kristin Scott-Tillery, MD
Phone: 406-435-8490
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Birmingham, Alabama 35294
Principal Investigator: Jose Tallaj, MD
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Bloomington, Indiana 47403
Principal Investigator: Kevin Zawacki, MD
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201 Northwest R D Mize Road
Blue Springs, Missouri 64014
Principal Investigator: Michael Liston, MD
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Bradenton, Florida 34209
Principal Investigator: Ashok Krishnamurthy, MD, FACC
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Bradenton, Florida 34208
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Camden, New Jersey 08103
Principal Investigator: Robert Mohapatra, MD
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Charlotte, North Carolina 28203
Principal Investigator: Jewell Carr, MD
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
Principal Investigator: Payman Sattar, MD
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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Chicago, Illinois 60612
Principal Investigator: Tom Stamos, MD
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Clinton, Maryland 20735
Principal Investigator: Alex Ryzhikov, MD
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1400 East Boulder Street
Colorado Springs, Colorado 80909
Principal Investigator: J. Russell Strader, MD
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Columbia, Maryland 21044
Principal Investigator: Keith Friedman, MD
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Cottonwood, Arizona 86326
Principal Investigator: Samuel Butman, MD
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1227 East Rusholme Street
Davenport, Iowa 52803
Principal Investigator: Vijay Rajendran, MD
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: Rajan Krishnamani, MD
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Detroit, Michigan 48236
Principal Investigator: Thomas Lalonde, MD
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Detroit, Michigan 48202
Principal Investigator: Vinay Shah, MD
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Duluth, Minnesota 55802
Principal Investigator: James Mohn, MD
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Durham, North Carolina 27705
Principal Investigator: Tracy DeWald, PharmD
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913 North Dixie Highway
Elizabethtown, Kentucky 42701
Principal Investigator: Krishnan Challappa, MD
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Elyria, Ohio 44035
Principal Investigator: Ademola Abiose, MD
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Principal Investigator: Aron Schwarcz, MD
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Fort Lauderdale, Florida 33308
Principal Investigator: Joel Gellman, MD
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Joel Gellman, MD
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Smith, Arkansas 72901
Principal Investigator: Robert Parris, MD
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Fort Worth, Texas 76104
Principal Investigator: Amir Malik, MD, FACC, FSCAI
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743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Principal Investigator: Brenda Hott, MD
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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Glendale, California 91206
Principal Investigator: John McKenzie, MD
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Grand Rapids, Michigan 49503
Principal Investigator: Milena Jani, MD
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Greeley, Colorado 80631
Principal Investigator: Sashi Adigopula, MD
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Greenwood, South Carolina 29646
Principal Investigator: Priya Kumar, MD
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Gulfport, Mississippi 39502
Principal Investigator: Paul Mullen, MD
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Hialeah, Florida 33012
Principal Investigator: Luis Martinez, MD
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Michael Brodsky, MD
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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1504 Taub Loop
Houston, Texas 77030
(713) 873-2000
Principal Investigator: Arunima Misra, MD
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Huntington, New York 11743
Principal Investigator: Paul Maccaro, MD
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27 Park Street
Hyannis, Massachusetts 02601
Principal Investigator: Elissa Thompson, MD
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Jackson, Tennessee 38305
Principal Investigator: Michael Osayamen, MD
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Shahyar Gharacholou, MD
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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33-57 Harrison Street
Johnson City, New York 13790
Principal Investigator: Afzal Rehman, MD, PhD
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315 Locust St # 2A
Johnstown, Pennsylvania 15905
Principal Investigator: Archana Sodagam, MD
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Kalispell, Montana
Principal Investigator: Eve Gillespie, MD, PhD
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Kansas City, Missouri 64114
Principal Investigator: Luis Couchonnal, MD
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Knoxville, Tennessee 37920
Principal Investigator: Muddassir Mehmood, MD
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700 West Avenue South
La Crosse, Wisconsin 54601
Principal Investigator: Charles Cagin, DO
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Lansing, Michigan 48910
Principal Investigator: Ibrahim Shah, MD
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Principal Investigator: Chowdhury Ahsan, MD
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Lebanon, Pennsylvania 17042
Principal Investigator: Adrian Bell, MD
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1 Saint Joseph Drive
Lexington, Kentucky 40504
Principal Investigator: Steve Lin, MD
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Lincoln, Nebraska 68506
Principal Investigator: John Steuter, MD
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Little Rock, Arkansas 72211
Principal Investigator: Andre Paixao, MD
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Longview, Texas 75601
Principal Investigator: Kash Vahdat, MD
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4001 Dutchmans Lane
Louisville, Kentucky 40205
Principal Investigator: Janet Smith, MD
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4950 Norton Healthcare Boulevard
Louisville, Kentucky 40241
Principal Investigator: Janet Smith, MD
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2936 North Elm Street
Lumberton, North Carolina 28358
Principal Investigator: Christopher Walters, MD
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777 Hemlock Street
Macon, Georgia 31201
Principal Investigator: Erskine James, MD
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Madison Heights, Michigan 48071
Principal Investigator: Herman Kado, MD
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Madisonville, Kentucky 42431
Principal Investigator: Steven Heatherly, MD, PhD
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Memphis, Tennessee 38120
Principal Investigator: Frank McGrew, MD
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Midland, Michigan 48670
Principal Investigator: Jeffrey Martindale, DO
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Milwaukee, Wisconsin 53211
Principal Investigator: Robert Roth, MD
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1700 Coffee Rd
Modesto, California 95355
(209) 526-4500
Principal Investigator: Amar Pohwani, MD
Memorial Medical Center Memorial is affiliated with Sutter Health, a family of not-for-profit hospitals, physician...
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Mount Clemens, Michigan 48043
Principal Investigator: Timothy Logan, DO
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Muncie, Indiana 47303
Principal Investigator: Wayne Gray, MD
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Nashua, New Hampshire 03060
Principal Investigator: Paul Boffetti, MD
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Nashville, Tennessee 37203
Principal Investigator: Andrew McRae III, MD
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501 Keyser Avenue
Natchitoches, Louisiana 71457
Principal Investigator: Otis Barnum, DO, FACP
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