The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C.
Clinical trial
Comparative effectiveness
Emergency department
HCV
Hepatitis C
Implementation
Linkage-to-care
Methods
Navigation
Randomized trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
27 Jan 2023
27 Jan 2023
Historique:
received:
15
11
2022
accepted:
15
12
2022
entrez:
28
1
2023
pubmed:
29
1
2023
medline:
1
2
2023
Statut:
epublish
Résumé
Hepatitis C (HCV) poses a major public health problem in the USA. While early identification is a critical priority, subsequent linkage to a treatment specialist is a crucial step that bridges diagnosed patients to treatment, cure, and prevention of ongoing transmission. Emergency departments (EDs) serve as an important clinical setting for HCV screening, although optimal methods of linkage-to-care for HCV-diagnosed individuals remain unknown. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial. The DETECT Hep C Linkage-to-Care Trial will be a single-center prospective comparative effectiveness randomized two-arm parallel-group superiority trial to test the effectiveness of linkage navigation and clinician referral among ED patients identified with untreated HCV with a primary hypothesis that linkage navigation plus clinician referral is superior to clinician referral alone when using treatment initiation as the primary outcome. Participants will be enrolled in the ED at Denver Health Medical Center (Denver, CO), an urban, safety-net hospital with approximately 75,000 annual adult ED visits. This trial was designed to enroll a maximum of 280 HCV RNA-positive participants with one planned interim analysis based on methods by O'Brien and Fleming. This trial will further inform the evaluation of cost effectiveness, disparities, and social determinants of health in linkage-to-care, treatment, and disease progression. When complete, the DETECT Hep C Linkage-to-Care Trial will significantly inform how best to perform linkage-to-care among ED patients identified with HCV. ClinicalTrials.gov ID: NCT04026867 Original date: July 1, 2019 URL: https://clinicaltrials.gov/ct2/show/NCT04026867.
Sections du résumé
BACKGROUND
BACKGROUND
Hepatitis C (HCV) poses a major public health problem in the USA. While early identification is a critical priority, subsequent linkage to a treatment specialist is a crucial step that bridges diagnosed patients to treatment, cure, and prevention of ongoing transmission. Emergency departments (EDs) serve as an important clinical setting for HCV screening, although optimal methods of linkage-to-care for HCV-diagnosed individuals remain unknown. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial.
METHODS
METHODS
The DETECT Hep C Linkage-to-Care Trial will be a single-center prospective comparative effectiveness randomized two-arm parallel-group superiority trial to test the effectiveness of linkage navigation and clinician referral among ED patients identified with untreated HCV with a primary hypothesis that linkage navigation plus clinician referral is superior to clinician referral alone when using treatment initiation as the primary outcome. Participants will be enrolled in the ED at Denver Health Medical Center (Denver, CO), an urban, safety-net hospital with approximately 75,000 annual adult ED visits. This trial was designed to enroll a maximum of 280 HCV RNA-positive participants with one planned interim analysis based on methods by O'Brien and Fleming. This trial will further inform the evaluation of cost effectiveness, disparities, and social determinants of health in linkage-to-care, treatment, and disease progression.
DISCUSSION
CONCLUSIONS
When complete, the DETECT Hep C Linkage-to-Care Trial will significantly inform how best to perform linkage-to-care among ED patients identified with HCV.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov ID: NCT04026867 Original date: July 1, 2019 URL: https://clinicaltrials.gov/ct2/show/NCT04026867.
Identifiants
pubmed: 36707909
doi: 10.1186/s13063-022-07018-w
pii: 10.1186/s13063-022-07018-w
pmc: PMC9880363
doi:
Banques de données
ClinicalTrials.gov
['NCT04026867']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
63Subventions
Organisme : NIDA NIH HHS
ID : P30 DA040500
Pays : United States
Investigateurs
Amy Adler
(A)
Musheng Alishahi
(M)
Gideon D Avornu
(GD)
Alexis Becerra
(A)
Erika Becerra-Ashby
(E)
Meghan Bellamy
(M)
Samantha Bot
(S)
Alexander J Boyle
(AJ)
Annetta M Bracey
(AM)
Michael Breyer
(M)
Claudia Camacho
(C)
Alicia Cupelo
(A)
Gaby Dashler
(G)
Pamela Doyle
(P)
Amy Eicher
(A)
Heather Gardner
(H)
Carrie Anne de Gruiter
(CA)
Sophia Henry
(S)
David Higgins
(D)
Trevor Hill
(T)
Rachel Houk
(R)
Nyah Johnson
(N)
Alex Kile
(A)
Janet Liebl
(J)
Barbara Maliszewski
(B)
Kendall Maliszewski
(K)
Robert McGoey
(R)
Catherine McKenzie
(C)
Matthew S Minturn
(MS)
Deanna Myer
(D)
Kendra Neumann
(K)
Cole Ossian
(C)
Rebekah K Peacock
(RK)
Danielle Perez
(D)
Tannishtha Pramanick
(T)
Erin P Ricketts
(EP)
Benji Riggan
(B)
Sherry Riser
(S)
Genie Roosevelt
(G)
Mustapha Saheed
(M)
Sarah Schumacher
(S)
Bradley Shy
(B)
Scott Simpson
(S)
Matthew F Toerper
(MF)
Gil Trest
(G)
Madison Unsworth
(M)
Laura Waltrous
(L)
Brooke Watson
(B)
Informations de copyright
© 2023. The Author(s).
Références
Ann Emerg Med. 2016 Jan;67(1):129-30
pubmed: 26342899
Trials. 2022 Apr 25;23(1):354
pubmed: 35468807
Lancet. 2013 Jan 12;381(9861):91-2
pubmed: 23305999
MMWR Morb Mortal Wkly Rep. 2020 May 15;69(19):569-574
pubmed: 32407307
PLoS One. 2014 Jul 02;9(7):e101554
pubmed: 24988388
AIDS Care. 2012;24(12):1496-503
pubmed: 22452446
Acad Emerg Med. 2007 Dec;14(12):1149-57
pubmed: 18045889
Ann Emerg Med. 2016 Jan;67(1):119-28
pubmed: 26253712
J Infect Dis. 2020 Nov 27;222(Suppl 9):S741-S744
pubmed: 33245351
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Lancet Gastroenterol Hepatol. 2022 May;7(5):396-415
pubmed: 35180382
Clin Infect Dis. 2016 May 15;62(10):1287-1288
pubmed: 26936668
Open Forum Infect Dis. 2014 May 14;1(1):ofu009
pubmed: 25734083
Ann Emerg Med. 2013 Mar;61(3):353-61
pubmed: 23290527
AIDS Patient Care STDS. 2007 Jun;21(6):418-25
pubmed: 17594251
Clin Infect Dis. 2018 Oct 30;67(10):1477-1492
pubmed: 30215672
Hepatology. 2015 Mar;61(3):776-82
pubmed: 25179527
BMJ. 2010 Mar 23;340:c869
pubmed: 20332511
Rev Panam Salud Publica. 2015 Dec;38(6):506-14
pubmed: 27440100
Clin Infect Dis. 2016 Mar 1;62(5):613-6
pubmed: 26611776
J Infect Dis. 2020 Sep 2;222(Suppl 5):S384-S391
pubmed: 32877565
Hepatology. 2015 Jun;61(6):1793-7
pubmed: 25846014
BMC Health Serv Res. 2010 Aug 20;10:246
pubmed: 20727189
J Gen Intern Med. 2019 Oct;34(10):2003-2004
pubmed: 31197736
Open Forum Infect Dis. 2021 Dec 16;9(2):ofab636
pubmed: 35111867
PLoS One. 2014 May 19;9(5):e97317
pubmed: 24842841