Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

PREP-IT Investigators; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; PREP-IT Clinical Sites; Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE

doi:10.1016/j.conctc.2021.100787

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

PREP-IT Investigators
, Steering Committee
, Adjudication Committee
, Data and Safety Monitoring Committee
, Research Methodology Core
, Patient Centred Outcomes Core
, Orthopaedic Surgery Core
, Operating Room Core
, Infectious Disease Core
, Military Core
, PREP-IT Clinical Sites
, Aqueous-PREP and PREPARE
, Aqueous-PREP
, PREPARE

University of Texas Health Science Center at Houston
Sanford USD Medical Center
Sanford Health
McMaster University
Fraser Health
University of Maryland, Baltimore
University of Maryland Medical System
University of Maryland Prince George's Capital Region Health
Core Institute
Brigham and Women’s Hospital
Inova Fairfax Medical Campus
Wake Forest University
Trauma Survivors Network
Walter Reed Army Institute of Research
Association of periOperative Registered Nurses
University of Missouri
Greenville Health System
Prisma Health - Upstate
LSU Health
Stanford University
University of Washington
Washington University St. Louis
University of Ottawa
Slate Magazine
Trauma Survivor Network
Dartmouth College
Dartmouth-Hitchcock Medical Center
University of California at San Francisco
Hamilton Health Sciences
United States Army
Canadian Armed Forces
IU Health Methodist Hospital
University of Florida
Vanderbilt University
Banner University Medical Center - Tucson
Wright State University
Hospital Universitari Parc Tauli
Hospital Universitari Vall d'Hebron
Case Western Reserve University
Carolinas Medical Center
University of Utah
Massachusetts General Hospital
University of Mississippi
University of Pennsylvania
Duke University

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Original language	English
Article number	100787
Journal	Contemporary Clinical Trials Communications
Volume	22
DOIs	https://doi.org/10.1016/j.conctc.2021.100787
Publication status	Published - Jun 2021
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 16 Peace, Justice and Strong Institutions

Keywords

Cluster randomized crossover
Consent
Deferred consent
Patient advisors
Stakeholder engagement
Trial design

ASJC Scopus subject areas

General Medicine
Pharmacology

Access to Document

10.1016/j.conctc.2021.100787

Cite this

PREP-IT Investigators, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, PREP-IT Clinical Sites, Aqueous-PREP and PREPARE, Aqueous-PREP, & PREPARE (2021). Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials. Contemporary Clinical Trials Communications, 22, Article 100787. https://doi.org/10.1016/j.conctc.2021.100787

@article{5f814e8b959c4d8fb3feff00e1d88865,

title = "Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials",

abstract = "Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7\%, and 0.67\% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.",

keywords = "Cluster randomized crossover, Consent, Deferred consent, Patient advisors, Stakeholder engagement, Trial design",

author = "\{PREP-IT Investigators\} and \{Steering Committee\} and \{Adjudication Committee\} and \{Data and Safety Monitoring Committee\} and \{Research Methodology Core\} and \{Patient Centred Outcomes Core\} and \{Orthopaedic Surgery Core\} and \{Operating Room Core\} and \{Infectious Disease Core\} and \{Military Core\} and \{PREP-IT Clinical Sites\} and \{Aqueous-PREP and PREPARE\} and Aqueous-PREP and PREPARE and Guillermo Pechero and Branden Pfaff and Mayank Rao and David Pogorzelski and Paula McKay and Ella Spicer and Andrea Howe and Demyanovich, \{Haley K.\} and Sietsema, \{Debra L.\} and McTague, \{Michael F.\} and Lolita Ramsey and Martha Holden and Joshua Rudnicki and Jeff Wells and Michelle Medeiros and Slobogean, \{Gerard P.\} and Sheila Sprague and Jeffrey Wells and Mohit Bhandari and D'Alleyrand, \{Jean Claude\} and Harris, \{Anthony D.\} and Mullins, \{Daniel C.\} and Lehana Thabane and Amber Wood and \{Della Rocca\}, \{Gregory J.\} and Joan Hebden and Jeray, \{Kyle J.\} and Lucas Marchand and O'Hara, \{Lyndsay M.\} and Robert Zura and Gardner, \{Michael J.\} and Jenna Blasman and Jonah Davies and Stephen Liang and Monica Taljaard and Devereaux, \{P. J.\} and Guyatt, \{Gordon H.\} and Diane Heels-Ansdell and Debra Marvel and Jana Palmer and Jeff Friedrich and O'Hara, \{Nathan N.\} and Grissom, \{Ms Frances\} and Gitajn, \{I. Leah\} and Saam Morshed and O'Toole, \{Robert V.\} and Petrisor, \{Bradley A.\} and Megan Camara and Franca Mossuto and Joshi, \{Manjari G.\}",

note = "Publisher Copyright: {\textcopyright} 2021 The Authors",

year = "2021",

month = jun,

doi = "10.1016/j.conctc.2021.100787",

language = "English",

volume = "22",

journal = "Contemporary Clinical Trials Communications",

issn = "2451-8654",

publisher = "Elsevier Inc.",

}

PREP-IT Investigators, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, PREP-IT Clinical Sites, Aqueous-PREP and PREPARE, Aqueous-PREP & PREPARE 2021, 'Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials', Contemporary Clinical Trials Communications, vol. 22, 100787. https://doi.org/10.1016/j.conctc.2021.100787

TY - JOUR

T1 - Implementing stakeholder engagement to explore alternative models of consent

T2 - An example from the PREP-IT trials

AU - PREP-IT Investigators

AU - Steering Committee

AU - Adjudication Committee

AU - Data and Safety Monitoring Committee

AU - Research Methodology Core

AU - Patient Centred Outcomes Core

AU - Orthopaedic Surgery Core

AU - Operating Room Core

AU - Infectious Disease Core

AU - Military Core

AU - PREP-IT Clinical Sites

AU - Aqueous-PREP and PREPARE

AU - Aqueous-PREP

AU - PREPARE

AU - Pechero, Guillermo

AU - Pfaff, Branden

AU - Rao, Mayank

AU - Pogorzelski, David

AU - McKay, Paula

AU - Spicer, Ella

AU - Howe, Andrea

AU - Demyanovich, Haley K.

AU - Sietsema, Debra L.

AU - McTague, Michael F.

AU - Ramsey, Lolita

AU - Holden, Martha

AU - Rudnicki, Joshua

AU - Wells, Jeff

AU - Medeiros, Michelle

AU - Slobogean, Gerard P.

AU - Sprague, Sheila

AU - Wells, Jeffrey

AU - Bhandari, Mohit

AU - D'Alleyrand, Jean Claude

AU - Harris, Anthony D.

AU - Mullins, Daniel C.

AU - Thabane, Lehana

AU - Wood, Amber

AU - Della Rocca, Gregory J.

AU - Hebden, Joan

AU - Jeray, Kyle J.

AU - Marchand, Lucas

AU - O'Hara, Lyndsay M.

AU - Zura, Robert

AU - Gardner, Michael J.

AU - Blasman, Jenna

AU - Davies, Jonah

AU - Liang, Stephen

AU - Taljaard, Monica

AU - Devereaux, P. J.

AU - Guyatt, Gordon H.

AU - Heels-Ansdell, Diane

AU - Marvel, Debra

AU - Palmer, Jana

AU - Friedrich, Jeff

AU - O'Hara, Nathan N.

AU - Grissom, Ms Frances

AU - Gitajn, I. Leah

AU - Morshed, Saam

AU - O'Toole, Robert V.

AU - Petrisor, Bradley A.

AU - Camara, Megan

AU - Mossuto, Franca

AU - Joshi, Manjari G.

PY - 2021/6

Y1 - 2021/6

N2 - Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

AB - Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

KW - Cluster randomized crossover

KW - Consent

KW - Deferred consent

KW - Patient advisors

KW - Stakeholder engagement

KW - Trial design

UR - https://www.scopus.com/pages/publications/85109375394

U2 - 10.1016/j.conctc.2021.100787

DO - 10.1016/j.conctc.2021.100787

M3 - Article

AN - SCOPUS:85109375394

SN - 2451-8654

VL - 22

JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

M1 - 100787

ER -

PREP-IT Investigators, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core et al. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials. Contemporary Clinical Trials Communications. 2021 Jun;22:100787. doi: 10.1016/j.conctc.2021.100787

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Abstract

UN SDGs

Keywords

ASJC Scopus subject areas

Access to Document

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