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A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138227
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Temple University

Brief Summary:
The purpose of this study is to evaluate the efficacy and generalizability of a communication intervention (Communication Effectively about Donation (CEaD)) for Organ Procurement Organization (OPO) staff requesters and to compare two conditions of delivering the CEaD. The experimental design will test: (1) the overall efficacy of the intervention on timely referral and consent for organ donation and (2) whether a completely autonomous condition (no outside training assistance) is clinically equivalent to the assisted condition (training provided by outside consultants) in terms of the final outcome of consent to donation.

Condition or disease Intervention/treatment Phase
Organ Donation Behavioral: Assisted CEaD Condition Behavioral: Autonomous CEaD Condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation
Study Start Date : January 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Active Comparator: Assisted CEaD Condition
In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.
Behavioral: Assisted CEaD Condition
In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills. OPO requesters will be assisted by having the CEaD DVD supplemented through working the scenarios with live simulated patients who will be trained to act out the scenarios with the OPO requesters and provide feedback.

Active Comparator: Autonomous CEaD Condition
In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.
Behavioral: Autonomous CEaD Condition
In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.




Primary Outcome Measures :
  1. Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients [ Time Frame: Baseline and continuously for 3 years post intervention ]
    OPO requesters completed a brief, web-based survey after every family approach, regardless of whether the family ultimately consented to donation. Rates of baseline and post-intervention consent to donation were compared. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level.


Secondary Outcome Measures :
  1. Change in Requesters' Aggregated Relational Communication Skills [ Time Frame: Baseline and continuously for 3 years post intervention ]
    Using a family interview, we will examine the family's experience with the donation process, specifically focusing on family self-report of comfort, satisfaction with the communication and decision-making process, content of the conversation, and measurement of the relational aspects of the communication. The instrument is based on a well-developed interview that was used in a seminal study of family experience and decision-making for organ donation in acute care hospital settings. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level. The aggregate scores of fourteen (14) 7-point scale items with an aggregate range of 14 to 98. Higher values represent a better outcome.

  2. Change in Request Staff's Comfort Answering Donation-related Questions During the Approach to Family Decision Makers [ Time Frame: Baseline and continuously for 3 years post intervention ]
    Requester staff self-report assessment utilizing a seven-point scale to rate his/her own comfort and satisfaction with the overall request process following each family contact. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level. The assessment was performed using a Likert scale ratin with a range of 1 to 7, with higher values representing better outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OPO requester staff employed at a participating OPO
  • Family decision makers (FDM) approached by a participating OPO requester about the option of donating the organs of their loved one
  • 16 years of age or older (16 and 17 year old FDM will require consent of custodial adult)

Exclusion Criteria:

  • OPO requester staff not employed at a participating OPO
  • FDM not approached by a participating OPO requester
  • FDM younger than 16 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138227


Locations
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United States, Alabama
Alabama Organ Center
Birmingham, Alabama, United States, 35233
United States, Arizona
Donor Network of Arizona
Phoenix, Arizona, United States, 85013
United States, Florida
TransLife of Orlando
Winter Park, Florida, United States, 32789
United States, Massachusetts
New England Organ Bank
Waltham, Massachusetts, United States, 02451
United States, Missouri
Mid-America Transplant Services
Springfield, Missouri, United States, 65707
United States, New York
New York Organ Donor Network
New York, New York, United States, 10001
United States, Ohio
LifeBanc
Cleveland, Ohio, United States, 44128
United States, Texas
LifeGift Organ Donation Center
Houston, Texas, United States, 77005
United States, Virginia
LifeNet
Richmond, Virginia, United States, 23227
Sponsors and Collaborators
Temple University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Laura Siminoff, PhD Temple University
Principal Investigator: Heather M Traino, PhD Virginia Commonwealth University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02138227    
Other Study ID Numbers: 5R01DK081118 ( U.S. NIH Grant/Contract )
5R01DK081118 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2014    Key Record Dates
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017
Last Verified: October 2017
Keywords provided by Temple University:
Organ donation request
Effective Communication