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

NCT02138227 | Completed Results

• 1 other identifier: 5R01DK081118
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 9

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.

Conditions

Organ Donation

Keywords

Organ donation request; Effective Communication

Outcome Measures

Primary Outcomes (1)

• Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients

  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.

  Baseline and continuously for 3 years post intervention

Secondary Outcomes (2)

• Change in Requesters' Aggregated Relational Communication Skills

  Baseline and continuously for 3 years post intervention

• Change in Request Staff's Comfort Answering Donation-related Questions During the Approach to Family Decision Makers

  Baseline and continuously for 3 years post intervention

Study Arms (2)

Assisted CEaD Condition

ACTIVE COMPARATOR

In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.

Behavioral: Assisted CEaD Condition

Autonomous CEaD Condition

ACTIVE COMPARATOR

In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.

Behavioral: Autonomous CEaD Condition

Interventions

Assisted CEaD Condition BEHAVIORAL

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.

Assisted CEaD Condition

Autonomous CEaD Condition BEHAVIORAL

In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.

Autonomous CEaD Condition

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older (16 and 17 year old FDM will require consent of custodial adult)

You may not qualify if:

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

Sponsors & Collaborators

• Temple University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (9)

Alabama Organ Center

Birmingham, Alabama, 35233, United States

Location

Donor Network of Arizona

Phoenix, Arizona, 85013, United States

Location

TransLife of Orlando

Winter Park, Florida, 32789, United States

Location

New England Organ Bank

Waltham, Massachusetts, 02451, United States

Location

Mid-America Transplant Services

Springfield, Missouri, 65707, United States

Location

New York Organ Donor Network

New York, New York, 10001, United States

Location

LifeBanc

Cleveland, Ohio, 44128, United States

Location

LifeGift Organ Donation Center

Houston, Texas, 77005, United States

Location

LifeNet

Richmond, Virginia, 23227, United States

Location

Related Publications (2)

• Traino HM, Siminoff LA. Attitudes and acceptance of First Person Authorization: a national comparison of donor and nondonor families. J Trauma Acute Care Surg. 2013 Jan;74(1):294-300. doi: 10.1097/TA.0b013e318270dafc.

  PMID: 23147186 RESULT

• Siminoff LA, Alolod GP, Gardiner HM, Hasz RD, Mulvania PA, Wilson-Genderson M. A Comparison of the Content and Quality of Organ Donation Discussions with African American Families Who Authorize and Refuse Donation. J Racial Ethn Health Disparities. 2021 Apr;8(2):485-493. doi: 10.1007/s40615-020-00806-7. Epub 2020 Jun 30.

  PMID: 32607720 DERIVED

Results Point of Contact

• Title: Dr. Laura Siminoff
• Organization: Temple University

lasiminoff@temple.edu

(215) 204-8726

Study Officials

• Laura Siminoff, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

• Heather M Traino, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 14, 2014
• Study Start: January 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 9, 2017
• Results First Posted: November 9, 2017

Record last verified: 2017-10

Locations

US (9)