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

NCT02138227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2017-11-09

Study results available
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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

Interventions

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.

BEHAVIORAL

Autonomous CEaD Condition

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Temple University

    lead OTHER

Principal Investigators

  • Laura Siminoff, PhD · Temple University

  • Heather M Traino, PhD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02138227 on ClinicalTrials.gov