N/A
N=273
A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation
Organ Donation
Bottom Line
View on ClinicalTrials.gov: NCT02138227 ↗Enrolled (actual)
273
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients — 78; 80; 89; 81 Percentage of successful requests
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Assisted CEaD Condition (Behavioral); Autonomous CEaD Condition (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Temple University
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients |
78; 80; 89; 81; 76; 88 | — |
| SECONDARY Change in Requesters' Aggregated Relational Communication Skills |
75.22; 77.7; 78.0; 75.60; 75.0; 77.0 | <0.01 sig |
| SECONDARY Change in Request Staff's Comfort Answering Donation-related Questions During the Approach to Family Decision Makers |
4.91; 6.88; 6.89; 6.79; 6.99; 6.91 | <0.01 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02138227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.