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

For Organ Procurement Organizations (OPO) to be successful, they must be able to obtain consent for organ donation. Despite donor registries, first person consent, and the sharp rise in living donation, transplantation medicine continues to rely on the donation of organs from deceased individuals. Most of these requests are made to the deceased's next of kin. Of all the activities performed by OPOs, obtaining consent to donation is the most important activity as it facilitates all other aspects of the organ procurement and transplantation process. Moreover, communicating with families about the option to donate in a way that provides them with sufficient information to make an informed decision is essential to OPO success in obtaining consent. Our study tested an intervention strategy that addresses this critical aspect of obtaining consent to organ donation.

From 2003 - 2007, we tested the Communicating Effectively about Donation (CEaD) intervention as part of the Early Referral and Request Approach model (ERRA) (HRSA grant # R39 OT01126). The intervention demonstrated significant promise as the analysis of our data indicates an increase in the consent rate of 32.2% and taught OPO staff requesters communication skills that enable them to make effective requests to donor-eligible families. Training involved a series of simulated scenarios, and the intent of the CEaD intervention is to increase the number of organs available for transplantation through improved consent rates by incorporating a systematic approach to training staff for the crucial task of communication about organ donation with family decision-makers.

In our recently completed study (HRSA grant#), we examined the efficacy and generalizability of the CEaD in diverse geographic sites and to compare two conditions of delivering the CEaD. The experimental design tested: (1) the overall efficacy of the CEaD intervention on consent and (2) whether the more cost-saving "autonomous" condition is clinically equivalent to the "assisted" condition in terms of the final outcome of consent to donation. The major outcome measures were: 1) success in achieving relational communication with donor families and, 2) consent to donation.

The major goals of this study were to provide OPOs with the tools to assess and train OPO staff on a sustained basis. Specifically, we:

1. Packaged the CEaD as a self-teach tool so that OPOs can provide basic and continuous training for OPO staff requesters in the use of effective communication techniques when making requests to donor-eligible families.
2. Tested the effectiveness of the CEaD training program to increase consent rates, regardless of implementation condition, in a sample of OPOs. Our sub-hypotheses included the following: