Organ Donation Clinical Trial
Official title:
A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation
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.
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:
H2a: When compared to the 12 month pre-intervention control period, the
post-intervention period (after implementation of the CEaD) would be associated with a
greater percentage of requests that use the preferred communication techniques with
donor-eligible families.
H2b: When compared to the control period, the overall consent rate during the
post-intervention period will be significantly greater than the consent rate during the
control period.
3. Tested whether OPOs are able to implement the CEaD assessment and training intervention
using two methods for implementation. The two implementation methods tested were: 1) a
completely autonomous method in which the OPO does not employ any outside assistance to
implement the module, and 2) an assisted method whereby trained outside consultants play
a role in helping the OPO implement the CEaD. OPOs will be randomized to one of these
two conditions: 1) autonomous CEaD; and 2) assisted CEaD.
H3a: The autonomous CEaD implementation groups will not be as effective as the assisted CEaD
implementation groups as measured by preferred communication techniques with donor-eligible
families.
H3b: The autonomous CEaD implementation group will not be as effective as the assisted CEaD
implementation groups when controlling for the method of delivery for CEaD as measured by
consent rates.
The study 'subjects' included the 9 OPOs and their staff (n=273) who make requests to
families of deceased donor-eligible patients (termed 'OPO Requesters'). All OPO staff who
request organs from families were invited to participate in the study. We obtain written
informed consent from each participating requester before we administered surveys. Each
survey instrument reminded OPO staff that they are free to withdraw from the study at any
time and that the information provided by them was kept strictly confidential. Using a random
number generator, requesters were randomized on the OPO level to account for the differences
in OPO size, scope, and organizational structure. A total of 218 requesters were randomized
to the autonomous condition, and 55 were randomized to the assisted condition.
Intervention The intervention tested two methods of using the Communicating Effectively about
Donation (CEaD) intervention. The CEaD taught OPO staff requesters communication skills using
a series of simulated scenarios and was designed to allow requesters to make effective
requests to donor-eligible families. The training materials were made available on a secure
website (www.ceadtraining.org; user name: test; password: test). We compared two methods of
training: 1) using the training materials supplemented with simulators to practice the
communication skills (assisted) or, 2) viewing the training materials along with a workbook
(autonomous). The purpose of this design was to ascertain whether OPOs are capable of
successfully employing the CEaD training program on their own, without incurring the added
cost of hiring outside consultants.
Description of the Communicating Effectively about Donation (CEaD) Training Program The CEaD
intervention was not just a generic communications intervention, but one specifically and
uniquely tailored to the problem of making requests for organ donation to families of
deceased patients. The intervention was also designed to provide OPO requesters a basic
framework for the request conversation. The CEaD trains requesters to make effective requests
to donor-eligible families by allowing requesters to learn and practice relational
communication skills using a series of scenarios. These scenarios, created in consultation
with our partner OPO, involved the use of simulated patients (SPs), who played the role of
bereaved family members faced with the opportunity to donate a loved one's organs. Based on
our previous study, we developed four training scenarios, the first an uncomplicated
scenario, the second an African-American family, the third a pediatric patient whose parents
are divorced and at odds, and the fourth a donation after cardiac death (DCD) case. Each
scenario allows the requester to use basic requester skills including framing donation
positively, using statistics to explain donation benefits, engaging the family in a
discussion of their values, probing and responding to family fears or misinformation about
donation, and attending to family's emotional needs. The scenarios also allowed requesters to
work through increasingly more challenging donation situations and to encounter specific
issues such as the dysfunctional family, minority families, and families whose opinions about
whether or not to donate are divided.
The scenarios focused on training requesters to use the following communication skills:
(1) assessing families' and patients' beliefs and values regarding organ donation; (2)
assessing families' readiness to hear about organ donation; and, (3) using communication
skills, such as listening, responding empathetically, and dealing with ambivalence, when
dealing with grieving families.
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