Clinical trial NCT02138227: A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation
Official title: A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Donation
Keywords: Organ donation request
Effective Communication
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-05-14
Enrollment: 273
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

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

Primary outcomes:
measure: Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients
timeFrame: Baseline and continuously for 3 years post intervention
Secondary outcomes:
measure: Change in Requesters' Aggregated Relational Communication Skills
timeFrame: Baseline and continuously for 3 years post intervention
measure: Change in Request Staff's Comfort Answering Donation-related Questions During the Approach to Family Decision Makers
timeFrame: Baseline and continuously for 3 years post intervention
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Organ Center
state: Alabama
city: Phoenix
country: United States
facility: Donor Network of Arizona
state: Arizona
city: Winter Park
country: United States
facility: TransLife of Orlando
state: Florida
city: Waltham
country: United States
facility: New England Organ Bank
state: Massachusetts
city: Springfield
country: United States
facility: Mid-America Transplant Services
state: Missouri
city: New York
country: United States
facility: New York Organ Donor Network
state: New York
city: Cleveland
country: United States
facility: LifeBanc
state: Ohio
city: Houston
country: United States
facility: LifeGift Organ Donation Center
state: Texas
city: Richmond
country: United States
facility: LifeNet
state: Virginia
Study officials:
affiliation: Temple University
name: Laura Siminoff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Heather M Traino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.