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

• ClinicalTrials.gov Identifier: NCT02138227
• Recruitment Status: Completed
• First Posted: May 14, 2014
• Results First Posted: November 9, 2017
• Last Update Posted: November 9, 2017
• Sponsor: Temple University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Temple University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Organ Donation	Behavioral: Assisted CEaD Condition; Behavioral: Autonomous CEaD Condition	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 273 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation
• Study Start Date: January 2009
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: April 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Assisted CEaD Condition; In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.	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.
Active Comparator: Autonomous CEaD Condition; In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.	Behavioral: Autonomous CEaD Condition; In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.

Outcome Measures

Primary Outcome Measures :

1. Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients [ Time Frame: Baseline and continuously for 3 years post intervention ]
   OPO requesters completed a brief, web-based survey after every family approach, regardless of whether the family ultimately consented to donation. Rates of baseline and post-intervention consent to donation were compared. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level.

Secondary Outcome Measures :

1. Change in Requesters' Aggregated Relational Communication Skills [ Time Frame: Baseline and continuously for 3 years post intervention ]
   Using a family interview, we will examine the family's experience with the donation process, specifically focusing on family self-report of comfort, satisfaction with the communication and decision-making process, content of the conversation, and measurement of the relational aspects of the communication. The instrument is based on a well-developed interview that was used in a seminal study of family experience and decision-making for organ donation in acute care hospital settings. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level. The aggregate scores of fourteen (14) 7-point scale items with an aggregate range of 14 to 98. Higher values represent a better outcome.
2. Change in Request Staff's Comfort Answering Donation-related Questions During the Approach to Family Decision Makers [ Time Frame: Baseline and continuously for 3 years post intervention ]
   Requester staff self-report assessment utilizing a seven-point scale to rate his/her own comfort and satisfaction with the overall request process following each family contact. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level. The assessment was performed using a Likert scale ratin with a range of 1 to 7, with higher values representing better outcomes.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Alabama Organ Center

Birmingham, Alabama, United States, 35233

United States, Arizona

Donor Network of Arizona

Phoenix, Arizona, United States, 85013

United States, Florida

TransLife of Orlando

Winter Park, Florida, United States, 32789

United States, Massachusetts

New England Organ Bank

Waltham, Massachusetts, United States, 02451

United States, Missouri

Mid-America Transplant Services

Springfield, Missouri, United States, 65707

United States, New York

New York Organ Donor Network

New York, New York, United States, 10001

United States, Ohio

LifeBanc

Cleveland, Ohio, United States, 44128

United States, Texas

LifeGift Organ Donation Center

Houston, Texas, United States, 77005

United States, Virginia

LifeNet

Richmond, Virginia, United States, 23227

Sponsors and Collaborators

Temple University

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

Investigators

• Principal Investigator: Laura Siminoff, PhD; Temple University
• Principal Investigator: Heather M Traino, PhD; Virginia Commonwealth University

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT02138227
• Other Study ID Numbers: 5R01DK081118 ( U.S. NIH Grant/Contract ); 5R01DK081118 ( U.S. NIH Grant/Contract )
• First Posted: May 14, 2014
• Results First Posted: November 9, 2017
• Last Update Posted: November 9, 2017
• Last Verified: October 2017

Keywords provided by Temple University:

Organ donation request; Effective Communication