Organ Donation Clinical Trial
Official title:
A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation
Verified date | October 2017 |
Source | Temple University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 273 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Alabama Organ Center | Birmingham | Alabama |
United States | LifeBanc | Cleveland | Ohio |
United States | LifeGift Organ Donation Center | Houston | Texas |
United States | New York Organ Donor Network | New York | New York |
United States | Donor Network of Arizona | Phoenix | Arizona |
United States | LifeNet | Richmond | Virginia |
United States | Mid-America Transplant Services | Springfield | Missouri |
United States | New England Organ Bank | Waltham | Massachusetts |
United States | TransLife of Orlando | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Temple University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients | 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. | Baseline and continuously for 3 years post intervention | |
Secondary | Change in Requesters' Aggregated Relational Communication Skills | 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. | Baseline and continuously for 3 years post intervention | |
Secondary | Change in Request Staff's Comfort Answering Donation-related Questions During the Approach to Family Decision Makers | 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. | Baseline and continuously for 3 years post intervention |
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