Trial Outcomes & Findings for A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation (NCT NCT02138227)
NCT ID: NCT02138227
Last Updated: 2017-11-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
273 participants
Primary outcome timeframe
Baseline and continuously for 3 years post intervention
Results posted on
2017-11-09
Participant Flow
While 273 participants registered, data were used from only 134 subjects, who had encounters pre- and post-intervention.
Participant milestones
| Measure |
Assisted CEaD Condition
In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.
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.
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Autonomous CEaD Condition
In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.
Autonomous CEaD Condition: In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.
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|---|---|---|
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Overall Study
STARTED
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55
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218
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Overall Study
COMPLETED
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55
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218
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Trial of the Early Referral and Request Approach (ERRA) Intervention to Increase Consent to Organ Donation
Baseline characteristics by cohort
| Measure |
Assisted CEaD Condition
n=55 Participants
In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills.
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Autonomous CEaD Condition
n=218 Participants
In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.
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Total
n=273 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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46.72 years
STANDARD_DEVIATION 9.96 • n=5 Participants
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44.42 years
STANDARD_DEVIATION 9.46 • n=7 Participants
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44.88 years
STANDARD_DEVIATION 9.57 • n=5 Participants
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Sex: Female, Male
Female
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36 Participants
n=5 Participants
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161 Participants
n=7 Participants
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197 Participants
n=5 Participants
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Sex: Female, Male
Male
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19 Participants
n=5 Participants
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57 Participants
n=7 Participants
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76 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and continuously for 3 years post interventionOPO 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.
Outcome measures
| Measure |
Pre-Intervention Authorization Rate (All Novice)
n=144 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Novice participants are defined has having less than 12 months of experience.
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Post-Intervention Authorization Rate (Novice Autonomous Arm)
n=192 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Novice participants are defined has having less than 12 months of experience.
|
Post-Authorization Rate (Novice Assisted Arm)
n=137 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Novice participants are defined has having less than 12 months of experience.
|
Pre-Intervention Authorization Rate (All Mid-Level)
n=158 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
|
Post-Intervention Authorization Rate(Mid-Level Autonomous Arm)
n=101 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
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Post-Authorization Rate (Mid-Level Assisted Arm)
n=51 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
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Pre-Intervention Authorization Rate (All Senior)
n=266 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Senior participants are defined has having more than 36 months of experience.
|
Post-Intervention Authorization Rate (Senior Autonomous Arm)
n=170 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Senior participants are defined has having more than 36 months of experience.
|
Post-Authorization Rate (Senior Assisted Arm)
n=129 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Senior participants are defined has having more than 36 months of experience.
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|---|---|---|---|---|---|---|---|---|---|
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Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients
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78 Percentage of successful requests
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80 Percentage of successful requests
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89 Percentage of successful requests
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81 Percentage of successful requests
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76 Percentage of successful requests
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88 Percentage of successful requests
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89 Percentage of successful requests
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92 Percentage of successful requests
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83 Percentage of successful requests
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SECONDARY outcome
Timeframe: Baseline and continuously for 3 years post interventionUsing 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.
Outcome measures
| Measure |
Pre-Intervention Authorization Rate (All Novice)
n=144 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Novice participants are defined has having less than 12 months of experience.
|
Post-Intervention Authorization Rate (Novice Autonomous Arm)
n=192 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Novice participants are defined has having less than 12 months of experience.
|
Post-Authorization Rate (Novice Assisted Arm)
n=137 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Novice participants are defined has having less than 12 months of experience.
|
Pre-Intervention Authorization Rate (All Mid-Level)
n=158 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
|
Post-Intervention Authorization Rate(Mid-Level Autonomous Arm)
n=101 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
|
Post-Authorization Rate (Mid-Level Assisted Arm)
n=51 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
|
Pre-Intervention Authorization Rate (All Senior)
n=266 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Senior participants are defined has having more than 36 months of experience.
|
Post-Intervention Authorization Rate (Senior Autonomous Arm)
n=170 Total organ donation approach encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Senior participants are defined has having more than 36 months of experience.
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Post-Authorization Rate (Senior Assisted Arm)
n=12 Participants
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Senior participants are defined has having more than 36 months of experience.
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Change in Requesters' Aggregated Relational Communication Skills
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75.22 units on a scale
Standard Deviation 7.6
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77.7 units on a scale
Standard Deviation 7.8
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78.0 units on a scale
Standard Deviation 7.4
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75.60 units on a scale
Standard Deviation 9.0
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75.0 units on a scale
Standard Deviation 9.0
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77.0 units on a scale
Standard Deviation 7.3
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76.10 units on a scale
Standard Deviation 7.7
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76.13 units on a scale
Standard Deviation 7.7
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78.2 units on a scale
Standard Deviation 7.4
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SECONDARY outcome
Timeframe: Baseline and continuously for 3 years post interventionRequester 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.
Outcome measures
| Measure |
Pre-Intervention Authorization Rate (All Novice)
n=144 Organ Donation Encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Novice participants are defined has having less than 12 months of experience.
|
Post-Intervention Authorization Rate (Novice Autonomous Arm)
n=192 Organ Donation Encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Novice participants are defined has having less than 12 months of experience.
|
Post-Authorization Rate (Novice Assisted Arm)
n=137 Organ Donation Encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Novice participants are defined has having less than 12 months of experience.
|
Pre-Intervention Authorization Rate (All Mid-Level)
n=158 Organ Donation Encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
|
Post-Intervention Authorization Rate(Mid-Level Autonomous Arm)
n=101 Organ Donation Encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
|
Post-Authorization Rate (Mid-Level Assisted Arm)
n=51 Organ Donation Encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Mid-level participants are defined has having 13 to 36 months of experience.
|
Pre-Intervention Authorization Rate (All Senior)
n=266 Organ Donation Encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in aggregate before the intervention. Senior participants are defined has having more than 36 months of experience.
|
Post-Intervention Authorization Rate (Senior Autonomous Arm)
n=170 Organ Donation Encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the autonomous arm after the intervention. Senior participants are defined has having more than 36 months of experience.
|
Post-Authorization Rate (Senior Assisted Arm)
n=129 Organ Donation Encounters
This is the authorization rate (successful authorization requests/total authorization requests) of participants in the assisted arm after the intervention. Senior participants are defined has having more than 36 months of experience.
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|---|---|---|---|---|---|---|---|---|---|
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Change in Request Staff's Comfort Answering Donation-related Questions During the Approach to Family Decision Makers
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4.91 units on a scale
Standard Deviation 0.33
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6.88 units on a scale
Standard Deviation 0.41
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6.89 units on a scale
Standard Deviation 0.66
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6.79 units on a scale
Standard Deviation 0.66
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6.99 units on a scale
Standard Deviation 0.14
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6.91 units on a scale
Standard Deviation 0.30
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6.80 units on a scale
Standard Deviation 0.74
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6.98 units on a scale
Standard Deviation 0.21
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6.98 units on a scale
Standard Deviation 0.19
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Adverse Events
Assisted CEaD Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Autonomous CEaD Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place