DECIDE: Patient and Physician Intervention to Increase Organ Donation

Sponsor

Case Western Reserve University (Other)

Overall Status

Completed

CT.gov ID

NCT01697137

Collaborator

(none)

916

Enrollment

Location

Arms

19.9

Duration (Months)

45.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The number of persons on the national solid organ waiting list continues to increase while the number of donated organs has failed to keep pace. In some portions of northeastern Ohio the donation rate is as low as 32%. There is a positive association between discussing organ donation with a primary care physician and signing a donor card. However, such discussions are rare. The investigators propose a blinded randomized controlled trial to evaluate the effectiveness of two interventions: 1) showing a donation video to patients in primary care settings waiting to see their physician and 2) cueing of primary care providers to have donation discussions with their patients. The study will be conducted throughout Cuyahoga County in at least 10 ambulatory clinics associated with a single county medical system. Nine hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that patients exposed to the interventions will be 1) more likely to consent to donate organs, 2) more likely to have donation discussions with their primary care providers, and 3) equally satisfied with the time spent with their doctor compared to patients who are not exposed to the interventions.

Condition or Disease	Intervention/Treatment	Phase
Tissue and Organ Donation Communication	Behavioral: Participant Video and Provider Cueing	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

916 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Patient and Physician Intervention to Increase Organ Donation in Primary Care Settings

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Following enrollment, participants will visit with their primary care provider per usual.
Experimental: Participant Video and Provider Cueing Participants will watch a video prior to meeting with their provider. Participants will then cue their providers to discuss organ donation with them.	Behavioral: Participant Video and Provider Cueing Participants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing).

Arm

Intervention/Treatment

No Intervention: Usual Care

Following enrollment, participants will visit with their primary care provider per usual.

Experimental: Participant Video and Provider Cueing

Participants will watch a video prior to meeting with their provider. Participants will then cue their providers to discuss organ donation with them.

Behavioral: Participant Video and Provider Cueing

Participants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing).

Outcome Measures

Primary Outcome Measures

Proportion of participants who consent to donate organs [1 Day]
Consent either on the electronic donor registry or by completion of a organ donor card.

Secondary Outcome Measures

Proportion of participants who reported holding donation discussions with their primary care provider [1 Day]

Other Outcome Measures

Proportion of participants who were satisfied with time spent with their provider on the study date [1 Day]
Proportion of participants who were somewhat or very satisfied with the amount of time spent with their provider during the date of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

At least 2 visits with their primary care provider in the last 3 years
Not previously consented to organ donation
At least 15.5 years of age
Less than 78 years of age

Exclusion Criteria:

Visually impaired
Cognitively impaired
Non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The MetroHealth System	Cleveland	Ohio	United States	44109

Sponsors and Collaborators

Case Western Reserve University

Investigators

Principal Investigator: John D Thornton, MD, MPH, Case Western Reserve University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daryl Thornton, Assistant Professor, Case Western Reserve University

ClinicalTrials.gov Identifier:

NCT01697137

Other Study ID Numbers:

6 R39OT22056-01-01
R39OT22056

First Posted:

Oct 2, 2012

Last Update Posted:

Feb 23, 2015

Last Verified:

Feb 1, 2015

Study Results

No Results Posted as of Feb 23, 2015