Patient and Physician Intervention to Increase Organ Donation

Communication Clinical Trial

— DECIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697137
• Other study ID #: 6 R39OT22056-01-01
• Secondary ID: R39OT22056
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: February 19, 2015
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 916
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Communication
• Tissue and Organ Donation

Intervention

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).

Locations

Country	Name	City	State
United States	The MetroHealth System	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants who were satisfied with time spent with their provider on the study date	Proportion of participants who were somewhat or very satisfied with the amount of time spent with their provider during the date of the study.	1 Day	Yes
Primary	Proportion of participants who consent to donate organs	Consent either on the electronic donor registry or by completion of a organ donor card.	1 Day	No
Secondary	Proportion of participants who reported holding donation discussions with their primary care provider		1 Day	No