Patient and Physician Intervention to Increase Organ Donation (DECIDE)

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

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.

Study Overview

• Status: Completed
• Conditions: Communication; Tissue and Organ Donation
• Intervention / Treatment: Behavioral: Participant Video and Provider Cueing

• Study Type: Interventional
• Enrollment (Actual): 916
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • The MetroHealth System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants who reported holding donation discussions with their primary care provider	1 Day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Thornton JD, Sullivan C, Albert JM, Cedeno M, Patrick B, Pencak J, Wong KA, Allen MD, Kimble L, Mekesa H, Bowen G, Sehgal AR. Effects of a Video on Organ Donation Consent Among Primary Care Patients: A Randomized Controlled Trial. J Gen Intern Med. 2016 Aug;31(8):832-9. doi: 10.1007/s11606-016-3630-5.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 28, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 6 R39OT22056-01-01; R39OT22056 (Other Grant/Funding Number: Health Resources and Services Administration)