Patient and Physician Intervention to Increase Organ Donation

Study Overview
=================
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.

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

Conditions
-----------------
Tissue and Organ Donation, Communication

Intervention / Treatment
-----------------
* Behavioral: Participant Video and Provider Cueing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 78 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Following enrollment, participants will visit with their primary care provider per usual. | |
| Experimental: Participant Video and Provider Cueing<br>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<br>* Participants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing).<br>|

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