Patient and Physician Intervention to Increase Organ Donation (DECIDE)
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Purpose
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. We 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 physicians 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. We 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 physicians, and 3) equally satisfied with the time spent with their doctor compared to patients who are not exposed to the interventions.
| Condition | Intervention |
|---|---|
|
Tissue and Organ Procurement Communication |
Behavioral: Participant Video and Physician Cueing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Patient and Physician Intervention to Increase Organ Donation in Primary Care Settings |
- Proportion of participants who consent to donate organs [ Time Frame: 1 Day ] [ Designated as safety issue: No ]Consent either on the electronic donor registry or by completion of a organ donor card.
- Proportion of participants who reported holding donation discussions with their physician [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
- Proportion of participants who were satisfied with time spent with doctor on study date [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]Proportion of participants who were somewhat or very satisfied with the amount of time spent with their doctor during the date of the study.
| Estimated Enrollment: | 900 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Usual Care | |
|
Experimental: Participant Video and Physician Cueing
Participants will watch a video prior to meeting with their physician. Participants will then cue their physicians to discuss organ donation with them.
|
Behavioral: Participant Video and Physician Cueing |
Eligibility| Ages Eligible for Study: | 15 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- At least 2 visits with their primary care physician 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:
- < 15.5 years of age
- > 78 years of age
- Visually impaired
- Cognitively impaired
- Non-English speaking
- Previously consented to organ donation
- Have not had 2 visits with primary care physician in the last 3 years
Contacts and Locations| Contact: John D Thornton, MD, MPH | 216-778-3732 | john.thornton@case.edu |
| United States, Ohio | |
| The MetroHealth System | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Principal Investigator: John D Thornton, MD, MPH | |
| Principal Investigator: | John D Thornton, MD, MPH | Case Western Reserve University |
More Information
No publications provided
| Responsible Party: | Daryl Thornton, Assistant Professor, Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT01697137 History of Changes |
| Other Study ID Numbers: | 6 R39OT22056-01-01, R39OT22056 |
| Study First Received: | September 28, 2012 |
| Last Updated: | October 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 21, 2013