Patient and Physician Intervention to Increase Organ Donation (DECIDE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Case Western Reserve University
Sponsor:
Information provided by (Responsible Party):
Daryl Thornton, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01697137
First received: September 28, 2012
Last updated: February 12, 2014
Last verified: February 2014
  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. 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 Intervention
Tissue and Organ Donation
Communication
Behavioral: Participant Video and Provider 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

Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Proportion of participants who reported holding donation discussions with their primary care provider [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Proportion of participants who were satisfied with time spent with their provider on the 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 provider 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
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).

  Eligibility

Ages Eligible for Study:   15 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697137

Contacts
Contact: John D Thornton, MD, MPH 216-778-3732 john.thornton@case.edu

Locations
United States, Ohio
The MetroHealth System Recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: John D Thornton, MD, MPH         
Sponsors and Collaborators
Case Western Reserve University
Investigators
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: February 12, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 09, 2014