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Patient and Physician Intervention to Increase Organ Donation (DECIDE)

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ClinicalTrials.gov Identifier: NCT01697137
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Daryl Thornton, Case Western Reserve University

September 28, 2012
October 2, 2012
February 23, 2015
September 2012
May 2014   (Final data collection date for primary outcome measure)
Proportion of participants who consent to donate organs [ Time Frame: 1 Day ]
Consent either on the electronic donor registry or by completion of a organ donor card.
Same as current
Complete list of historical versions of study NCT01697137 on ClinicalTrials.gov Archive Site
Proportion of participants who reported holding donation discussions with their primary care provider [ Time Frame: 1 Day ]
Proportion of participants who reported holding donation discussions with their physician [ Time Frame: 1 Day ]
Proportion of participants who were satisfied with time spent with their provider on the study date [ Time Frame: 1 Day ]
Proportion of participants who were somewhat or very satisfied with the amount of time spent with their provider during the date of the study.
Proportion of participants who were satisfied with time spent with doctor on study date [ Time Frame: 1 Day ]
Proportion of participants who were somewhat or very satisfied with the amount of time spent with their doctor during the date of the study.
 
Patient and Physician Intervention to Increase Organ Donation
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Tissue and Organ Donation
  • Communication
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).
  • 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.
    Intervention: Behavioral: Participant Video and Provider Cueing
Thornton JD, Sullivan C, Albert JM, Cedeño 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
916
900
May 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years to 78 Years   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01697137
6 R39OT22056-01-01
R39OT22056 ( Other Grant/Funding Number: Health Resources and Services Administration )
No
Not Provided
Not Provided
Daryl Thornton, Case Western Reserve University
Case Western Reserve University
Not Provided
Principal Investigator: John D Thornton, MD, MPH Case Western Reserve University
Case Western Reserve University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP