Patient and Physician Intervention to Increase Organ Donation

NCT ID: NCT01697137

Last Updated: 2015-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 916 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-05-31

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.

Conditions

Tissue and Organ Donation; Communication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Usual Care

Following enrollment, participants will visit with their primary care provider per usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Participant Video and Provider Cueing

Intervention Type: BEHAVIORAL

Participants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing).

Interventions

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Daryl Thornton

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John D Thornton, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

The MetroHealth System

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26921161 (View on PubMed)

Other Identifiers

R39OT22056

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

6 R39OT22056-01-01

Identifier Type: -

Identifier Source: org_study_id