Patient and Physician Intervention to Increase Organ Donation

NCT01697137 | Completed

• 2 other identifiers: 6 R39OT22056-01-01R39OT22056
• Study Type: interventional
• Target: 916
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of participants who reported holding donation discussions with their primary care provider

  1 Day

Other Outcomes (1)

• Proportion of participants who were satisfied with time spent with their provider on the study date

  1 Day

Study Arms (2)

Usual Care

NO INTERVENTION

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

Participant Video and Provider Cueing

EXPERIMENTAL

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

Interventions

Participant Video and Provider Cueing BEHAVIORAL

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

Participant Video and Provider Cueing

Eligibility Criteria

• Age: 15 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Visually impaired
• Cognitively impaired
• Non-English speaking

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

The MetroHealth System

Cleveland, Ohio, 44109, United States

Location

Related Publications (1)

• 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.

  PMID: 26921161 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• John D Thornton, MD, MPH

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 23, 2015

Record last verified: 2015-02

Locations

US (1)