Tissue and Organ DonationDECIDENCT01697137
Patient and Physician Intervention to Increase Organ Donation
A study testing Participant Video and Provider Cueing in people with Tissue and Organ Donation and Communication, run by Case Western Reserve University at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 15 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue and Organ Donation, Communication
- What is being tested?
- Participant Video and Provider Cueing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 916 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 78 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Visually impaired
- Cognitively impaired
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tissue and Organ Donation, Communication
- Being tested
- Participant Video and Provider Cueing
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant Video and Provider CueingBehavioural
Participants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Participant Video and Provider Cueing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who consent to donate organs
Consent either on the electronic donor registry or by completion of a organ donor card.
Measured: 1 Day
Secondary outcomes (1)
Proportion of participants who reported holding donation discussions with their primary care provider
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tissue and Organ DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 916 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daryl Thornton, Case Western Reserve University
- Investigators
- John D Thornton, MD, MPH, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697137
- Sponsor's protocol ID
- 6 R39OT22056-01-01
- Other IDs
- R39OT22056
- Acronym
- DECIDE
- Status last verified
- Feb 2015
- First submitted
- 28 Sep 2012
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26921161
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Physician Intervention to Increase Organ Donation in Primary Care Settings
- ClinicalTrials.gov ID
- NCT01697137
- Acronym / sponsor ID
- DECIDE / 6 R39OT22056-01-01
- Conditions
- Tissue and Organ Donation, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 916 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Following enrollment, participants will visit with their primary care provider per usual. |
| Participant Video and Provider Cueing | Experimental | Behavioral: Participant Video and Provider CueingParticipants will watch a video prior to meeting with their provider. Participants will then cue their providers to discuss organ donation with them. |
Who may qualify
- Ages
- 15 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Visually impaired
- Cognitively impaired
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant Video and Provider CueingParticipants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing). | Behavioural | Participant Video and Provider Cueing |
Primary outcome
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.
1 secondary outcome
Proportion of participants who reported holding donation discussions with their primary care provider
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Derived from this study: PubMed 26921161Thornton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Thornton, MD, MPH principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participant Video and Provider Cueing in people with Tissue and Organ Donation and Communication, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who consent to donate organs (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01697137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.