Promoting Organ Donor Registration in Family Physician Offices

NCT ID: NCT03213171

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-27
• Study Completion Date: 2019-04-01

Brief Summary

This study evaluates the effects of using reception staff to prompt patients by providing a pamphlet and an opportunity to register in the waiting room via a mobile tablet on deceased organ donor registration rates.

Detailed Description

Background: There is a worldwide shortage of organs available for transplant, leading to preventable morbidity and mortality. While the majority of the general public in many countries support organ donation, actual donor registration rates are substantially out of step with these views. For instance, in Canada most Canadians support organ donation but less than 25% in most provinces have registered. The family physician office is a promising yet underused setting in which to address known barriers and facilitators to registration for deceased organ and tissue donation and to provide an immediate opportunity to register while in the waiting room for those wanting to do so.

Methods/Design: The investigators aim to evaluate the effects of having reception staff in family physician offices to prompt patients upon check-in with an educational pamphlet using a cluster, stepped-wedge randomized design. A mobile tablet will also be added to the waiting area to provide patients with the immediate opportunity to register. Family physicians are also provided with an educational booklet and encouraged to discuss organ donation with their patients. The investigators will use behaviour change techniques designed to address previously anticipated barriers and enablers to organ and tissue donation registration. The investigators will evaluate the effectiveness of the intervention conducted in six family physician offices in Ontario, Canada. Following a two-week baseline control period, offices will cross sequentially into the intervention arm in a random sequence at two-week intervals until all offices deliver the intervention (baseline + two weeks for each of six offices). The primary outcome will be the proportion of patients that have registered for deceased organ donation following in the 7 days following their office visit, using routinely collected registry data (i.e. administrative databases). The investigators will also conduct a qualitative post-trial process evaluation will assess reception staff and family physicians experiences with the intervention.

Discussion: Promoting organ and donor registration remains an important strategy for organ procurement organizations and patients worldwide. The results of this trial will inform a provincial roll-out strategy to promote organ donation in family physician offices.

Conditions

Organ Donation; Registration for Deceased Organ Donation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Usual care

Usual care / Standard of care No intervention implemented

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Reception staff providing handout; Mobile tablet that provides the immediate opportunity for patients to register in the waiting room

Group Type: EXPERIMENTAL

Reception staff providing handout.

Intervention Type: BEHAVIORAL

Reception staff will provide an educational pamphlet to patients that have not yet registered for organ donation

Mobile Tablet (e.g. iPad)

Intervention Type: BEHAVIORAL

Patients will have the opportunity to immediately register for organ donation using an a mobile tablet (e.g. IPad)

Interventions

Reception staff providing handout.

Reception staff will provide an educational pamphlet to patients that have not yet registered for organ donation

Intervention Type: BEHAVIORAL

Mobile Tablet (e.g. iPad)

Patients will have the opportunity to immediately register for organ donation using an a mobile tablet (e.g. IPad)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients that visited a family physician
• Patients that are at least 16 years of age with a valid health card (eligibility criteria to register for organ donation in Ontario)

• Working at a site that sees at least 100 patients per week

Exclusion Criteria

• Working at multiple sites that cannot be separated in analyses

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

Institute for Clinical Evaluative Sciences

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Amit Garg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

City of London

London, Ontario, Canada

City of Stratford

Stratford, Ontario, Canada

Countries

Canada

References

Li AH, Garg AX, Grimshaw JM, Prakash V, Dunnett AJ, Dixon SN, Taljaard M, Mitchell J, Naylor KL, Faulds C, Bevan R, Getchell L, Knoll G, Kim SJ, Sontrop J, Tong A, Bjerre LM, Hyjek K, Currie D, Edwards S, Sullivan M, Harvey-Rioux L, Presseau J. Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1): a pragmatic stepped-wedge, cluster randomized controlled registry trial. BMC Med. 2022 Mar 3;20(1):75. doi: 10.1186/s12916-022-02266-8.

Reference Type: RESULT

PMID: 35236353 (View on PubMed)

Li AH, Garg AX, Prakash V, Grimshaw JM, Taljaard M, Mitchell J, Matti D, Linklater S, Naylor KL, Dixon S, Faulds C, Bevan R, Getchell L, Knoll G, Kim SJ, Sontrop J, Bjerre LM, Tong A, Presseau J. Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry. Trials. 2017 Dec 21;18(1):610. doi: 10.1186/s13063-017-2333-5.

Reference Type: RESULT

PMID: 29268758 (View on PubMed)

Other Identifiers

CIHR-SCT-151609

Identifier Type: -

Identifier Source: org_study_id