Promoting Organ Donor Registration in Family Physician Offices

Promoting Organ and Tissue Donation Registration in Family Physician Offices: a Pragmatic Stepped-wedge Cluster Randomized Controlled Registry Trial (RegisterNow Trial)

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.

Study Overview

• Status: Completed
• Conditions: Organ Donation; Registration for Deceased Organ Donation
• Intervention / Treatment: Behavioral: Reception staff providing handout.; Behavioral: Mobile Tablet (e.g. iPad)

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • City of London
    • Stratford, Ontario, Canada
      • City of Stratford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 105 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion/Exclusion Criteria for Patients

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)

Inclusion/Exclusion Criteria for Family Physicians (Cluster level)

Inclusion Criteria:

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

Exclusion Criteria:

- Working at multiple sites that cannot be separated in analyses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Usual care / Standard of care No intervention implemented
Experimental: Intervention; Reception staff providing handout; Mobile tablet that provides the immediate opportunity for patients to register in the waiting room	Behavioral: Reception staff providing handout.; Reception staff will provide an educational pamphlet to patients that have not yet registered for organ donation; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donor registration status at 7 days	Donor registration status (Yes/ Not registered)	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donor registration status at 14 days	Donor registration status (Yes/ Not registered)	14 days
Donor registration status at 30 days	Donor registration status (Yes/ Not registered)	30 days

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Ottawa Hospital Research Institute; Institute for Clinical Evaluative Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: primary care; clinical trial; organ donation; family physician; registry trial; cluster trial; stepped-wedge
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: CIHR-SCT-151609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No