Promoting Organ Donor Registration in Family Physician Offices

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT03213171

Collaborator

Ottawa Hospital Research Institute (Other), Institute for Clinical Evaluative Sciences (Other), Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Locations

Arms

18.1

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Organ Donation Registration for Deceased Organ Donation	Behavioral: Reception staff providing handout. Behavioral: Mobile Tablet (e.g. iPad)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Stepped-wedge cluster randomized trialStepped-wedge cluster randomized trial

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 27, 2017

Actual Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Donor registration status at 7 days [7 days]
Donor registration status (Yes/ Not registered)

Secondary Outcome Measures

Donor registration status at 14 days [14 days]
Donor registration status (Yes/ Not registered)
Donor registration status at 30 days [30 days]
Donor registration status (Yes/ Not registered)

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)