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Completed

NCT Number: NCT03213171

Promoting Organ Donor Registration in Family Physician Offices

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.

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Key information

Age range

16 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of London, London, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reception staff providing handout.

Behavioral

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

Mobile Tablet (e.g. iPad)

Behavioral

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

Primary outcomes

  1. Donor registration status at 7 days

    Time frame: 7 days

    Donor registration status (Yes/ Not registered)

Secondary outcomes

  1. Donor registration status at 14 days

    Time frame: 14 days

    Donor registration status (Yes/ Not registered)

  2. Donor registration status at 30 days

    Time frame: 30 days

    Donor registration status (Yes/ Not registered)

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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