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Promoting Organ Donor Registration in Family Physician Offices

Primary Purpose

Organ Donation, Registration for Deceased Organ Donation

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Reception staff providing handout.
Mobile Tablet (e.g. iPad)
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Organ Donation focused on measuring organ donation, family physician, primary care, clinical trial, registry trial, cluster trial, stepped-wedge

Eligibility Criteria

16 Years - 105 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • City of London
  • City of Stratford

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Intervention

Arm Description

Usual care / Standard of care No intervention implemented

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2017
Last Updated
August 14, 2018
Sponsor
Lawson Health Research Institute
Collaborators
Ottawa Hospital Research Institute, Institute for Clinical Evaluative Sciences, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03213171
Brief Title
Promoting Organ Donor Registration in Family Physician Offices
Official Title
Promoting Organ and Tissue Donation Registration in Family Physician Offices: a Pragmatic Stepped-wedge Cluster Randomized Controlled Registry Trial (RegisterNow Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 27, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
April 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Ottawa Hospital Research Institute, Institute for Clinical Evaluative Sciences, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Organ Donation, Registration for Deceased Organ Donation
Keywords
organ donation, family physician, primary care, clinical trial, registry trial, cluster trial, stepped-wedge

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-wedge cluster randomized trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care / Standard of care No intervention implemented
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Reception staff providing handout; Mobile tablet that provides the immediate opportunity for patients to register in the waiting room
Intervention Type
Behavioral
Intervention Name(s)
Reception staff providing handout.
Intervention Description
Reception staff will provide an educational pamphlet to patients that have not yet registered for organ donation
Intervention Type
Behavioral
Intervention Name(s)
Mobile Tablet (e.g. iPad)
Intervention Description
Patients will have the opportunity to immediately register for organ donation using an a mobile tablet (e.g. IPad)
Primary Outcome Measure Information:
Title
Donor registration status at 7 days
Description
Donor registration status (Yes/ Not registered)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Donor registration status at 14 days
Description
Donor registration status (Yes/ Not registered)
Time Frame
14 days
Title
Donor registration status at 30 days
Description
Donor registration status (Yes/ Not registered)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
City of London
City
London
State/Province
Ontario
Country
Canada
Facility Name
City of Stratford
City
Stratford
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35236353
Citation
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.
Results Reference
derived
PubMed Identifier
29268758
Citation
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.
Results Reference
derived

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Promoting Organ Donor Registration in Family Physician Offices

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