Clinical trial NCT03213171: 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
Overall status: COMPLETED
Phase: NA
Conditions: Organ Donation
Registration for Deceased Organ Donation
Keywords: organ donation
family physician
primary care
clinical trial
registry trial
cluster trial
stepped-wedge
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
name: Institute for Clinical Evaluative Sciences
name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-07-11
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge cluster randomized trial
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Donor registration status at 7 days
timeFrame: 7 days
Secondary outcomes:
measure: Donor registration status at 14 days
timeFrame: 14 days
measure: Donor registration status at 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: Canada
facility: City of London
state: Ontario
city: Stratford
country: Canada
facility: City of Stratford
state: Ontario
Study officials:
References:
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.
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.