An interventional study of Co-created PEM in Patient Educational Materials, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-01.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Health services research
Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA) test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have disseminated patient educational materials (PEMs) on PSA screening widely in Ontario, yet men remain confused about screening harms and benefits. One potential contributing factor may be that PEMs are typically developed by researchers and clinicians and may not address patient barriers to change. The investigators will assess whether a PSA screening PEM that is co-created with patients provides added value over PEMs developed using the traditional approach (i.e., researchers and clinicians develop a PEM with patient involvement in usability testing only. The investigators will also assess satisfaction with the engagement process and calculate the costs and resources required for each method (i.e. co-creation, usability, and recommendations only). This study will generate a PSA screening PEM to help patients make evidence-based screening decisions. It will also help Ontario organizations, including Cancer Care Ontario, identify optimal methods for developing PEMs for PSA screening and other areas of preventive health care, such as breast and colorectal cancer screening.
Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A co-created PEM has been designed in collaboration with patients. Participants receiving the intervention will be asked to read and answer questions before and after viewing the co-created PEM.
Other: Co-created PEM
Participants will be asked to read and answer questions before and after viewing the traditional PEM created by clinicians and researchers.
A co-created PEM has been designed in collaboration with patients.
Pretest-posttest change in prostate cancer screening decisional conflict and intention to be screened between the co-created PEM group and the traditional PEM group.
The investigators will assess differences and changes in prostate cancer screening decisional conflict and intention to be screened for the co-created PEM group and the traditional PEM group using repeated measures ANOVAs.
Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Pretest-posttest change in knowledge of prostate cancer screening
The investigators will assess the differences in the pretest-posttest change in prostate cancer screening knowledge between the co-created PEM group and the traditional PEM group using a 7-item knowledge measure. Assessed by conducting a repeated measures analysis of variance (ANOVA).
Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Comparison of PEM usability
The investigators will assess the differences between the two study arms in PEM/recommendation usability using a one-way ANOVA
Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Participant preference of PEM
The investigators will evaluate participants' preferred material (co-created or traditional PEM). Use a chi-square test to analyze the difference in the proportion of patients who prefer each type of material.
Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month
Resources use for PEM development
The investigators will record the resources required (e.g., personnel hours and participant reimbursement) for a health care organization to develop a co-created PEM in comparison to a PEM created by clinicians and researchers.
Time frame: This measure will be assessed after the intervention (survey) is administered (i.e., post analysis), up to 1 month.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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