Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery
Understanding of an operation and its risks has been shown to give patients more realistic expectations, increase cooperation and result in higher satisfaction. Traditionally, informed consent for surgical procedures involve a discussion between the surgeon and the patient, but many patients easily forget the details of these talks. The investigators wish to investigate if providing a written pamphlet along with the standard oral discussion improves patients' ability to remember the details of the operation, improving the quality of the informed consent process.
In addition, we will test whether a group consultation format provides a model for large-volume, low-variation, low-urgency surgery without reducing ability to recall risks of surgery or overall satisfaction.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery|
- Number of risks recalled [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]Number of risks discussed at time of initial visit that are remembered by the patient at a 2 week follow up phone call.
- Patient Satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]Patients' perceived satisfaction, as measured by a visual-analogue scale rating their satisfaction with the procedure.
|Study Start Date:||May 2014|
|Study Completion Date:||December 2015|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Patient group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation.
Written pamphlet outlining the risks of surgery as discussed in consultation.
No Intervention: No pamphlet, individual
Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation.
Experimental: Group Consultation
Patient group that will receive informed consent discussion in a group-format.
Behavioral: Group Consultation
Informed consent discussion in group-format
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02071238
|Canada, Nova Scotia|
|Capital District Health Authority|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Principal Investigator:||Michael Bezuhly, MD MSc SM||902-470-8168|