Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02071238|
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : January 13, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel||Behavioral: Pamphlet Behavioral: Group Consultation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||December 2015|
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
- Number of risks recalled [ Time Frame: 2-3 weeks ]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 ]Patients' perceived satisfaction, as measured by a visual-analogue scale rating their satisfaction with the procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071238
|Canada, Nova Scotia|
|Capital District Health Authority|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Principal Investigator:||Michael Bezuhly, MD MSc SM||902-470-8168|