Clinical Trial: Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery

Brief Summary:

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.


Detailed Summary:

Objective of this study The investigators' study objectives are to see if additionally providing a written document along with the discussion of surgical risks improves risk recall for patient seen in consultation for open carpal tunnel release, and if this has any effect on overall satisfaction after the procedure.

To accomplish this goal, the investigators intend to provide patients with a written document outlining the same risks as are discussed in consultation and investigate if their recall of the risks is improved compared to patients who receive discussion alone. The investigators will also see whether risk recall is affected if patients participate in a group format informed consent discussion compared to a standard individual discussion. The investigators propose to do this as a two-part prospective randomized control trial of patients who are new referrals to the Halifax Infirmary Plastic Surgery Clinic.

Background The informed consent process The risks and benefits of an operation or procedure are typically discussed as part of the informed consent process for an initial surgical consultation. Informed consent is a legal requirement for surgery and is based on the components of disclosure, comprehension, competence and voluntary choice. Despite this, patients are often unable to recall the specific risks that were reviewed. Additionally, failure to understand the possible risks and failure of communication are more common reasons for patients to seek legal action. Patients have historically reported that they wished they had received more information about their operation prior to surgery.

Increased understanding of a procedure and its risks has been shown to give patients more realistic expectations, increase cooperation and result in higher satisfaction. Tradi
Sponsor: Michael Bezuhly

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient Satisfaction [ Time Frame: 3 months ]

Patients' perceived satisfaction, as measured by a visual-analogue scale rating their satisfaction with the procedure.


Original Secondary Outcome: Same as current

Information By: Nova Scotia Health Authority

Dates:
Date Received: February 21, 2014
Date Started: May 2014
Date Completion:
Last Updated: January 12, 2016
Last Verified: January 2016