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Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02071238
First Posted: February 25, 2014
Last Update Posted: January 13, 2016
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.
Information provided by (Responsible Party):
Michael Bezuhly, Nova Scotia Health Authority
  Purpose

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 Intervention
Carpal Tunnel Behavioral: Pamphlet Behavioral: Group Consultation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery

Resource links provided by NLM:


Further study details as provided by Michael Bezuhly, Nova Scotia Health Authority:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: 3 months ]
    Patients' perceived satisfaction, as measured by a visual-analogue scale rating their satisfaction with the procedure.


Enrollment: 140
Study Start Date: May 2014
Study Completion Date: December 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pamphlet
Patient group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation.
Behavioral: Pamphlet
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Referral to the Halifax Infirmary plastic surgery clinic for consultation for open carpal tunnel release

Exclusion Criteria:

  • Age less than 16 years
  • Inability to fluently communicate in English
  • Discussion of additional procedures
  • Prior open (not percutaneous) hand surgery
  • Inability to give informed consent
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Michael Bezuhly
Investigators
Principal Investigator: Michael Bezuhly, MD MSc SM 902-470-8168
  More Information

Publications:

Responsible Party: Michael Bezuhly, Plastic Surgeon, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02071238     History of Changes
Other Study ID Numbers: CDHA-RS/2014-244
First Submitted: February 21, 2014
First Posted: February 25, 2014
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Michael Bezuhly, Nova Scotia Health Authority:
Carpal tunnel
Carpal tunnel release
Risk Recall
Patient satisfaction
Pamphlet
Brochure

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries