Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT02071238
First received: February 21, 2014
Last updated: June 24, 2014
Last verified: March 2014
  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 Blind (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 Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071238

Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Capital District Health Authority, Canada
  More Information

Publications:

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT02071238     History of Changes
Other Study ID Numbers: CDHA-RS/2014-244
Study First Received: February 21, 2014
Last Updated: June 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
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

ClinicalTrials.gov processed this record on August 18, 2014