NCT02071238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

February 21, 2014

Last Update Submit

January 12, 2016

Conditions

Carpal Tunnel

Keywords

Carpal tunnelCarpal tunnel releaseRisk RecallPatient satisfactionPamphletBrochure

Outcome Measures

Primary Outcomes (1)

  • Number of risks recalled

    Number of risks discussed at time of initial visit that are remembered by the patient at a 2 week follow up phone call.

    2-3 weeks

Secondary Outcomes (1)

  • Patient Satisfaction

    3 months

Study Arms (3)

Pamphlet

EXPERIMENTAL

Patient group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation.

Behavioral: Pamphlet

No pamphlet, individual

NO INTERVENTION

Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation.

Group Consultation

EXPERIMENTAL

Patient group that will receive informed consent discussion in a group-format.

Behavioral: Group Consultation

Interventions

PamphletBEHAVIORAL

Written pamphlet outlining the risks of surgery as discussed in consultation.

Pamphlet
Group ConsultationBEHAVIORAL

Informed consent discussion in group-format

Group Consultation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (10)

  • Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90. doi: 10.1136/bmj.306.6882.885.

    PMID: 8490411BACKGROUND

  • Nadeau DP, Rich JN, Brietzke SE. Informed consent in pediatric surgery: Do parents understand the risks? Arch Otolaryngol Head Neck Surg. 2010 Mar;136(3):265-9. doi: 10.1001/archoto.2010.5.

    PMID: 20231645BACKGROUND

  • Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making. 2011 Jan-Feb;31(1):151-73. doi: 10.1177/0272989X10364247. Epub 2010 Mar 31.

    PMID: 20357225BACKGROUND

  • Leclercq WK, Keulers BJ, Scheltinga MR, Spauwen PH, van der Wilt GJ. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg. 2010 Jul;34(7):1406-15. doi: 10.1007/s00268-010-0542-0.

    PMID: 20372902BACKGROUND

  • Kessler TM, Nachbur BH, Kessler W. Patients' perception of preoperative information by interactive computer program-exemplified by cholecystectomy. Patient Educ Couns. 2005 Nov;59(2):135-40. doi: 10.1016/j.pec.2004.10.009.

    PMID: 16257617BACKGROUND

  • Siau D, List RJ, Hussin N, Woolford TJ. Do printed information leaflets improve recall of the procedure and risks in adult tonsillectomy? How we do it. Clin Otolaryngol. 2010 Dec;35(6):503-6. doi: 10.1111/j.1749-4486.2010.02227.x. No abstract available.

    PMID: 21199416BACKGROUND

  • Hong P, Makdessian AS, Ellis DA, Taylor SM. Informed consent in rhinoplasty: prospective randomized study of risk recall in patients who are given written disclosure of risks versus traditional oral discussion groups. J Otolaryngol Head Neck Surg. 2009 Jun;38(3):369-74.

    PMID: 19476770BACKGROUND

  • Ono S, Clapham PJ, Chung KC. Optimal management of carpal tunnel syndrome. Int J Gen Med. 2010 Aug 30;3:255-61. doi: 10.2147/ijgm.s7682.

    PMID: 20830201BACKGROUND

  • Platt J, Baxter N, Jones J, Metcalfe K, Causarano N, Hofer SO, O'Neill A, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial. Trials. 2013 Jul 6;14:199. doi: 10.1186/1745-6215-14-199.

    PMID: 23829442BACKGROUND

  • Weiss MG, Ramakrishna J, Somma D. Health-related stigma: rethinking concepts and interventions. Psychol Health Med. 2006 Aug;11(3):277-87. doi: 10.1080/13548500600595053.

    PMID: 17130065BACKGROUND

MeSH Terms

Conditions

Median NeuropathyPatient Satisfaction

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Michael Bezuhly, MD MSc SM

    902-470-8168

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Plastic Surgeon

Study Record Dates

First Submitted

February 21, 2014

First Posted

February 25, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

CA(1)