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Improving Informed Consent for Cleft Palate Repair

Primary Purpose

Cleft Palate, Jaw Abnormalities, Maxillofacial Abnormalities

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pamphlet
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cleft Palate focused on measuring Risk Recall, Pamphlet, Brochure, Patient satisfaction, Informed Consent

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parents/guardians of a child referred to the IWK Cleft Palate Clinic for primary cleft palate repair surgery

Exclusion Criteria:

  • Inability to fluently communicate in English
  • Inability to read at a grade 8 level
  • Inability to provide informed consent

Sites / Locations

  • IWK Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pamphlet

No Pamphlet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of risks recalled
The number of risks that are recalled by the patient at a 3 week follow up phone call.

Secondary Outcome Measures

Participant Satisfaction as measured with the visual-analogue scale
Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale.

Full Information

First Posted
November 2, 2015
Last Updated
March 7, 2017
Sponsor
IWK Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02595307
Brief Title
Improving Informed Consent for Cleft Palate Repair
Official Title
Role of a Written Summary on Risk Recall During Consent Process for Cleft Palate Repair
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IWK Health Centre

4. Oversight

5. Study Description

Brief Summary
To determine if providing a written document in addition to the standard oral discussion of surgical risks improves risk recall for the parents/guardians of a child seen in consultation for cleft palate surgery, and if this has any effect on overall satisfaction after the procedure
Detailed Description
The current standard of care as it relates to informed consent in the pediatric population involves providing the parents or guardians of the child undergoing surgery with an oral discussion prior to the surgical procedure. However, providing parents with an oral discussion alone may be insufficient in the informed consent process as it has been shown that oral information tends to be retained poorly and crucial pieces of information tend to be forgotten. Conversely, it has been shown that properly informed patients are more satisfied, have a higher commitment to their treatment, and demonstrate less tendency toward filing legal claims. Furthermore, written material may help reduce anxiety in patients facing stressful events, such as surgery, and have been linked with overall improvement in satisfaction with their treatment The investigators hypothesize that providing a written document in conjunction with the standard oral discussion improves the participants' risk recall in the informed consent process for their child's cleft palate repair surgery and increases their subjective satisfaction with the operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate, Jaw Abnormalities, Maxillofacial Abnormalities, Mouth Abnormalities, Congenital Abnormalities, Jaw Diseases, Musculoskeletal Diseases, Craniofacial Abnormalities, Musculoskeletal Abnormalities, Stomatognathic Diseases, Stomatognathic System Abnormalities
Keywords
Risk Recall, Pamphlet, Brochure, Patient satisfaction, Informed Consent

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pamphlet
Arm Type
Experimental
Arm Description
Participant group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation.
Arm Title
No Pamphlet
Arm Type
No Intervention
Arm Description
Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation.
Intervention Type
Behavioral
Intervention Name(s)
Pamphlet
Intervention Description
Written pamphlet outlining the risks of surgery as discussed in consultation.
Primary Outcome Measure Information:
Title
Number of risks recalled
Description
The number of risks that are recalled by the patient at a 3 week follow up phone call.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Participant Satisfaction as measured with the visual-analogue scale
Description
Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parents/guardians of a child referred to the IWK Cleft Palate Clinic for primary cleft palate repair surgery Exclusion Criteria: Inability to fluently communicate in English Inability to read at a grade 8 level Inability to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Bezuhly, MD FRCSC
Phone
902-470-8168
Email
Michael.Bezuhly@iwk.nshealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Al-Taha, MD Candidate
Phone
902-441-8300
Email
mona.altaha@dal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bezuhly, MD FRCSC
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bev White
Phone
(902) 470-8520
Email
bev.white@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Michael Bezuhly, MD FRCSC
First Name & Middle Initial & Last Name & Degree
Paul Hong, MD FRSCS
First Name & Middle Initial & Last Name & Degree
Mona Al-Taha, MD Candidate

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate results only will be shared.
Citations:
PubMed Identifier
21093107
Citation
Aremu SK, Alabi BS, Segun-Busari S. The role of informed consent in risks recall in otorhinolaryngology surgeries: verbal (nonintervention) vs written (intervention) summaries of risks. Am J Otolaryngol. 2011 Nov-Dec;32(6):485-9. doi: 10.1016/j.amjoto.2010.09.012. Epub 2010 Nov 19.
Results Reference
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PubMed Identifier
20231645
Citation
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.
Results Reference
background
PubMed Identifier
8490411
Citation
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.
Results Reference
background
PubMed Identifier
23336609
Citation
Leclercq WK, Keulers BJ, Houterman S, Veerman M, Legemaate J, Scheltinga MR. A survey of the current practice of the informed consent process in general surgery in the Netherlands. Patient Saf Surg. 2013 Jan 21;7(1):4. doi: 10.1186/1754-9493-7-4.
Results Reference
background
PubMed Identifier
20372902
Citation
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.
Results Reference
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PubMed Identifier
12431168
Citation
Chan Y, Irish JC, Wood SJ, Rotstein LE, Brown DH, Gullane PJ, Lockwood GA. Patient education and informed consent in head and neck surgery. Arch Otolaryngol Head Neck Surg. 2002 Nov;128(11):1269-74. doi: 10.1001/archotol.128.11.1269.
Results Reference
background
PubMed Identifier
21199416
Citation
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.
Results Reference
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Improving Informed Consent for Cleft Palate Repair

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