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Improving Informed Consent for Cleft Palate Repair

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. Identifier: NCT02595307
Recruitment Status : Unknown
Verified March 2017 by IWK Health Centre.
Recruitment status was:  Recruiting
First Posted : November 3, 2015
Last Update Posted : March 8, 2017
Information provided by (Responsible Party):
IWK Health Centre

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

Condition or disease Intervention/treatment Phase
Cleft Palate Jaw Abnormalities Maxillofacial Abnormalities Mouth Abnormalities Congenital Abnormalities Jaw Diseases Musculoskeletal Diseases Craniofacial Abnormalities Musculoskeletal Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Behavioral: Pamphlet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Role of a Written Summary on Risk Recall During Consent Process for Cleft Palate Repair
Study Start Date : May 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pamphlet
Participant 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
Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation.

Primary Outcome Measures :
  1. Number of risks recalled [ Time Frame: 3 weeks ]
    The number of risks that are recalled by the patient at a 3 week follow up phone call.

Secondary Outcome Measures :
  1. Participant Satisfaction as measured with the visual-analogue scale [ Time Frame: 3 months ]
    Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale.

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.

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

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

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 identifier (NCT number): NCT02595307

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Contact: Michael Bezuhly, MD FRCSC 902-470-8168
Contact: Mona Al-Taha, MD Candidate 902-441-8300

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Canada, Nova Scotia
IWK Health Center Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Bev White    (902) 470-8520   
Principal Investigator: Michael Bezuhly, MD FRCSC         
Sub-Investigator: Paul Hong, MD FRSCS         
Sub-Investigator: Mona Al-Taha, MD Candidate         
Sponsors and Collaborators
IWK Health Centre
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Principal Investigator: Michael Bezuhly, MD FRCSC IWK Health Centre

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Responsible Party: IWK Health Centre Identifier: NCT02595307    
Other Study ID Numbers: 1015947
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate results only will be shared.
Keywords provided by IWK Health Centre:
Risk Recall
Patient satisfaction
Informed Consent
Additional relevant MeSH terms:
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Cleft Palate
Craniofacial Abnormalities
Maxillofacial Abnormalities
Musculoskeletal Abnormalities
Jaw Abnormalities
Jaw Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases