Improving Informed Consent for Cleft Palate Repair

Not Applicable

• Conditions: Cleft Palate; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Mouth Abnormalities; Jaw Diseases; Musculoskeletal Diseases
• Interventions: Behavioral: Pamphlet

• Registration Number: NCT02595307
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-08
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Participant Satisfaction as measured with the visual-analogue scale	3 months	Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale.

Trial Locations

Locations (1)

IWK Health Center; 🇨🇦 Halifax, Nova Scotia, Canada