Improving Informed Consent for Cleft Palate Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of a Written Summary on Risk Recall During Consent Process for Cleft Palate Repair

Conditions
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Cleft Palate, Jaw Abnormalities, Maxillofacial Abnormalities, Mouth Abnormalities, Congenital Abnormalities, Jaw Diseases, Musculoskeletal Diseases, Craniofacial Abnormalities, Musculoskeletal Abnormalities, Stomatognathic Diseases, Stomatognathic System Abnormalities

Intervention / Treatment
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* Behavioral: Pamphlet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pamphlet<br>Participant group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation. | Behavioral: Pamphlet<br>* Written pamphlet outlining the risks of surgery as discussed in consultation.<br>|
| No Intervention: No Pamphlet<br>Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of risks recalled | The number of risks that are recalled by the patient at a 3 week follow up phone call. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Satisfaction as measured with the visual-analogue scale | Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risk Recall, Pamphlet, Brochure, Patient satisfaction, Informed Consent