Improving Informed Consent for Cleft Palate Repair

IWK Health Centre

Status: Unknown

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

Treatments: Behavioral: Pamphlet

Study type: Interventional

Funder types: Other

Identifiers

NCT02595307

1015947

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Pamphlet

Experimental group

Description:

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

Treatment:

Behavioral: Pamphlet

No Pamphlet

No Intervention group

Description:

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