Clinical Trial: Improving Informed Consent for Cleft Palate Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: IWK Health Centre

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: IWK Health Centre

Dates:
Date Received: November 2, 2015
Date Started: May 2014
Date Completion: December 2017
Last Updated: March 7, 2017
Last Verified: March 2017