Improving Informed Consent for Cleft Palate Repair

Musculoskeletal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02595307
• Other study ID #: 1015947
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2015
• Last updated: March 7, 2017
• Start date: May 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: IWK Health Centre
• Contact: Michael Bezuhly, MD FRCSC
• Phone: 902-470-8168
• Email: Michael.Bezuhly[@]iwk.nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Pamphlet
Written pamphlet outlining the risks of surgery as discussed in consultation.

Locations

Country	Name	City	State
Canada	IWK Health Center	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Aremu SK, Alabi BS, Segun-Busari S. The role of informed consent in risks recall in otorhinolaryngology surgeries: verbal (nonintervention) vs written (intervention) summaries of risks. Am J Otolaryngol. 2011 Nov-Dec;32(6):485-9. doi: 10.1016/j.amjoto.2010.09.012. — View Citation

Chan Y, Irish JC, Wood SJ, Rotstein LE, Brown DH, Gullane PJ, Lockwood GA. Patient education and informed consent in head and neck surgery. Arch Otolaryngol Head Neck Surg. 2002 Nov;128(11):1269-74. — View Citation

Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90. — View Citation

Leclercq WK, Keulers BJ, Houterman S, Veerman M, Legemaate J, Scheltinga MR. A survey of the current practice of the informed consent process in general surgery in the Netherlands. Patient Saf Surg. 2013 Jan 21;7(1):4. doi: 10.1186/1754-9493-7-4. — View Citation

Leclercq WK, Keulers BJ, Scheltinga MR, Spauwen PH, van der Wilt GJ. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg. 2010 Jul;34(7):1406-15. doi: 10.1007/s00268-010-0542-0. Review. — View Citation

Nadeau DP, Rich JN, Brietzke SE. Informed consent in pediatric surgery: Do parents understand the risks? Arch Otolaryngol Head Neck Surg. 2010 Mar;136(3):265-9. doi: 10.1001/archoto.2010.5. — View Citation

Siau D, List RJ, Hussin N, Woolford TJ. Do printed information leaflets improve recall of the procedure and risks in adult tonsillectomy? How we do it. Clin Otolaryngol. 2010 Dec;35(6):503-6. doi: 10.1111/j.1749-4486.2010.02227.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant Satisfaction as measured with the visual-analogue scale	Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale.	3 months