Improving Informed Consent for Cleft Palate Repair

NCT02595307 | Unknown

• 1 other identifier: 1015947
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Risk Recall; Pamphlet; Brochure; Patient satisfaction; Informed Consent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant Satisfaction as measured with the visual-analogue scale

  3 months

Study Arms (2)

Pamphlet

EXPERIMENTAL

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

Behavioral: Pamphlet

No Pamphlet

NO INTERVENTION

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

Interventions

Pamphlet BEHAVIORAL

Written pamphlet outlining the risks of surgery as discussed in consultation.

Pamphlet

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents/guardians of a child referred to the IWK Cleft Palate Clinic for primary cleft palate repair surgery

You may not qualify if:

• Inability to fluently communicate in English
• Inability to read at a grade 8 level
• Inability to provide informed consent

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Center

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Related 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. Epub 2010 Nov 19.

  PMID: 21093107 BACKGROUND

• 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.

  PMID: 20231645 BACKGROUND

• Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90. doi: 10.1136/bmj.306.6882.885.

  PMID: 8490411 BACKGROUND

• 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.

  PMID: 23336609 BACKGROUND

• 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.

  PMID: 20372902 BACKGROUND

• 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. doi: 10.1001/archotol.128.11.1269.

  PMID: 12431168 BACKGROUND

• 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. No abstract available.

  PMID: 21199416 BACKGROUND

MeSH Terms

Conditions

Cleft Palate; Jaw Abnormalities; Maxillofacial Abnormalities; Mouth Abnormalities; Congenital Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mouth Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michael Bezuhly, MD FRCSC

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bezuhly, MD FRCSC

CONTACT

902-470-8168; Michael.Bezuhly@iwk.nshealth.ca

Mona Al-Taha, MD Candidate

CONTACT

902-441-8300; mona.altaha@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: May 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)