Improving Informed Consent for Cleft Palate Repair

NCT ID: NCT02595307

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-12-31

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Pamphlet

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

Group Type: EXPERIMENTAL

Pamphlet

Intervention Type: BEHAVIORAL

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

No Pamphlet

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pamphlet

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IWK Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Bezuhly, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Locations

IWK Health Center

Halifax, Nova Scotia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Michael Bezuhly, MD FRCSC

Role: CONTACT

Michael.Bezuhly@iwk.nshealth.ca

902-470-8168

Mona Al-Taha, MD Candidate

Role: CONTACT

mona.altaha@dal.ca

902-441-8300

Facility Contacts

Bev White

Role: primary

bev.white@iwk.nshealth.ca

(902) 470-8520

References

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.

Reference Type: BACKGROUND

PMID: 21199416 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20372902 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12431168 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21093107 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20231645 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8490411 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23336609 (View on PubMed)

Other Identifiers

1015947

Identifier Type: -

Identifier Source: org_study_id