Musculoskeletal Diseases Clinical Trial
Official title:
Role of a Written Summary on Risk Recall During Consent Process for Cleft Palate Repair
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
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 |
Country | Name | City | State |
---|---|---|---|
Canada | IWK Health Center | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
IWK Health Centre |
Canada,
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
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 |
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