Improving Informed Consent for Cleft Palate Repair

March 7, 2017 updated by: IWK Health Centre

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Recruiting
        • IWK Health Center
        • Contact:
        • Principal Investigator:
          • Michael Bezuhly, MD FRCSC
        • Sub-Investigator:
          • Paul Hong, MD FRSCS
        • Sub-Investigator:
          • Mona Al-Taha, MD Candidate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pamphlet
Participant group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation.
Behavioral: Pamphlet
Written pamphlet outlining the risks of surgery as discussed in consultation.
No Intervention: No Pamphlet
Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Investigators

  • Principal Investigator: Michael Bezuhly, MD FRCSC, IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1015947

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate results only will be shared.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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