Determining Parental Attitudes Toward Day of Surgery Consent for Research

Surgery Clinical Trial

Official title:

Determining Parental Attitudes Toward Day of Surgery Consent for Research

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04613505
• Other study ID #: 1000066221
• Status: Active, not recruiting
• Start date: January 22, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There are no studies examining parents' attitudes towards day of surgery consent for research. The purpose of the study is to determine the attitudes parents of potential research participants have toward being approached for day of surgery consent. The primary objective is to determine parental attitudes regarding day of surgery consent for anesthesia research. The secondary objective is to determine the boundaries for day of surgery consent (e.g., study types, interventions, risk factors).

Description:

This is a multi-phase prospective cohort study. In the first phase the investigators will interview parents and consult the Family Research Advisory Committee (FRAC) to determine their attitudes toward day of surgery research consent. The investigators will use the participants' responses and instruments already found in the literature to develop the questionnaire. In the second phase, the investigators will interview parents and consult FRAC about the questionnaire to determine which items to add, remove, or modify. In the third phase, the investigators will distribute the adapted questionnaire to clarify parents' attitudes surrounding day of surgery consent. The investigators will use the results of the third phase to develop a table of guidelines for day of surgery consent. In the final phase, the investigators will interview parents, healthcare professionals, and consult FRAC for feedback and modification of the table of guidelines.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria:

• The parents of children undergoing elective surgical procedures at Sickkids will be invited to participate in the study.
• If multiple parents are present, they are permitted to participate jointly; however, their participation will count as a single response. Exclusion Criteria: -Parents of children who are undergoing urgent or add-on procedures will be excluded.

Related Conditions & MeSH terms

• Consent
• Surgery

Intervention

Behavioral:
• Semi-structured interview
Participants will be asked a set of questions as applicable to each phase. Researchers will be able to ask additional questions as they arise within each interview.
• Same day consent questionnaire
A questionnaire (yet to be developed) will be administered to participants.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental attitude towards day of surgery consent	Semi-structured interviews	Day of surgery
Secondary	Boundary for day of surgery consent	Semi-structured interview	Day of surgery
Secondary	Boundary for day of surgery consent	Questionnaires to be developed in phases 1 and 2 of the study	Day of surgery