Determining Parental Attitudes Toward Day of Surgery Consent for Research

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery; Consent
• Intervention / Treatment: Behavioral: Semi-structured interview; Behavioral: Same day consent questionnaire

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Katherine Taylor; Phone Number: 416-813-7654; Email: katherine.taylor@sickkids.ca
• Study Contact Backup: Name: Carolyne Pehora; Phone Number: 416-813-7654; Email: carolyne.pehora@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All participants receiving same day surgery at our institution are eligible to participate.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase 1: Instrument Development; Parents will be asked to participate in a semi-structured interview with one of the researchers that will explore their attitudes toward day of surgery consent. Particular attention will be given to a) study designs, b) previous research experience, and c) previous medical experiences.	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.
Phase 2: Questionnaire Adaptation; Parents will be given approximately 5 minutes to review a questionnaire we developed using participant responses in Phase 1. After reviewing the questionnaire, participants will be asked to participate in a semi-structured interview with one of the investigators.	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.
Phase 3: Questionnaire Application & Development of Day of surgery consent Table of Guidelines; Participants will be asked to complete the questionnaire developed in Phase 2.	Behavioral: Same day consent questionnaire; A questionnaire (yet to be developed) will be administered to participants.
Phase 4: Table of Guidelines Refinement; Participants will be given approximately 5 minutes to review the table of guidelines developed in Phase 3. After reviewing the guidelines, participants will be asked to participate in a semi-structured interview with one of the investigators.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental attitude towards day of surgery consent	Semi-structured interviews	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boundary for day of surgery consent	Semi-structured interview	Day of surgery
Boundary for day of surgery consent	Questionnaires to be developed in phases 1 and 2 of the study	Day of surgery

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Katherine Taylor, Staff Anesthesiologist

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1000066221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No