Determining Parental Attitudes Toward Day of Surgery Consent for Research

The Hospital for Sick Children

Status: Completed

Conditions: Consent; Surgery

Treatments: Behavioral: Same day consent questionnaire; Behavioral: Semi-structured interview

Study type: Observational

Funder types: Other

Identifiers

NCT04613505

1000066221

Details and patient eligibility

About

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).

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

214 participants in 4 patient groups

Phase 1: Instrument Development

Description:

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.

Treatment:

Behavioral: Semi-structured interview

Phase 2: Questionnaire Adaptation

Description:

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.

Treatment:

Behavioral: Semi-structured interview

Phase 3: Questionnaire Application & Development of Day of surgery consent Table of Guidelines

Description:

Participants will be asked to complete the questionnaire developed in Phase 2.

Treatment:

Behavioral: Same day consent questionnaire

Phase 4: Table of Guidelines Refinement

Description:

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.

Treatment:

Behavioral: Semi-structured interview