Determining Parental Attitudes Toward Day of Surgery Consent for Research
- Conditions
- SurgeryConsent
- Interventions
- Behavioral: Semi-structured interviewBehavioral: Same day consent questionnaire
- Registration Number
- NCT04613505
- Lead Sponsor
- The Hospital for Sick Children
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
- 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.
-Parents of children who are undergoing urgent or add-on procedures will be excluded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Phase 1: Instrument Development Semi-structured interview 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. Phase 3: Questionnaire Application & Development of Day of surgery consent Table of Guidelines Same day consent questionnaire Participants will be asked to complete the questionnaire developed in Phase 2. Phase 2: Questionnaire Adaptation Semi-structured interview 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. Phase 4: Table of Guidelines Refinement Semi-structured interview 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.
- Primary Outcome Measures
Name Time Method Parental attitude towards day of surgery consent Day of surgery Semi-structured interviews
- Secondary Outcome Measures
Name Time Method Boundary for day of surgery consent Day of surgery Questionnaires to be developed in phases 1 and 2 of the study
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada