Determining Parental Attitudes Toward Day of Surgery Consent for Research

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determining Parental Attitudes Toward Day of Surgery Consent for Research

Conditions
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Surgery, Consent

Intervention / Treatment
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* Behavioral: Semi-structured interview
* Behavioral: Same day consent questionnaire


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1: Instrument Development<br>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<br>* 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.<br>|
| Phase 2: Questionnaire Adaptation<br>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<br>* 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.<br>|
| Phase 3: Questionnaire Application & Development of Day of surgery consent Table of Guidelines<br>Participants will be asked to complete the questionnaire developed in Phase 2. | Behavioral: Same day consent questionnaire<br>* A questionnaire (yet to be developed) will be administered to participants.<br>|
| Phase 4: Table of Guidelines Refinement<br>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<br>* 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.<br>|

What is the study measuring?
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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 |