Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey

NCT ID: NCT03468608

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-26
• Study Completion Date: 2024-06-30

Brief Summary

The quality of care associated with medical procedures, such as procedural sedation, has historically been assessed from the perspective of the healthcare professional, wherein the appropriateness of the services provided and the skill with which this care was performed were considered. However, more recently, the perspectives of consumers of healthcare services (i.e. the patients) have also been sought in the form of patient satisfaction. A review of the literature shows that patient satisfaction is routinely assessed when determining the effectiveness of sedation; however, it is less frequently assessed as the primary outcome. In child-specific, validated studies, limitations are noted with respect to being validated in a language other than English and failing to encompass a variety of procedures. As a result, these validated tools are not appropriate for use with pediatric populations undergoing procedural sedation in North America, nor are these validated tools amenable to comparison with our proposed tool.

Detailed Description

Due to the central unit procedural sedation team servicing several areas of specialty, a varied patient satisfaction tool is required to ensure all concerns pertaining to sedation in each specialty are addressed, as well as allowing consistency between specialties to be examined. Therefore, the objective is to develop and validate a procedural sedation satisfaction tool for use with a variety of specialties requiring pediatric procedural sedation.

Conditions

Satisfaction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Phase 1: Instrument Development

An initial set of questionnaire items will be created based on the questionnaires noted in the literature review as well as the semi-structured interviews conducted with parents and healthcare team members in our facility.

No interventions assigned to this group

Phase 2: Pre-Test Evaluation

Parents and healthcare team members will be asked to comment on the quality of the draft questionnaire created in phase 1 of this study.

No interventions assigned to this group

Phase 3: Pilot

Parents will be asked to complete the questionnaire developed during phase 2 of this study. Upon completing the questionnaire, parents will be asked to rate the overall face validity of the tool using a 5-point Likert scale.

Healthcare team members will be asked to rate the content validity of each item on the questionnaire.

No interventions assigned to this group

Phase 4: Validation

Parents will be asked to complete the questionnaire developed during phase 3 of this study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• child is receiving procedural sedation within the central unit at our facility
• child is aged 0-8 years

• work within the central unit providing procedural sedation at our facility

Exclusion Criteria

• parent self-identifies as not being able to speak or read English

• none

• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Mark Crawford

Anesthesiologist-in-Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Crawford

Role: PRINCIPAL_INVESTIGATOR

Anesthesiologist-in-Cheif

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000056420

Identifier Type: -

Identifier Source: org_study_id