NCT01850329

Brief Summary

This study is planning to develop the computed-assisted information program and determine whether the computed-assisted information program are superior to routine discussion for informing parents in the emergency department (ED) about risks, benefits, and alternatives to receiving procedural sedation for their children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2009

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2014

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

April 15, 2013

Last Update Submit

April 5, 2017

Conditions

Informed Consent Process

Outcome Measures

Primary Outcomes (1)

  • structured questionnaire

    a structured questionnaire with knowledge measure and satisfaction will be delivered to the participants for data collection.

    before and immediately after the intervention when participants are in the emergency department, it is expected to take an expected average time of one hour

Study Arms (2)

control

NO INTERVENTION

No computed-assisted information program will be administered.

intervention

EXPERIMENTAL

computed-assisted information program will be administered.

Other: computed-assisted information program

Interventions

computed-assisted information programOTHER
intervention

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Parents with patients under 18 years of age
  • patients receive the procedural sedation and anesthesia in the emergency department

You may not qualify if:

  • clinically unstable
  • refuse to participate
  • unable to understand the consent process for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung, Taiwan, 807, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

April 15, 2013

First Posted

May 9, 2013

Study Start

December 7, 2009

Primary Completion

September 9, 2014

Study Completion

September 9, 2014

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

TW(1)