Trial Outcomes & Findings for Satisfaction Rates Among Parents of Children With Autism in the ED (NCT NCT02675933)
NCT ID: NCT02675933
Last Updated: 2024-12-09
Results Overview
Parental satisfaction as rated on a Likert Scale (1-5) with higher number/scores (5) meaning a better outcome.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
through study completion, 1 day (clinic visit)
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
Standard of Care
The control arm participants will receive only a satisfaction survey once disposition is determined by the physician provider. The satisfaction survey will be collected by the research associated and kept in a protected location, along with all other study materials.
All patients will receive standard of care, which at this institution is the help of Child Life Specialists, when they are available and requested by the physician. Physicians will be instructed to request Child Life Specialists with the same discretion as with all patients.
|
Questionnaire
Participants who are randomized to the questionnaire arm will receive a patient-centered questionnaire at the beginning of their visit. This single page document will ask questions about their child including, but not limited to, diagnoses, suggestions for distraction, sensory issues that may affect their visit, and method to best administer medications. The research associate will ask them to fill it out to the best of their ability and will collect the questionnaire prior to a physician provider seeing the patient. At least one physician provider must review the questionnaire prior to seeing the patient.
Once disposition is determined, the satisfaction survey will be distributed by the research associate along with an envelope for the parent to seal their survey within.
Questionnaire: There will be a single page document, a patient-centered questionnaire, distributed to parents of study participants who have been randomized to the intervention arm.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=32 Participants
The control arm participants will receive only a satisfaction survey once disposition is determined by the physician provider. The satisfaction survey will be collected by the research associated and kept in a protected location, along with all other study materials.
All patients will receive standard of care, which at this institution is the help of Child Life Specialists, when they are available and requested by the physician. Physicians will be instructed to request Child Life Specialists with the same discretion as with all patients.
|
Questionnaire
n=31 Participants
Participants who are randomized to the questionnaire arm will receive a patient-centered questionnaire at the beginning of their visit. This single page document will ask questions about their child including, but not limited to, diagnoses, suggestions for distraction, sensory issues that may affect their visit, and method to best administer medications. The research associate will ask them to fill it out to the best of their ability and will collect the questionnaire prior to a physician provider seeing the patient. At least one physician provider must review the questionnaire prior to seeing the patient.
Once disposition is determined, the satisfaction survey will be distributed by the research associate along with an envelope for the parent to seal their survey within.
Questionnaire: There will be a single page document, a patient-centered questionnaire, distributed to parents of study participants who have been randomized to the intervention arm.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=32 Participants
|
31 Participants
n=31 Participants
|
63 Participants
n=63 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=63 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=63 Participants
|
|
Age, Continuous
|
8.32 years
n=32 Participants
|
8.72 years
n=31 Participants
|
8.52 years
n=63 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=32 Participants
|
26 Participants
n=31 Participants
|
50 Participants
n=63 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=32 Participants
|
5 Participants
n=31 Participants
|
13 Participants
n=63 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
31 participants
n=31 Participants
|
63 participants
n=63 Participants
|
PRIMARY outcome
Timeframe: through study completion, 1 day (clinic visit)Parental satisfaction as rated on a Likert Scale (1-5) with higher number/scores (5) meaning a better outcome.
Outcome measures
| Measure |
Standard of Care
n=32 Participants
The control arm participants will receive only a satisfaction survey once disposition is determined by the physician provider. The satisfaction survey will be collected by the research associated and kept in a protected location, along with all other study materials.
All patients will receive standard of care, which at this institution is the help of Child Life Specialists, when they are available and requested by the physician. Physicians will be instructed to request Child Life Specialists with the same discretion as with all patients.
|
Questionnaire
n=31 Participants
Participants who are randomized to the questionnaire arm will receive a patient-centered questionnaire at the beginning of their visit. This single page document will ask questions about their child including, but not limited to, diagnoses, suggestions for distraction, sensory issues that may affect their visit, and method to best administer medications. The research associate will ask them to fill it out to the best of their ability and will collect the questionnaire prior to a physician provider seeing the patient. At least one physician provider must review the questionnaire prior to seeing the patient.
Once disposition is determined, the satisfaction survey will be distributed by the research associate along with an envelope for the parent to seal their survey within.
Questionnaire: There will be a single page document, a patient-centered questionnaire, distributed to parents of study participants who have been randomized to the intervention arm.
|
|---|---|---|
|
Satisfaction Scores
|
4.1 score on a scale
Interval 1.0 to 5.0
|
4.5 score on a scale
Interval 1.0 to 5.0
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Questionnaire
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care
n=32 participants at risk
The control arm participants will receive only a satisfaction survey once disposition is determined by the physician provider. The satisfaction survey will be collected by the research associated and kept in a protected location, along with all other study materials.
All patients will receive standard of care, which at this institution is the help of Child Life Specialists, when they are available and requested by the physician. Physicians will be instructed to request Child Life Specialists with the same discretion as with all patients.
|
Questionnaire
n=31 participants at risk
Participants who are randomized to the questionnaire arm will receive a patient-centered questionnaire at the beginning of their visit. This single page document will ask questions about their child including, but not limited to, diagnoses, suggestions for distraction, sensory issues that may affect their visit, and method to best administer medications. The research associate will ask them to fill it out to the best of their ability and will collect the questionnaire prior to a physician provider seeing the patient. At least one physician provider must review the questionnaire prior to seeing the patient.
Once disposition is determined, the satisfaction survey will be distributed by the research associate along with an envelope for the parent to seal their survey within.
Questionnaire: There will be a single page document, a patient-centered questionnaire, distributed to parents of study participants who have been randomized to the intervention arm.
|
|---|---|---|
|
Investigations
Data breach
|
0.00%
0/32 • through study completion, 1 day (clinic visit)
This study involved collection of patient and parent preference data through the use of a questionnaire. There were no medications or devices involved in the study.
|
0.00%
0/31 • through study completion, 1 day (clinic visit)
This study involved collection of patient and parent preference data through the use of a questionnaire. There were no medications or devices involved in the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Catherine Yee
Dell Children's Medical Center of Central Texas
Phone: 5123240000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place