Trial Outcomes & Findings for A Multifaceted Prompting Intervention for Urban Children With Asthma (NCT NCT01105754)
NCT ID: NCT01105754
Last Updated: 2016-02-08
Results Overview
The primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
638 participants
Primary outcome timeframe
2 month follow-up assessment
Results posted on
2016-02-08
Participant Flow
Participant milestones
| Measure |
Standard Care
Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
|
Intervention
Multifaceted Prompting Intervention
Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form.
|
|---|---|---|
|
Overall Study
STARTED
|
319
|
319
|
|
Overall Study
COMPLETED
|
304
|
307
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multifaceted Prompting Intervention for Urban Children With Asthma
Baseline characteristics by cohort
| Measure |
Standard Care
n=319 Participants
Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
|
Intervention
n=319 Participants
Multifaceted Prompting Intervention
Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form.
|
Total
n=638 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.70 years
STANDARD_DEVIATION 2.9 • n=93 Participants
|
6.72 years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
6.71 years
STANDARD_DEVIATION 3.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=93 Participants
|
144 Participants
n=4 Participants
|
271 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=93 Participants
|
175 Participants
n=4 Participants
|
367 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
126 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
229 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
193 Participants
n=93 Participants
|
216 Participants
n=4 Participants
|
409 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
103 Participants
n=93 Participants
|
127 Participants
n=4 Participants
|
230 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
138 Participants
n=93 Participants
|
113 Participants
n=4 Participants
|
251 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
319 participants
n=93 Participants
|
319 participants
n=4 Participants
|
638 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 month follow-up assessmentThe primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.
Outcome measures
| Measure |
Standard Care
n=297 Participants
Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
|
Intervention
n=300 Participants
Multifaceted Prompting Intervention
Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form.
|
|---|---|---|
|
Symptom Free Days
|
9.5 Days
Standard Deviation 5.1
|
10.2 Days
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 2 week follow-up, and medical record reviewThe number of children who received guideline-based asthma care (eg: inhaled steroid prescription, counseling for triggers, counseling for adherence) at the intervention visit based on parent interview at the 2-week follow-up and medical record review.
Outcome measures
| Measure |
Standard Care
n=319 Participants
Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
|
Intervention
n=319 Participants
Multifaceted Prompting Intervention
Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form.
|
|---|---|---|
|
Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.
|
105 participants
|
184 participants
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place