Trial Outcomes & Findings for Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination (NCT NCT03066596)
NCT ID: NCT03066596
Last Updated: 2025-10-21
Results Overview
The percentage of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR) is reported. Results are summarized in number/percentage of participants with 1 or more guideline-based corrective actions taken by study arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
530 participants
Primary outcome timeframe
Immediately post-intervention, up to 1 year
Results posted on
2025-10-21
Participant Flow
Because children with asthma (ages 2-12) were the subjects of the study, caregivers had to complete validated surveys/questionnaires in order to collect child-specific data and outcome measures about their child's asthma. The study was exclusively for children with asthma. Parents were not subjects in the study.
Unit of analysis: clinic
Participant milestones
| Measure |
Enhanced Multifaceted Prompting Intervention (eMPI)
The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management.
eMPI: The core elements of the multilevel strategy for implementation include:
Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines
|
Enhanced Usual Care (eUC) Practices
Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided.
|
|---|---|---|
|
Overall Study
STARTED
|
265 9
|
265 9
|
|
Overall Study
COMPLETED
|
247 9
|
253 9
|
|
Overall Study
NOT COMPLETED
|
18 0
|
12 0
|
Reasons for withdrawal
| Measure |
Enhanced Multifaceted Prompting Intervention (eMPI)
The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management.
eMPI: The core elements of the multilevel strategy for implementation include:
Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines
|
Enhanced Usual Care (eUC) Practices
Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
14
|
10
|
Baseline Characteristics
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Baseline characteristics by cohort
| Measure |
Enhanced Multifaceted Prompting Intervention (eMPI)
n=265 Participants
The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management.
eMPI: The core elements of the multilevel strategy for implementation include:
Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines
|
Enhanced Usual Care (eUC) Practices
n=265 Participants
Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided.
|
Total
n=530 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.65 years
STANDARD_DEVIATION 2.75 • n=5 Participants
|
6.68 years
STANDARD_DEVIATION 2.94 • n=7 Participants
|
6.66 years
STANDARD_DEVIATION 2.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
184 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
103 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
46 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
82 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
265 participants
n=5 Participants
|
265 participants
n=7 Participants
|
530 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately post-intervention, up to 1 yearPopulation: All randomized subjects were analyzed.
The percentage of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR) is reported. Results are summarized in number/percentage of participants with 1 or more guideline-based corrective actions taken by study arm.
Outcome measures
| Measure |
Enhanced Multifaceted Prompting Intervention (eMPI)
n=265 Participants
The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management.
eMPI: The core elements of the multilevel strategy for implementation include:
Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines
|
Enhanced Usual Care (eUC) Practices
n=265 Participants
Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided.
|
|---|---|---|
|
Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken
|
241 Participants
|
197 Participants
|
SECONDARY outcome
Timeframe: Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluationsPopulation: The number of participants analyzed at each timepoint for both arms is depicted in the table below.
The number of days without symptoms during the past 14 days is summarized by study arm at baseline and every 3 months up through the 12 month follow up evaluation.
Outcome measures
| Measure |
Enhanced Multifaceted Prompting Intervention (eMPI)
n=265 Participants
The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management.
eMPI: The core elements of the multilevel strategy for implementation include:
Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines
|
Enhanced Usual Care (eUC) Practices
n=265 Participants
Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided.
|
|---|---|---|
|
Symptom Free Days (SFDs)
Baseline
|
5.79 number of symptom free days
Standard Deviation 4.70
|
6.41 number of symptom free days
Standard Deviation 4.72
|
|
Symptom Free Days (SFDs)
3 month
|
9.33 number of symptom free days
Standard Deviation 4.95
|
9.17 number of symptom free days
Standard Deviation 4.82
|
|
Symptom Free Days (SFDs)
6 month
|
9.68 number of symptom free days
Standard Deviation 4.52
|
10.33 number of symptom free days
Standard Deviation 4.06
|
|
Symptom Free Days (SFDs)
9 month
|
10.07 number of symptom free days
Standard Deviation 4.37
|
10.78 number of symptom free days
Standard Deviation 4.36
|
|
Symptom Free Days (SFDs)
12 month
|
10.53 number of symptom free days
Standard Deviation 4.16
|
10.44 number of symptom free days
Standard Deviation 4.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: every 3 months up to 12 monthscaregiver asthma related quality of life
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: every 3 months up to 12 monthsnumber of ED visits for asthma
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: every 3 months up to 12 monthsnumber hospitalizations for asthma
Outcome measures
Outcome data not reported
Adverse Events
Enhanced Multifaceted Prompting Intervention (eMPI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care (eUC) Practices
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