Asthma Childhood
Conditions
Brief summary
The overall goal of this research study is to test the effectiveness of a multifaceted and multi-level prompting intervention in a real world urban primary care office setting on improving provider-delivered guideline-based asthma care and reducing asthma morbidity among urban children with persistent or uncontrolled asthma.
Detailed description
Investigators will conduct a cluster randomized trial comparing the intervention to enhanced usual care (eUC) in 20 Bronx practices serving over 5,000 children ages 2-12 years with persistent or uncontrolled asthma. Eleven eUC practices will receive guideline information and assess children's asthma severity and control, but active intervention components will not be provided. Practices will join the study in 4 waves over 4 years (4-6 practices per year). Provider adoption of guidelines and utilization of care in all patients (\ 5,000) ages 2-12 years with persistent or uncontrolled asthma from intervention and eUC practices will be evaluated using Electronic Health Records (EHR) data and practice-based screening for asthma severity and control. Investigators will also enroll a random subset of 512 caregivers of children with persistent/uncontrolled asthma from both study arms to systematically evaluate caregiver-reported child morbidity outcomes and obtain measures not available in EHR. Intervention consists of academic detailing in the EHR that follow national asthma guidelines and outreach worker care coordination for patients with persistent or uncontrolled asthma. Comment: While caregivers reported on child outcomes, caregivers were not subjects of the study. See Pre-Assignment Details section within the Participant Flow module for more details.
Interventions
BEHAVIORALeMPI
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
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Follow up assessments will be collected by blinded interviewers
Intervention model description
Cluster randomized design
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
The criteria listed below will apply to \ 5,000 children from eMPI and eUC practices: * Physician-diagnosed asthma (based on EHR) * Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines, any one of the following: in past month, \> 2 days/week with asthma symptoms, \>2 days/week with rescue medication use, \>2 days/month with nighttime symptoms, or \> 2 episodes in the past year that required systemic corticosteroids * Age 2 and 12 years, inclusive Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes: * Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel * Consent from the primary caregiver, caregiver permission for the child to participate as well as assent from the child (\>7 years). If there are eligible siblings, only one child will be randomly selected
Exclusion criteria
* The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken | Immediately post-intervention, up to 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Free Days (SFDs) | Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | every 3 months up to 12 months | caregiver asthma related quality of life |
| Health Care Utilization: Number of ED Visits for Asthma | every 3 months up to 12 months | number of ED visits for asthma |
| Health Care Utilization: Number Hospitalizations for Asthma | every 3 months up to 12 months | number hospitalizations for asthma |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 265 |
| 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. | 265 |
| Total | 530 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 10 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Enhanced Multifaceted Prompting Intervention (eMPI) | Total | Enhanced Usual Care (eUC) Practices |
|---|---|---|---|
| Age, Continuous | 6.65 years STANDARD_DEVIATION 2.75 | 6.66 years STANDARD_DEVIATION 2.84 | 6.68 years STANDARD_DEVIATION 2.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 184 Participants | 364 Participants | 180 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 163 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 210 Participants | 107 Participants |
| Race (NIH/OMB) More than one race | 46 Participants | 102 Participants | 56 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 82 Participants | 157 Participants | 75 Participants |
| Race (NIH/OMB) White | 30 Participants | 53 Participants | 23 Participants |
| Region of Enrollment United States | 265 participants | 530 participants | 265 participants |
| Sex: Female, Male Female | 109 Participants | 204 Participants | 95 Participants |
| Sex: Female, Male Male | 156 Participants | 326 Participants | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 265 | 0 / 265 |
| other Total, other adverse events | 0 / 265 | 0 / 265 |
| serious Total, serious adverse events | 0 / 265 | 0 / 265 |
Outcome results
Primary
Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken
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.
Time frame: Immediately post-intervention, up to 1 year
Population: All randomized subjects were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Multifaceted Prompting Intervention (eMPI) | Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken | 241 Participants |
| Enhanced Usual Care (eUC) Practices | Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken | 197 Participants |
p-value: <0.00195% CI: [1.98, 6.08]GLM with GEE
p-value: <0.00195% CI: [1.97, 6.82]GLM with GEE
Secondary
Symptom Free Days (SFDs)
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.
Time frame: Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations
Population: The number of participants analyzed at each timepoint for both arms is depicted in the table below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Multifaceted Prompting Intervention (eMPI) | Symptom Free Days (SFDs) | 3 month | 9.33 number of symptom free days | Standard Deviation 4.95 |
| Enhanced Multifaceted Prompting Intervention (eMPI) | Symptom Free Days (SFDs) | 12 month | 10.53 number of symptom free days | Standard Deviation 4.16 |
| Enhanced Multifaceted Prompting Intervention (eMPI) | Symptom Free Days (SFDs) | 6 month | 9.68 number of symptom free days | Standard Deviation 4.52 |
| Enhanced Multifaceted Prompting Intervention (eMPI) | Symptom Free Days (SFDs) | 9 month | 10.07 number of symptom free days | Standard Deviation 4.37 |
| Enhanced Multifaceted Prompting Intervention (eMPI) | Symptom Free Days (SFDs) | Baseline | 5.79 number of symptom free days | Standard Deviation 4.7 |
| Enhanced Usual Care (eUC) Practices | Symptom Free Days (SFDs) | 9 month | 10.78 number of symptom free days | Standard Deviation 4.36 |
| Enhanced Usual Care (eUC) Practices | Symptom Free Days (SFDs) | Baseline | 6.41 number of symptom free days | Standard Deviation 4.72 |
| Enhanced Usual Care (eUC) Practices | Symptom Free Days (SFDs) | 3 month | 9.17 number of symptom free days | Standard Deviation 4.82 |
| Enhanced Usual Care (eUC) Practices | Symptom Free Days (SFDs) | 6 month | 10.33 number of symptom free days | Standard Deviation 4.06 |
| Enhanced Usual Care (eUC) Practices | Symptom Free Days (SFDs) | 12 month | 10.44 number of symptom free days | Standard Deviation 4.49 |
Comparison: 3 month follow upp-value: 0.17495% CI: [0.95, 1.34]GLM with GEE
Comparison: 6 month follow upp-value: 0.74195% CI: [0.85, 1.27]GLM with GEE
Comparison: 9 month follow upp-value: 0.72495% CI: [0.85, 1.25]GLM with GEE
Comparison: 12 month follow upp-value: 0.22995% CI: [0.93, 1.34]GLM with GEE
Comparison: 3 month follow upp-value: 0.18695% CI: [0.94, 1.34]GLM with GEE
Comparison: 6 month follow upp-value: 0.74495% CI: [0.84, 1.27]GLM with GEE
Comparison: 9 month follow upp-value: 0.76595% CI: [0.85, 1.25]GLM with GEE
Comparison: 12 month follow upp-value: 0.24195% CI: [0.93, 1.33]GLM with GEE
Other Pre-specified
Health Care Utilization: Number Hospitalizations for Asthma
number hospitalizations for asthma
Time frame: every 3 months up to 12 months
Other Pre-specified
Health Care Utilization: Number of ED Visits for Asthma
number of ED visits for asthma
Time frame: every 3 months up to 12 months
Other Pre-specified
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
caregiver asthma related quality of life
Time frame: every 3 months up to 12 months