Asthma
Conditions
Brief summary
The overall goal of this project is to evaluate whether a multifaceted prompting intervention, administered in the urban primary care office setting, reduces morbidity among urban children with asthma. This study builds on our experience with a pilot study in two urban continuity clinics, in which we found that prompting clinicians about asthma severity and care guidelines at the time of an office visit resulted in improved preventive care delivery to inner-city children. This type of prompting program has the potential to substantially improve care for impoverished children with asthma, and we propose to establish: 1) whether these findings can be replicated in a similar study including a larger sample of urban children from different types of practices, and 2) whether the positive effects can be enhanced by more specific prompting directed towards both the provider and the caregiver and by providing practice-level supports and feedback. We hypothesize that children receiving a multifaceted prompting intervention (MPI) will experience less asthma-related morbidity (defined by symptom-free days at the 2-month follow-up) compared to children receiving usual care. Our secondary hypothesis is that children receiving the MPI will receive improved preventive asthma care (defined by guideline-based corrective actions taken at the index visit) compared to children receiving usual care.
Interventions
BEHAVIORALMultifaceted 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Physician-diagnosed asthma * Mild persistent or more severe asthma severity, or poor asthma control * Age \>2 and \<12 years. * Parent or caregiver must give permission to the study, and children \>7 will must provide assent.
Exclusion criteria
* Inability to speak and understand English or Spanish * No access to a working phone for follow-up surveys * The child having other significant medical conditions, * Children in foster care or other situations in which consent cannot be obtained from a guardian. * Prior enrollment in the study. * Child will not be seen by a physician or nurse practitioner during their visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Free Days | 2 month follow-up assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit. | 2 week follow-up, and medical record review | The 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 319 |
| 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. | 319 |
| Total | 638 |
Baseline characteristics
| Characteristic | Standard Care | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 6.70 years STANDARD_DEVIATION 2.9 | 6.71 years STANDARD_DEVIATION 3 | 6.72 years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 126 Participants | 229 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 193 Participants | 409 Participants | 216 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 230 Participants | 127 Participants |
| Race (NIH/OMB) More than one race | 138 Participants | 251 Participants | 113 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) White | 77 Participants | 151 Participants | 74 Participants |
| Region of Enrollment United States | 319 participants | 638 participants | 319 participants |
| Sex: Female, Male Female | 127 Participants | 271 Participants | 144 Participants |
| Sex: Female, Male Male | 192 Participants | 367 Participants | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 319 | 0 / 319 |
| serious Total, serious adverse events | 0 / 319 | 0 / 319 |
Outcome results
Primary
Symptom Free Days
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.
Time frame: 2 month follow-up assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Symptom Free Days | 9.5 Days | Standard Deviation 5.1 |
| Intervention | Symptom Free Days | 10.2 Days | Standard Deviation 4.8 |
Secondary
Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.
The 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.
Time frame: 2 week follow-up, and medical record review
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit. | 105 participants |
| Intervention | Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit. | 184 participants |