Childhood Asthma, Community Health Workers
Conditions
Keywords
asthma disparities, community health worker, childhood asthma
Brief summary
This project uses community health workers (CHW) or lay health educators to implement asthma interventions that have been proven to work in the primary care setting and in schools. The objective is to integrate the home, school, healthcare system, and community for 600 school-aged asthmatic children in West Philadelphia through use of CHWs. The children enrolled in the study will be randomized to one of four groups including: primary care CHW, school CHW, primary care and school CHW or the control group (no CHW).
Detailed description
The Community Asthma Prevention Program (CAPP) at the Children's Hospital of Philadelphia has a two-decade history of utilizing CHWs to improve asthma outcomes of children in Philadelphia. Building on this foundation, a network of stakeholders was established including, The West Philadelphia Asthma Care Collaborative (WEPACC), with representation from public housing, healthcare, community, and schools. As a result of assessment of local needs, resource mapping, and months of planning, Investigators designed an asthma care implementation program with the broad objective of integrating home, school, healthcare system, and community for school-aged asthmatic children in West Philadelphia. Investigators seek to accomplish this goal using CHWs to deliver sustainable patient-centered evidence-based interventions. The evidence-based interventions include (1) a primary care-based Yes We Can intervention with home visitation and (2) a comprehensive and rigorously evaluated school-based intervention, Open Airways for schools and School Based Asthma Therapy. CHWs will function as the hub of each interventions, serving either as primary care CHWs or school CHWs to provide a network of education, care coordination support, and to facilitate communication for families of children with asthma between the four sectors. This project seeks to integrate interventions in a comprehensive and sustainable manner to reduce asthma disparities in poor, minority children. Using a factorial design, Investigators will recruit and randomize 640 asthmatic children (ages 5-13 years) from up to five inner-city primary care clinics who attend one of 36 West Philadelphia schools to one of four study conditions: both interventions (both primary care and school CHWs intervention), primary care CHW or school-CHW alone, or control and follow for one year. As a part of this project the Investigators seek to accomplish the following objectives: Objective 1. Compare effectiveness of the primary care and school interventions to improve asthma control and reduce symptom days using main and simple effects from the factorial design. Objective 2. Explore moderators and mechanisms of effectiveness and sustainability of the interventions. Objective 3. Use mixed methods to explore implementation determinants and outcomes of school intervention that promote effectiveness, fidelity and sustainability Objective 4. Examine the costs, savings, and cost effectiveness associated with the intervention and implementation strategies to promote sustainability.
Interventions
The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.
School-Based Asthma Therapy includes enhanced care coordination for prescribed daily controller medication. The school nurse will coordinate with teachers and the school CHW to schedule daily controller asthma medication administration. The school CHW will assist in obtaining a current asthma care plan and medication administration form from the primary care provider.
Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes: 1. Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester. 2. Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment. 3. Asthma education for school staff/personnel at the start of each school year. 4. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia.
Sponsors
Study design
Masking description
The Principal Investigator (PI) will be masked to the participant-level intervention group. Unmasking will occur if there is an adverse event that warrants investigation or if the Data Safety and Monitoring Board (DSMB) instructs the PI to become unmasked.
Intervention model description
A factorial design has enhanced statistical power and can handle cluster randomization of schools. Statistical methods will be used to estimate variation in the effect across schools over time. Linear mixed effects models with random intercepts and slopes for school, and fixed effects for the school-level intervention, time, and time-by-intervention interaction will be applied. Second, marginal models using generalized estimating equations will produce robust estimates that adjust for clustering at the school level. Third, assumption-free, randomization-test-based methods do not rely on assumptions of parametric models. Investigators will use conventional levels of statistical significance (p=0.05) for all pre-specified comparisons for our objectives. Variability of the intervention effect across schools will reflect consistency of intervention effects and thus generalizability in new settings. Both mixed effects models and permutation-test methods will estimate variance components.
Eligibility
Inclusion criteria
1. Children 5-13 years of age and their parents/guardians 2. Children with a diagnosis of asthma 3. Children with uncontrolled asthma (as evidenced within the previous 12 months by an asthma exacerbation requiring oral steroids -OR- an Emergency Department (ED) visit for asthma -OR- an inpatient admission for asthma) 4. West Philadelphia residence in zip code 19104, 19131, 19139, 19142, 19143, 19151 or 19153 5. Children in grades K-8 6. Pediatric primary care received at Children's Hospital of Philadelphia Care Network (CN) Karabots, Cobbs Creek, or South Philadelphia locations or pediatric care received at the Pediatric and Adolescent Medicine Centers of Philadelphia (PAMCOP) serving West Philadelphia residents 7. Parental/guardian permission (informed consent) and, if appropriate, child assent 8. English Language Speaking
Exclusion criteria
1. Subjects with other chronic respiratory illnesses such as cystic fibrosis 2. Cyanotic congenital heart disease 3. Mental retardation and/or cerebral palsy (MRCP) 4. Severe Neurological Disorder 5. Cyanotic congenital heart disease 6. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control | Baseline and 12 months | Asthma Control Questionnaire (ACQ) developed by E.F. Juniper et al. is a 6-item recall of asthma control indicators over the past week. The 6-item recall includes awakening at night with asthma symptoms, asthma symptoms upon waking, activity limitations due to asthma symptoms, shortness of breath, wheezing, and administration of asthma rescue medications. The score range for the ACQ is 0 to 6, with lower numbers indicating greater asthma control and higher numbers indicating worse asthma control. Based on existing literature, the minimal clinically important difference (MCID) is 0.5. The range for this cohort is 0.2-2.3) For all analyses, we combined the P+S- group with the P+S0 group to describe the P+ only group. Similarly, we combined the P-S- group with the P-S0 group to create the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nighttime Symptoms | Baseline and 12 months | Comparison of the change in nighttime symptoms from baseline to 12 months for each intervention group. This question asks how many days the child has had nighttime asthma symptoms in the last 2 weeks and the number of days with asthma symptoms is the answer value (0-14 days). P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care). |
| Change in School Absences | Baseline and 12 months | School report of child's school absences pre and post study enrollment |
| Change in Emergency Department (ED) Visits | Baseline and 12 months | Comparison of the change in asthma-related Emergency Department visits from baseline to 12 months for each intervention group |
| Change in Hospitalizations | Baseline and 12 months | Comparison of the change in asthma-related hospitalizations from baseline to 12 months for each intervention group |
| Change in Daytime Asthma Symptoms | Baseline and 12 months | Comparison of the change in daytime symptoms from baseline to 12 months for each intervention group. This data was collected at 3 month intervals with a 2 week recall for number of days with symptoms. This question asks how many days the child has had daytime asthma symptoms in the last 2 weeks and the number of days with asthma symptoms is the answer value (0-14 days). P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care). |
| Change in Activity Limitations Domain | Baseline and 12 months | Comparison of the change in caregivers' self-reported quality of life from baseline to 12 months for each intervention group. he Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) by Juniper et al. is a 13-item measure of asthma caregiver's quality of life in two domains, including activity limitation. The score for the subscale is the mean of the answers for the subscale. All items are weighted equally and the score range is 1 - 7, with lower numbers indicating poor quality of life and higher numbers indicating better quality of life around caring for a child with asthma. |
| Baseline School Organizational Climate Index | At start of school intervention | The Standardized Organizational Climate Index (SOCI) is a 30-item descriptive measure for schools. The index has four dimensions: principal leadership, teacher professionalism, achievement press for students to perform academically, and vulnerability to the community. The score range for each questionnaire item is 1 - 4. The answers assign the value of 1 to rarely occurs, 2 to sometimes occurs, 3 to often occurs, and 4 to very frequently occurs. For the subscores, ninety-nine percent of the scores range from 200 to 800 with a population mean of 500 and a population standard deviation of 100. Higher scores indicate a better school climate. Scores are converted to standardized scores and compared with national norms. |
| Baseline School Leadership | At start of school intervention | The Implementation Leadership Scale (ILS) is comprised of 12 items assessing the degree to which a leader is Proactive, Knowledgeable, Supportive, and shows Perseverance in implementing evidence-based practice. The range for total score and each subscale score is 0 - 4. Higher scores represent better implementation leadership. The mean of the subscale scores yields the total score. |
| Baseline School Staff Attitudes | At start of school intervention | The Evidence-Based Practice Attitude Scale (EBPAS) is a 15-item self-report measure of attitudes toward adoption of EBPs. It consists of four subscales: Appeal (is EBP intuitively appealing), Requirements (would an EBP be used if required), Openness (general openness to innovation), and Divergence (perceived divergence between EBP and current practice). Total score range is 0 - 60. The Appeal, Openness, and Divergence subscales have a range of 0 - 16. The Requirements subscale has a range of 0 - 12. Higher scores indicate more positive attitudes. Subscales are summed to compute a total score. |
| Change in Asthma Emotional Functioning Domain | Baseline and 12 months | Comparison of the change in caregivers' self-reported quality of life from baseline to 12 months for each intervention group. Data was collected using Juniper's Pediatric Asthma Caregiver's Quality of Life Questionnaire designed for children aged 7 to 17 years of age. The PAQLQ has 23 questions in 3 domains, including emotional function. The questions ask about a 1 week recall. The range for answer choices is 1-7, with the higher number indicating a better quality of life. The score for the subscale is the mean of the answers for that subscale. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| P+S+ (Partner School) This arm includes children who attend one of the partnering schools and are randomized to receive the enhanced school intervention Open Airways for Schools Plus, School-Based Asthma Therapy and the primary care intervention Yes We Can Children's Asthma Program. | 121 |
| P-S+ (Partner School) This arm includes children who attend one of the partnering schools and are randomized to receive the school intervention Open Airways for Schools Plus.
Open Airways for School Plus: Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes:
1. Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester.
2. Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment.
3. Asthma education for school staff/personnel at the start of each school year.
4. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia. | 112 |
| P+S- (Partner School) This arm includes children who attend one of the partnering schools and are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.
Yes We Can Children's Asthma Program: The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice. | 110 |
| P-S- (Partner School) This arm includes children who attend one of the partnering schools and are randomized to the control group (no primary care or school intervention). | 112 |
| P+S0 (Non-Partner School) This arm includes children who do not attend one of the partnering schools and are randomized to receive the primary care intervention Yes We Can Children's Asthma Program. | 82 |
| P-S0 (Non-Partner School) This arm includes children who do not attend one of the partnering schools and are randomized to the control group (no primary care intervention and ineligible for the school intervention). | 89 |
| Total | 626 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 3 | 2 | 0 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 3 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | P+S+ (Partner School) | P-S+ (Partner School) | P+S- (Partner School) | P-S- (Partner School) | P+S0 (Non-Partner School) | P-S0 (Non-Partner School) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous Age | 9.3 years STANDARD_DEVIATION 2.4 | 8.8 years STANDARD_DEVIATION 2.3 | 8.7 years STANDARD_DEVIATION 2.6 | 8.4 years STANDARD_DEVIATION 2.4 | 8.4 years STANDARD_DEVIATION 2.4 | 8.5 years STANDARD_DEVIATION 2.4 | 8.7 years STANDARD_DEVIATION 2.4 |
| Asthma Control Score | 1.3 units on a scale STANDARD_DEVIATION 1.3 | 1.4 units on a scale STANDARD_DEVIATION 1.3 | 1.5 units on a scale STANDARD_DEVIATION 1.2 | 1.3 units on a scale STANDARD_DEVIATION 1.2 | 1.3 units on a scale STANDARD_DEVIATION 1.2 | 1.4 units on a scale STANDARD_DEVIATION 1.3 | 1.4 units on a scale STANDARD_DEVIATION 1.3 |
| Asthma Control Score Groups 0 to <1.25 | 68 Participants | 58 Participants | 51 Participants | 59 Participants | 43 Participants | 49 Participants | 328 Participants |
| Asthma Control Score Groups >=1.25 | 52 Participants | 54 Participants | 58 Participants | 53 Participants | 37 Participants | 40 Participants | 294 Participants |
| Asthma Control Score Groups Missing | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 4 Participants |
| BMI < 5th Percentile | 1 Participants | 1 Participants | 0 Participants | 5 Participants | 1 Participants | 2 Participants | 10 Participants |
| BMI 5th to 84th Percentile | 55 Participants | 63 Participants | 45 Participants | 54 Participants | 33 Participants | 42 Participants | 292 Participants |
| BMI 85th to 94th Percentile | 12 Participants | 15 Participants | 15 Participants | 15 Participants | 18 Participants | 12 Participants | 87 Participants |
| BMI At or Above 95th Percentile | 49 Participants | 31 Participants | 44 Participants | 37 Participants | 28 Participants | 30 Participants | 219 Participants |
| BMI Missing | 4 Participants | 2 Participants | 6 Participants | 1 Participants | 2 Participants | 3 Participants | 18 Participants |
| Emergency Department Visit for Asthma Ever | 109 Participants | 94 Participants | 90 Participants | 92 Participants | 74 Participants | 78 Participants | 537 Participants |
| Emergency Department Visit for Asthma Past 12 Months | 66 Participants | 60 Participants | 64 Participants | 46 Participants | 43 Participants | 49 Participants | 328 Participants |
| Hospitalized Overnight for Asthma Ever | 78 Participants | 73 Participants | 79 Participants | 71 Participants | 46 Participants | 61 Participants | 408 Participants |
| Hospitalized Overnight for Asthma Past 12 Months | 36 Participants | 40 Participants | 51 Participants | 33 Participants | 23 Participants | 31 Participants | 214 Participants |
| In the ICU for Asthma Ever | 17 Participants | 12 Participants | 17 Participants | 9 Participants | 9 Participants | 11 Participants | 75 Participants |
| In the ICU for Asthma Past 12 Months | 0 Participants | 1 Participants | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 8 Participants |
| On a Prednisone Burst for Asthma Ever | 121 Participants | 112 Participants | 110 Participants | 112 Participants | 82 Participants | 89 Participants | 626 Participants |
| On a Prednisone Burst for Asthma Past 12 Months | 120 Participants | 112 Participants | 110 Participants | 112 Participants | 82 Participants | 89 Participants | 625 Participants |
| Quality of Life Score (Overall) | 5.5 units on a scale STANDARD_DEVIATION 1.2 | 5.6 units on a scale STANDARD_DEVIATION 1.2 | 5.2 units on a scale STANDARD_DEVIATION 1.4 | 5.4 units on a scale STANDARD_DEVIATION 1.3 | 5.7 units on a scale STANDARD_DEVIATION 1.1 | 5.5 units on a scale STANDARD_DEVIATION 1.4 | 5.5 units on a scale STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 11 Participants |
| Race/Ethnicity, Customized Black or African American | 119 Participants | 103 Participants | 106 Participants | 106 Participants | 79 Participants | 88 Participants | 601 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 5 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Female | 61 Participants | 43 Participants | 45 Participants | 40 Participants | 34 Participants | 40 Participants | 263 Participants |
| Sex: Female, Male Male | 60 Participants | 69 Participants | 65 Participants | 72 Participants | 48 Participants | 49 Participants | 363 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 112 | 0 / 110 | 0 / 112 | 0 / 82 | 0 / 89 |
| other Total, other adverse events | 0 / 121 | 0 / 112 | 0 / 110 | 0 / 112 | 0 / 82 | 0 / 89 |
| serious Total, serious adverse events | 0 / 121 | 0 / 112 | 0 / 110 | 0 / 112 | 0 / 82 | 0 / 89 |
Outcome results
Change in Asthma Control
Asthma Control Questionnaire (ACQ) developed by E.F. Juniper et al. is a 6-item recall of asthma control indicators over the past week. The 6-item recall includes awakening at night with asthma symptoms, asthma symptoms upon waking, activity limitations due to asthma symptoms, shortness of breath, wheezing, and administration of asthma rescue medications. The score range for the ACQ is 0 to 6, with lower numbers indicating greater asthma control and higher numbers indicating worse asthma control. Based on existing literature, the minimal clinically important difference (MCID) is 0.5. The range for this cohort is 0.2-2.3) For all analyses, we combined the P+S- group with the P+S0 group to describe the P+ only group. Similarly, we combined the P-S- group with the P-S0 group to create the control group.
Time frame: Baseline and 12 months
Population: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).~Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| P+S+ | Change in Asthma Control | Baseline | 1.35 units on a scale |
| P+S+ | Change in Asthma Control | Difference (Month 12 minus Baseline) | -0.61 units on a scale |
| P+S+ | Change in Asthma Control | 12 Months | 0.74 units on a scale |
| S+ Alone | Change in Asthma Control | Baseline | 1.42 units on a scale |
| S+ Alone | Change in Asthma Control | Difference (Month 12 minus Baseline) | -0.57 units on a scale |
| S+ Alone | Change in Asthma Control | 12 Months | 0.85 units on a scale |
| P+ Alone | Change in Asthma Control | 12 Months | 0.85 units on a scale |
| P+ Alone | Change in Asthma Control | Baseline | 1.38 units on a scale |
| P+ Alone | Change in Asthma Control | Difference (Month 12 minus Baseline) | -0.53 units on a scale |
| Control | Change in Asthma Control | Baseline | 1.37 units on a scale |
| Control | Change in Asthma Control | Difference (Month 12 minus Baseline) | -0.39 units on a scale |
| Control | Change in Asthma Control | 12 Months | 0.97 units on a scale |
Baseline School Leadership
The Implementation Leadership Scale (ILS) is comprised of 12 items assessing the degree to which a leader is Proactive, Knowledgeable, Supportive, and shows Perseverance in implementing evidence-based practice. The range for total score and each subscale score is 0 - 4. Higher scores represent better implementation leadership. The mean of the subscale scores yields the total score.
Time frame: At start of school intervention
Population: School teachers and staff are the respondents to the surveys, not the children who are the participants of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P+S+ | Baseline School Leadership | 1.76 units on a scale | Standard Deviation 1.16 |
| S+ Alone | Baseline School Leadership | 1.82 units on a scale | Standard Deviation 1.24 |
| P+ Alone | Baseline School Leadership | 1.57 units on a scale | Standard Deviation 1.2 |
| Control | Baseline School Leadership | 1.7 units on a scale | Standard Deviation 1.2 |
| ILS Perseverant Leadership | Baseline School Leadership | 2.03 units on a scale | Standard Deviation 1.27 |
Baseline School Organizational Climate Index
The Standardized Organizational Climate Index (SOCI) is a 30-item descriptive measure for schools. The index has four dimensions: principal leadership, teacher professionalism, achievement press for students to perform academically, and vulnerability to the community. The score range for each questionnaire item is 1 - 4. The answers assign the value of 1 to rarely occurs, 2 to sometimes occurs, 3 to often occurs, and 4 to very frequently occurs. For the subscores, ninety-nine percent of the scores range from 200 to 800 with a population mean of 500 and a population standard deviation of 100. Higher scores indicate a better school climate. Scores are converted to standardized scores and compared with national norms.
Time frame: At start of school intervention
Population: School teachers and staff are the respondents to the surveys, not the children who are the participants of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P+S+ | Baseline School Organizational Climate Index | 538.83 units on a scale | Standard Deviation 110.95 |
| S+ Alone | Baseline School Organizational Climate Index | 528.8 units on a scale | Standard Deviation 144.88 |
| P+ Alone | Baseline School Organizational Climate Index | 471.46 units on a scale | Standard Deviation 121.64 |
| Control | Baseline School Organizational Climate Index | 441.59 units on a scale | Standard Deviation 86.28 |
Baseline School Staff Attitudes
The Evidence-Based Practice Attitude Scale (EBPAS) is a 15-item self-report measure of attitudes toward adoption of EBPs. It consists of four subscales: Appeal (is EBP intuitively appealing), Requirements (would an EBP be used if required), Openness (general openness to innovation), and Divergence (perceived divergence between EBP and current practice). Total score range is 0 - 60. The Appeal, Openness, and Divergence subscales have a range of 0 - 16. The Requirements subscale has a range of 0 - 12. Higher scores indicate more positive attitudes. Subscales are summed to compute a total score.
Time frame: At start of school intervention
Population: School teachers and staff are the respondents to the surveys, not the children who are the participants of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P+S+ | Baseline School Staff Attitudes | 2.53 units on a scale | Standard Deviation 0.65 |
| S+ Alone | Baseline School Staff Attitudes | 2.31 units on a scale | Standard Deviation 1.2 |
| P+ Alone | Baseline School Staff Attitudes | 2.42 units on a scale | Standard Deviation 0.91 |
| Control | Baseline School Staff Attitudes | 2.56 units on a scale | Standard Deviation 0.87 |
| ILS Perseverant Leadership | Baseline School Staff Attitudes | 1.01 units on a scale | Standard Deviation 0.86 |
Change in Activity Limitations Domain
Comparison of the change in caregivers' self-reported quality of life from baseline to 12 months for each intervention group. he Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) by Juniper et al. is a 13-item measure of asthma caregiver's quality of life in two domains, including activity limitation. The score for the subscale is the mean of the answers for the subscale. All items are weighted equally and the score range is 1 - 7, with lower numbers indicating poor quality of life and higher numbers indicating better quality of life around caring for a child with asthma.
Time frame: Baseline and 12 months
Population: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).~Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| P+S+ | Change in Activity Limitations Domain | Baseline | 5.13 units on a scale | Standard Deviation 1.51 |
| P+S+ | Change in Activity Limitations Domain | 12 Months | 6.09 units on a scale | Standard Deviation 1.13 |
| S+ Alone | Change in Activity Limitations Domain | 12 Months | 5.89 units on a scale | Standard Deviation 1.25 |
| S+ Alone | Change in Activity Limitations Domain | Baseline | 5.18 units on a scale | Standard Deviation 1.53 |
| P+ Alone | Change in Activity Limitations Domain | Baseline | 5.00 units on a scale | Standard Deviation 1.67 |
| P+ Alone | Change in Activity Limitations Domain | 12 Months | 5.79 units on a scale | Standard Deviation 1.47 |
| Control | Change in Activity Limitations Domain | Baseline | 5.09 units on a scale | Standard Deviation 1.69 |
| Control | Change in Activity Limitations Domain | 12 Months | 5.91 units on a scale | Standard Deviation 1.43 |
Change in Asthma Emotional Functioning Domain
Comparison of the change in caregivers' self-reported quality of life from baseline to 12 months for each intervention group. Data was collected using Juniper's Pediatric Asthma Caregiver's Quality of Life Questionnaire designed for children aged 7 to 17 years of age. The PAQLQ has 23 questions in 3 domains, including emotional function. The questions ask about a 1 week recall. The range for answer choices is 1-7, with the higher number indicating a better quality of life. The score for the subscale is the mean of the answers for that subscale.
Time frame: Baseline and 12 months
Population: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).~Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| P+S+ | Change in Asthma Emotional Functioning Domain | 12 Months | 6.47 units on a scale | Standard Deviation 0.78 |
| P+S+ | Change in Asthma Emotional Functioning Domain | Baseline | 5.72 units on a scale | Standard Deviation 1.26 |
| S+ Alone | Change in Asthma Emotional Functioning Domain | Baseline | 5.79 units on a scale | Standard Deviation 1.18 |
| S+ Alone | Change in Asthma Emotional Functioning Domain | 12 Months | 6.21 units on a scale | Standard Deviation 1 |
| P+ Alone | Change in Asthma Emotional Functioning Domain | Baseline | 5.55 units on a scale | Standard Deviation 1.32 |
| P+ Alone | Change in Asthma Emotional Functioning Domain | 12 Months | 6.15 units on a scale | Standard Deviation 1.08 |
| Control | Change in Asthma Emotional Functioning Domain | 12 Months | 6.16 units on a scale | Standard Deviation 1.1 |
| Control | Change in Asthma Emotional Functioning Domain | Baseline | 5.63 units on a scale | Standard Deviation 1.25 |
Change in Daytime Asthma Symptoms
Comparison of the change in daytime symptoms from baseline to 12 months for each intervention group. This data was collected at 3 month intervals with a 2 week recall for number of days with symptoms. This question asks how many days the child has had daytime asthma symptoms in the last 2 weeks and the number of days with asthma symptoms is the answer value (0-14 days). P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Time frame: Baseline and 12 months
Population: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).~Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| P+S+ | Change in Daytime Asthma Symptoms | 12 Months | 0 number of symptom days |
| P+S+ | Change in Daytime Asthma Symptoms | Baseline | 1 number of symptom days |
| S+ Alone | Change in Daytime Asthma Symptoms | Baseline | 1.5 number of symptom days |
| S+ Alone | Change in Daytime Asthma Symptoms | 12 Months | 1 number of symptom days |
| P+ Alone | Change in Daytime Asthma Symptoms | Baseline | 1 number of symptom days |
| P+ Alone | Change in Daytime Asthma Symptoms | 12 Months | 0 number of symptom days |
| Control | Change in Daytime Asthma Symptoms | 12 Months | 1 number of symptom days |
| Control | Change in Daytime Asthma Symptoms | Baseline | 1 number of symptom days |
Change in Emergency Department (ED) Visits
Comparison of the change in asthma-related Emergency Department visits from baseline to 12 months for each intervention group
Time frame: Baseline and 12 months
Population: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).~Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| P+S+ | Change in Emergency Department (ED) Visits | 12 months | 0 number of ED visits |
| P+S+ | Change in Emergency Department (ED) Visits | baseline | 1 number of ED visits |
| S+ Alone | Change in Emergency Department (ED) Visits | 12 months | 0 number of ED visits |
| S+ Alone | Change in Emergency Department (ED) Visits | baseline | 1 number of ED visits |
| P+ Alone | Change in Emergency Department (ED) Visits | 12 months | 0 number of ED visits |
| P+ Alone | Change in Emergency Department (ED) Visits | baseline | 1 number of ED visits |
| Control | Change in Emergency Department (ED) Visits | 12 months | 0 number of ED visits |
| Control | Change in Emergency Department (ED) Visits | baseline | 1 number of ED visits |
Change in Hospitalizations
Comparison of the change in asthma-related hospitalizations from baseline to 12 months for each intervention group
Time frame: Baseline and 12 months
Population: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).~Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| P+S+ | Change in Hospitalizations | baseline | 0 number of hospitalizations |
| P+S+ | Change in Hospitalizations | 12 months | 0 number of hospitalizations |
| S+ Alone | Change in Hospitalizations | 12 months | 0 number of hospitalizations |
| S+ Alone | Change in Hospitalizations | baseline | 0 number of hospitalizations |
| P+ Alone | Change in Hospitalizations | 12 months | 0 number of hospitalizations |
| P+ Alone | Change in Hospitalizations | baseline | 0 number of hospitalizations |
| Control | Change in Hospitalizations | 12 months | 0 number of hospitalizations |
| Control | Change in Hospitalizations | baseline | 0 number of hospitalizations |
Change in Nighttime Symptoms
Comparison of the change in nighttime symptoms from baseline to 12 months for each intervention group. This question asks how many days the child has had nighttime asthma symptoms in the last 2 weeks and the number of days with asthma symptoms is the answer value (0-14 days). P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Time frame: Baseline and 12 months
Population: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).~Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| P+S+ | Change in Nighttime Symptoms | 12 Months | 0 number of symptom days |
| P+S+ | Change in Nighttime Symptoms | Baseline | 0 number of symptom days |
| S+ Alone | Change in Nighttime Symptoms | Baseline | 0 number of symptom days |
| S+ Alone | Change in Nighttime Symptoms | 12 Months | 0 number of symptom days |
| P+ Alone | Change in Nighttime Symptoms | 12 Months | 0 number of symptom days |
| P+ Alone | Change in Nighttime Symptoms | Baseline | 0 number of symptom days |
| Control | Change in Nighttime Symptoms | 12 Months | 0 number of symptom days |
| Control | Change in Nighttime Symptoms | Baseline | 0 number of symptom days |
Change in School Absences
School report of child's school absences pre and post study enrollment
Time frame: Baseline and 12 months
Population: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).~Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| P+S+ | Change in School Absences | Baseline | 11 days |
| P+S+ | Change in School Absences | 12 Months | 12 days |
| S+ Alone | Change in School Absences | 12 Months | 13 days |
| S+ Alone | Change in School Absences | Baseline | 10 days |
| P+ Alone | Change in School Absences | Baseline | 17 days |
| P+ Alone | Change in School Absences | 12 Months | 16 days |
| Control | Change in School Absences | Baseline | 13 days |
| Control | Change in School Absences | 12 Months | 12 days |