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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HL138687-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| Education-Plus, Inc. | OTHER |
| The School District of Philadelphia | OTHER |
| National Institutes of Health (NIH) |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P+S- (Partner School) | Active Comparator | This arm includes children who attend one of the partnering schools and who are randomized to receive the primary care intervention Yes We Can Children's Asthma Program. |
|
| P-S+ (Partner School) | Active Comparator | This arm includes children who attend one of the partnering schools and who are randomized to receive the school intervention Open Airways for Schools Plus. |
|
| P+S+ (Partner School) | Active Comparator | This arm includes children who attend one of the partnering schools and who 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. |
|
| P-S- (Partner School) | No Intervention | This arm includes children who attend one of the partnering schools, and are randomized to the control group (no primary care or school intervention). | |
| P+ (Non-Partner School) | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yes We Can Children's Asthma Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyra Bryant-Stephens, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39432292 | Derived | Bryant-Stephens T, Kenyon CC, Tingey C, Apter A, Pappas J, Minto N, Stewart YS, Shults J. Community Health Workers Linking Clinics and Schools and Asthma Control: A Randomized Clinical Trial. JAMA Pediatr. 2024 Dec 1;178(12):1260-1269. doi: 10.1001/jamapediatrics.2024.3967. |
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Investigators do not plan to share individual level participant data with other researchers, however Investigators plan to make the results (de-identified, aggregate data) available to other researchers and stakeholders interested in asthma and the reduction of asthma disparities. Investigators plan to share results during presentations at organizational and scientific meetings, annual Asthma Summit and published manuscripts. The results will also be shared with the PubMed Data Library.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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:
|
| FG002 | 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. |
| FG003 | 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). |
| FG004 | 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. |
| FG005 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12 months |
Adverse event data was collected for up to 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This study was conducted during the pandemic. For this reason, the school intervention was disrupted as schools were closed down completely for six months and then only virtual for three months. This prevented us from conducting the school intervention as per protocol for most of the children in the study. This impacted our outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tyra Bryant-Stephens, MD | Children's Hospital of Philadelphia | 215-590-5261 | stephenst@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2021 | Nov 1, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2022 | Nov 1, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011320 | Primary Health Care |
| D012574 | Schools |
| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D000072182 | Non-Medical Public and Private Facilities |
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| NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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.
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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.
This arm includes children who do not attend one of the partnering schools and who are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.
|
| P- (Non-Partner School) | No Intervention | This arm includes children who do not attend one of the partnering schools and who are randomized to the control group (no primary care intervention and ineligible for the school intervention). |
|
|
| School-Based Asthma Therapy | Behavioral | 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 School Plus | Behavioral | 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:
|
|
|
| Baseline and 12 months |
| 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). | Baseline and 12 months |
| Change in School Absences | School report of child's school absences pre and post study enrollment | Baseline and 12 months |
| 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 | Baseline and 12 months |
| Change in Hospitalizations | Comparison of the change in asthma-related hospitalizations from baseline to 12 months for each intervention group | Baseline and 12 months |
| 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. | Baseline and 12 months |
| 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. | Baseline and 12 months |
| 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. | At start of school intervention |
| 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. | At start of school intervention |
| 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. | At start of school intervention |
| Withdrawal by Subject |
|
| 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:
|
| BG002 | 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. |
| BG003 | 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). |
| BG004 | 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. |
| BG005 | 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). |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| BMI | Data reported from Electronic Health Record | Count of Participants | Participants |
|
| Asthma Control Score | Asthma control was measured using Juniper's Asthma Control Questionnaire (ACQ), a validated instrument with a 6-point scale (with answer values of 0 to 6). The total score is a mean of the 6 answer values. The minimum total score is 0 and the maximum total score is 6. Lower scores indicate better control and a threshold above 1.25 is considered poor control for children. The Minimal Clinically Important Difference (MCID) is 0.5. | Mean | Standard Deviation | units on a scale |
|
| Asthma Control Score Groups | Asthma control was measured using Juniper's Asthma Control Questionnaire (ACQ), a validated instrument with a 6-point scale. Lower scores indicate better control and a threshold above 1.25 is considered poor control for children. | Count of Participants | Participants |
|
| Hospitalized Overnight for Asthma | Data reported from Electronic Health Record | Count of Participants | Participants |
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| In the ICU for Asthma | Data reported from Electronic Health Record | Count of Participants | Participants |
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| Emergency Department Visit for Asthma | Data reported from Electronic Health Record | Count of Participants | Participants |
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| On a Prednisone "Burst" for Asthma | Data reported from Electronic Health Record | Count of Participants | Participants |
|
| Quality of Life Score (Overall) | 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 (symptoms, activity limitation and emotional function). The activity domain contains 3 'patient-specific' questions within a 1 week recall. The overall score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. The range is 1-7, with the higher number indicating a better quality of life. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | P+S+ | This group includes children who attend one of the partnering schools and were randomized to receive both 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). |
| OG001 | S+ Alone | This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy). |
| OG002 | P+ Alone | This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). |
| OG003 | Control | This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0). |
|
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| Secondary | 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). | 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). | Posted | Median | Inter-Quartile Range | number of symptom days | Baseline and 12 months |
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| Secondary | 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). | 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). | Posted | Median | Inter-Quartile Range | number of symptom days | Baseline and 12 months |
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| Secondary | Change in School Absences | School report of child's school absences pre and post study enrollment | 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). | Posted | Median | Inter-Quartile Range | days | Baseline and 12 months |
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| Secondary | 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 | 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). | Posted | Median | Inter-Quartile Range | number of ED visits | Baseline and 12 months |
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| Secondary | Change in Hospitalizations | Comparison of the change in asthma-related hospitalizations from baseline to 12 months for each intervention group | 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). | Posted | Median | Inter-Quartile Range | number of hospitalizations | Baseline and 12 months |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
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| Secondary | 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. | School teachers and staff are the respondents to the surveys, not the children who are the participants of this study. | Posted | Mean | Standard Deviation | units on a scale | At start of school intervention |
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| Secondary | 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. | School teachers and staff are the respondents to the surveys, not the children who are the participants of this study. | Posted | Mean | Standard Deviation | units on a scale | At start of school intervention |
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| Secondary | 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. | School teachers and staff are the respondents to the surveys, not the children who are the participants of this study. | Posted | Mean | Standard Deviation | units on a scale | At start of school intervention |
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| 0 |
| 121 |
| 0 |
| 121 |
| 0 |
| 121 |
| EG001 | 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:
| 0 | 112 | 0 | 112 | 0 | 112 |
| EG002 | 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. | 0 | 110 | 0 | 110 | 0 | 110 |
| EG003 | 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). | 0 | 112 | 0 | 112 | 0 | 112 |
| EG004 | 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. | 0 | 82 | 0 | 82 | 0 | 82 |
| EG005 | 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). | 0 | 89 | 0 | 89 | 0 | 89 |
Not provided
|
| 12 Months |
|
|
|
Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. |
| Mean Difference (Net) |
| 0.46 |
| 2-Sided |
| 95 |
| 0.04 |
| 0.88 |
| Superiority |
| Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.65 | 2-Sided | 95 | -1.06 | -0.23 | Superiority |
| Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -1.03 | 2-Sided | 95 | -1.39 | -0.67 | Superiority |
| Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.57 | 2-Sided | 95 | -0.95 | -0.18 | Superiority |
|
| 12 Months |
|
|
|
Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. |
| Median Difference (Net) |
| -0.09 |
| 2-Sided |
| 95 |
| -0.45 |
| 0.26 |
| Superiority |
| Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.25 | 2-Sided | 95 | -0.60 | 0.10 | Superiority |
| Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Median Difference (Net) | -0.28 | 2-Sided | 95 | -0.57 | 0.01 | Superiority |
| Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.38 | 2-Sided | 95 | -0.72 | -0.04 | Superiority |
| 12 Months |
|
| Mixed-effects generalized linear model with binomial family (n=number of school-days [varies per child]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | 4.49 | 2-Sided | 95 | 2.54 | 6.43 | Superiority |
| Mixed-effects generalized linear model with binomial family (n=number of school-days [varies per child]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.97 | 2-Sided | 95 | -2.78 | 0.84 | Superiority |
| Mixed-effects generalized linear model with binomial family (n=number of school-days [varies per child]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -3.07 | 2-Sided | 95 | -5.03 | -1.12 | Superiority |
| Mixed-effects generalized linear model with binomial family (n=number of school-days [varies per child]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | 1.41 | 2-Sided | 95 | -0.48 | 3.31 | Superiority |
|
| 12 months |
|
|
Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. |
| Mean Difference (Net) |
| 0.03 |
| 2-Sided |
| 95 |
| -0.28 |
| 0.35 |
| Superiority |
| Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.34 | 2-Sided | 95 | -0.68 | -0.01 | Superiority |
| Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.2 | 2-Sided | 95 | -0.48 | 0.08 | Superiority |
| Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.17 | 2-Sided | 95 | -0.48 | 0.14 | Superiority |
|
| 12 months |
|
|
Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. |
| Mean Difference (Net) |
| 0.16 |
| 2-Sided |
| 95 |
| -0.03 |
| 0.34 |
| Superiority |
| Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.001 | 2-Sided | 95 | -0.19 | 0.18 | Superiority |
| Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.07 | 2-Sided | 95 | -0.23 | 0.09 | Superiority |
| Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | 0.09 | 2-Sided | 95 | -0.09 | 0.26 | Superiority |
|
| 12 Months |
|
|
|
Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. |
| Mean Difference (Net) |
| 0.16 |
| 2-Sided |
| 95 |
| -0.12 |
| 0.45 |
| Superiority |
| Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.11 | 2-Sided | 95 | -0.40 | 0.18 | Superiority |
| Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | 0.05 | 2-Sided | 95 | -0.20 | 0.29 | Superiority |
| Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | 0.21 | 2-Sided | 95 | -0.08 | 0.50 | Superiority |
|
| 12 Months |
|
|
|
Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. |
| Mean Difference (Net) |
| 0.25 |
| 2-Sided |
| 95 |
| -0.14 |
| 0.63 |
| Superiority |
| Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.10 | 2-Sided | 95 | -0.49 | 0.30 | Superiority |
| Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | -0.10 | 2-Sided | 95 | -0.43 | 0.24 | Superiority |
| Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic. | Mean Difference (Net) | 0.15 | 2-Sided | 95 | -0.24 | 0.54 | Superiority |