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West Philadelphia Controls Asthma

West Philadelphia Asthma Care Implementation Plan

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03514485
Acronym
WPCA
Enrollment
626
Registered
2018-05-02
Start date
2018-05-17
Completion date
2022-06-30
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Asthma, Community Health Workers

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

BEHAVIORALYes 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.

BEHAVIORALSchool-Based Asthma Therapy

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.

BEHAVIORALOpen 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.

Sponsors

University of Pennsylvania
CollaboratorOTHER
Education-Plus, Inc.
CollaboratorOTHER
The School District of Philadelphia
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

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

Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Change in Asthma ControlBaseline and 12 monthsAsthma 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

MeasureTime frameDescription
Change in Nighttime SymptomsBaseline and 12 monthsComparison 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 AbsencesBaseline and 12 monthsSchool report of child's school absences pre and post study enrollment
Change in Emergency Department (ED) VisitsBaseline and 12 monthsComparison of the change in asthma-related Emergency Department visits from baseline to 12 months for each intervention group
Change in HospitalizationsBaseline and 12 monthsComparison of the change in asthma-related hospitalizations from baseline to 12 months for each intervention group
Change in Daytime Asthma SymptomsBaseline and 12 monthsComparison 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 DomainBaseline and 12 monthsComparison 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 IndexAt start of school interventionThe 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 LeadershipAt start of school interventionThe 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 AttitudesAt start of school interventionThe 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 DomainBaseline and 12 monthsComparison 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

ArmCount
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
Total626

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyLost to Follow-up532014
Overall StudyWithdrawal by Subject013121

Baseline characteristics

CharacteristicP+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 Score1.3 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 Participants58 Participants51 Participants59 Participants43 Participants49 Participants328 Participants
Asthma Control Score Groups
>=1.25
52 Participants54 Participants58 Participants53 Participants37 Participants40 Participants294 Participants
Asthma Control Score Groups
Missing
1 Participants0 Participants1 Participants0 Participants2 Participants0 Participants4 Participants
BMI
< 5th Percentile
1 Participants1 Participants0 Participants5 Participants1 Participants2 Participants10 Participants
BMI
5th to 84th Percentile
55 Participants63 Participants45 Participants54 Participants33 Participants42 Participants292 Participants
BMI
85th to 94th Percentile
12 Participants15 Participants15 Participants15 Participants18 Participants12 Participants87 Participants
BMI
At or Above 95th Percentile
49 Participants31 Participants44 Participants37 Participants28 Participants30 Participants219 Participants
BMI
Missing
4 Participants2 Participants6 Participants1 Participants2 Participants3 Participants18 Participants
Emergency Department Visit for Asthma
Ever
109 Participants94 Participants90 Participants92 Participants74 Participants78 Participants537 Participants
Emergency Department Visit for Asthma
Past 12 Months
66 Participants60 Participants64 Participants46 Participants43 Participants49 Participants328 Participants
Hospitalized Overnight for Asthma
Ever
78 Participants73 Participants79 Participants71 Participants46 Participants61 Participants408 Participants
Hospitalized Overnight for Asthma
Past 12 Months
36 Participants40 Participants51 Participants33 Participants23 Participants31 Participants214 Participants
In the ICU for Asthma
Ever
17 Participants12 Participants17 Participants9 Participants9 Participants11 Participants75 Participants
In the ICU for Asthma
Past 12 Months
0 Participants1 Participants5 Participants1 Participants1 Participants0 Participants8 Participants
On a Prednisone Burst for Asthma
Ever
121 Participants112 Participants110 Participants112 Participants82 Participants89 Participants626 Participants
On a Prednisone Burst for Asthma
Past 12 Months
120 Participants112 Participants110 Participants112 Participants82 Participants89 Participants625 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 Participants3 Participants1 Participants3 Participants1 Participants1 Participants11 Participants
Race/Ethnicity, Customized
Black or African American
119 Participants103 Participants106 Participants106 Participants79 Participants88 Participants601 Participants
Race/Ethnicity, Customized
More than one race
0 Participants5 Participants2 Participants2 Participants2 Participants0 Participants11 Participants
Race/Ethnicity, Customized
White
0 Participants1 Participants1 Participants1 Participants0 Participants0 Participants3 Participants
Sex: Female, Male
Female
61 Participants43 Participants45 Participants40 Participants34 Participants40 Participants263 Participants
Sex: Female, Male
Male
60 Participants69 Participants65 Participants72 Participants48 Participants49 Participants363 Participants

Adverse events

Event typeEG000
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 / 1210 / 1120 / 1100 / 1120 / 820 / 89
other
Total, other adverse events
0 / 1210 / 1120 / 1100 / 1120 / 820 / 89
serious
Total, serious adverse events
0 / 1210 / 1120 / 1100 / 1120 / 820 / 89

Outcome results

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.

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).

ArmMeasureGroupValue (MEAN)
P+S+Change in Asthma ControlBaseline1.35 units on a scale
P+S+Change in Asthma ControlDifference (Month 12 minus Baseline)-0.61 units on a scale
P+S+Change in Asthma Control12 Months0.74 units on a scale
S+ AloneChange in Asthma ControlBaseline1.42 units on a scale
S+ AloneChange in Asthma ControlDifference (Month 12 minus Baseline)-0.57 units on a scale
S+ AloneChange in Asthma Control12 Months0.85 units on a scale
P+ AloneChange in Asthma Control12 Months0.85 units on a scale
P+ AloneChange in Asthma ControlBaseline1.38 units on a scale
P+ AloneChange in Asthma ControlDifference (Month 12 minus Baseline)-0.53 units on a scale
ControlChange in Asthma ControlBaseline1.37 units on a scale
ControlChange in Asthma ControlDifference (Month 12 minus Baseline)-0.39 units on a scale
ControlChange in Asthma Control12 Months0.97 units on a scale
Comparison: Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. 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.95% CI: [-0.34, 0.25]
Comparison: Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.95% CI: [-0.34, 0.18]
Comparison: Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.95% CI: [-0.48, 0.04]
Comparison: Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.95% CI: [-0.44, 0.9]
Comparison: Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.95% CI: [-0.36, 0.09]
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.

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.

ArmMeasureValue (MEAN)Dispersion
P+S+Baseline School Leadership1.76 units on a scaleStandard Deviation 1.16
S+ AloneBaseline School Leadership1.82 units on a scaleStandard Deviation 1.24
P+ AloneBaseline School Leadership1.57 units on a scaleStandard Deviation 1.2
ControlBaseline School Leadership1.7 units on a scaleStandard Deviation 1.2
ILS Perseverant LeadershipBaseline School Leadership2.03 units on a scaleStandard Deviation 1.27
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.

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.

ArmMeasureValue (MEAN)Dispersion
P+S+Baseline School Organizational Climate Index538.83 units on a scaleStandard Deviation 110.95
S+ AloneBaseline School Organizational Climate Index528.8 units on a scaleStandard Deviation 144.88
P+ AloneBaseline School Organizational Climate Index471.46 units on a scaleStandard Deviation 121.64
ControlBaseline School Organizational Climate Index441.59 units on a scaleStandard Deviation 86.28
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.

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.

ArmMeasureValue (MEAN)Dispersion
P+S+Baseline School Staff Attitudes2.53 units on a scaleStandard Deviation 0.65
S+ AloneBaseline School Staff Attitudes2.31 units on a scaleStandard Deviation 1.2
P+ AloneBaseline School Staff Attitudes2.42 units on a scaleStandard Deviation 0.91
ControlBaseline School Staff Attitudes2.56 units on a scaleStandard Deviation 0.87
ILS Perseverant LeadershipBaseline School Staff Attitudes1.01 units on a scaleStandard Deviation 0.86
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.

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).

ArmMeasureGroupValue (MEAN)Dispersion
P+S+Change in Activity Limitations DomainBaseline5.13 units on a scaleStandard Deviation 1.51
P+S+Change in Activity Limitations Domain12 Months6.09 units on a scaleStandard Deviation 1.13
S+ AloneChange in Activity Limitations Domain12 Months5.89 units on a scaleStandard Deviation 1.25
S+ AloneChange in Activity Limitations DomainBaseline5.18 units on a scaleStandard Deviation 1.53
P+ AloneChange in Activity Limitations DomainBaseline5.00 units on a scaleStandard Deviation 1.67
P+ AloneChange in Activity Limitations Domain12 Months5.79 units on a scaleStandard Deviation 1.47
ControlChange in Activity Limitations DomainBaseline5.09 units on a scaleStandard Deviation 1.69
ControlChange in Activity Limitations Domain12 Months5.91 units on a scaleStandard Deviation 1.43
Comparison: 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.95% CI: [-0.19, 0.69]
Comparison: 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.95% CI: [-0.14, 0.63]
Comparison: 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.95% CI: [-0.49, 0.3]
Comparison: 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.95% CI: [-0.43, 0.24]
Comparison: 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.95% CI: [-0.24, 0.54]
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.

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).

ArmMeasureGroupValue (MEAN)Dispersion
P+S+Change in Asthma Emotional Functioning Domain12 Months6.47 units on a scaleStandard Deviation 0.78
P+S+Change in Asthma Emotional Functioning DomainBaseline5.72 units on a scaleStandard Deviation 1.26
S+ AloneChange in Asthma Emotional Functioning DomainBaseline5.79 units on a scaleStandard Deviation 1.18
S+ AloneChange in Asthma Emotional Functioning Domain12 Months6.21 units on a scaleStandard Deviation 1
P+ AloneChange in Asthma Emotional Functioning DomainBaseline5.55 units on a scaleStandard Deviation 1.32
P+ AloneChange in Asthma Emotional Functioning Domain12 Months6.15 units on a scaleStandard Deviation 1.08
ControlChange in Asthma Emotional Functioning Domain12 Months6.16 units on a scaleStandard Deviation 1.1
ControlChange in Asthma Emotional Functioning DomainBaseline5.63 units on a scaleStandard Deviation 1.25
Comparison: 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.95% CI: [0, 0.65]
Comparison: 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.95% CI: [-0.12, 0.45]
Comparison: 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.95% CI: [-0.4, 0.18]
Comparison: 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.95% CI: [-0.2, 0.29]
Comparison: 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.95% CI: [-0.08, 0.5]
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).

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).

ArmMeasureGroupValue (MEDIAN)
P+S+Change in Daytime Asthma Symptoms12 Months0 number of symptom days
P+S+Change in Daytime Asthma SymptomsBaseline1 number of symptom days
S+ AloneChange in Daytime Asthma SymptomsBaseline1.5 number of symptom days
S+ AloneChange in Daytime Asthma Symptoms12 Months1 number of symptom days
P+ AloneChange in Daytime Asthma SymptomsBaseline1 number of symptom days
P+ AloneChange in Daytime Asthma Symptoms12 Months0 number of symptom days
ControlChange in Daytime Asthma Symptoms12 Months1 number of symptom days
ControlChange in Daytime Asthma SymptomsBaseline1 number of symptom days
Comparison: 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.95% CI: [-0.39, 0.55]
Comparison: 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.95% CI: [0.04, 0.88]
Comparison: 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.95% CI: [-1.06, -0.23]
Comparison: 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.95% CI: [-1.39, -0.67]
Comparison: 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.95% CI: [-0.95, -0.18]
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

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).

ArmMeasureGroupValue (MEDIAN)
P+S+Change in Emergency Department (ED) Visits12 months0 number of ED visits
P+S+Change in Emergency Department (ED) Visitsbaseline1 number of ED visits
S+ AloneChange in Emergency Department (ED) Visits12 months0 number of ED visits
S+ AloneChange in Emergency Department (ED) Visitsbaseline1 number of ED visits
P+ AloneChange in Emergency Department (ED) Visits12 months0 number of ED visits
P+ AloneChange in Emergency Department (ED) Visitsbaseline1 number of ED visits
ControlChange in Emergency Department (ED) Visits12 months0 number of ED visits
ControlChange in Emergency Department (ED) Visitsbaseline1 number of ED visits
Comparison: 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.95% CI: [-0.19, 0.54]
Comparison: 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.95% CI: [-0.28, 0.35]
Comparison: 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.95% CI: [-0.68, -0.01]
Comparison: 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.95% CI: [-0.48, 0.08]
Comparison: 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.95% CI: [-0.48, 0.14]
Secondary

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).

ArmMeasureGroupValue (MEDIAN)
P+S+Change in Hospitalizationsbaseline0 number of hospitalizations
P+S+Change in Hospitalizations12 months0 number of hospitalizations
S+ AloneChange in Hospitalizations12 months0 number of hospitalizations
S+ AloneChange in Hospitalizationsbaseline0 number of hospitalizations
P+ AloneChange in Hospitalizations12 months0 number of hospitalizations
P+ AloneChange in Hospitalizationsbaseline0 number of hospitalizations
ControlChange in Hospitalizations12 months0 number of hospitalizations
ControlChange in Hospitalizationsbaseline0 number of hospitalizations
Comparison: 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.95% CI: [-0.11, 0.29]
Comparison: 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.95% CI: [-0.03, 0.34]
Comparison: 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.95% CI: [-0.19, 0.18]
Comparison: 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.95% CI: [-0.23, 0.09]
Comparison: 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.95% CI: [-0.09, 0.26]
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).

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).

ArmMeasureGroupValue (MEDIAN)
P+S+Change in Nighttime Symptoms12 Months0 number of symptom days
P+S+Change in Nighttime SymptomsBaseline0 number of symptom days
S+ AloneChange in Nighttime SymptomsBaseline0 number of symptom days
S+ AloneChange in Nighttime Symptoms12 Months0 number of symptom days
P+ AloneChange in Nighttime Symptoms12 Months0 number of symptom days
P+ AloneChange in Nighttime SymptomsBaseline0 number of symptom days
ControlChange in Nighttime Symptoms12 Months0 number of symptom days
ControlChange in Nighttime SymptomsBaseline0 number of symptom days
Comparison: 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.95% CI: [-0.53, 0.28]
Comparison: 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.95% CI: [-0.45, 0.26]
Comparison: 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.95% CI: [-0.6, 0.1]
Comparison: 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.95% CI: [-0.57, 0.01]
Comparison: 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.95% CI: [-0.72, -0.04]
Secondary

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).

ArmMeasureGroupValue (MEDIAN)
P+S+Change in School AbsencesBaseline11 days
P+S+Change in School Absences12 Months12 days
S+ AloneChange in School Absences12 Months13 days
S+ AloneChange in School AbsencesBaseline10 days
P+ AloneChange in School AbsencesBaseline17 days
P+ AloneChange in School Absences12 Months16 days
ControlChange in School AbsencesBaseline13 days
ControlChange in School Absences12 Months12 days
Comparison: 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.95% CI: [0.58, 4.19]
Comparison: 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.95% CI: [2.54, 6.43]
Comparison: 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.95% CI: [-2.78, 0.84]
Comparison: 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.95% CI: [-5.03, -1.12]
Comparison: 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.95% CI: [-0.48, 3.31]

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026