- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514485
West Philadelphia Controls Asthma (WPCA)
West Philadelphia Asthma Care Implementation Plan
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 640 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).
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children 5-13 years of age and their parents/guardians
- Children with a diagnosis of asthma
- Children with uncontrolled asthma (as evidenced within the previous 12 months by an asthma exacerbation requiring oral steroids -OR- an ED visit for asthma -OR- an inpatient admission for asthma)
- West Philadelphia residence in zip code 19104, 19131, 19139, 19142, 19143, 19151 or 19153
- Children in grades K-8
- 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
- Parental/guardian permission (informed consent) and, if appropriate, child assent
- English Language Speaking
Exclusion Criteria:
- Subjects with other chronic respiratory illnesses such as cystic fibrosis
- Cyanotic congenital heart disease
- Mental retardation and/or cerebral palsy (MRCP)
- Severe Neurological Disorder
- Cyanotic congenital heart disease
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: P+S- (Partner School)
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.
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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.
Other Names:
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Active Comparator: P-S+ (Partner School)
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.
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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:
Other Names:
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Active Comparator: P+S+ (Partner School)
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.
|
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.
Other Names:
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:
Other Names:
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.
Other Names:
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No Intervention: 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).
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Active Comparator: P+ (Non-Partner School)
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.
|
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.
Other Names:
|
No Intervention: P- (Non-Partner School)
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Asthma Control
Time Frame: Baseline and 3, 6, 9, and 12 months
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Asthma Control Questionnaire (ACQ) developed by E.F.
Juniper et al. is a 6-item recall of asthma control indicators over the past week and one objective measure of airway caliber (FEV1%) through pulmonary function testing.
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 - 6, with lower numbers indicating poor asthma control and higher numbers indicating greater asthma control.
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Baseline and 3, 6, 9, and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Asthma Symptoms
Time Frame: Baseline and 3, 6, 9, and 12 months
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Asthma symptoms will be measured using a 2-week recall diary
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Baseline and 3, 6, 9, and 12 months
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Change in School Absences
Time Frame: Baseline and 12 months
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School and parental report of child's school absences pre and post study enrollment
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Baseline and 12 months
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Change in Emergency Department (ED) visits and hospitalizations
Time Frame: Baseline and 3, 6, 9, and 12 months
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ED visits and hospitalizations for an asthma-related cause in the 12 months pre and post study enrollment
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Baseline and 3, 6, 9, and 12 months
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Intervention Cost-Effectiveness
Time Frame: Baseline and 3, 6, 9, and 12 months
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Healthcare costs for child during the 12-month follow-up period will be measured by parental report using a 3-month recall diary
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Baseline and 3, 6, 9, and 12 months
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Change in Asthma Caregiver's Quality of Life
Time Frame: Baseline and 12 months
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The 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, activity limitation and emotional function, over the past week.
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.
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Baseline and 12 months
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Baseline School Asthma Program Sustainability
Time Frame: At start of school intervention
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Semi-structured interviews with key school staff members and parents at the start of the intervention to assess barriers to sustainability of the intervention
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At start of school intervention
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Post-Intervention School Asthma Program Sustainability
Time Frame: One year post end of school intervention
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Semi-structured interviews with key school staff members and parents one year after the school intervention has ended to assess barriers to sustainability of the intervention
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One year post end of school intervention
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Baseline School Climate
Time Frame: At start of school intervention
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The Organizational Climate Index (OCI) 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 range for the principal leadership and teacher professionalism dimensions is 7 - 28.
The range for achievement press is 8 - 32.
The range for vulnerability to the community is 5 - 20.
Higher scores reflect a better organizational climate.
The total school score, range 27 - 108, is computed by summing the subscale means.
Total school score can be converted to standardized scores and compared with national norms.
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At start of school intervention
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Post-Intervention School Climate
Time Frame: One year post end of school intervention
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The Organizational Climate Index (OCI) 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 range for the principal leadership and teacher professionalism dimensions is 7 - 28.
The range for achievement press is 8 - 32.
The range for vulnerability to the community is 5 - 20.
Higher scores reflect a better organizational climate.
The total school score, range 27 - 108, is computed by summing the subscale means.
Total school score can be converted to standardized scores and compared with national norms.
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One year post end of school intervention
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Baseline School Leadership
Time Frame: At start of school intervention
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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.
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At start of school intervention
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Post-Intervention School Leadership
Time Frame: One year post end of school intervention
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The Implementation Leadership Scale (ILS) is comprised of 12 items assessing the degree to which a leader is Proactive, Knowledgeable, Supportive, and Perseverant 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.
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One year post end of school intervention
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Baseline School Staff Attitudes
Time Frame: At start of school intervention
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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.
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At start of school intervention
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Post-Intervention School Staff Attitudes
Time Frame: One year post end of school intervention
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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.
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One year post end of school intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tyra Bryant-Stephens, MD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-013892
- 1U01HL138687-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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