West Philadelphia Controls Asthma

Childhood Asthma Clinical Trial

— WPCA  

Official title:

West Philadelphia Asthma Care Implementation Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514485
• Other study ID #: 17-013892
• Secondary ID: 1U01HL138687-01
• Status: Completed
• Phase: N/A
• Start date: May 17, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 627
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

Inclusion Criteria:

1. Children 5-13 years of age and their parents/guardians

2. Children with a diagnosis of asthma

3. Children with uncontrolled asthma (as evidenced within the previous 12 months by an asthma exacerbation requiring oral steroids -OR- an 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

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma
• Community Health Workers

Intervention

Behavioral:
• 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.
• School-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.
• 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: Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester. 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. Asthma education for school staff/personnel at the start of each school year. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 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.	Baseline and 3, 6, 9, and 12 months
Secondary	Change in Asthma Symptoms	Asthma symptoms will be measured using a 2-week recall diary	Baseline and 3, 6, 9, and 12 months
Secondary	Change in School Absences	School and parental report of child's school absences pre and post study enrollment	Baseline and 12 months
Secondary	Change in Emergency Department (ED) visits and hospitalizations	ED visits and hospitalizations for an asthma-related cause in the 12 months pre and post study enrollment	Baseline and 3, 6, 9, and 12 months
Secondary	Intervention Cost-Effectiveness	Healthcare costs for child during the 12-month follow-up period will be measured by parental report using a 3-month recall diary	Baseline and 3, 6, 9, and 12 months
Secondary	Change in Asthma Caregiver's Quality of Life	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.	Baseline and 12 months
Secondary	Baseline School Asthma Program Sustainability	Semi-structured interviews with key school staff members and parents at the start of the intervention to assess barriers to sustainability of the intervention	At start of school intervention
Secondary	Post-Intervention School Asthma Program Sustainability	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	One year post end of school intervention
Secondary	Baseline School Climate	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.	At start of school intervention
Secondary	Post-Intervention School Climate	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.	One year post end of school intervention
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.	At start of school intervention
Secondary	Post-Intervention School Leadership	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.	One year post end of school intervention
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.	At start of school intervention
Secondary	Post-Intervention 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.	One year post end of school intervention