ClinicalTrials.gov
ClinicalTrials.gov Menu

West Philadelphia Controls Asthma (WPCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03514485
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : June 4, 2018
Sponsor:
Collaborators:
University of Pennsylvania
Education Plus Health
School District of Philadelphia
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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).


Condition or disease Intervention/treatment Phase
Childhood Asthma Community Health Workers Behavioral: Yes We Can Children's Asthma Program Behavioral: School-Based Asthma Therapy Behavioral: Open Airways for School Plus Not Applicable

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 600 asthmatic children (ages 6-12 years) from three inner-city primary care clinics who attend one of 23 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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.
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 DSMB instructs the PI to become unmasked.
Primary Purpose: Other
Official Title: West Philadelphia Asthma Care Implementation Plan
Actual Study Start Date : May 17, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.
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.
Other Name: Primary Care Intervention

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.
Behavioral: 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.
Other Name: School Intervention (Partner School)

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.
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.
Other Name: Primary Care Intervention

Behavioral: 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.
Other Name: Primary Care and School Intervention (Partner School)

Behavioral: 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.
Other Name: School Intervention (Partner School)

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).
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.
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.
Other Name: Primary Care Intervention

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).



Primary Outcome Measures :
  1. Change in Asthma Control [ Time Frame: Baseline and 3, 6, 9, and 12 months ]
    Asthma Control Questionnaire (ACQ) developed by E.F. Juniper et al. is a 6-item recall of asthma control indicators over the past week 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.


Secondary Outcome Measures :
  1. Change in Asthma Symptoms [ Time Frame: Baseline and 3, 6, 9, and 12 months ]
    Asthma symptoms will be measured using a 2-week recall diary

  2. Change in School Absences [ Time Frame: Baseline and 12 months ]
    School and parental report of child's school absences pre and post study enrollment

  3. Change in Emergency Department (ED) visits and hospitalizations [ Time Frame: Baseline and 3, 6, 9, and 12 months ]
    ED visits and hospitalizations for an asthma-related cause in the 12 months pre and post study enrollment

  4. Intervention Cost-Effectiveness [ Time Frame: Baseline and 3, 6, 9, and 12 months ]
    Healthcare costs for child during the 12-month follow-up period will be measured by parental report using a 3-month recall diary

  5. Change in Asthma Caregiver's Quality of Life [ Time Frame: Baseline and 12 months ]
    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.

  6. Baseline School Asthma Program Sustainability [ Time Frame: At start of school intervention ]
    Semi-structured interviews with key school staff members and parents at the start of the intervention to assess barriers to sustainability of the intervention

  7. Post-Intervention School Asthma Program Sustainability [ Time Frame: One year post end of school intervention ]
    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

  8. Baseline School Climate [ Time Frame: At start of school intervention ]
    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.

  9. Post-Intervention School Climate [ Time Frame: One year post end of school intervention ]
    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.

  10. Baseline School Leadership [ Time Frame: At start of school intervention ]
    The Implementation Leadership Scale (ILS) is comprised of 12 items assessing the degree to which a leader is Proactive, Knowledgeable, Supportive, and 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.

  11. Post-Intervention School Leadership [ Time Frame: One year post end of school intervention ]
    The Implementation Leadership Scale (ILS) is comprised of 12 items assessing the degree to which a leader is Proactive, Knowledgeable, Supportive, and 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.

  12. Baseline School Staff Attitudes [ Time Frame: At start of school intervention ]
    The Evidence-Based Practice Attitude Scale (EBPAS) is a 15-item self-report measure of attitudes toward adoption of EBPs. It consists of four subscales: Appeal (is EBP intuitively appealing), Requirements (would an EBP be used if required), Openness (general openness to innovation), and Divergence (perceived divergence between EBP and current practice). Total score range is 0 - 60. The Appeal, Openness, and Divergence subscales have a range of 0 - 16. The Requirements subscale has a range of 0 - 12. Higher scores indicate more positive attitudes. Subscales are summed to compute a total score.

  13. Post-Intervention School Staff Attitudes [ Time Frame: One year post end of school intervention ]
    The Evidence-Based Practice Attitude Scale (EBPAS) is a 15-item self-report measure of attitudes toward adoption of EBPs. It consists of four subscales: Appeal (is EBP intuitively appealing), Requirements (would an EBP be used if required), Openness (general openness to innovation), and Divergence (perceived divergence between EBP and current practice). Total score range is 0 - 60. The Appeal, Openness, and Divergence subscales have a range of 0 - 16. The Requirements subscale has a range of 0 - 12. Higher scores indicate more positive attitudes. Subscales are summed to compute a total score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children 6-12 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 2 or more asthma exacerbations requiring oral steroids -OR- 2 or more ED visits for asthma -OR- 1 inpatient admission for asthma)
  4. West Philadelphia residence in zip code 19104, 19131, 19139, 19143 or 19151
  5. Children in grades 1-6
  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 up to two Federally Qualified Health Centers (FQHCs) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514485


Contacts
Contact: Tyra Bryant-Stephens, MD 215-590-5020 stephenst@email.chop.edu
Contact: Yolanda S Williams, MPH 267-425-1363 williamsys@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Chair, CHOP Committee for the Protection of Human Subjects    215-590-2830    IRBoffice@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Education Plus Health
School District of Philadelphia
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Tyra Bryant-Stephens, MD Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03514485     History of Changes
Other Study ID Numbers: 17-013892
1U01HL138687-01 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital of Philadelphia:
asthma disparities
community health worker
childhood asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases