Childhood Asthma
Conditions
Keywords
asthma, childhood asthma, stakeholder engagement, medication adherence, school-supervised asthma therapy, real-world, pragmatic trial
Brief summary
The goal of this study is to assess the feasibility of a clinical trial to evaluate the impact and process of deploying school-supervised asthma therapy in a real-world setting for children with poorly controlled asthma (aged 6-17 years).
Detailed description
The proposed 4-site pilot cluster randomized controlled trial will assess the feasibility of conducting a clinical trial of Asthma Link, a real-world school-supervised asthma therapy program. We will compare the impact of Asthma Link deployed in 2 pediatric practice sites versus Enhanced usual care deployed in 2 comparator sites, with 18 parent-child dyads enrolled per site (N=72 dyads). Primary trial outcomes will be participant recruitment, retention, and intervention fidelity. Secondary trial outcomes will be differences in the frequency of asthma symptoms, emergency department visits, hospital admissions, courses of oral corticosteroids, spirometry values, medication adherence and school absences between intervention and enhanced usual care sites at 3, 6 and 12 month follow up. Additionally we will assess process outcomes (acceptability, adoption, costs, sustainability).
Interventions
OTHERAsthma Link
Providers enroll patients in school nurse supervised daily controller asthma medication delivery
OTHEREnhanced Usual Care
Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
STUDY INCLUSION/
Exclusion criteria
Child Inclusion Criteria: * Meet the eligibility criteria for Asthma Link (as described below) * Enrolled in Asthma Link (if randomized to the Asthma Link Condition) * Able and willing to provide informed assent Child
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Procedures Assessed by Number of Patients Screened | Baseline | Research staff will track number of patients screened during enrollment process. |
| Recruitment Procedures Assessed by Number of Eligible Participants | Baseline | Research staff will track number of eligible participants who meeting study criteria during the enrollment process. |
| Recruitment Procedures Assessed by Number of Patients Recruited Into the Study | Baseline | Research staff will track number of patients recruited into the study after they are assessed for eligibility. |
| Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate. | Baseline | Research staff will track the number of patients that were not enrolled or refused to participate in the study along with the reasons for non-enrollment. |
| Retention of Study Participants (Drop Out) | Up to end of study, approximately 12 months | Research staff to track number of participants who drop out of the study and note reasons for not completing study. |
| Retention of Study Participants (Lost to Follow-up) | Up to end of study, approximately 12 months | Research staff to track number of participants lost to follow-up, who did not complete the 12 month study assessment. |
| Intervention Fidelity - Pediatric Practice | Baseline | Research staff to assess for intervention fidelity within the pediatric practice through a checklist for pediatric staff to assess percentage of eligible children enrolled. |
| Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention | Up to end of study, approximately 12 months | Research staff to assess for intervention fidelity by school nurse report of percentage of enrolled students receiving supervised therapy. |
| Intervention Fidelity - School Nurse and Family Participation | Up to end of study, approximately 12 months | Research staff to assess for intervention fidelity by school nurse checklist of each enrolled child attending daily school nurse sessions and his/her family bringing medication to school. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Healthcare Utilization Over Time | Baseline, 3 months, 6 months, 12 months | Research staff will assess the frequency of healthcare utilization (# of emergency room visits, # of hospital admissions, # of oral steroid courses, and # of urgent care visits) due to asthma through parent report on surveys and medical record review. |
| Acceptability - Participants | 3 months, 6 months, 12 months | Research staff will assess acceptability of the study among stakeholders (parent-child dyads, medical providers, school nurses) via a survey in which we will ask stakeholders to rate each component of the Asthma Link intervention using a study specific Acceptability scale ranging from 1 (strongly disagree) to 5 (strongly agree). Qualitative interviews will be performed with stakeholders at 12 months |
| School Absences | Baseline, 3 months, 6 months, 12 months | Research staff will assess school absences via parent report and school nurse report |
| Medication Adherence | Baseline, 3 months, 6 months, 12 months | Research staff will assess medication adherence via a survey questions administered to parents and through pharmacy refill data. |
| Adoption of Asthma Link Intervention - Medical Provider | Baseline, 3 months, 6 months, 12 months | Research staff will assess adoption of the intervention via Pediatric practice log to track number of providers offering Asthma Link. |
| Adoption of Asthma Link Intervention - Participant | 3 months, 6 months, 12 months | Research staff will assess adoption of the intervention via survey to family at each survey timepoint of study to assess ability to obtain 2 inhalers (one for home and one for school) and deliver medicine to school. |
| Adoption of Asthma Link Intervention - School Nurse | Baseline, 3 months, 6 months, 12 months | Research staff will assess adoption of the intervention via school nurse log to track family bringing in medicine to school and frequency of child coming to nurses office to receive the medication. |
| Cost Effectiveness of Intervention | School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months | Research staff will use survey questions to assess time and costs for school nurses to review the toolkit and administer the intervention, pediatric providers to implement the program, and parents to participate in the intervention |
| Sustainability of Intervention | 3 months, 6 months, 12 months | Research staff will use a survey questions to parents, pediatric practice staff and school staff |
| Asthma Symptoms - Spirometry | Baseline, 3 months, 6 months, 12 months | Research staff will assess asthma symptoms utilizing spirometry to measure Forced Expiratory Volume. |
| Asthma Symptoms - Asthma Control Test | Baseline, 3 months, 6 months, 12 months | Research staff will assess asthma symptoms utilizing the validated measure: Asthma Control Test (ACT) which consists of parent's assessment of level of control over child's asthma symptoms in the previous 4 weeks. |
| Asthma Symptoms - Maximum Symptoms Days | Baseline, 3 months, 6 months, 12 months | Research staff will assess asthma symptoms utilizing the validated measure: Maximum Symptom Days (the largest value of the number of days in the previous 2 weeks that a parent reports that their child experienced a) cough, wheezing, or shortness of breath, b) slowed activities due to symptoms, or 3)nocturnal awakening due to these symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Asthma Link Site providers will be trained to efficiently discuss school-supervised medication administration with families and school nurses. Providers identify children with poorly controlled asthma and poor medication adherence and offer enrollment in Asthma Link to provide school-supervised asthma therapy. Ongoing communication occurs between the pediatric practice, school nurse and families through electronic medical record messaging and phone communication. Data will be collected at baseline (study entry) and at 3-, 6-and 12-month follow-up.
Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery | 31 |
| Enhanced Usual Care Sites will receive pediatric pulmonologist-delivered training and a workbook for pediatric practices to provide to patients on behavioral strategies to help promote asthma medication adherence. Providers identify children with poorly controlled asthma and poor medication adherence and offer enrollment to this Enhanced Usual Care condition of study (receipt of workbook). Data will also be collected at baseline (study entry) and at 3-, 6-and 12-month follow-up.
Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence. | 35 |
| Total | 66 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Total | Asthma Link |
|---|---|---|---|
| Age, Customized < 18 years | 35 Participants | 66 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 43 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 23 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 22 Participants | 14 Participants |
| Race (NIH/OMB) White | 15 Participants | 23 Participants | 8 Participants |
| Sex: Female, Male Female | 20 Participants | 34 Participants | 14 Participants |
| Sex: Female, Male Male | 15 Participants | 32 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 35 |
| other Total, other adverse events | 0 / 31 | 0 / 35 |
| serious Total, serious adverse events | 0 / 31 | 0 / 35 |
Outcome results
Primary
Intervention Fidelity - Pediatric Practice
Research staff to assess for intervention fidelity within the pediatric practice through a checklist for pediatric staff to assess percentage of eligible children enrolled.
Time frame: Baseline
Population: These numbers reflect the number of patients eligible for the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Link | Intervention Fidelity - Pediatric Practice | 31 Participants |
| Enhanced Usual Care | Intervention Fidelity - Pediatric Practice | 35 Participants |
Primary
Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention
Research staff to assess for intervention fidelity by school nurse report of percentage of enrolled students receiving supervised therapy.
Time frame: Up to end of study, approximately 12 months
Population: Participants in the Enhanced Usual Care group did not receive school supervised therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Link | Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention | 31 Participants |
| Enhanced Usual Care | Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention | 0 Participants |
Primary
Intervention Fidelity - School Nurse and Family Participation
Research staff to assess for intervention fidelity by school nurse checklist of each enrolled child attending daily school nurse sessions and his/her family bringing medication to school.
Time frame: Up to end of study, approximately 12 months
Population: Participants in the Enhanced Usual Care group did not receive school supervised therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Link | Intervention Fidelity - School Nurse and Family Participation | 31 Participants |
| Enhanced Usual Care | Intervention Fidelity - School Nurse and Family Participation | 0 Participants |
Primary
Recruitment Procedures Assessed by Number of Eligible Participants
Research staff will track number of eligible participants who meeting study criteria during the enrollment process.
Time frame: Baseline
Population: These numbers reflect the number of participants who were eligible based on initial screening.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Link | Recruitment Procedures Assessed by Number of Eligible Participants | 66 Participants |
| Enhanced Usual Care | Recruitment Procedures Assessed by Number of Eligible Participants | 55 Participants |
Primary
Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate.
Research staff will track the number of patients that were not enrolled or refused to participate in the study along with the reasons for non-enrollment.
Time frame: Baseline
Population: These numbers reflect the number of eligible participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Link | Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate. | 35 Participants |
| Enhanced Usual Care | Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate. | 20 Participants |
Primary
Recruitment Procedures Assessed by Number of Patients Recruited Into the Study
Research staff will track number of patients recruited into the study after they are assessed for eligibility.
Time frame: Baseline
Population: Overall number of participants analyzed reflects the number of participants who were eligible on initial screen.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Link | Recruitment Procedures Assessed by Number of Patients Recruited Into the Study | 31 Participants |
| Enhanced Usual Care | Recruitment Procedures Assessed by Number of Patients Recruited Into the Study | 35 Participants |
Primary
Recruitment Procedures Assessed by Number of Patients Screened
Research staff will track number of patients screened during enrollment process.
Time frame: Baseline
Population: These numbers reflect the total number of patients screened for eligibility.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Link | Recruitment Procedures Assessed by Number of Patients Screened | 143 Participants |
| Enhanced Usual Care | Recruitment Procedures Assessed by Number of Patients Screened | 208 Participants |
Primary
Retention of Study Participants (Drop Out)
Research staff to track number of participants who drop out of the study and note reasons for not completing study.
Time frame: Up to end of study, approximately 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Link | Retention of Study Participants (Drop Out) | 0 Participants |
| Enhanced Usual Care | Retention of Study Participants (Drop Out) | 0 Participants |
Primary
Retention of Study Participants (Lost to Follow-up)
Research staff to track number of participants lost to follow-up, who did not complete the 12 month study assessment.
Time frame: Up to end of study, approximately 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Link | Retention of Study Participants (Lost to Follow-up) | 4 Participants |
| Enhanced Usual Care | Retention of Study Participants (Lost to Follow-up) | 3 Participants |
Secondary
Acceptability - Participants
Research staff will assess acceptability of the study among stakeholders (parent-child dyads, medical providers, school nurses) via a survey in which we will ask stakeholders to rate each component of the Asthma Link intervention using a study specific Acceptability scale ranging from 1 (strongly disagree) to 5 (strongly agree). Qualitative interviews will be performed with stakeholders at 12 months
Time frame: 3 months, 6 months, 12 months
Secondary
Adoption of Asthma Link Intervention - Medical Provider
Research staff will assess adoption of the intervention via Pediatric practice log to track number of providers offering Asthma Link.
Time frame: Baseline, 3 months, 6 months, 12 months
Secondary
Adoption of Asthma Link Intervention - Participant
Research staff will assess adoption of the intervention via survey to family at each survey timepoint of study to assess ability to obtain 2 inhalers (one for home and one for school) and deliver medicine to school.
Time frame: 3 months, 6 months, 12 months
Secondary
Adoption of Asthma Link Intervention - School Nurse
Research staff will assess adoption of the intervention via school nurse log to track family bringing in medicine to school and frequency of child coming to nurses office to receive the medication.
Time frame: Baseline, 3 months, 6 months, 12 months
Secondary
Asthma Symptoms - Asthma Control Test
Research staff will assess asthma symptoms utilizing the validated measure: Asthma Control Test (ACT) which consists of parent's assessment of level of control over child's asthma symptoms in the previous 4 weeks.
Time frame: Baseline, 3 months, 6 months, 12 months
Secondary
Asthma Symptoms - Maximum Symptoms Days
Research staff will assess asthma symptoms utilizing the validated measure: Maximum Symptom Days (the largest value of the number of days in the previous 2 weeks that a parent reports that their child experienced a) cough, wheezing, or shortness of breath, b) slowed activities due to symptoms, or 3)nocturnal awakening due to these symptoms.
Time frame: Baseline, 3 months, 6 months, 12 months
Secondary
Asthma Symptoms - Spirometry
Research staff will assess asthma symptoms utilizing spirometry to measure Forced Expiratory Volume.
Time frame: Baseline, 3 months, 6 months, 12 months
Secondary
Cost Effectiveness of Intervention
Research staff will use survey questions to assess time and costs for school nurses to review the toolkit and administer the intervention, pediatric providers to implement the program, and parents to participate in the intervention
Time frame: School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months
Secondary
Frequency of Healthcare Utilization Over Time
Research staff will assess the frequency of healthcare utilization (# of emergency room visits, # of hospital admissions, # of oral steroid courses, and # of urgent care visits) due to asthma through parent report on surveys and medical record review.
Time frame: Baseline, 3 months, 6 months, 12 months
Secondary
Medication Adherence
Research staff will assess medication adherence via a survey questions administered to parents and through pharmacy refill data.
Time frame: Baseline, 3 months, 6 months, 12 months
Secondary
School Absences
Research staff will assess school absences via parent report and school nurse report
Time frame: Baseline, 3 months, 6 months, 12 months
Secondary
Sustainability of Intervention
Research staff will use a survey questions to parents, pediatric practice staff and school staff
Time frame: 3 months, 6 months, 12 months