Promoting Partnership and Improving Self-Management for Children With Persistent Asthma

Study Design:

The investigators propose a clinic-based intervention of asthma education and medication
labeling to promote medication knowledge and self-efficacy for adherence among both
caregivers and children. Approximately 40 children with uncontrolled persistent asthma and
their caregivers will be enrolled prior to outpatient visits for asthma care (well child care
or asthma-specific visits; total of 80 participants). After the scheduled encounter with a
provider has concluded, enrolled dyads will receive an intervention of nurse-delivered asthma
education and medication labeling. Dyads will then be followed prospectively for 3 months
after the index visit. This follow-up period will include a clinic-based follow-up with a
repeat of the intervention (1 month after enrollment, consistent with the follow-up interval
suggested by national guidelines for uncontrolled asthma) and a second follow-up by telephone
(2 months after clinic follow-up). Families will be invited to complete an additional
in-depth interview following the 1 month clinic follow-up.

Subjects and Setting:

Children and adolescents 7-14 years of age will be screened for eligibility at a single
ambulatory care location: the Golisano Children's Hospital Pediatric Practice, a National
Committee for Quality Assurance (NCQA) accredited patient centered medical home (PCMH) in
urban Rochester, New York. The investigators plan to enroll a convenience sample of 40 dyads
of caregivers/children (total of 80 subjects) over an 8 month period. Children and
adolescents will be enrolled equally from two age-based categories (7-10 years, 11-14 years).
The range of child/adolescent ages is intended to select families with a range of shared
responsibility for asthma medication use between the caregiver and child/adolescent. Some
children independently use medications as early as six years old. On average, children bear
half of the responsibility for controller medication use by age 11 years and have more
responsibility than caregivers after age 13 years. Given these data, the specified age-based
sub-groups are structured to reflect family dynamics in which children have <50% of
responsibility for medications (7-10 years old) and ≥50% of responsibility for medications
(11-14 years).

Study Procedures:

Screening Procedures: Screening will occur in a rolling fashion from January 2018 through
August 2018. The investigators will identify potentially eligible children through a weekly
review of pediatric clinic patients ages 7-14 years old who are (1) scheduled for well-child
or asthma care over the following week, (2) have persistent asthma on their problem list, (3)
have a current (within the last year) prescription for an inhaled controller medication, and
(4) are covered by Medication or a Medicaid managed care program. After the reports are
furnished, Dr. Frey will conduct a brief review of the patient's chart to determine whether
key eligibility criteria are met (no known language barriers, no other significant medical or
developmental conditions). Remaining eligibility criteria (i.e. determination of
persistent/uncontrolled asthma per NHLBI guidelines) will be assessed during a single
screening phone call prior to the scheduled visit, or by approaching caregivers at the time
of scheduled visits if we are unable to reach caregivers by phone.

Baseline Assessment: The baseline survey assessment will be conducted following enrollment by
the team research assistant within a private space in the clinic. All survey instruments will
be available in English, and questions will be read aloud to the caregiver and child. If the
baseline semi-structured survey is not completed before the provider encounter, caregivers
will be given the option to complete the baseline either (a) before leaving clinic, or (b)
over the telephone; completion in the clinic will be preferred so that children/adolescents
can be separately interviewed in the presence of their caregivers.

Medication Selection and Delivery: Providers will be notified that their patients are
enrolled into the program, and will be tasked with determining whether any changes in daily
controller medications are indicated. The provider will electronically transmit prescriptions
for both rescue and controller medications to the Strong Outpatient Pharmacy, located within
the same building as the Pediatric Practice. All asthma prescriptions will be filled at this
pharmacy during the trial in order to ensure that medications will be available for labeling
in clinic, and parents will be informed of this during the consent process. The research
assistant will call the pharmacy to notify them of new prescriptions; once these asthma
prescriptions are filled, they pharmacy will send them to the Pediatrics Practice via the
institution's pneumatic tube system. Any prescription medications that are not directly
related to asthma management (including adjuvant therapies for allergic rhinitis) would be
sent to the pharmacy of their choosing for normal processing and patient pick-up.

Nurse-delivered Education: The nurse will give the educational intervention after the
provider encounter concludes. Nurses will be trained in intervention delivery and national
asthma guidelines by Dr. Frey and Cindy Trubisky, Senior Director of Health Education for the
American Lung Association (ALA) in Rochester, NY. This intervention will be directed toward
both the caregiver and the child.

1. The nurse will give the parent and child a brief, scripted overview of asthma, and
discuss asthma control, asthma triggers, and indications for using inhaled controller
vs. rescue medications.

2. Parents will be given simple, written information about asthma and asthma management
designed for low health-literacy audiences, specifically written at or below 6th grade
reading levels, including:

1. Information on appropriate metered dose inhaler (MDI)/ spacer technique

2. An updated asthma action plan, with clear indications for when to use each inhaled
medication (i.e., controller vs. rescue medications).

3. A list of other local asthma resources and smoking cessation resources (as
appropriate) will be given to caregivers

3. The nurse will provide colored medication labels to distinguish controller from rescue
medications, following the action plan color scheme (green labels for controller
medications, red labels for rescue medications). These labels will be applied to
medications by the child/adolescent in clinic under nurse supervision.

1. If medications are not filled in the Strong Outpatient Pharmacy and thus not
available during the educational session, labels and instructions will be provided
for patients to label medications at home. Care coordinators will follow-up with
families to ensure appropriate labeling in this situation.

2. Teach-back methods will be used to elicit understanding of correct indications of
use for each medication (patient and caregiver).

4. The nurse will demonstrate the technique for MDI medications using a spacer, with
teach-back performed by both the patient and caregiver.

5. They will discuss age-appropriate caregiver and child responsibility for asthma
management within the family, with an overview of transitioning responsibility designed
to reinforce the cooperative participation of both patients and caregivers.

6. Patients will be asked to make a 1 month follow-up appointment for asthma care.

Care Coordination: Pediatric practice care coordinators will contact all enrolled patient
families by telephone 1 week prior to the scheduled follow-up appointment. In addition to
functioning as a personalized reminder of the upcoming appointment, this phone call will also
allow care coordinators to identify any surmountable barriers to scheduled care and remind
families to bring all of the child's asthma medications to the visit.

Follow-Up Assessments: The study, including all follow-up assessments, will continue until
the end of the 2018 calendar year. After the baseline assessment, each patient will have two
additional follow-ups. The first will be completed in clinic, approximately 1 month (~4-6
weeks) after the baseline visit. As all enrolled patients will have symptomatic or poorly
controlled persistent asthma, this follow-up interval is appropriate and supported by NHLBI
guidelines.(2) A brief follow-up survey will be conducted prior to the provider encounter,
and will include a repeat assessment of key measures from the baseline assessment. Additional
asthma education will be repeated at this clinic visit, with a specific emphasis on
reinforcing both the medication teaching and the importance of dyadic co-management. Asthma
medication refills will be delivered to clinic and labeled with stickers as necessary. The
second follow-up will occur approximately 2 months after the follow-up clinic visit (3 months
after baseline), and will be a semi-structured interview conducted over the phone by the
research assistant.

In-depth Interviews: During the clinic follow-up, caregivers and children will be invited to
separately participate in in-depth interviews before leaving clinic; this use of qualitative
research methods will allow for an enhanced understanding of family behaviors around
medication management. The interview guide will specifically explore respondent thoughts on
medication identification, the parent-to-child transfer of responsibility for medication use,
and the usefulness of different intervention components. Interviews will be conducted in
clinic if possible or over the phone if necessary; audio recordings will be transcribed.
Thematic analysis will be conducted on interview transcripts until theoretical saturation is
achieved within each subgroup of child/adolescent ages.

Compensation: Each participating caregiver/child dyad will receive $25 after completion of
the initial baseline assessment and clinic visit in the form of a prepaid debit card.
Participants will be paid an additional $25 after each follow-up assessment (one in clinic,
one by phone), and a final payment of $25 will be available for any dyads that decide to
participate in optional qualitative data collection (in-depth interviews). After the
telephone follow-up, payment will be sent via mail. Total payment will be no more than $100
per dyad.

Inclusion Criteria: (all 5 criteria must be met)

1. Physician diagnosis of asthma, based on review of medical records.

2. Uncontrolled asthma consistent with National Heart, Lung, and Blood Institute (NHLBI)
guidelines, with at least 1 of the following based on caregiver report:

a. If the child is 7-11 years old: i. An average of >2 days per week with asthma
symptoms ii. >2 days per week with rescue medication use iii. >2 days per month with
nighttime symptoms iv. ≥2 episodes of asthma during the past year that have required
systemic corticosteroids b. If the child is 12-14 years old: i. An average of >2 days
per week with asthma symptoms ii. >2 days per week with rescue medication use iii.
Nighttime symptoms 1-3 times per week iv. ≥2 episodes of asthma during the past year
that have required systemic

3. The child must have a current prescription (within the past year) of an inhaled asthma
controller medication, such as an inhaled corticosteroid (ICS), based on review of
electronic medical records.

4. The child/adolescent is between ≥7 and ≤14 years old.

5. The child/adolescent is insured by Medicaid or Medicaid managed care program.

Exclusion Criteria:

1. An inability to speak and understand English. Parents and children with low literacy /
health-literacy skills will be eligible, as survey instruments will be administered
verbally and educational materials will be designed for low-literacy populations.

2. No access to a working phone for follow-up, including care coordinator calls and the
final follow-up survey.

3. Another significant medical condition identified in the child's medical record that
could interfere with assessment of asthma control, including Cystic Fibrosis,
congenital heart disease, or other chronic pulmonary disease.

4. A diagnosed developmental condition (e.g. Autism spectrum disorder or significant
developmental delay) identified in the child's medical record that could impact the
transition of responsibility for inhaled asthma medications from caregiver to child.

5. If the child or family is currently enrolled in a study conducted by The Preventive
Care Program for Urban Children with Asthma (led by Dr. Jill Halterman).