Promoting Partnership and Improving Self-Management for Children With Persistent Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The goal of this study is to evaluate a pilot of clinic-based intervention of asthma
      education. After a scheduled outpatient encounter for well-child care or asthma care has
      concluded, a pediatric nurse will teach participants (children and their caregivers) about
      asthma, provide clearly written information about how to manage asthma, and discuss how to
      manage asthma at home with cooperation between caregivers and children. Families will also
      receive current asthma prescriptions in clinic, and colored labels will be attached to
      medications in order to match the color scheme of asthma action plans (green labels for
      controller medications, red labels for rescue medications). Families will be followed for 3
      months after the first clinic visit, including a follow-up visit in clinic 1 month later and
      a follow-up telephone call 3 months after starting. The nurse will reinforce key educational
      points and review medication use at the follow-up clinic visit. Families will also be invited
      to complete an additional in-depth interview following the 1 month clinic follow-up. The
      investigator hypothesizes that knowledge, self-efficacy, and reported adherence with asthma
      medications will increase for both caregivers and children/adolescents following the
      intervention and labeling of delivered medications. In addition, the investigator
      hypothesizes that children/adolescents will have more symptom free days and improved control
      following the intervention.
    

Detailed description: 
      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.
    

Intervention name(s): Nurse-delivered education
Intervention type(s): Other
Intervention description(s): The nurse will:
Give the caregiver and child an overview of asthma, and discuss asthma control, triggers, and medications.
Give caregivers information about asthma management written at or below 6th grade reading levels.
Provide colored medication labels to distinguish controller from rescue medications following the action plan color scheme (green for controller medications, red for rescue medications). Teach-back methods will be used to elicit understanding of correct indications of use.
Demonstrate MDI/spacer technique with teach-back.
Discuss age-appropriate caregiver and child responsibility for asthma management within the family, with an overview of transitioning responsibility.
Ask patients to make a 1 month follow-up appointment for asthma care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research