Family Learning on Asthma Topics
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      1. Hypothesis: The Family Learning on Asthma Topics (F.L.O.A.T) in the form of a a group
           teaching environment for family education stemming from standardized education materials
           on asthma, created and taught by nationally certified asthma educators will promote
           optimal asthma knowledge, management and quality of life among the individuals with
           asthma and their caregivers.

        2. Aim 1: To determine if the availability of educational services outside of regular
           clinic hours or admission status could improve asthma outcomes and decrease unnecessary
           medical utilization.

        3. Aim 2: By providing small-group learning environments for families, the investigators
           aim to encourage families to learn from each other's experiences and to decrease stigma
           around the disease.
    

Detailed description: 
      I. Hypotheses and Specific Aims:

        1. Hypothesis: The Family Learning on Asthma Topics (F.L.O.A.T) in the form of a a group
           teaching environment for family education stemming from standardized education materials
           on asthma, created and taught by nationally certified asthma educators will promote
           optimal asthma knowledge, management and quality of life among the individuals with
           asthma and their caregivers.

        2. Aim 1: To determine if the availability of educational services outside of regular
           clinic hours or admission status could improve asthma outcomes and decrease unnecessary
           medical utilization.

        3. Aim 2: By providing small-group learning environments for families, the investigators
           aim to encourage families to learn from each other's experiences and to decrease stigma
           around the disease.

      II. Background and Significance:

      Despite recent improvements in treatment and the ongoing research in better understanding of
      the disease, emergency room visits and hospitalization rates for asthma remain high. The
      Centers for Disease Control and Prevention surveillance data reports that at a national
      level, health care use for emergency department services for asthma was 1.6 million in 2013,
      and that of 439,435 hospital admissions for asthma 136,669 or 31% are for children below the
      age of 18 years of age. The annual cost of asthma on the U.S. economy equates to more than
      $80 billion in medical expenses, including days missed from school, work and even death.
      Nurmagambetov, et.al. in their study state that the "combined costs of medical care,
      mortality, and absenteeism render the total cost of asthma a substantial and serious economic
      burden on society. These findings highlight the critical need to support and further
      strengthen asthma control strategies through increased provision of guideline-based care,
      improvements in self-management, and reduction of environmental asthma triggers to reduce ER
      visits, hospitalizations, absenteeism, and mortality".

      Bäuerle et al. used a prospective single-center controlled trial to show that by providing
      motivating and patient-oriented didactics on asthma, there is a statistically significant
      increase in asthma health outcomes and that asthma control can be improved by education
      measures. Although it is a key component of all international asthma guidelines, education in
      self-management is still insufficiently available in primary care settings. In the ambulatory
      setting, there are some families that require more extensive education and time is limited in
      a usual care appointment to address all their specific asthma needs.

      Providing patient education by an experienced asthma educator is an important step in
      supporting patients and families as they are diagnosed with asthma and as they adapt to life
      with a chronic condition. Educating families about the nature of the disease, triggers,
      identification of early signs and symptoms, principles of treatment, and asthma management
      can reduce children's use of acute care services. According to Srof et al., asthma management
      education programs should be connected to the chronic illness management within the fabric of
      the family system. The paradigm of group education supports engagement, promoting
      communication among all participants including facilitator to enhance a social construct for
      validating personal experiences, empowering caregivers, and solving asthma management
      problems.

      III. Preliminary Studies/Progress Report: none

      IV. Research Methods

      A. Outcome Measure(s):

      Decrease emergency room visits, hospitalizations, and systemic steroid use for each child 12
      months after completing the three, group classroom educational sessions.

        1. Description of Population to be Enrolled:

           The investigators will enroll legal guardians and or primary caregiver (18 years and
           older) of children 4-17 years of age along with those children/adolescents who have a
           diagnosis of asthma, and have documented poor control as evidenced by requiring two or
           more systemic steroids, one or more hospitalizations and/or two or more ED visits due to
           asthma in the 12 months prior to the asthma clinic or hospital visit. Patients and
           caregivers will be English or Spanish speaking.

        2. Study Design and Research Methods:

           Patients and caregivers will be recruited from the Pulmonary outpatient clinic and
           inpatient services at Children's Hospital Colorado. Patients will also be referred to
           the Family Learning on Asthma Topic (F.L.O.A.T) program by health care providers
           participating in these clinics/inpatient service. Children will be: 1) 4-17 years age,
           2) have poor evidence of asthma control based on > 2 systemic steroid courses; > 2
           Emergency Room visits; and >1 hospitalization for asthma exacerbation in the preceding
           12 months. The investigators anticipate to enroll 75 patients and enrollment to begin in
           the Spring 2019 through the Spring 2020.

           Family Learning on Asthma Topics classes will aim to emphasize, encourage, and support
           teaching methods that include standardized instructions. There will be three topics
           lasting approximately 45 minutes: General Asthma Knowledge; Asthma Triggers,
           Medications, and Self-Management. These topics were chosen based on the EPR-3 guideline
           recommendations to ensure the continuity of messaging. Each class size will be
           approximately 8 persons and will be taught by a Certified Asthma Educator (AE-C) and
           will be held in the Family Learning Center at the Children's Hospital Colorado. Classes
           will be taught in both English and Spanish. An in person Spanish asthma educator will be
           available to help teach the classes.

           The materials used for each class were created by the CHCO Health Literacy Team in
           collaboration with Asthma Educator Certified members of the Breathing Institute to
           ensure that evidence-based information will be communicated effectively to patients and
           families. Instead of a lecture style course, each class will facilitate interactive
           learning for patients and families to help them prepare for real life problem-solving
           and to promote self-awareness regarding medication use.

           Patient and families enrolled will be notified of the class schedule and receive
           reminders 1 week and the day before each of their classes either through email, phone
           call and or text messaging.

           There will be a general asthma knowledge questionnaire consisting of 12 questions and
           the standardized Asthma Control Test (ACT) that consists of 7 standardized questions,
           one for children 4 - 11 years of age and one for children 12 years and older, that
           participants will fill out at the start of their first class. After each class, there
           will be 4 questions to be answered regarding their understanding of that class. Handouts
           and visuals will be available in English and Spanish pertaining to information about
           that class. Other class materials will include a folder to keep their handouts in and
           paper and pencils for note taking. Peak flow meters and their Asthma Action Plans will
           also be provided. At the completion of the class series there will be a satisfaction
           survey, participants will fill out anonymously.

           Twelve months following the completion of the class series, the investigators will be
           conducting a chart review gathering data on frequency of emergency room visits,
           hospitalizations and systemic steroid use for asthma exacerbations along with any
           routine follow up visits for asthma.

        3. Description, Risks and Justification of Procedures and Data Collection Tools:

      Data collected will be through pre and post class questionnaires, Asthma Control Test (ACT),
      validated Inhaler Technique Assessment Tool (iDAT), and demographic information filled out by
      the families and noted in their EMR (EPIC). Information about participant's asthma care
      utilization and systemic steroid use will be obtained through EMR/EPIC chart review, 12
      months prior to enrollment and 12 months post last completed class. All information will be
      entered in to a secure REDCap data base and paper copies will be kept in the locked research
      cabinet of study personnel.

      E. Potential Scientific Problems: The investigators do not anticipate any scientific problems

      F. Data Analysis Plan:

      Inclusion requirements will be defined through the electronic medical record based on
      inclusion requirements by either the outpatient pulmonary team or inpatient asthma education
      team.

      After enrollment the following information will be placed into RedCap (HIPPA compliant
      database) from the EMR: Childs name, DOB, Race, Ethnicity, Cell phone number, Email, Zip
      Code, Sex, Preferred language (caregiver), Pulmonary or Allergy specialist seen within the
      previous year, Payer, Hospital visits (ED and hospital visits) 12 months prior to consent.

      Right after enrollment a pre-knowledge base survey of 12 questions and asthma control survey
      of 7 questions will be sent via RedCap to caregivers defined phone and email. The data will
      be collected electronically and stored in RedCap.

      Throughout the 4-month study period, every week an administrative support person will pull
      the child's name, caregivers name, designated contact phone number, and email from RedCap
      databased to send a text, email, and phone call reminders of upcoming classes and asking the
      caregiver to reply electronically if they are planning on attending. The administrative
      assistant will review the reply's and notify the educators of the number of class attendees
      and their names.

      Upon completing each of the three classes the instructor will ask for the administrative
      assistant to send a post knowledge bases survey of 4 questions out of RedCap to the primary
      caregiver. The electronic responses will be electronically entered into RedCap.

      Upon completion of the 3 classes and/or 4months the administrative assistant will send a
      post-knowledge survey consisting of 12 questions, an asthma control test survey of 7
      questions, and a satisfaction survey to the primary caregiver. The electronic responses will
      be entered into RedCap.

      Each quarter the overview of pre-knowledge base survey results, post-knowledge survey results
      and satisfaction survey will be reviewed by the team members to evaluate if any changes need
      to be made to the education curriculum.

      Child specific data will be reviewed 12 months after completion of the classes and/or study.

      G. Summarize Knowledge to be Gained:

      By conducting this group focused asthma education series for high risk asthmatics and their
      care givers, the investigators anticipate improved knowledge along with retention of
      knowledge gained through these classes thereby reducing exacerbations, and need for acute
      care interventions. Group centered learning will enhance opportunities to learn from others
      who may have similar experiences and will generate discussion and new skills and ideas.
    

Intervention name(s): Group Classes
Intervention type(s): Other
Intervention description(s): Family Learning on Asthma Topics classes will aim to emphasize, encourage, and support teaching methods that include standardized instructions. There will be three topics lasting approximately 45 minutes: General Asthma Knowledge; Asthma Triggers, Medications, and Self-Management. These topics were chosen based on the EPR-3 guideline recommendations to ensure the continuity of messaging. Each class size will be approximately 8 persons and will be taught by a Certified Asthma Educator (AE-C) and will be held in the Family Learning Center at the Children's Hospital Colorado. Classes will be taught in both English and Spanish.
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Despite recent improvements in treatment and the ongoing research in better understanding
        of the disease, emergency room visits and hospitalization rates for asthma remain high,
        with 31% of these visits are children below the age of 18 years of age.

        Providing patient education by an experienced asthma educator is an important step in
        supporting patients and families as they are diagnosed with asthma and as they adapt to
        life with a chronic condition. Educating families about the nature of the disease,
        triggers, identification of early signs and symptoms, principles of treatment, and asthma
        management can reduce children's use of acute care services.