Promoting Partnership and Improving Self-Management for Children With Persistent Asthma: A Pilot Program of Clinic-Based Asthma Education and Medication Labeling
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Change in caregiver reported adherence from baseline to 1 month and 3 month follow-up
Study Overview
Brief 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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(all 5 criteria must be met)
- •Physician diagnosis of asthma, based on review of medical records.
- •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
- •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.
- •The child/adolescent is between ≥7 and ≤14 years old.
- •The child/adolescent is insured by Medicaid or Medicaid managed care program.
Exclusion Criteria
- •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.
- •No access to a working phone for follow-up, including care coordinator calls and the final follow-up survey.
- •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.
- •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.
- •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).
Arms & Interventions
Asthma education
Intervention: Nurse-delivered education (Other)
Outcomes
Primary Outcomes
Change in caregiver reported adherence from baseline to 1 month and 3 month follow-up
Time Frame: Baseline, 1 month follow-up, 3 month follow-up
Caregiver interview about adherence with controller medication over the previous 2 weeks. We will ask about the number of controller medication doses missed over the previous 2 weeks. As many children are instructed to use controller medications twice every day (once in the morning and once at night), the number of missed doses of controller medication ranges from 0 to 28 doses.
Change in caregiver self-efficacy from baseline to 1 month and 3 month follow-up
Time Frame: Baseline, 1 month follow-up, 3 month follow-up
Parent asthma self-efficacy scale. This is a 13 item survey tool with 2 subscales: attack prevention (questions 1-6) and attack management (questions 7-13). For each question about perceived ability to manage asthma, parents select responses from a 5 point Likert scale (with 1 representing 'not at all sure' and 5 representing 'completely sure'). Responses to items in each subscale are averaged together to generate a subscale score. Higher mean subscale scores indicated increasing parent ability to perform asthma management tasks.
Change in child reported adherence from baseline to 1 month and 3 month follow-up
Time Frame: Baseline, 1 month follow-up, 3 month follow-up
Child interview about adherence with controller medication over the previous 2 weeks. We will ask about the number of controller medication doses missed over the previous 2 weeks. As many children are instructed to use controller medications twice every day (once in the morning and once at night), the number of missed doses of controller medication ranges from 0 to 28 doses.
Change in child self-efficacy from baseline to 1 month and 3 month follow-up
Time Frame: Baseline, 1 month follow-up, 3 month follow-up
Child asthma self-efficacy scale. This is a 14 item survey tool with 2 subscales: attack prevention (questions 1-8) and attack management (questions 9-14). For each question about perceived ability to manage asthma, children select responses from a 5 point Likert scale (with 1 representing 'not at all sure' and 5 representing 'completely sure'). Responses to items in each subscale are averaged together to generate a subscale score. Higher mean subscale scores indicated increasing child ability to perform asthma management tasks.
Secondary Outcomes
- Changes in child report of symptom free days from baseline to 1 month and 3 month follow-up(Baseline, 1 month follow-up, 3 month follow-up)
- Changes in caregiver and child asthma control from baseline to 1 month and 3 month follow-up (children ages 7-11 years)(Baseline, 1 month follow-up, 3 month follow-up)
- Changes in child assessment of asthma control from baseline to 1 month and 3 month follow-up (children 12 years and older).(Baseline, 1 month follow-up, 3 month follow-up)
- Changes in caregiver report of symptom free days from baseline to 1 month and 3 month follow-up(Baseline, 1 month follow-up, 3 month follow-up)
- Changes in caregiver assessment of asthma control from baseline to 1 month and 3 month follow-up (children 12 years and older).(Baseline, 1 month follow-up, 3 month follow-up)
Investigators
Sean Frey
Assistant Professor
University of Rochester