Clinical trial NCT02258308: CDC Medicaid Asthma Home Visit Project
Official title: Medicaid Asthma Home Visit Project: Improving Health and Reducing Costs of Health Care for Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Public Health - Seattle and King County
Sponsor class: OTHER_GOV
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2014-10-07
Enrollment: 373
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Asthmatic children age 3-17 from low income households in King County are randomly assigned into a community health worker (CHW) intervention group and a control group. The intervention is in-home education and support related to asthma self-management. The main outcome measures are asthma symptom-free days, caretaker's asthma-related quality of life score, and health care utilization for asthma measured at baseline and 12 months after baseline enrollment.

Detailed description: This is a randomized controlled trial. Potentially eligible subjects come from lists generated by health plans (Community Health Plan of Washington and Molina, who insure the majority of Medicaid enrollees in King County), individuals referred by primary care providers, and self referral. Eligible subjects that agree to participate are randomly assigned into a CHW intervention group or a control group. We expected to complete the study with 200 in each group.

The intervention is in-home education and support by a community health worker (CHW). At the first home visit, the CHW assesses the participant's knowledge and skills related to asthma self-management, current status of the child's asthma, and resources and support for asthma self-management using a baseline questionnaire. The CHW inspects the home environment using an Environmental Home Checklist to identify environmental triggers that can cause asthma symptoms and affect asthma control. The CHW makes up to three follow-up visits and two telephone visits during the year the participant is in the study. Participants receive resources to help them control asthma, including vacuum cleaner, dust covers for a pillow and mattress and a "green" cleaning kit with cleaning supplies.

The control group receives standard asthma care, as provided by a primary health care provider during the 12 months after enrollment. When the intervention period is over, the control group receives one visit with a CHW and the resources provided to the intervention group participants.

The main outcome variables include asthma symptom-free days, caretaker asthma-related quality of life, and urgent health care utilization.

Eligibility criteria: Inclusion Criteria:

* caretaker is age 18 or older and child is age 3-17
* have not controlled as thma
* residence in King County
* spoken language is English or Spanish
* Child is enrolled in a Medicaid managed care health plan offered by Community Health Plan of Washington (CHPW) or Molina Health Plan of Washington, Inc (Molina).

Exclusion Criteria:

* Parent/guardian plans to move out of King County within the next year or lacks permanent housing.
* Parent/guardian has a mental or physical disability making it impossible to participate in the protocols.
* The household appears to be unsafe for visitation by the CHW.
* The child has other serious chronic medical conditions (e.g. poorly controlled sickle cell disease, cystic fibrosis) that cause sufficient limitation in functional status so that that asthma control is not a priority.
* The family is enrolled in another asthma research study within the past three years. This is to avoid the potential confounding effect from other studies.
* The child is in foster care or group care settings.

Primary outcomes:
measure: Asthma symptom free days
timeFrame: last 14 days
measure: Caretaker quality of life
timeFrame: last week
measure: Health care utilization for asthma
timeFrame: 12 months
measure: cost analysis
timeFrame: 12 months
Secondary outcomes:
measure: nights with asthma symptoms
timeFrame: 14 days
measure: days with activity limitation due to asthma
timeFrame: 14 days
measure: days used asthma rescue medicine
timeFrame: 14 days
measure: asthma episodes
timeFrame: 3 months
measure: asthma control level
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References:
citation: Campbell JD, Brooks M, Hosokawa P, Robinson J, Song L, Krieger J. Community Health Worker Home Visits for Medicaid-Enrolled Children With Asthma: Effects on Asthma Outcomes and Costs. Am J Public Health. 2015 Nov;105(11):2366-72. doi: 10.2105/AJPH.2015.302685. Epub 2015 Aug 13.