CDC Medicaid Asthma Home Visit Project

Asthma Clinical Trial

Official title:

Medicaid Asthma Home Visit Project: Improving Health and Reducing Costs of Health Care for Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258308
• Other study ID #: PHSKC
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: April 12, 2017
• Start date: May 2010
• Est. completion date: October 2012

Study information

• Verified date: April 2017
• Source: Public Health - Seattle and King County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• CHW intervention
Home education and support for asthma self management

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Public Health - Seattle and King County	Centers for Disease Control and Prevention

References & Publications (1)

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.2015.30 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma symptom free days	14 - During the past 14 days (that is, during the past fourteen 24 hour periods that include daytime and nighttime), on how many DAYS did your child have any asthma symptoms, such as wheezing, coughing, tightness in the chest, shortness of breath, waking up at night because of asthma symptoms, or slowing down of usual activities because of asthma?	last 14 days
Primary	Caretaker quality of life	Juniper Mini Asthma Quality of Life Questionnaire	last week
Primary	Health care utilization for asthma	number of unscheduled clinic visits+emergency department visits+hospitalization for asthma	12 months
Primary	cost analysis	costs associated with health care utilization for asthma	12 months
Secondary	nights with asthma symptoms	During the nighttime in the past 14 nights, how many nights did your child wake up because of asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough?	14 days
Secondary	days with activity limitation due to asthma	During the past 14 days, how many days did your child have to slow down or stop his/her play or usual activities or missed school because of asthma, wheezing or tightness in the chest, or cough.	14 days
Secondary	days used asthma rescue medicine	During the past 14 days, about how many days did your child use asthma rescue medicine (sometimes called a quick relief medicine) such as albuterol, proventil, or ventolin?	14 days
Secondary	asthma episodes	During the past three months, about how many asthma episodes did your child have?	3 months
Secondary	asthma control level	(% with well controlled asthma and % with very poorly controlled asthma)	14 days