Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial

Not Applicable

Completed

• Conditions: Infantile Asthma
• Interventions: Behavioral: CALMA plus; Behavioral: CALMA

• Registration Number: NCT02141893
• Lead Sponsor: University of Puerto Rico

Brief Summary

The aim of this group-randomized trial was to test the effectiveness of a new comprehensive program, which the investigators called CALMA -plus, in increasing controller medication use and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention, plus educational training of physicians and nurses, as well as screening for asthma in clinics serving Medicaid island Puerto Rican children with asthma. Because the provider training was expected to have an impact on the entire clinical setting where trained providers work, as well as the patients using that setting, the investigators randomized clinic groups rather than individual patients. The investigators compared the CALMA-Plus intervention to a CALMA-only group, which the investigators expected to obtain the same benefits as the investigators have previously documented.

Detailed Description

Puerto Rico has high rates of pediatric asthma and morbidity associated in part with poor family asthma management and low rates of controller medication use. A previous study found a family management intervention called CALMA to be effective in reducing asthma symptoms and service utilization. However, CALMA was not effective in increasing the use of controller medications. CALMA- plus was developed to address this issue by adding to CALMA components of educational training of physicians and nurses, and screening for asthma in clinics serving Medicaid Puerto Rican children with persistent asthma. A total of 404 children in eight clinics were studied after forming four pairs of clinics and randomizing the clinics (1:1) to CALMA-only or CALMA-plus within each pair. After adjusting for clinic variation, the study failed to demonstrate that the CALMA-plus intervention was more efficacious than the CALMA- only intervention for increasing reported controller medication use or decreasing symptoms in children with persistent asthma. Both groups had lower rates of asthma symptoms and service utilization consistent with previous results of the CALMA-only intervention. Limitations of the study were small number of clinics available, comparison of the experimental intervention with an evidence based intervention, and limited exposure to some aspects of the intervention. More effective interventions may include aggressive case management, and providing the physician with more relevant information.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-02
• Study Completion: 2013-07
• Status Verified: 2014-05
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-19
• Last Update Submitted: 2014-05-19
• Study First Posted: 2014-05-20
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

Inclusion Criteria

• Inclusion criteria required that the child have at least one claim with a diagnostic code for asthma or reactive airway disease (International Classification of Diseases (ICD 9) diagnostic code 493.xx) and in the last year period had either1) been hospitalized for asthma
• had at least 2 Emergency Department (ED) visits
• 3-5 ambulatory visits due to asthma
• utilized asthma medications from 2 of the following therapeutic categories: Anticholinergics, cromolyn, sympathomimetics, steroid inhalants, methylxanthines, leukotriene inhibitors, or corticosteroids.

Exclusion Criteria

• currently participating in another asthma study
• no appropriate address for follow-up in the claims data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CALMA	CALMA plus	Participants only received a family education intervention (previously tested) known as CALMA
CALMA	CALMA	Participants only received a family education intervention (previously tested) known as CALMA
Calma plus	CALMA plus	Participants in Arm 2 received the CALMA family education intervention and physician education and organizational change of the clinics were addressed with a culturally tailored program developed by adapting content from several evidence-based provider training programs.

Primary Outcome Measures

Name	Time	Method
Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up	Baseline, 12

Secondary Outcome Measures

Name	Time	Method
Change in the Reduction of asthma symptomatology from baseline to 12 month follow-up	baseline, 12

Trial Locations

Locations (1)

Behavioral Sciences Research Institute; 🇵🇷 San Juan, Puerto Rico