Supporting Asthma Management Behaviors in Aging Adults

Study Overview
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Brief Summary
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A 3-arm, patient-randomized trial among Latino and African-American older adults with poorly-controlled asthma will be conducted to compare the effectiveness of clinic-based vs. home-based asthma care coordination / self-management support (CC/SMS) vs. usual care.

Detailed Description
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Older asthmatics experience worse outcomes than younger adults, especially if they identify as Latino or African-American. Several factors contribute to worse outcomes in these populations including frailty, cognitive impairment, managing multiple chronic diseases and multiple daily medications, low health literacy and English proficiency, high healthcare costs, and misunderstandings about asthma. To our knowledge, there are no programs designed to help older asthmatics manage their illness. In order to address these factors two emerging patient-centered strategies, clinic- and home-based care coordination and self-management support led by an Asthma Care Coach (ACC) and a community health worker (CHW), respectively, will be tested. These strategies will be combined a clinician-centered strategy, use of electronic medical record (EMR)-based asthma decision support that guides medication prescribing, basic counseling, and provision of asthma action plans. Specific aims are: To compare the effectiveness of (1) ACC/clinic- or (2) CHW/home-based asthma care coordination and self-management support with (3) no care coordination/self-management support (usual care) for improving asthma-related outcomes; To identify subsets of individuals who have greater benefit from home-based care coordination and self-management support compared to clinic-based support. A 3-arm, randomized trial will be conducted among 450 adult asthmatics ages 60 and older at primary care practices in East and Central Harlem and the South Bronx. All patients, regardless of assignment, will receive care from primary care providers (PCP) with access to the EMR-based asthma decision support. Patients in the ACC and CHW arms will be assessed for barriers to asthma control and will receive support specifically tailored to the identified barriers, including those arising from physical, mental, social/economic, or cognitive issues. Program participation will be 12 months, during which the ACCs and CHWs will also work with the patients' PCPs to optimize care. The study team will engage stakeholders (patients and caregivers, clinicians, community-based organizations, others) to develop and prepare study materials and protocols. In addition to studying patient outcomes, the process of implementing these models of care will be evaluated and documented. Patients in the ACC and CHW arms will have similar asthma outcomes (asthma control, quality of life, use of urgent care, appointment keeping, medication adherence, use of asthma actions plans). Compared to usual care, patients in the ACC and CHW arms will perform better on these outcomes. Patients with more severe asthma and those at greater risk of missed clinic appointments because of physical or cognitive impairment and psychosocial issues (e.g., substance abuse, mental illness) will be more likely to benefit from the CHW/home-based intervention.

Official Title
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Clinic-based vs. Home-based Support to Improve Care and Outcomes for Older Asthmatics

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages ≤60 years physician diagnosis of asthma English- or Spanish-speaking Exclusion Criteria: physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or other chronic lung condition ≤15 pack-years enrollment in another asthma self-management program

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinic-based care coordination<br>The ACC and CHW programs for asthma CC/SMS will have the same objectives and provide the same general services at the office/clinic. The ACC and CHW programs were developed from existing, successfully operating programs at the participating sites, and in the East Harlem and South Bronx communities. | Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)<br>* The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). All interventions, including usual care, will include EMR-based asthma self-management and decision support tools for clinicians in all practice sites. The ACC and CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months. Outcomes will be measured through interviews, EMR chart abstractions, and from the Statewide Planning and Research Cooperative System (SPARCS) dataset to identify all ED visits and hospitalizations to any New York State facility.<br>* Other names: SAMBA;|
| Active Comparator: Home-based care coordination<br>The ACC and CHW programs for asthma CC/SMS will have the same objectives and provide the same general services at participant's home. The ACC and CHW programs were developed from existing, successfully operating programs at the participating sites, and in the East Harlem and South Bronx communities. | Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)<br>* The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). All interventions, including usual care, will include EMR-based asthma self-management and decision support tools for clinicians in all practice sites. The ACC and CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months. Outcomes will be measured through interviews, EMR chart abstractions, and from the Statewide Planning and Research Cooperative System (SPARCS) dataset to identify all ED visits and hospitalizations to any New York State facility.<br>* Other names: SAMBA;|
| No Intervention: Usual care<br>Clinician-centric strategy and EMR-based clinician decision support | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Asthma Control Test (ACT) | The Asthma Control Test™ is a quick test for people with asthma 12 years and older. The ACT is a 5 items, with 4-week recall (on symptoms and daily functioning) patient self-administered tool for identifying those with poorly controlled asthma. Each items is scored on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled), The total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. It provides a numerical score to help assess asthma control at 12 months compared to baseline. | baseline, 3 months, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Asthma Quality of Life Questionnaire (AQLQ) | The mini AQLQ is a 15-item self-administered questionnaire, each question scored on a 7-point scale, from 1 (all of the time) to 7 (none of the time) for the first 11 questions, and 1 (totally limited) to 7 (not at all limited) for the last 4 question , with total scale as an average from 1 to 7, with higher score indicating better quality of life or less impairment. | baseline, 3 months, 6 months, and 12 months | 
| Change in Percent of Patients With >=1 Emergency Dept Visits | Percent of patients with one or more acute asthma-related Emergency Department visits at 12 months compared to baseline for participants in Home-based care coordination and Clinic-based care coordination. | 12 months | 
| Medication Adherence Rating Scale (MARS) | Adherence to ICS and leukotriene receptor antagonists will be assessed with the MARS, a 10-item self-reported measure of adherence to inhaler medications at 12 months compared to baseline. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood), with higher score indicating higher likelihood of medication adherence | baseline, 3 months, 6 months, and 12 months | 
| Number of Participants With Correct MDI Technique | Number of participants demonstrating MDI technique, correctly completed steps at 12 months as compared to baseline | baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, high-risk, adult, elderly, care coordination, community health worker, electronic medical record