Supporting Asthma Management Behaviors in Aging Adults (SAMBA)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)

Detailed Description

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:

1. 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;
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 406
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10003
      • The Institute for Family Health
    • New York, New York, United States, 10025
      • Mount Sinai-St. Luke's Roosevelt Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinic-based care coordination; 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); 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.; Other Names: SAMBA
Active Comparator: Home-based care coordination; 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); 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.; Other Names: SAMBA
No Intervention: Usual care; Clinician-centric strategy and EMR-based clinician decision support

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Alex Federman, MD,MPH, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• Federman AD, Thanik E, O'Conor R, Arora A, Wolf MS, Wisnivesky JP. Patient characteristics associated with improvements in asthma control and reduction in emergency department visits for older adults with asthma. J Asthma. 2021 Nov;58(11):1528-1535. doi: 10.1080/02770903.2020.1805753. Epub 2020 Aug 19.
• Federman AD, O'Conor R, Mindlis I, Hoy-Rosas J, Hauser D, Lurio J, Shroff N, Lopez R, Erblich J, Wolf MS, Wisnivesky JP. Effect of a Self-management Support Intervention on Asthma Outcomes in Older Adults: The SAMBA Study Randomized Clinical Trial. JAMA Intern Med. 2019 Aug 1;179(8):1113-1121. doi: 10.1001/jamainternmed.2019.1201.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): February 2, 2018
• Study Completion (Actual): February 2, 2018

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 12, 2014

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: adult; asthma; elderly; care coordination; community health worker; high-risk; electronic medical record
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: GCO 13-1401; AS-1307-05584 (Other Identifier: Patient-Centered Outcomes Research Institute (PCORI))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No