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Supporting Asthma Management Behaviors in Aging Adults (SAMBA)

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Mount Sinai Health System

Status

Completed

Conditions

Asthma

Treatments

Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)

Study type

Interventional

Funder types

Other

Identifiers

NCT02316223
GCO 13-1401
AS-1307-05584 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

406 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

406 participants in 3 patient groups

Clinic-based care coordination
Experimental group
Description:
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.
Treatment:
Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)
Home-based care coordination
Active Comparator group
Description:
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.
Treatment:
Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)
Usual care
No Intervention group
Description:
Clinician-centric strategy and EMR-based clinician decision support

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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