Supporting Asthma Management Behaviors in Aging Adults

NCT ID: NCT02316223

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-02-02

Brief Summary

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

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Supporting Asthma Management Behaviors in Aging Adults (SAMBA)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Supporting Asthma Management Behaviors in Aging Adults (SAMBA)

Intervention Type: BEHAVIORAL

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.

Usual care

Clinician-centric strategy and EMR-based clinician decision support

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SAMBA

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Federman, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

The Institute for Family Health

New York, New York, United States

Mount Sinai-St. Luke's Roosevelt Hospital Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32812836 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31180474 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AS-1307-05584

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 13-1401

Identifier Type: -

Identifier Source: org_study_id