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| ID | Type | Description | Link |
|---|---|---|---|
| AS-1307-05584 | Other Identifier | Patient-Centered Outcomes Research Institute (PCORI) |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic-based care coordination | Experimental | 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. |
|
| Home-based care coordination | Active Comparator | 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. |
|
| Usual care | No Intervention | Clinician-centric strategy and EMR-based clinician decision support |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supporting Asthma Management Behaviors in Aging Adults (SAMBA) | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Federman, MD,MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Family Health | New York | New York | 10003 | United States | ||
| Mount Sinai-St. Luke's Roosevelt Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32812836 | Derived | 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. | |
| 31180474 | Derived |
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Enrollment period from 2015 to 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinic-based Care Coordination | Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC 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. |
| FG001 | Home-based Care Coordination | 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). 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. |
| FG002 | Usual Care | Clinician-centric strategy and EMR-based clinician decision support |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Only those who received the allocated intervention were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Clinician-centric strategy and EMR-based clinician decision support |
| BG001 | Home-based Care Coordination | 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). The 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | only those who completed the respective study visits were included in the data results | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, and 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home-based Care Coordination | 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). The 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alex Federman | Icahn School of Medicine at Mount Sinai | 212-824-7565 | alex.federman@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2016 | Dec 10, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2016 | Dec 10, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
|
| 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 |
| New York |
| New York |
| 10025 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| 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. |
| COPD Diagnosis |
|
| Reside outside study area |
|
| No asthma |
|
| Discontinued by PI |
|
| BG002 | Clinic-based Care Coordination | Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Limited English Proficiency | Count of Participants | Participants |
|
| Monthly Household Income <$1350 | Count of Participants | Participants |
|
| Married or Partner | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Physical Impairment, severe | Count of Participants | Participants |
|
| Cognitive Impairment | Count of Participants | Participants |
|
| Moderate-severed Depression | Count of Participants | Participants |
|
| Diabetes Mellitus Co-morbid Medical Condition | Count of Participants | Participants |
|
| High Cholesterol Co-morbid Medical Condition | Count of Participants | Participants |
|
| Hypertension Co-morbid Medical Condition | Count of Participants | Participants |
|
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). The 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.
| OG001 | Clinic-based Care Coordination | Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC 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. |
| OG002 | Usual Care | Clinician-centric strategy and EMR-based clinician decision support |
|
|
| Secondary | 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. | only those who completed the respective study visits were included in the data results | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, and 12 months |
|
|
|
| Secondary | 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. | only those who completed the study at 12 months were included for the data results for the 12 month mark | Posted | Number | percentage of participants | 12 months |
|
|
|
| Secondary | 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 | only those who completed the respective study visits were included in the data results | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, and 12 months |
|
|
|
| Secondary | Number of Participants With Correct MDI Technique | Number of participants demonstrating MDI technique, correctly completed steps at 12 months as compared to baseline | only those who completed the study at 12 months were included for the data results for the 12 month mark | Posted | Count of Participants | Participants | baseline and 12 months |
|
|
|
| 0 |
| 128 |
| 0 |
| 128 |
| 0 |
| 128 |
| EG001 | Clinic-based Care Coordination | Supporting Asthma Management Behaviors in Aging Adults (SAMBA): The SAMBA program will be led by an asthma care coach (ACC). The ACC 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. | 0 | 129 | 0 | 129 | 0 | 129 |
| EG002 | Usual Care | Clinician-centric strategy and EMR-based clinician decision support | 0 | 134 | 0 | 134 | 0 | 134 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| 3 months |
|
|
| 6 months |
|
|
| 12 months |
|
|
| Title | Measurements |
|---|---|
|
| 3 months |
|
|
| 6 months |
|
|
| 12 months |
|
|
| 12 months |
|
|