Asthma
Conditions
Keywords
asthma, high-risk, adult, elderly, care coordination, community health worker, electronic medical record
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.
Interventions
BEHAVIORALSupporting 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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control Test (ACT) | baseline, 3 months, 6 months, and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini Asthma Quality of Life Questionnaire (AQLQ) | baseline, 3 months, 6 months, and 12 months | 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. |
| Change in Percent of Patients With >=1 Emergency Dept Visits | 12 months | 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. |
| Medication Adherence Rating Scale (MARS) | baseline, 3 months, 6 months, and 12 months | 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 |
| Number of Participants With Correct MDI Technique | baseline and 12 months | Number of participants demonstrating MDI technique, correctly completed steps at 12 months as compared to baseline |
Countries
United States
Participant flow
Recruitment details
Enrollment period from 2015 to 2017
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Clinician-centric strategy and EMR-based clinician decision support | 134 |
| 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. | 128 |
| 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. | 129 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | COPD Diagnosis | 3 | 2 | 3 |
| Overall Study | Discontinued by PI | 11 | 19 | 3 |
| Overall Study | Lack of Efficacy | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 27 | 34 | 36 |
| Overall Study | No asthma | 2 | 0 | 0 |
| Overall Study | Reside outside study area | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Home-based Care Coordination | Clinic-based Care Coordination | Total |
|---|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 8.1 | 67.8 years STANDARD_DEVIATION 7.4 | 66.5 years STANDARD_DEVIATION 6.4 | 67.3 years STANDARD_DEVIATION 7 |
| Age, Customized 60-69 | 88 Participants | 84 Participants | 98 Participants | 270 Participants |
| Age, Customized 70-79 | 27 Participants | 32 Participants | 24 Participants | 83 Participants |
| Age, Customized 80+ | 19 Participants | 12 Participants | 7 Participants | 38 Participants |
| Cognitive Impairment | 75 Participants | 63 Participants | 66 Participants | 204 Participants |
| Diabetes Mellitus Co-morbid Medical Condition | 52 Participants | 44 Participants | 57 Participants | 153 Participants |
| Education Level College graduate | 13 Participants | 22 Participants | 27 Participants | 62 Participants |
| Education Level High school graduate | 27 Participants | 31 Participants | 24 Participants | 82 Participants |
| Education Level Less than high school | 63 Participants | 50 Participants | 50 Participants | 163 Participants |
| Education Level Some college | 31 Participants | 25 Participants | 28 Participants | 84 Participants |
| High Cholesterol Co-morbid Medical Condition | 74 Participants | 70 Participants | 66 Participants | 210 Participants |
| Hypertension Co-morbid Medical Condition | 106 Participants | 88 Participants | 89 Participants | 283 Participants |
| Limited English Proficiency | 52 Participants | 49 Participants | 43 Participants | 144 Participants |
| Married or Partner | 39 Participants | 33 Participants | 22 Participants | 94 Participants |
| Moderate-severed Depression | 10 Participants | 12 Participants | 10 Participants | 32 Participants |
| Monthly Household Income <$1350 | 86 Participants | 87 Participants | 89 Participants | 262 Participants |
| Physical Impairment, severe | 22 Participants | 16 Participants | 20 Participants | 58 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 43 Participants | 37 Participants | 39 Participants | 119 Participants |
| Race/Ethnicity, Customized Hispanic | 76 Participants | 74 Participants | 70 Participants | 220 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 5 Participants | 9 Participants | 23 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 6 Participants | 12 Participants | 11 Participants | 29 Participants |
| Sex: Female, Male Female | 117 Participants | 109 Participants | 107 Participants | 333 Participants |
| Sex: Female, Male Male | 17 Participants | 19 Participants | 22 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 128 | 0 / 129 | 0 / 134 |
| other Total, other adverse events | 0 / 128 | 0 / 129 | 0 / 134 |
| serious Total, serious adverse events | 0 / 128 | 0 / 129 | 0 / 134 |
Outcome results
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.
Time frame: baseline, 3 months, 6 months, and 12 months
Population: only those who completed the respective study visits were included in the data results
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based Care Coordination | Change in Asthma Control Test (ACT) | Baseline | 15.0 score on a scale | Standard Deviation 3.8 |
| Home-based Care Coordination | Change in Asthma Control Test (ACT) | 3 months | 16.6 score on a scale | Standard Deviation 4.4 |
| Home-based Care Coordination | Change in Asthma Control Test (ACT) | 6 months | 16.8 score on a scale | Standard Deviation 4.3 |
| Home-based Care Coordination | Change in Asthma Control Test (ACT) | 12 months | 17.4 score on a scale | Standard Deviation 4.8 |
| Clinic-based Care Coordination | Change in Asthma Control Test (ACT) | 12 months | 16.9 score on a scale | Standard Deviation 4.7 |
| Clinic-based Care Coordination | Change in Asthma Control Test (ACT) | Baseline | 14.6 score on a scale | Standard Deviation 4 |
| Clinic-based Care Coordination | Change in Asthma Control Test (ACT) | 6 months | 15.8 score on a scale | Standard Deviation 4.4 |
| Clinic-based Care Coordination | Change in Asthma Control Test (ACT) | 3 months | 15.7 score on a scale | Standard Deviation 4.4 |
| Usual Care | Change in Asthma Control Test (ACT) | 12 months | 16.1 score on a scale | Standard Deviation 4.3 |
| Usual Care | Change in Asthma Control Test (ACT) | 3 months | 14.6 score on a scale | Standard Deviation 4.8 |
| Usual Care | Change in Asthma Control Test (ACT) | 6 months | 14.6 score on a scale | Standard Deviation 4.9 |
| Usual Care | Change in Asthma Control Test (ACT) | Baseline | 14.3 score on a scale | Standard Deviation 4 |
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.
Time frame: 12 months
Population: only those who completed the study at 12 months were included for the data results for the 12 month mark
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Home-based Care Coordination | Change in Percent of Patients With >=1 Emergency Dept Visits | Baseline | 13.1 percentage of participants |
| Home-based Care Coordination | Change in Percent of Patients With >=1 Emergency Dept Visits | 12 months | 7.7 percentage of participants |
| Clinic-based Care Coordination | Change in Percent of Patients With >=1 Emergency Dept Visits | Baseline | 9.3 percentage of participants |
| Clinic-based Care Coordination | Change in Percent of Patients With >=1 Emergency Dept Visits | 12 months | 6.2 percentage of participants |
| Usual Care | Change in Percent of Patients With >=1 Emergency Dept Visits | Baseline | 9.7 percentage of participants |
| Usual Care | Change in Percent of Patients With >=1 Emergency Dept Visits | 12 months | 12.7 percentage of participants |
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
Time frame: baseline, 3 months, 6 months, and 12 months
Population: only those who completed the respective study visits were included in the data results
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based Care Coordination | Medication Adherence Rating Scale (MARS) | Baseline | 3.6 score on a scale | Standard Deviation 0.7 |
| Home-based Care Coordination | Medication Adherence Rating Scale (MARS) | 3 months | 3.9 score on a scale | Standard Deviation 0.6 |
| Home-based Care Coordination | Medication Adherence Rating Scale (MARS) | 6 months | 3.9 score on a scale | Standard Deviation 0.7 |
| Home-based Care Coordination | Medication Adherence Rating Scale (MARS) | 12 months | 3.8 score on a scale | Standard Deviation 0.8 |
| Clinic-based Care Coordination | Medication Adherence Rating Scale (MARS) | 12 months | 4.0 score on a scale | Standard Deviation 0.7 |
| Clinic-based Care Coordination | Medication Adherence Rating Scale (MARS) | Baseline | 3.7 score on a scale | Standard Deviation 0.6 |
| Clinic-based Care Coordination | Medication Adherence Rating Scale (MARS) | 6 months | 4.0 score on a scale | Standard Deviation 0.7 |
| Clinic-based Care Coordination | Medication Adherence Rating Scale (MARS) | 3 months | 3.9 score on a scale | Standard Deviation 0.6 |
| Usual Care | Medication Adherence Rating Scale (MARS) | 12 months | 3.8 score on a scale | Standard Deviation 0.7 |
| Usual Care | Medication Adherence Rating Scale (MARS) | 3 months | 3.8 score on a scale | Standard Deviation 0.7 |
| Usual Care | Medication Adherence Rating Scale (MARS) | 6 months | 3.8 score on a scale | Standard Deviation 0.7 |
| Usual Care | Medication Adherence Rating Scale (MARS) | Baseline | 3.8 score on a scale | Standard Deviation 0.7 |
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.
Time frame: baseline, 3 months, 6 months, and 12 months
Population: only those who completed the respective study visits were included in the data results
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based Care Coordination | Mini Asthma Quality of Life Questionnaire (AQLQ) | Baseline | 4.4 score on a scale | Standard Deviation 1.2 |
| Home-based Care Coordination | Mini Asthma Quality of Life Questionnaire (AQLQ) | 3 months | 4.8 score on a scale | Standard Deviation 1.8 |
| Home-based Care Coordination | Mini Asthma Quality of Life Questionnaire (AQLQ) | 6 months | 4.9 score on a scale | Standard Deviation 1.2 |
| Home-based Care Coordination | Mini Asthma Quality of Life Questionnaire (AQLQ) | 12 months | 4.9 score on a scale | Standard Deviation 1.3 |
| Clinic-based Care Coordination | Mini Asthma Quality of Life Questionnaire (AQLQ) | 12 months | 4.8 score on a scale | Standard Deviation 1.4 |
| Clinic-based Care Coordination | Mini Asthma Quality of Life Questionnaire (AQLQ) | Baseline | 4.4 score on a scale | Standard Deviation 1.2 |
| Clinic-based Care Coordination | Mini Asthma Quality of Life Questionnaire (AQLQ) | 6 months | 4.5 score on a scale | Standard Deviation 1.4 |
| Clinic-based Care Coordination | Mini Asthma Quality of Life Questionnaire (AQLQ) | 3 months | 4.6 score on a scale | Standard Deviation 1.2 |
| Usual Care | Mini Asthma Quality of Life Questionnaire (AQLQ) | 12 months | 4.6 score on a scale | Standard Deviation 1.3 |
| Usual Care | Mini Asthma Quality of Life Questionnaire (AQLQ) | 3 months | 4.3 score on a scale | Standard Deviation 1.3 |
| Usual Care | Mini Asthma Quality of Life Questionnaire (AQLQ) | 6 months | 4.3 score on a scale | Standard Deviation 1.3 |
| Usual Care | Mini Asthma Quality of Life Questionnaire (AQLQ) | Baseline | 4.3 score on a scale | Standard Deviation 1.1 |
Secondary
Number of Participants With Correct MDI Technique
Number of participants demonstrating MDI technique, correctly completed steps at 12 months as compared to baseline
Time frame: baseline and 12 months
Population: only those who completed the study at 12 months were included for the data results for the 12 month mark
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home-based Care Coordination | Number of Participants With Correct MDI Technique | Baseline | 77 Participants |
| Home-based Care Coordination | Number of Participants With Correct MDI Technique | 12 months | 54 Participants |
| Clinic-based Care Coordination | Number of Participants With Correct MDI Technique | Baseline | 71 Participants |
| Clinic-based Care Coordination | Number of Participants With Correct MDI Technique | 12 months | 55 Participants |
| Usual Care | Number of Participants With Correct MDI Technique | Baseline | 86 Participants |
| Usual Care | Number of Participants With Correct MDI Technique | 12 months | 55 Participants |