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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Background: Asthma morbidity is high in inner-city minority adults, despite the existence of efficacious therapy. Tailored, patient-centered interventions are needed to improve access to care and patient-provider communication. Access and communication increasingly rely on information technology (IT) as new incentives arise to use the Electronic Health Record (EHR). The EHR patient portal (PP) gives patients web-based communication with providers and practices. How the poor and those with limited educational opportunities can take advantage of these is unclear. In contrast, the investigators have found that home visits (HVs) by community health workers (CHWs) can improve access to care for children and promote caretaker-clinician communication. The investigators also found many inner-city adults have internet access and are willing to learn to use the PP.
Objective: to examine the benefits for adults of using the PP with and without HVs by CHWs who will encourage/facilitate PP use, understand patients' social context, and enhance communication with the medical team. The investigator hypothesize all patients will benefit from PPs, and that the addition of HVs will be particularly helpful for those with low literacy or language barriers. Specific Aims test if the 1-year interventions result in 1) better within-group asthma outcomes, 2) better outcomes in one group over the other, 3) more communication (use of PP) and access (appointments made and kept) which mediate the interventions' effects on asthma outcomes, and 4) effect modification by literacy level, primary language, and convenience of internet access.
Methods: In a randomized controlled trial, 301 adults, predominantly African American and Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods will be assured internet access and taught to use the PP, with and without HVs from a CHW. CHWs will 1) train patients to competency in PP use, 2) enhance care coordination, 3) transmit a view of the complex social circumstances of patients' lives to providers, and 4) make up for differences in patients' health literacy skills.
Patient Outcomes are asthma control, asthma-related quality of life, emergency department (ED) visits, and hospitalizations for asthma or any cause. Together asthma and other health conditions affect patients' ability to perform their daily tasks and care for their families. Potential benefits of the intervention are enhanced patient-clinician communication, access to care, improved health, and ability to use IT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portal training and home visits | Experimental | Portal training and home visits from a community health worker to promote care coordination and use of the patient portal |
|
| portal training | Active Comparator | Participants are assured internet access and taught to use the patient portal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portal training and home visits | Behavioral | patient portal training and home visits by CHW to coordinate care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score of Asthma Control Questionnaire | This is a validated test with 6 items each with Likert score 0 to 6, reflecting symptoms over the past week. Lower score is a better outcome. We measured change in Asthma Control Questionnaire score from baseline to at least 12 months. | baseline and over a year |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma-related Quality of Life | Quality of life is a 15-item questionnaire with 7 point response scale (1-7), higher score is better quality of life. We measured the change from baseline and over a year. | baseline and over a year |
| Emergency Department Visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea J Apter, MD, MSc, MA | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34634975 | Derived | Localio AM, Klusaritz H, Morales KH, Ruggieri DG, Han X, Apter AJ. Primary language and the electronic health record patient portal: Barriers to use among Spanish-speaking adults with asthma. J Asthma. 2022 Oct;59(10):2081-2090. doi: 10.1080/02770903.2021.1989462. Epub 2021 Oct 20. | |
| 31181221 | Derived | Apter AJ, Localio AR, Morales KH, Han X, Perez L, Mullen AN, Rogers M, Klusaritz H, Howell JT, Canales MN, Bryant-Stephens T. Home visits for uncontrolled asthma among low-income adults with patient portal access. J Allergy Clin Immunol. 2019 Sep;144(3):846-853.e11. doi: 10.1016/j.jaci.2019.05.030. Epub 2019 Jun 7. |
| Label | URL |
|---|---|
| Patient Centered Outcomes Research Institute | View source |
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We intended to enroll 300 participants. Because several research coordinators were working at once, and calls were pending to patients, we identified and enrolled and randomized 301 participants..
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| ID | Title | Description |
|---|---|---|
| FG000 | Portal Training and Home Visits | Portal training and home visits from a community health worker to promote care coordination and use of the patient portal Portal training and home visits: patient portal training and home visits by CHW to coordinate care |
| FG001 | Portal Training | Participants are assured internet access and taught to use the patient portal Portal training: training in use of patient portal |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Portal Training and Home Visits | Portal training and home visits from a community health worker to promote care coordination and use of the patient portal Portal training and home visits: patient portal training and home visits by CHW to coordinate care |
| BG001 | Portal Training |
| 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 | Score of Asthma Control Questionnaire | This is a validated test with 6 items each with Likert score 0 to 6, reflecting symptoms over the past week. Lower score is a better outcome. We measured change in Asthma Control Questionnaire score from baseline to at least 12 months. | The result is the mean change in asthma control (lower is improved control) at 12 months from baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline and over a year |
|
One year
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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 | Portal Training and Home Visits | Portal training and home visits from a community health worker to promote care coordination and use of the patient portal Portal training and home visits: patient portal training and home visits by CHW to coordinate care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bronchospasm | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment | Uncontrolled asthma is an inclusion requirement. The vast number of adverse events are asthma-related exacerbations. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea J Apter, MD | University of Pennsylvania | 215 349-5120 | andrea.apter@uphs.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2018 | Feb 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D006792 | House Calls |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Portal training | Behavioral | training in use of patient portal |
|
Emergency department visits for asthma from one year before baseline to one year after baseline. |
| one year before baseline to one year after baseline |
| Hospitalizations | Hospitalizations for asthma in the year before baseline to one year after baseline. | Hospitalizations for asthma in the year before baseline to one year after baseline |
| Prednisone Bursts | new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year. | bursts at baseline and at one year |
| Death |
|
| withdrawn by research team |
|
Participants are assured internet access and taught to use the patient portal Portal training: training in use of patient portal |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| asthma control questionnaire | The Asthma Control Questionnaire is a validated 6-item questionnaire, range 0 to 6, that reflects asthma symptoms over the past week. Lower score is better control. | Mean | Standard Deviation | units on a scale |
|
| Portal Training |
Participants are assured internet access and taught to use the patient portal Portal training: training in use of patient portal |
|
|
|
| Secondary | Asthma-related Quality of Life | Quality of life is a 15-item questionnaire with 7 point response scale (1-7), higher score is better quality of life. We measured the change from baseline and over a year. | Quality of life is a 15-item questionnaire with 7 point response scale (1-7), higher score is better quality of life. Here we measure change in quality of life over time in the study. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline and over a year |
|
|
|
|
| Secondary | Emergency Department Visits | Emergency department visits for asthma from one year before baseline to one year after baseline. | ED visits per year over period of participation | Posted | Least Squares Mean | 95% Confidence Interval | ED visits per year | one year before baseline to one year after baseline |
|
|
|
|
| Secondary | Hospitalizations | Hospitalizations for asthma in the year before baseline to one year after baseline. | rate per year | Posted | Least Squares Mean | 95% Confidence Interval | hospitalizations per year | Hospitalizations for asthma in the year before baseline to one year after baseline |
|
|
|
|
| Secondary | Prednisone Bursts | new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year. | new prescriptions of prednisone or increases in an already-prescribed dose ("bursts") per year for an asthma exacerbation | Posted | Least Squares Mean | 95% Confidence Interval | bursts per year | bursts at baseline and at one year |
|
|
|
|
| 3 |
| 151 |
| 49 |
| 151 |
| 14 |
| 151 |
| EG001 | Portal Training | Participants are assured internet access and taught to use the patient portal Portal training: training in use of patient portal | 2 | 150 | 63 | 150 | 18 | 150 |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment | pneumonia |
|
| chest pain | Cardiac disorders | Safety Profiler | Systematic Assessment |
|
| allergic reaction | Immune system disorders | Safety Profiler | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Safety Profiler | Systematic Assessment |
|
| hypertension | Cardiac disorders | Safety Profiler | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| headache | Nervous system disorders | Safety Profiler | Systematic Assessment |
|
| injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Safety Profiler | Systematic Assessment | dog bite |
|
| bronchial infection | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Safety Profiler | Systematic Assessment |
|
| GI reflux | Gastrointestinal disorders | Safety Profiler | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Safety Profiler | Systematic Assessment |
|
| chest wall pain | Cardiac disorders | Safety Profiler | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| pain | General disorders | Safety Profiler | Systematic Assessment |
|
| anaphlaxis | Immune system disorders | Safety Profiler | Systematic Assessment |
|
| heart attack, myocardial infarction | Cardiac disorders | Safety Profiler | Systematic Assessment |
|
| cardiac disorder | Cardiac disorders | Safety Profiler | Systematic Assessment |
|
| colitis | Gastrointestinal disorders | Safety Profiler | Systematic Assessment |
|
| heart failure | Cardiac disorders | Safety Profiler | Systematic Assessment |
|
| hyperglycemia | Endocrine disorders | Safety Profiler | Systematic Assessment |
|
| immune system disorder- Graves disease | Immune system disorders | Safety Profiler | Systematic Assessment |
|
| oral pain | Gastrointestinal disorders | Safety Profiler | Systematic Assessment |
|
| palpitations | Cardiac disorders | Safety Profiler | Systematic Assessment |
|
| respiratory failure | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| Seizures | Nervous system disorders | Safety Profiler | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| sinusitis | Infections and infestations | Safety Profiler | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | Safety Profiler | Systematic Assessment |
|
| urticaria | Skin and subcutaneous tissue disorders | Safety Profiler | Systematic Assessment |
|
| penile infection | Infections and infestations | Safety Profiler | Systematic Assessment |
|
| stroke | Nervous system disorders | Safety Profiler | Systematic Assessment |
|
| anxiety | Psychiatric disorders | Safety Profiler | Systematic Assessment |
|
| flu like symptoms | General disorders | Safety Profiler | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| wheeze | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| bronchial infection | Infections and infestations | Safety Profiler | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Safety Profiler | Systematic Assessment |
|
| acid reflux | Gastrointestinal disorders | Safety Profiler | Systematic Assessment |
|
| allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| chest pain | Cardiac disorders | Safety Profiler | Systematic Assessment |
|
| dry eye | Eye disorders | Safety Profiler | Systematic Assessment |
|
| short of breath | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| laryngitis | Infections and infestations | Safety Profiler | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Safety Profiler | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Safety Profiler | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |