Asthma, Communication
Conditions
Keywords
asthma,, asthma control,, asthma-related quality of life, electronic health record,, portal,, health literacy
Brief summary
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.
Interventions
patient portal training and home visits by CHW to coordinate care
training in use of patient portal
Sponsors
Study design
Eligibility
Inclusion criteria
* adults predominantly African American and Hispanic/Latino with uncontrolled asthma recruited from low income urban neighborhoods
Exclusion criteria
* severe psychiatric or cognitive problems that would make it impossible to understand and complete the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of Asthma Control Questionnaire | baseline and over a year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma-related Quality of Life | 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. We measured the change from baseline and over a year. |
| Emergency Department Visits | one year before baseline to one year after baseline | Emergency department visits for asthma from 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 | bursts at baseline and at one year | new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year. |
Countries
United States
Participant flow
Pre-assignment details
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..
Participants by arm
| Arm | Count |
|---|---|
| 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 | 151 |
| Portal Training Participants are assured internet access and taught to use the patient portal
Portal training: training in use of patient portal | 150 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 2 |
| Overall Study | Lost to Follow-up | 9 | 7 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
| Overall Study | withdrawn by research team | 2 | 2 |
Baseline characteristics
| Characteristic | Portal Training and Home Visits | Portal Training | Total |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 14 | 48 years STANDARD_DEVIATION 12 | 49 years STANDARD_DEVIATION 15 |
| asthma control questionnaire | 2.4 units on a scale STANDARD_DEVIATION 1.1 | 2.4 units on a scale STANDARD_DEVIATION 1.2 | 2.4 units on a scale STANDARD_DEVIATION 1.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 35 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 114 Participants | 231 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 116 Participants | 113 Participants | 229 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 26 Participants | 48 Participants |
| Race (NIH/OMB) White | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Female | 136 Participants | 134 Participants | 270 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 151 | 2 / 150 |
| other Total, other adverse events | 14 / 151 | 18 / 150 |
| serious Total, serious adverse events | 49 / 151 | 63 / 150 |
Outcome results
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.
Time frame: baseline and over a year
Population: The result is the mean change in asthma control (lower is improved control) at 12 months from baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Portal Training and Home Visits | Score of Asthma Control Questionnaire | -0.48 score on a scale |
| Portal Training | Score of Asthma Control Questionnaire | -0.27 score on a scale |
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.
Time frame: baseline and over a year
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Portal Training and Home Visits | Asthma-related Quality of Life | 0.64 score on a scale |
| Portal Training | Asthma-related Quality of Life | 0.45 score on a scale |
Emergency Department Visits
Emergency department visits for asthma from one year before baseline to one year after baseline.
Time frame: one year before baseline to one year after baseline
Population: ED visits per year over period of participation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Portal Training and Home Visits | Emergency Department Visits | -3.29 ED visits per year |
| Portal Training | Emergency Department Visits | -2.69 ED visits per year |
Hospitalizations
Hospitalizations for asthma in the year before baseline to one year after baseline.
Time frame: Hospitalizations for asthma in the year before baseline to one year after baseline
Population: rate per year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Portal Training and Home Visits | Hospitalizations | -1.19 hospitalizations per year |
| Portal Training | Hospitalizations | -0.66 hospitalizations per year |
Prednisone Bursts
new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year.
Time frame: bursts at baseline and at one year
Population: new prescriptions of prednisone or increases in an already-prescribed dose (bursts) per year for an asthma exacerbation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Portal Training and Home Visits | Prednisone Bursts | -0.21 bursts per year |
| Portal Training | Prednisone Bursts | -0.12 bursts per year |