Skip to content

Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults

Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02086565
Enrollment
301
Registered
2014-03-13
Start date
2014-07-17
Completion date
2017-06-30
Last updated
2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Communication

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

BEHAVIORALPortal training and home visits

patient portal training and home visits by CHW to coordinate care

BEHAVIORALPortal training

training in use of patient portal

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Score of Asthma Control Questionnairebaseline and over a yearThis 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

MeasureTime frameDescription
Asthma-related Quality of Lifebaseline and over a yearQuality 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 Visitsone year before baseline to one year after baselineEmergency department visits for asthma from one year before baseline to one year after baseline.
HospitalizationsHospitalizations for asthma in the year before baseline to one year after baselineHospitalizations for asthma in the year before baseline to one year after baseline.
Prednisone Burstsbursts at baseline and at one yearnew 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

ArmCount
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
Total301

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath32
Overall StudyLost to Follow-up97
Overall StudyWithdrawal by Subject21
Overall Studywithdrawn by research team22

Baseline characteristics

CharacteristicPortal Training and Home VisitsPortal TrainingTotal
Age, Continuous50 years
STANDARD_DEVIATION 14
48 years
STANDARD_DEVIATION 12
49 years
STANDARD_DEVIATION 15
asthma control questionnaire2.4 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 Participants35 Participants66 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
117 Participants114 Participants231 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants1 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
116 Participants113 Participants229 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
22 Participants26 Participants48 Participants
Race (NIH/OMB)
White
11 Participants10 Participants21 Participants
Sex: Female, Male
Female
136 Participants134 Participants270 Participants
Sex: Female, Male
Male
15 Participants16 Participants31 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 1512 / 150
other
Total, other adverse events
14 / 15118 / 150
serious
Total, serious adverse events
49 / 15163 / 150

Outcome results

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.

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Portal Training and Home VisitsScore of Asthma Control Questionnaire-0.48 score on a scale
Portal TrainingScore of Asthma Control Questionnaire-0.27 score on a scale
95% CI: [-0.56, 0.15]
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.

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Portal Training and Home VisitsAsthma-related Quality of Life0.64 score on a scale
Portal TrainingAsthma-related Quality of Life0.45 score on a scale
95% CI: [-0.27, 0.68]
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)
Portal Training and Home VisitsEmergency Department Visits-3.29 ED visits per year
Portal TrainingEmergency Department Visits-2.69 ED visits per year
95% CI: [-2.21, 0.97]
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)
Portal Training and Home VisitsHospitalizations-1.19 hospitalizations per year
Portal TrainingHospitalizations-0.66 hospitalizations per year
95% CI: [-1.08, -0.24]
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.

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

ArmMeasureValue (LEAST_SQUARES_MEAN)
Portal Training and Home VisitsPrednisone Bursts-0.21 bursts per year
Portal TrainingPrednisone Bursts-0.12 bursts per year
95% CI: [-0.24, 0.06]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026