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

Primary Purpose

Asthma, Communication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portal training and home visits
Portal training
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring asthma,, asthma control,, asthma-related quality of life, electronic health record,, portal,, health literacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pennsylvania Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Portal training and home visits

portal training

Arm Description

Portal training and home visits from a community health worker to promote care coordination and use of the patient portal

Participants are assured internet access and taught to use the patient portal

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Emergency Department Visits
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.
Prednisone Bursts
new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year.

Full Information

First Posted
March 11, 2014
Last Updated
June 10, 2019
Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02086565
Brief Title
Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults
Official Title
Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 17, 2014 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Communication
Keywords
asthma,, asthma control,, asthma-related quality of life, electronic health record,, portal,, health literacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Portal training and home visits
Arm Type
Experimental
Arm Description
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
Arm Title
portal training
Arm Type
Active Comparator
Arm Description
Participants are assured internet access and taught to use the patient portal
Intervention Type
Behavioral
Intervention Name(s)
Portal training and home visits
Intervention Description
patient portal training and home visits by CHW to coordinate care
Intervention Type
Behavioral
Intervention Name(s)
Portal training
Intervention Description
training in use of patient portal
Primary Outcome Measure Information:
Title
Score of Asthma Control Questionnaire
Description
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
Secondary Outcome Measure Information:
Title
Asthma-related Quality of Life
Description
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
Title
Emergency Department Visits
Description
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
Title
Hospitalizations
Description
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
Title
Prednisone Bursts
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea J Apter, MD, MSc, MA
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34634975
Citation
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.
Results Reference
derived
PubMed Identifier
31181221
Citation
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.
Results Reference
derived
Links:
URL
http://www.pcori.org/
Description
Patient Centered Outcomes Research Institute

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

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