NCT02086565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

July 17, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 5, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

March 11, 2014

Results QC Date

June 28, 2018

Last Update Submit

June 10, 2019

Conditions

Keywords

asthma,asthma control,asthma-related quality of lifeelectronic health record,portal,health literacy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Asthma-related Quality of Life

    baseline and over a year

  • Emergency Department Visits

    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

    bursts at baseline and at one year

Study Arms (2)

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

Behavioral: Portal training and home visits

portal training

ACTIVE COMPARATOR

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

Behavioral: Portal training

Interventions

patient portal training and home visits by CHW to coordinate care

Portal training and home visits
Portal trainingBEHAVIORAL

training in use of patient portal

portal training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults predominantly African American and Hispanic/Latino with uncontrolled asthma recruited from low income urban neighborhoods

You may not qualify if:

  • severe psychiatric or cognitive problems that would make it impossible to understand and complete the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

AsthmaCommunication

Interventions

House Calls

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Results Point of Contact

Title
Andrea J Apter, MD
Organization
University of Pennsylvania

Study Officials

  • Andrea J Apter, MD, MSc, MA

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 13, 2014

Study Start

July 17, 2014

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

June 19, 2019

Results First Posted

June 5, 2019

Record last verified: 2019-06

Locations