Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02086565
Recruitment Status : Completed
First Posted : March 13, 2014
Results First Posted : June 5, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Pennsylvania

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.


Condition or disease Intervention/treatment Phase
Asthma Communication Behavioral: Portal training and home visits Behavioral: Portal training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults
Actual Study Start Date : July 17, 2014
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: Portal training and home visits
patient portal training and home visits by CHW to coordinate care

Active Comparator: portal training
Participants are assured internet access and taught to use the patient portal
Behavioral: Portal training
training in use of patient portal




Primary Outcome Measures :
  1. Score of Asthma Control Questionnaire [ Time Frame: 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 Outcome Measures :
  1. Asthma-related Quality of Life [ Time Frame: 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.

  2. Emergency Department Visits [ Time Frame: one year before baseline to one year after baseline ]
    Emergency department visits for asthma from one year before baseline to one year after baseline.

  3. Hospitalizations [ Time Frame: 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.

  4. Prednisone Bursts [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086565


Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Andrea J Apter, MD, MSc, MA University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:

Additional Information:
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02086565     History of Changes
Other Study ID Numbers: R-1307-05218
First Posted: March 13, 2014    Key Record Dates
Results First Posted: June 5, 2019
Last Update Posted: June 19, 2019
Last Verified: June 2019
Keywords provided by University of Pennsylvania:
asthma,
asthma control,
asthma-related quality of life
electronic health record,
portal,
health literacy
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases