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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02086565
Other study ID # R-1307-05218
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 17, 2014
Est. completion date June 30, 2017

Study information

Verified date June 2019
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 301
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Portal training and home visits
patient portal training and home visits by CHW to coordinate care
Portal training
training in use of patient portal

Locations

Country Name City State
United States University of Pennsylvania Health System Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. baseline and over a year
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. baseline and over a year
Secondary Emergency Department Visits Emergency department visits for asthma from one year before baseline to one year after baseline. one year before baseline to one year after baseline
Secondary 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
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. bursts at baseline and at one year
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