- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03354000
An RCT of an Online Training for Vulnerable Patients to Use an Online Patient Portal Website
April 17, 2019 updated by: Courtney Lyles, University of California, San Francisco
Engaging Diverse Patients in Using an Online Patient Portal
Online patient portals are becoming ubiquitous in the US.
Previous research has documented substantial usability barriers, especially among patients with limited health literacy.
This pilot randomized pilot trial had the goal of determining the effectiveness of an in-person training with a scalable online video-based training program to increase portal use among patients in a safety net healthcare setting.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The intervention in this study was a patient portal training curriculum with simple instructions and 11 how-to videos for accessing features of an online patient portal.
Using a deeply participatory approach, this curriculum was created in consultation with a patient advisory board from the San Francisco Health Network, a local Medicaid health plan.
From June until October 2016, 93 patients with 1 or more chronic diseases were randomized to receive either: 1) an in-person tutorial with a trained research assistant versus 2) a link to view the videos on their own.
The primary outcome was portal log-in (yes/no) between 3 and 6 months post-training, assessed through a portal administrative dashboard within the EHR.
Secondary outcome included baseline and follow-up survey measures on participants' perceptions of the portal use and their care, as well as views of the web-based lessons.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English-speaking as portal is only available in English
- diagnosed with at least one chronic condition
Exclusion Criteria:
- cognitive impairment
- visual impairment
- severe mental health conditions
- any circumstances that would make participation in the study difficult
- no previous email use
- self-reported usage of MYSFHEALTH
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Take-home online training
Participants received a link to access the online tutorial videos on their own.
|
We randomized patients to receive a link to access the online tutorial on their own.
Participants in the take-home arm were given a paper handout with a link to the training materials and an outline of the steps for accessing the training curriculum.
|
|
Active Comparator: In-person online training
Participants received an in-person tutorial of how to use the patient portal website with a trained research assistant.
|
For participants randomized to the in-person training arm, a trained research assistant prompted participants to log into the learning platform and guided them in accessing the training materials for portal features that were of interest to them.
The staff member provided further explanation or clarification if participants had questions about the training material.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Portal log-ins
Time Frame: 3-6 months post-training
|
Logging into the portal website in the 3-6 months post-training (yes/no)
|
3-6 months post-training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
eHealth Literacy
Time Frame: 3-6 months post-training
|
The eHEALS is a measure of eHealth literacy developed to measure consumers' combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems.
eHEALS was measured at baseline and follow-up via surveys
|
3-6 months post-training
|
|
Portal sign-up
Time Frame: 3-6 months post-training
|
Initiating sign-up process for the portal website (yes/no), as pulled from EHR chart review
|
3-6 months post-training
|
|
Digital literacy skills
Time Frame: 3-6 months post-training
|
Confidence in having skills to be able to use online portal website (scored from 1 to 0), as self-reported via baseline and follow-up surveys
|
3-6 months post-training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Courtney Lyles, PhD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
July 31, 2017
Study Completion (Actual)
July 31, 2018
Study Registration Dates
First Submitted
November 9, 2017
First Submitted That Met QC Criteria
November 21, 2017
First Posted (Actual)
November 27, 2017
Study Record Updates
Last Update Posted (Actual)
April 19, 2019
Last Update Submitted That Met QC Criteria
April 17, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R00HS022408-05 (U.S. AHRQ Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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