Electronic Health RecordsNCT03354000
An RCT of an Online Training for Vulnerable Patients to Use an Online Patient Portal Website
A study testing Take-home online training and In-person online training in people with Electronic Health Records and Chronic Disease, run by University of California, San Francisco.
Trial summary
Online patient portals are becoming ubiquitous in the US. Previous research has documented substantial usability barriers, especially among patients with limited health literacy. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Health Records, Chronic Disease, Health Literacy
- What is being tested?
- Take-home online training and In-person online training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking as portal is only available in English
- diagnosed with at least one chronic condition
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Electronic Health Records, Chronic Disease, Health Literacy
- Being tested
- Take-home online training, In-person online training
- Keywords
- Patient Portal, Healthcare disparities, Safety net healthcare system
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take-home online trainingBehavioural
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.
In-person online trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Take-home online training | Placebo comparator | Participants received a link to access the online tutorial videos on their own. Receives: Behavioral: Take-home online training |
| In-person online training | Active comparator | Participants received an in-person tutorial of how to use the patient portal website with a trained research assistant. Receives: Behavioral: In-person online training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal log-ins
Logging into the portal website in the 3-6 months post-training (yes/no)
Measured: 3-6 months post-training
Secondary outcomes (3)
eHealth Literacy
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
Measured: 3-6 months post-training
Portal sign-up
Initiating sign-up process for the portal website (yes/no), as pulled from EHR chart review
Measured: 3-6 months post-training
Digital literacy skills
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
Measured: 3-6 months post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Aug 2015
- Primary completion31 Jul 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electronic Health RecordsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney Lyles, University of California, San Francisco
- Investigators
- Courtney Lyles, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354000
- Sponsor's protocol ID
- 5R00HS022408-05
- Status last verified
- Apr 2019
- First submitted
- 9 Nov 2017
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27.
PubMed 17213046
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Diverse Patients in Using an Online Patient Portal
- ClinicalTrials.gov ID
- NCT03354000
- Acronym / sponsor ID
- 5R00HS022408-05
- Conditions
- Electronic Health Records, Chronic Disease, Health Literacy
- Keywords
- Patient Portal, Healthcare disparities, Safety net healthcare system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Take-home online training | Placebo comparator | Behavioral: Take-home online trainingParticipants received a link to access the online tutorial videos on their own. |
| In-person online training | Active comparator | Behavioral: In-person online trainingParticipants received an in-person tutorial of how to use the patient portal website with a trained research assistant. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English-speaking as portal is only available in English
- diagnosed with at least one chronic condition
Key exclusion criteria (6 listed)
- cognitive impairment
- visual impairment
- severe mental health conditions
- any circumstances that would make participation in the study difficult
- no previous email use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take-home online trainingWe 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. | Behavioural | Take-home online training |
| In-person online trainingFor 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. | Behavioural | In-person online training |
Primary outcome
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 secondary outcomes
eHealth Literacy
Time frame: 3-6 months post-training
Portal sign-up
Time frame: 3-6 months post-training
Digital literacy skills
Time frame: 3-6 months post-training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Background: PubMed 17213046Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27.
- Published paper summarizing trial findings - A Randomized Trial to Train Vulnerable Primary Care Patients to Use a Patient PortalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Lyles, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Take-home online training and In-person online training in people with Electronic Health Records and Chronic Disease, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal log-ins (time frame: 3-6 months post-training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.