Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03666026 |
| Other study ID # |
17-001889 |
| Secondary ID |
1R01AI135029-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2, 2018 |
| Est. completion date |
April 2, 2019 |
Study information
| Verified date |
October 2021 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This trial is taking place in Los Angeles, CA at clinics within the UCLA Health System.
Despite the Advisory Committee on Immunization Practices (ACIP) recommendation in 2010 that
all people above 6 months of age should receive an annual flu vaccine, vaccination rates
remain low: at 6m-4.9 yrs. (70%), 5-17.9 yrs. (56%), 18-64.9 yrs. (38%), and >65 yrs. (63%).
The investigators will assess the effectiveness and cost-effectiveness of 1, 2, 3 MyChart R/R
messages as compared to the standard of care control (no messages).
Description:
Annual epidemics of influenza cause substantial morbidity in the U.S. with up to 40,000
deaths/year and many hospitalizations, emergency and outpatient visits, and significant
costs. Concerns about pandemic influenza elevate the need to prevent flu outbreaks.
Numerous studies, including Cochrane or systematic reviews, and reports by the CDC and the
Task Force on Community Preventive Services, highlight 4 evidence-based strategies to raise
child and adult influenza vaccination rates: 1) increase patient demand by reminder-recall or
education, 2) expand patient access to influenza vaccinations (e.g., flu vaccine clinics), 3)
implement provider strategies such as prompts or standing orders, and 4) use societal
strategies (e.g., reducing costs).
Reminder/recall (R/R), sent by phone, mail or other modality, can improve child and adult
influenza vaccination rates. However, fewer than one-fifth of pediatric or adult primary care
practices utilize patient R/R. Barriers are lack of finances, personnel, and algorithms to
identify eligible patients.
A technological breakthrough that might overcome these barriers involves patient portals--
secure, web-based communication systems, embedded within electronic health records (EHRs),
for patients and providers to communicate with each other via email and the internet. Portals
are used by about half of Americans and half of UCLA patients. Portals can theoretically
improve upon phone, mail or text R/R by adding information such as web links, videos, or
images, allowing patients to schedule their own visits, and linking to the medical chart to
customize messages.
For this randomized control trial, the intent is to evaluate the impact of patient portal
(MyChart) reminder recalls - either 1, 2, or 3 reminders versus the standard of care control
group, specifically in relation to raising influenza vaccination rates among UCLA Health
System's primary care patients aged 6 months and older.
The proposed design of this 4-arm RCT:
1. Standard of care control (no messages)
2. Up to 1 portal R/R messages
3. Up to 2 portal R/R messages
4. Up to 3 portal R/R messages
Hypothesis 1: >1 portal R/R will increase vaccination rates vs. no R/R. Hypothesis 2: More
R/R messages will raise vaccination rates (3R/R > 2R/R > 1R/R > 0R/R).
For the primary analysis, only the data from the randomly selected index patients (1 index
patient per household) will be included.
For relevant study arms, the first R/R message will be sent in October 2018.
