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Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- RCT 2

Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal- RCT #2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04110314
Enrollment
430636
Registered
2019-10-01
Start date
2019-10-18
Completion date
2020-04-01
Last updated
2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Respiratory Tract Infections

Keywords

Vaccination, Reminder recall, Patient Portal

Brief summary

This trial is taking place in Los Angeles, CA among patients from primary care practices 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. The investigators will assess the effectiveness of message-framing (gain-framed, loss-framed messages, no messages), as well as the effectiveness of a pre-commitment prompt (pre-commitment prompt, no prompt) asking about a patient's intention to get the influenza vaccination, using a 3 x 2 factorial design.

Detailed description

Sub-optimal vaccination rates are a significant problem in the U.S., despite their effectiveness in preventing morbidity and mortality from vaccine-preventable illness. For influenza specifically, annual epidemics of influenza cause substantial morbidity in the U.S. with up to 40,00-80,000 deaths/year and many hospitalizations, emergency and outpatient visits, and significant costs. Reminder/recall (R/R), sent by phone, mail or other modality, can improve child and adult influenza vaccination rates. However, the majority of pediatric or adult primary care practices to not conduct 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. There has been considerable research on how best to communicate about vaccines with families. A number of studies have examined the impact of gain-framed (messages emphasizing the benefits of vaccination) versus loss-framed (messages emphasizing the risks of not getting vaccinated); however, the findings have been inconsistent across studies and by sub-population. In addition to framing, another potential influence on the decision to vaccinate is pre-commitment. Previous studies suggest that, upon being prompted, indicating an intention to do something increases the likelihood of following through. Therefore, a pre-commitment prompt is being asked of half the participants in each arm to evaluate its impact on influenza vaccination. The purpose of this randomized controlled trial is to evaluate the impact of gain-framed and loss-framed reminder-recall messages sent via the patient portal, pre-commitment prompts sent via the patient portal, and the interactions between the two type of messages and pre-commitment on influenza vaccination among UCLA Health System's primary care patients aged 6 months and older. The proposed design of this randomized-controlled trial is a 3 x 2 factorial design. Standard of care control (no reminder messages, no pre-commitment prompt) No portal messages, pre-commitment prompt Gain-framed portal messages, pre-commitment prompt Gain-framed portal messages, no pre-commitment prompt Loss-framed portal messages, pre-commitment prompt Loss-framed portal messages, no pre-commitment prompt Hyp 1. Vaccination rates will differ by receipt of no reminders, gain-framed reminders and loss-framed reminders. 1a. Vaccination rates will be higher among patients receiving gain-framed reminders than among patients receiving no reminders. 1b. Vaccination rates will be higher among patients receiving loss-framed reminders than among patients receiving no reminders. 1c. Vaccination rates will be higher among patients receiving gain-framed reminders than among patients receiving loss-framed reminders. Hyp 2. Vaccination rates will be higher among patients receiving a pre-commitment prompt than among patients not receiving any prompt. For relevant study arms, the first R/R messages will be sent in October 2019.

Interventions

BEHAVIORALPortal Reminders for Influenza Vaccination: Gain-framed

Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.

BEHAVIORALPortal Reminders for Influenza Vaccination: Loss-framed

Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.

Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
4 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* A patient within the UCLA Health System identified as a primary care patient per an internal algorithm,

Exclusion criteria

* A patient within the UCLA Health System not identified as a primary care patient per an internal algorithm

Design outcomes

Primary

MeasureTime frameDescription
Receipt of the Annual Influenza Vaccine Among Index Patients.6 monthsReceipt of the annual influenza vaccination (between 10/2/19 - 4/1/20) among index patients. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data. Index patients will be randomly selected individuals within an included household, eligible for the following groups (\<18, 18-64 non-diabetic, 65+ non-diabetic, and 18+ diabetic). One index patient per group may be selected from each household. The index patients must also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/19, excluding activity on the user's initial profile activation date). Individuals not affiliated with any primary care practice will be excluded from the primary analysis.

Countries

United States

Participant flow

Participants by arm

ArmCount
Gain-framed Portal Reminders + Pre-commitment Prompts
Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Portal Reminders for Influenza Vaccination: Gain-framed: Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination. Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
36,526
Gain-framed Portal Reminders + No Pre-commitment Prompt
Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Portal Reminders for Influenza Vaccination: Gain-framed: Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
36,388
Loss-framed Portal Reminders + Pre-commitment Prompt
Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Portal Reminders for Influenza Vaccination: Loss-framed: Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination. Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
36,541
Loss-framed Portal Reminders + No Pre-commitment Prompt
Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Portal Reminders for Influenza Vaccination: Loss-framed: Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.
36,377
No Portal Reminder + Pre-commitment Prompt
Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal but do receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Pre-commitment prompt: Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
36,289
No Portal Reminders + No Pre-commitment Prompt
Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal and do not receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season
36,411
Total218,532

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyDid not meet inclusion criteria35,25535,10435,63635,13535,24735,727

Baseline characteristics

CharacteristicNo Portal Reminder + Pre-commitment PromptTotalGain-framed Portal Reminders + Pre-commitment PromptsNo Portal Reminders + No Pre-commitment PromptGain-framed Portal Reminders + No Pre-commitment PromptLoss-framed Portal Reminders + Pre-commitment PromptLoss-framed Portal Reminders + No Pre-commitment Prompt
Adults with diabetes3534 Participants21525 Participants3660 Participants3539 Participants3644 Participants3663 Participants3485 Participants
Age, Categorical
<=18 years
3655 Participants22046 Participants3686 Participants3736 Participants3632 Participants3727 Participants3610 Participants
Age, Categorical
>=65 years
6454 Participants39315 Participants6552 Participants6598 Participants6565 Participants6549 Participants6597 Participants
Age, Categorical
Between 18 and 65 years
26180 Participants157171 Participants26288 Participants26077 Participants26191 Participants26265 Participants26170 Participants
Insurance Type
Other/UNK
557 Participants3407 Participants577 Participants569 Participants578 Participants568 Participants558 Participants
Insurance Type
Private
31148 Participants187217 Participants31307 Participants31167 Participants31164 Participants31302 Participants31129 Participants
Insurance Type
Public
4584 Participants27908 Participants4642 Participants4675 Participants4646 Participants4671 Participants4690 Participants
Race/Ethnicity, Customized
Asian
3715 Participants22985 Participants3867 Participants3828 Participants3789 Participants3886 Participants3900 Participants
Race/Ethnicity, Customized
Black/African American
1727 Participants9906 Participants1674 Participants1533 Participants1666 Participants1657 Participants1649 Participants
Race/Ethnicity, Customized
Other/Unknown
10815 Participants64808 Participants10889 Participants10649 Participants10800 Participants10883 Participants10772 Participants
Race/Ethnicity, Customized
White
20401 Participants121202 Participants20096 Participants20401 Participants20133 Participants20115 Participants20056 Participants
Region of Enrollment
United States
36289 participants218532 participants36526 participants36411 participants36388 participants36541 participants36377 participants
Sex/Gender, Customized
Female Female
20947 Participants125866 Participants21088 Participants20835 Participants20881 Participants21058 Participants21057 Participants
Sex/Gender, Customized
Male
15342 Participants92661 Participants15437 Participants15575 Participants15506 Participants15482 Participants15319 Participants
Sex/Gender, Customized
Other
0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants
Sex/Gender, Customized
Unknown
0 Participants4 Participants1 Participants1 Participants1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

Receipt of the Annual Influenza Vaccine Among Index Patients.

Receipt of the annual influenza vaccination (between 10/2/19 - 4/1/20) among index patients. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data. Index patients will be randomly selected individuals within an included household, eligible for the following groups (\<18, 18-64 non-diabetic, 65+ non-diabetic, and 18+ diabetic). One index patient per group may be selected from each household. The index patients must also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/19, excluding activity on the user's initial profile activation date). Individuals not affiliated with any primary care practice will be excluded from the primary analysis.

Time frame: 6 months

Population: Each row represents a combination of intervention conditions in our factorial design. Each column represents patient subpopulations which received different versions of the intervention. The number analyzed in each cell is the number from that column's subpopulation assigned to that row's intervention combination.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Young Adults 18-64yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Gain-frame reminders and no pre-commitment8796 Participants
Young Adults 18-64yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Loss-framed reminders and no pre-commitment8880 Participants
Young Adults 18-64yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Gain-frame reminders and pre-commitment8883 Participants
Young Adults 18-64yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.No reminders and no pre-commitment8804 Participants
Young Adults 18-64yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Loss-frame reminders and pre-commitment9055 Participants
Young Adults 18-64yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.No reminders and pre-commitment8937 Participants
Older Adults Greater Than or Equal to 65 yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.No reminders and no pre-commitment2795 Participants
Older Adults Greater Than or Equal to 65 yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Loss-frame reminders and pre-commitment2753 Participants
Older Adults Greater Than or Equal to 65 yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Gain-frame reminders and pre-commitment2741 Participants
Older Adults Greater Than or Equal to 65 yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Loss-framed reminders and no pre-commitment2752 Participants
Older Adults Greater Than or Equal to 65 yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Gain-frame reminders and no pre-commitment2772 Participants
Older Adults Greater Than or Equal to 65 yr Without DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.No reminders and pre-commitment2757 Participants
Adults 18years or Older With DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.No reminders and pre-commitment2144 Participants
Adults 18years or Older With DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Gain-frame reminders and no pre-commitment2183 Participants
Adults 18years or Older With DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.No reminders and no pre-commitment2163 Participants
Adults 18years or Older With DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Gain-frame reminders and pre-commitment2249 Participants
Adults 18years or Older With DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Loss-framed reminders and no pre-commitment2077 Participants
Adults 18years or Older With DiabetesReceipt of the Annual Influenza Vaccine Among Index Patients.Loss-frame reminders and pre-commitment2220 Participants
Children <18yReceipt of the Annual Influenza Vaccine Among Index Patients.Gain-frame reminders and pre-commitment2168 Participants
Children <18yReceipt of the Annual Influenza Vaccine Among Index Patients.Loss-frame reminders and pre-commitment2203 Participants
Children <18yReceipt of the Annual Influenza Vaccine Among Index Patients.No reminders and no pre-commitment2123 Participants
Children <18yReceipt of the Annual Influenza Vaccine Among Index Patients.Loss-framed reminders and no pre-commitment2056 Participants
Children <18yReceipt of the Annual Influenza Vaccine Among Index Patients.No reminders and pre-commitment2084 Participants
Children <18yReceipt of the Annual Influenza Vaccine Among Index Patients.Gain-frame reminders and no pre-commitment2076 Participants
95% CI: [1, 1.03]
95% CI: [0.99, 1.01]
95% CI: [0.99, 1.03]
95% CI: [1, 1.04]
95% CI: [0.98, 1.01]
0.95% CI: [0.97, 1.02]
95% CI: [0.97, 1.01]
95% CI: [0.98, 1.05]
95% CI: [0.99, 1.02]
95% CI: [0.98, 1.02]
95% CI: [0.97, 1.02]
95% CI: [1, 1.04]

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026