Influenza, Respiratory Tract Infections
Conditions
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
Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Receipt of the Annual Influenza Vaccine Among Index Patients. | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 218,532 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Did not meet inclusion criteria | 35,255 | 35,104 | 35,636 | 35,135 | 35,247 | 35,727 |
Baseline characteristics
| Characteristic | No Portal Reminder + Pre-commitment Prompt | Total | Gain-framed Portal Reminders + Pre-commitment Prompts | No Portal Reminders + No Pre-commitment Prompt | Gain-framed Portal Reminders + No Pre-commitment Prompt | Loss-framed Portal Reminders + Pre-commitment Prompt | Loss-framed Portal Reminders + No Pre-commitment Prompt |
|---|---|---|---|---|---|---|---|
| Adults with diabetes | 3534 Participants | 21525 Participants | 3660 Participants | 3539 Participants | 3644 Participants | 3663 Participants | 3485 Participants |
| Age, Categorical <=18 years | 3655 Participants | 22046 Participants | 3686 Participants | 3736 Participants | 3632 Participants | 3727 Participants | 3610 Participants |
| Age, Categorical >=65 years | 6454 Participants | 39315 Participants | 6552 Participants | 6598 Participants | 6565 Participants | 6549 Participants | 6597 Participants |
| Age, Categorical Between 18 and 65 years | 26180 Participants | 157171 Participants | 26288 Participants | 26077 Participants | 26191 Participants | 26265 Participants | 26170 Participants |
| Insurance Type Other/UNK | 557 Participants | 3407 Participants | 577 Participants | 569 Participants | 578 Participants | 568 Participants | 558 Participants |
| Insurance Type Private | 31148 Participants | 187217 Participants | 31307 Participants | 31167 Participants | 31164 Participants | 31302 Participants | 31129 Participants |
| Insurance Type Public | 4584 Participants | 27908 Participants | 4642 Participants | 4675 Participants | 4646 Participants | 4671 Participants | 4690 Participants |
| Race/Ethnicity, Customized Asian | 3715 Participants | 22985 Participants | 3867 Participants | 3828 Participants | 3789 Participants | 3886 Participants | 3900 Participants |
| Race/Ethnicity, Customized Black/African American | 1727 Participants | 9906 Participants | 1674 Participants | 1533 Participants | 1666 Participants | 1657 Participants | 1649 Participants |
| Race/Ethnicity, Customized Other/Unknown | 10815 Participants | 64808 Participants | 10889 Participants | 10649 Participants | 10800 Participants | 10883 Participants | 10772 Participants |
| Race/Ethnicity, Customized White | 20401 Participants | 121202 Participants | 20096 Participants | 20401 Participants | 20133 Participants | 20115 Participants | 20056 Participants |
| Region of Enrollment United States | 36289 participants | 218532 participants | 36526 participants | 36411 participants | 36388 participants | 36541 participants | 36377 participants |
| Sex/Gender, Customized Female Female | 20947 Participants | 125866 Participants | 21088 Participants | 20835 Participants | 20881 Participants | 21058 Participants | 21057 Participants |
| Sex/Gender, Customized Male | 15342 Participants | 92661 Participants | 15437 Participants | 15575 Participants | 15506 Participants | 15482 Participants | 15319 Participants |
| Sex/Gender, Customized Other | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 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 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Young Adults 18-64yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Gain-frame reminders and no pre-commitment | 8796 Participants |
| Young Adults 18-64yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Loss-framed reminders and no pre-commitment | 8880 Participants |
| Young Adults 18-64yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Gain-frame reminders and pre-commitment | 8883 Participants |
| Young Adults 18-64yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | No reminders and no pre-commitment | 8804 Participants |
| Young Adults 18-64yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Loss-frame reminders and pre-commitment | 9055 Participants |
| Young Adults 18-64yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | No reminders and pre-commitment | 8937 Participants |
| Older Adults Greater Than or Equal to 65 yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | No reminders and no pre-commitment | 2795 Participants |
| Older Adults Greater Than or Equal to 65 yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Loss-frame reminders and pre-commitment | 2753 Participants |
| Older Adults Greater Than or Equal to 65 yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Gain-frame reminders and pre-commitment | 2741 Participants |
| Older Adults Greater Than or Equal to 65 yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Loss-framed reminders and no pre-commitment | 2752 Participants |
| Older Adults Greater Than or Equal to 65 yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Gain-frame reminders and no pre-commitment | 2772 Participants |
| Older Adults Greater Than or Equal to 65 yr Without Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | No reminders and pre-commitment | 2757 Participants |
| Adults 18years or Older With Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | No reminders and pre-commitment | 2144 Participants |
| Adults 18years or Older With Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Gain-frame reminders and no pre-commitment | 2183 Participants |
| Adults 18years or Older With Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | No reminders and no pre-commitment | 2163 Participants |
| Adults 18years or Older With Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Gain-frame reminders and pre-commitment | 2249 Participants |
| Adults 18years or Older With Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Loss-framed reminders and no pre-commitment | 2077 Participants |
| Adults 18years or Older With Diabetes | Receipt of the Annual Influenza Vaccine Among Index Patients. | Loss-frame reminders and pre-commitment | 2220 Participants |
| Children <18y | Receipt of the Annual Influenza Vaccine Among Index Patients. | Gain-frame reminders and pre-commitment | 2168 Participants |
| Children <18y | Receipt of the Annual Influenza Vaccine Among Index Patients. | Loss-frame reminders and pre-commitment | 2203 Participants |
| Children <18y | Receipt of the Annual Influenza Vaccine Among Index Patients. | No reminders and no pre-commitment | 2123 Participants |
| Children <18y | Receipt of the Annual Influenza Vaccine Among Index Patients. | Loss-framed reminders and no pre-commitment | 2056 Participants |
| Children <18y | Receipt of the Annual Influenza Vaccine Among Index Patients. | No reminders and pre-commitment | 2084 Participants |
| Children <18y | Receipt of the Annual Influenza Vaccine Among Index Patients. | Gain-frame reminders and no pre-commitment | 2076 Participants |