Patient Portal - Flu Reminder Recall

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT03666026
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 164,205
• Location: 1
• Arms: 4
• Actual Duration (Months): 6
• Patients Per Site Per Month: 27461.5

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Influenza; Respiratory Tract Infections; Vaccines	Behavioral: 1 MyChart R/R; Behavioral: 2 MyChart R/R; Behavioral: 3 MyChart R/R	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 164205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal
• Actual Study Start Date: Oct 2, 2018
• Actual Primary Completion Date: Apr 2, 2019
• Actual Study Completion Date: Apr 2, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of care control Participants in this group will not receive any MyChart influenza vaccination reminders
Experimental: 1 MyChart R/R Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account	Behavioral: 1 MyChart R/R; Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
Experimental: 2 MyChart R/R Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account	Behavioral: 2 MyChart R/R; Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
Experimental: 3 MyChart R/R Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account	Behavioral: 3 MyChart R/R; Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.

Outcome Measures

Primary Outcome Measures

1. 1.Receipt of the Annual Influenza Vaccine (Between 10/1/18 - 4/2/19) Among Index Patients. Outcomes Will be Assessed Via Vaccine Data Extraction From the Electronic Health Record and External Claims and Pharmacy Data. [October 1, 2018 to April 2, 2019 during influenza vaccination season]

   Number of participants in each arm who received influenza vaccination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• A patient within the UCLA Health System identified by the system as a primary care patient per an internal algorithm, with a documented primary care visit within the last 3 years as of 8/1/18.

Exclusion Criteria:

• A patient not identified by the UCLA Health System's internal algorithm as a primary care patient.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Peter Szilagyi, MD MPH, University of California, Los Angeles

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2017

More Information

Publications

None provided.

• Responsible Party: Peter G Szilagyi, MD MPH, Executive Vice Chair, Clinical Research, UCLA David Geffen School of Medicine, Dept of Pediatrics, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03666026
• Other Study ID Numbers: 17-001889; 1R01AI135029-01
• First Posted: Sep 11, 2018
• Last Update Posted: Nov 17, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter G Szilagyi, MD MPH, Executive Vice Chair, Clinical Research, UCLA David Geffen School of Medicine, Dept of Pediatrics, University of California, Los Angeles: Reminder Recall (R/R); Influenza Vaccine; Electronic Health Record
• Additional relevant MeSH terms: Influenza, Human; Respiratory Tract Infections

Study Results

Participant Flow

Arm/Group Title	Standard of Care Control	1 MyChart R/R	2 MyChart R/R	3 MyChart R/R
Arm/Group Description	Participants in this group will not receive any MyChart influenza vaccination reminders	Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account 1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.	Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account 2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.	Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account 3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
Period Title: Overall Study
STARTED	41070	41055	41046	41034
COMPLETED	41070	41055	41046	41034
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Standard of Care Control	1 MyChart R/R	2 MyChart R/R	3 MyChart R/R	Total
Arm/Group Description	Participants in this group will not receive any MyChart influenza vaccination reminders	Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account 1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.	Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account 2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.	Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account 3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.	Total of all reporting groups
Overall Participants	41070	41055	41046	41034	164205
Age, Customized (Percent of participants) [Number]
0.5-17 years 0-5 years	7.4 0%	7.3 0%	7.3 0%	7.4 0%	7.4 0%
18-64 years	73.8 0.2%	73.9 0.2%	74.1 0.2%	74.0 0.2%	74.0 0%
>= 65 years	18.8 0%	18.8 0%	18.6 0%	18.5 0%	18.7 0%
Sex: Female, Male (Count of Participants)
Female	23985 58.4%	23935 58.3%	23889 58.2%	23964 58.4%	95773 58.3%
Male	17085 41.6%	17120 41.7%	17157 41.8%	17070 41.6%	68432 41.7%
Race/Ethnicity, Customized (Percent of participants) [Number]
White	57.3 0.1%	57.5 0.1%	57.2 0.1%	57.1 0.1%	57.3 0%
Black	4.4 0%	4.6 0%	4.7 0%	4.8 0%	4.6 0%
Asian	10.1 0%	10.4 0%	10.3 0%	10.3 0%	10.3 0%
Unkown	28.2 0.1%	27.6 0.1%	27.7 0.1%	27.9 0.1%	27.8 0%
Hispanic Ethnicity	46.9 0.1%	46.7 0.1%	46.7 0.1%	47.0 0.1%	46.9 0%
Received influenza vaccination in prior two years (Percent of participants) [Number]
Number [Percent of participants]	46.9 0.1%	46.7 0.1%	46.7 0.1%	47.0 0.1%	46.9 0%

Outcome Measures

1. Primary Outcome

Title	1.Receipt of the Annual Influenza Vaccine (Between 10/1/18 - 4/2/19) Among Index Patients. Outcomes Will be Assessed Via Vaccine Data Extraction From the Electronic Health Record and External Claims and Pharmacy Data.
Description	Number of participants in each arm who received influenza vaccination
Time Frame	October 1, 2018 to April 2, 2019 during influenza vaccination season

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Control	1 MyChart R/R	2 MyChart R/R	3 MyChart R/R
Arm/Group Description	Participants in this group will not receive any MyChart influenza vaccination reminders	Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account 1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.	Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account 2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.	Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account 3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
Measure Participants	41070	41055	41046	41034
Count of Participants [Participants]	15385 37.5%	15604 38%	15660 38.2%	15673 38.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care Control, 1 MyChart R/R
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard of Care Control, 2 MyChart R/R
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Standard of Care Control, 3 MyChart R/R
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	This pragmatic, 4-arm randomized clinical trial was performed from October 1, 2018, to April 2, 2019, across the UCLA (University of California, Los Angeles) health care system. A total of 164 205 patients in 52 primary care practices who had used the patient portal within 12 months were included. Adverse events were not assessed/monitored.
Adverse Event Reporting Description	We conducted a trial of whether reminder sent via the portal impacted influenza vaccination rates; we did not collect adverse event or serious event information.
Arm/Group Title	Standard of Care Control		1 MyChart R/R		2 MyChart R/R		3 MyChart R/R
Arm/Group Description	Participants in this group will not receive any MyChart influenza vaccination reminders		Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account 1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.		Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account 2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.		Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account 3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
All Cause Mortality
	Standard of Care Control		1 MyChart R/R		2 MyChart R/R		3 MyChart R/R
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Standard of Care Control		1 MyChart R/R		2 MyChart R/R		3 MyChart R/R
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Standard of Care Control		1 MyChart R/R		2 MyChart R/R		3 MyChart R/R
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.