NCT02266277

Brief Summary

The goal of this research study is to improve rates of appropriate influenza and pneumococcal vaccination among adults who receive care at a large multi-specialty group practice in central Massachusetts. The investigators plan to conduct a non-blinded randomized controlled trial during flu season 2014-2015 (Cycle 1). A total of 20,000 e-portal users and 10,000 non e-portal users who are identified in the Reliant Medical Group (RMG) Electronic Health Record (EHR) as not being up to date on their influenza vaccines will be randomized. E-portal users will be randomized to receive:

  • Arm 1: E-portal message with Interactive Voice Recognition (IVR) call
  • Arm 2: E-portal message with no IVR call
  • Arm 3: No e-portal message with IVR call OR
  • Arm 4: No e-portal message with no IVR call (Control, e-portal users) Non e-portal users will be randomized to receive either:
  • Arm 5: IVR call OR
  • Arm 6: no IVR call (Control, non e-portal users)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 28, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

October 10, 2014

Results QC Date

February 8, 2017

Last Update Submit

May 2, 2017

Conditions

InfluenzaInfections, Pneumococcal

Keywords

electronic health record, utilizationrandomized controlled trialpragmatic clinical trialinfluenza, prevention and controlpneumococcal vaccinesqualitative research

Outcome Measures

Primary Outcomes (1)

  • Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season

    To determine the impact of our interventions on influenza vaccine completion for the 2014-15 influenza season, we calculated frequencies and performed intention-to-treat bivariate analyses of randomized patients (30,000 patients), assessing whether randomization group was associated vaccine completion. Due to differential rates of vaccination at baseline between portal users and non-users, analyses in these groups were conducted separately. We then performed multivariate logistic regression analyses. We created dummy variables for assignment to the portal message arm (among portal users) and for assignment to the Interactive Voice Recognition (IVR) call arm (among both portal users and, separately, among non-portal users). Including these dummy variables and adjusting for demographic and practice-level covariates, we modeled the odds of receiving an influenza vaccine in the 2014-15 influenza season.

    Months 11-16

Secondary Outcomes (1)

  • Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion

    Months 11-16

Other Outcomes (1)

  • Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR)

    Months 11-16

Study Arms (6)

Arm 1: E-portal message with IVR call

ACTIVE COMPARATOR

Patients identified as e-portal users will receive an e-portal message with IVR call

Other: Arm 1: E-portal message with IVR call

Arm 2: E-portal message with no IVR call

ACTIVE COMPARATOR

Patients identified as e-portal users will receive an e-portal message only

Other: Arm 2: E-portal message with no IVR call

Arm 3: No e-portal message with IVR call

ACTIVE COMPARATOR

Patients identified as e-portal users will receive an IVR call only

Other: Arm 3: No e-portal message with IVR call

Arm 4: No E-portal message with no IVR call

NO INTERVENTION

Patients identified as e-portal users will receive neither an e-portal message nor an IVR call

Arm 5: IVR call

ACTIVE COMPARATOR

Patients identified as non e-portal users will receive an IVR call only

Other: Arm 5: IVR call

Arm 6: No IVR call

NO INTERVENTION

Patients identified as non e-portal users will not receive any outreach

Interventions

Arm 1: E-portal message with IVR callOTHER

Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers.

Arm 1: E-portal message with IVR call
Arm 2: E-portal message with no IVR callOTHER

Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers.

Arm 2: E-portal message with no IVR call
Arm 3: No e-portal message with IVR callOTHER

Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers.

Arm 3: No e-portal message with IVR call
Arm 5: IVR callOTHER

Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers.

Arm 5: IVR call

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • RMG Patients 18 years of age or older.
  • Overdue for vaccination against influenza and/or not up to date on vaccination for pneumococcal vaccine per RMG EHR data
  • No documented allergy to the vaccination in question.

You may not qualify if:

  • Patients who have selected the "Do not call" option in the RMG EHR or have an allergy to the influenza and/or pneumococcal vaccination will be excluded from participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reliant Medical Group

Worcester, Massachusetts, 01605, United States

Location

Related Publications (3)

  • Wijesundara JG, Ito Fukunaga M, Ogarek J, Barton B, Fisher L, Preusse P, Sundaresan D, Garber L, Mazor KM, Cutrona SL. Electronic Health Record Portal Messages and Interactive Voice Response Calls to Improve Rates of Early Season Influenza Vaccination: Randomized Controlled Trial. J Med Internet Res. 2020 Sep 25;22(9):e16373. doi: 10.2196/16373.

    PMID: 32975529DERIVED

  • Cutrona SL, Golden JG, Goff SL, Ogarek J, Barton B, Fisher L, Preusse P, Sundaresan D, Garber L, Mazor KM. Improving Rates of Outpatient Influenza Vaccination Through EHR Portal Messages and Interactive Automated Calls: A Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):659-667. doi: 10.1007/s11606-017-4266-9. Epub 2018 Jan 30.

    PMID: 29383550DERIVED

  • Cutrona SL, Sreedhara M, Goff SL, Fisher LD, Preusse P, Jackson M, Sundaresan D, Garber LD, Mazor KM. Improving Rates of Influenza Vaccination Through Electronic Health Record Portal Messages, Interactive Voice Recognition Calls and Patient-Enabled Electronic Health Record Updates: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 May 6;5(2):e56. doi: 10.2196/resprot.5478.

    PMID: 27153752DERIVED

MeSH Terms

Conditions

Influenza, HumanPneumococcal InfectionsPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

It is possible that our findings are not generalizable to patients in other parts of the country or to those without regular access to primary care.

Results Point of Contact

Title
Dr. Sarah Cutrona
Organization
University of Massachusetts Medical School
sarah.cutrona@umassmed.edu
508-856-3086

Study Officials

  • Sarah L Cutrona, MD, MPH

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 17, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

May 31, 2017

Results First Posted

March 28, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)