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System Alignment for VaccinE Delivery (SAVED): Improving Rates of Influenza and Pneumococcal Vaccination Through Patient Outreach, Improved Medical Record Accuracy and Targeted Physician Alerts

Primary Purpose

Influenza, Infections, Pneumococcal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm 1: E-portal message with IVR call
Arm 2: E-portal message with no IVR call
Arm 3: No e-portal message with IVR call
Arm 5: IVR call
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza focused on measuring electronic health record, utilization, randomized controlled trial, pragmatic clinical trial, influenza, prevention and control, pneumococcal vaccines, qualitative research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Failure to meet inclusion criteria.
  • 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.

Sites / Locations

  • Reliant Medical Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

Arm 1: E-portal message with IVR call

Arm 2: E-portal message with no IVR call

Arm 3: No e-portal message with IVR call

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

Arm 5: IVR call

Arm 6: No IVR call

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion
Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.

Full Information

First Posted
October 10, 2014
Last Updated
May 2, 2017
Sponsor
University of Massachusetts, Worcester
Collaborators
Reliant Medical Group, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02266277
Brief Title
System Alignment for VaccinE Delivery (SAVED): Improving Rates of Influenza and Pneumococcal Vaccination Through Patient Outreach, Improved Medical Record Accuracy and Targeted Physician Alerts
Official Title
System Alignment for VaccinE Delivery (SAVED): Improving Rates of Influenza and Pneumococcal Vaccination Through Patient Outreach, Improved Medical Record Accuracy and Targeted Physician Alerts.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Reliant Medical Group, Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)
Detailed Description
The study's multifaceted approach will address the gap between current and optimal vaccination rates via patient-, provider- and system-level interventions intended to target local barriers. Patient-level outreach consisting of education and access information about influenza and pneumococcal vaccines will be delivered through Interactive Voice Recognition (IVR) calls and electronic patient portal messages. The study will have two patient-level outreach cycles. These outreach cycles will address the 2014-2015 flu season (Cycle 1) and the 2015-2016 flu season (Cycle 2). A non-blinded randomized controlled trial design will be utilized during 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: (1) E-portal message with Interactive Voice Recognition (IVR) call; (2) E-portal message with no IVR call; (3) No e-portal message with IVR call; or (4) No e-portal message with no IVR call. Non e-portal users will be randomized to receive either (1) IVR call or (2) no IVR call. In Outreach Cycle 2, investigators will implement a broader outreach effort in which vaccination messages are sent to all e-portal users and IVR messages are sent to 15,000 patients who did not receive vaccinations in the 2014-2015 influenza season. The 15,000 patients receiving IVR calls will be randomly selected. In an attempt to improve the effectiveness of the intervention in Cycle 2, we will incorporate more detailed information (dates/times/locations on all RMG flu clinics) into both the IVR and e-portal messages. The rate at which e-portal messages can be distributed by RMG will limit the number that can be sent out before the scheduled flu clinics. Patients will therefore be randomly assigned to one of two groups: (A) half of the e-portal users will be sent early messages (approx. 19,000 patients anticipated), while (B) the other half of the e-portal users will not receive early messages. Those in the early message group will receive a message containing flu clinic location, dates, and times. Those in the non-early intervention group will be sent a simplified e-portal message in November 2015 (if they have not already been vaccinated for the 2015-2016 influenza season). The study team plans to conduct qualitative interviews with 20 patients as well as 10 providers and staff in order to tailor intervention components during Cycle 1. Provider-level components will include targeted and recurring educational materials for providers and their staff regarding the indications, risks and benefits of influenza and pneumococcal vaccination, and suggesting strategies for overcoming local barriers to vaccination. Beginning in year 2, providers will also receive individualized report cards providing feedback on their immunization rates. System-level components will include both the capability to capture patient reported vaccinations and automatic updating of EHR vaccination records with pneumococcal and influenza immunizations given at local hospitals and skilled nursing facilities. These system-level components will reduce inappropriate alerts and improve provider confidence in patient records. The key objectives are: To improve rates of influenza and pneumococcal vaccination in eligible patient populations via: Patient-level outreach targeted at unvaccinated patients; Provider- and staff-level educational interventions and system support. To improve the capture of vaccinations administered to Reliant Medical Group (RMG) patients in the community, hospitals and nursing facilities via system-level electronic Health Information Exchange (HIE)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Infections, Pneumococcal
Keywords
electronic health record, utilization, randomized controlled trial, pragmatic clinical trial, influenza, prevention and control, pneumococcal vaccines, qualitative research

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: E-portal message with IVR call
Arm Type
Active Comparator
Arm Description
Patients identified as e-portal users will receive an e-portal message with IVR call
Arm Title
Arm 2: E-portal message with no IVR call
Arm Type
Active Comparator
Arm Description
Patients identified as e-portal users will receive an e-portal message only
Arm Title
Arm 3: No e-portal message with IVR call
Arm Type
Active Comparator
Arm Description
Patients identified as e-portal users will receive an IVR call only
Arm Title
Arm 4: No E-portal message with no IVR call
Arm Type
No Intervention
Arm Description
Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
Arm Title
Arm 5: IVR call
Arm Type
Active Comparator
Arm Description
Patients identified as non e-portal users will receive an IVR call only
Arm Title
Arm 6: No IVR call
Arm Type
No Intervention
Arm Description
Patients identified as non e-portal users will not receive any outreach
Intervention Type
Other
Intervention Name(s)
Arm 1: E-portal message with IVR call
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Arm 2: E-portal message with no IVR call
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Arm 3: No e-portal message with IVR call
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Arm 5: IVR call
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season
Description
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.
Time Frame
Months 11-16
Secondary Outcome Measure Information:
Title
Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion
Description
Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.
Time Frame
Months 11-16
Other Pre-specified Outcome Measures:
Title
Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR)
Description
We calculated the percent of patients who used the portal or IVR to self-report influenza vaccine completion outside of the medical group, measured on April 1, 2015. We used as our denominator all those patients who received portal messages (10,000) and all those who received IVR calls (15,000).
Time Frame
Months 11-16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Failure to meet inclusion criteria. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah L Cutrona, MD, MPH
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reliant Medical Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32975529
Citation
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.
Results Reference
derived
PubMed Identifier
29383550
Citation
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.
Results Reference
derived
PubMed Identifier
27153752
Citation
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.
Results Reference
derived

Learn more about this trial

System Alignment for VaccinE Delivery (SAVED): Improving Rates of Influenza and Pneumococcal Vaccination Through Patient Outreach, Improved Medical Record Accuracy and Targeted Physician Alerts

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