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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

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ClinicalTrials.gov Identifier: NCT02266277
Recruitment Status : Completed
First Posted : October 17, 2014
Results First Posted : March 28, 2017
Last Update Posted : May 31, 2017
Sponsor:
Collaborators:
Reliant Medical Group
Pfizer
Information provided by (Responsible Party):
Sarah Cutrona, University of Massachusetts, Worcester

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)

Condition or disease Intervention/treatment Phase
Influenza Infections, Pneumococcal Other: Arm 1: E-portal message with IVR call Other: Arm 2: E-portal message with no IVR call Other: Arm 3: No e-portal message with IVR call Other: Arm 5: IVR call Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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.
Actual Study Start Date : November 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Arm 1: E-portal message with IVR call
Patients identified as e-portal users will receive an e-portal message with IVR call
Other: Arm 1: E-portal message with IVR call
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.

Active Comparator: Arm 2: E-portal message with no IVR call
Patients identified as e-portal users will receive an e-portal message only
Other: Arm 2: E-portal message with no IVR call
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.

Active Comparator: Arm 3: No e-portal message with IVR call
Patients identified as e-portal users will receive an IVR call only
Other: Arm 3: No e-portal message with IVR call
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.

No Intervention: Arm 4: No E-portal message with no IVR call
Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
Active Comparator: Arm 5: IVR call
Patients identified as non e-portal users will receive an IVR call only
Other: Arm 5: IVR call
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.

No Intervention: Arm 6: No IVR call
Patients identified as non e-portal users will not receive any outreach



Primary Outcome Measures :
  1. Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season [ Time Frame: Months 11-16 ]
    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 :
  1. Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion [ Time Frame: Months 11-16 ]
    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.


Other Outcome Measures:
  1. Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR) [ Time Frame: Months 11-16 ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266277


Locations
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United States, Massachusetts
Reliant Medical Group
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
Reliant Medical Group
Pfizer
Investigators
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Principal Investigator: Sarah L Cutrona, MD, MPH University of Massachusetts, Worcester

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sarah Cutrona, Assistant Professor of Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02266277     History of Changes
Other Study ID Numbers: 9713747
H00006928 ( Other Identifier: University of Massachusetts Medical School IRB )
First Posted: October 17, 2014    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sarah Cutrona, University of Massachusetts, Worcester:
electronic health record, utilization
randomized controlled trial
pragmatic clinical trial
influenza, prevention and control
pneumococcal vaccines
qualitative research

Additional relevant MeSH terms:
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Influenza, Human
Pneumococcal Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs