System Alignment for VaccinE Delivery (SAVED): Improving Rates of Influenza and Pneumococcal Vaccination Through Patient Outreach, Improved Medical Record Accuracy and Targeted Physician Alerts
NCT02266277
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- 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.
- 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.
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- Worcester, Massachusetts
Descriptive Information | ||||
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Brief Title ICMJE | 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 ICMJE | System Alignment for VaccinE Delivery (SAVED): Improving Rates of Influenza and Pneumococcal Vaccination Through Patient Outreach, Improved Medical Record Accuracy and Targeted Physician Alerts. | |||
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:
Non e-portal users will be randomized to receive either:
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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:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Health Services Research | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 30000 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2016 | |||
Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02266277 | |||
Other Study ID Numbers ICMJE | 9713747 H00006928 ( Other Identifier: University of Massachusetts Medical School IRB ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Sarah Cutrona, University of Massachusetts, Worcester | |||
Study Sponsor ICMJE | University of Massachusetts, Worcester | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Massachusetts, Worcester | |||
Verification Date | May 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |