Influenza Clinical Trial
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.
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)
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:
1. To improve rates of influenza and pneumococcal vaccination in eligible patient
populations via:
1. Patient-level outreach targeted at unvaccinated patients;
2. Provider- and staff-level educational interventions and system support.
2. 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)
;
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