title: 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.
abstract: BACKGROUND
  Clinical decision support (CDS), including computerized reminders for providers and patients, can improve health outcomes. CDS promoting influenza vaccination, delivered directly to patients via an electronic health record (EHR) patient portal and interactive voice recognition (IVR) calls, offers an innovative approach to improving patient care.
  
  
  OBJECTIVE
  To test the effectiveness of an EHR patient portal and IVR outreach to improve rates of influenza vaccination in a large multispecialty group practice in central Massachusetts.
  
  
  METHODS
  We describe a nonblinded, randomized controlled trial of EHR patient portal messages and IVR calls designed to promote influenza vaccination. In our preparatory phase, we conducted qualitative interviews with patients, providers, and staff to inform development of EHR portal messages with embedded questionnaires and IVR call scripts. We also provided practice-wide education on influenza vaccines to all physicians and staff members, including information on existing vaccine-specific EHR CDS. Outreach will target adult patients who remain unvaccinated for more than 2 months after the start of the influenza season. Using computer-generated randomization and a factorial design, we will assign 20,000 patients who are active users of electronic patient portals to one of the 4 study arms: (1) receipt of a portal message promoting influenza vaccines and offering online appointment scheduling; (2) receipt of an IVR call with similar content but without appointment facilitation; (3) both (1) and (2); or (4) neither (1) nor (2) (usual care). We will randomize patients without electronic portals (10,000 patients) to (1) receipt of IVR call or (2) usual care. Both portal messages and IVR calls promote influenza vaccine completion. Our primary outcome is percentage of eligible patients with influenza vaccines administered at our group practice during the 2014-15 influenza season. Both outreach methods also solicit patient self-report on influenza vaccinations completed outside the clinic or on barriers to influenza vaccination. Self-reported data from both outreach modes will be uploaded into the EHR to increase accuracy of existing provider-directed EHR CDS (vaccine alerts).
  
  
  RESULTS
  With our proposed sample size and using a factorial design, power calculations using baseline vaccination rate estimates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided). Intention-to-treat unadjusted chi-square analyses will be performed to assess the impact of portal messages, either alone or in combination with the IVR call, on influenza vaccination rates. The project was funded in January 2014. Patient enrollment for the project described here completed in December 2014. Data analysis is currently under way and first results are expected to be submitted for publication in 2016.
  
  
  CONCLUSIONS
  If successful, this study's intervention may be adapted by other large health care organizations to increase vaccination rates among their eligible patients.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02266277; https://clinicaltrials.gov/ct2/show/NCT02266277 (Archived by WebCite at http://www.webcitation.org/6fbLviHLH).
authors.affiliation: University of Massachusetts School of Medicine, Division of General Medicine/Primary Care, Worcester, MA, United States. Sarah.Cutrona@umassmemorial.org.
authors.forename: Sarah L
authors.identifier: http://orcid.org/0000-0002-4795-8377
authors.initials: SL
authors.lastname: Cutrona
authors.forename: Meera
authors.identifier: http://orcid.org/0000-0002-0917-7377
authors.initials: M
authors.lastname: Sreedhara
authors.forename: Sarah L
authors.identifier: http://orcid.org/0000-0003-2005-1369
authors.initials: SL
authors.lastname: Goff
authors.forename: Lloyd D
authors.identifier: http://orcid.org/0000-0001-6246-8213
authors.initials: LD
authors.lastname: Fisher
authors.forename: Peggy
authors.identifier: http://orcid.org/0000-0001-9163-4946
authors.initials: P
authors.lastname: Preusse
authors.forename: Madeline
authors.identifier: http://orcid.org/0000-0003-4411-415X
authors.initials: M
authors.lastname: Jackson
authors.forename: Devi
authors.identifier: http://orcid.org/0000-0003-3597-5548
authors.initials: D
authors.lastname: Sundaresan
authors.forename: Lawrence D
authors.identifier: http://orcid.org/0000-0003-1500-5421
authors.initials: LD
authors.lastname: Garber
authors.forename: Kathleen M
authors.identifier: http://orcid.org/0000-0002-9491-9872
authors.initials: KM
authors.lastname: Mazor
keywords: Electronic Mail; Health Records, Personal; Internet; Medical Informatics Applications; Telephone; clinical decision support; electronic health records; influenza vaccines