Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02266277
Previous Study | Return to List | Next Study

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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE October 17, 2014
Results First Submitted Date  ICMJE February 8, 2017
Results First Posted Date  ICMJE March 28, 2017
Last Update Posted Date May 31, 2017
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2014)
  • Rate of RMG patients with EHR documentation of influenza vaccine completion [ Time Frame: Months 11-16 ]
    Proposed Analyses I. Did IVR call receipt increase likelihood of flu vaccine completion overall? • Intention-to-treat analysis using Chi-square (Arm 3 + 5) vs (Arm 4+ 6) II. Did e-portal message receipt increase likelihood of flu vaccine completion compared to control? • Unadjusted Chi-square (Arm 2 vs 4) III. Did e-portal message receipt plus IVR call increase likelihood of flu vaccine completion compared to e-portal message alone? • Unadjusted Chi-square (Arm 1 vs 2) IV. Did IVR call alone increase likelihood of flu vaccine completion compared to control among e-portal users? • Unadjusted Chi-square (Arm 3 vs 4) V. Did IVR call alone increase likelihood of flu vaccine completion compared to control among non e-portal users? • Unadjusted Chi-square (Arm 5 vs 6) VI. What is incremental value for a subgroup of adding IVR call? • Stratify by: age, race, gender, flu vaccine last year (y/n) & level of healthcare utilization
  • Rate of RMG patients with EHR documentation of pneumococcal vaccine completion [ Time Frame: Months 11-16 ]
    Proposed Analyses I. Did IVR call receipt increase likelihood of pneumococcal vaccine completion overall? • Intention-to-treat analysis using Chi-square (Arm 3 + 5) vs (Arm 4+ 6) II. Did e-portal message receipt increase likelihood of pneumococcal vaccine completion compared to control? • Unadjusted Chi-square (Arm 2 vs 4) III. Did e-Portal message receipt plus IVR call increase likelihood of pneumo vaccine completion compared to e-portal message alone? • Unadjusted Chi-square (Arm 1 vs 2) IV. Did IVR call alone increase likelihood of pneumo vaccine completion compared to control among e-portal users? • Unadjusted Chi-square (Arm 3 vs 4) V. Did IVR call alone increase likelihood of pneumo vaccine completion compared to control among non e-portal users? • Unadjusted Chi-square (Arm 5 vs 6) VI. What is incremental value for a subgroup of adding IVR call? • Stratify by: age, race, gender, pneumo vaccine last year & level of healthcare utilization
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2014)
  • Percent of intervention patients with self-reported influenza vaccinations documented in Electronic Health Record (EHR) [ Time Frame: Months 11-16 ]
  • Number of vaccinations reported via electronic Health Information Exchange (HIE) [ Time Frame: Months 18-30 ]
    Investigators aim to improve the capture of vaccinations administered to Reliant Medical Group (RMG) patients in the community, hospitals and nursing facilities via system-level HIE.
Current Other Pre-specified Outcome Measures
 (submitted: February 8, 2017)
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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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:

  • 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:

  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)
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
  • Influenza
  • Infections, Pneumococcal
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Other: Arm 1: E-portal message with IVR call
  • Active Comparator: Arm 2: E-portal message with no IVR call
    Patients identified as e-portal users will receive an e-portal message only
    Intervention: Other: Arm 2: E-portal message with no IVR call
  • Active Comparator: Arm 3: No e-portal message with IVR call
    Patients identified as e-portal users will receive an IVR call only
    Intervention: Other: Arm 3: No e-portal message with IVR call
  • 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
    Intervention: Other: Arm 5: IVR call
  • No Intervention: Arm 6: No IVR call
    Patients identified as non e-portal users will not receive any outreach
Publications *

*   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
 (submitted: October 16, 2014)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Plan to Share IPD: No
Responsible Party Sarah Cutrona, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE
  • Reliant Medical Group
  • Pfizer
Investigators  ICMJE
Principal Investigator: Sarah L Cutrona, MD, MPH University of Massachusetts, Worcester
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