System Alignment for VaccinE Delivery (SAVED): Improving Rates of Influenza and Pneumococcal Vaccination Through Patient Outreach, Improved Medical Record Accuracy and Targeted Physician Alerts

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02266277
• Other study ID #: 9713747
• Secondary ID: H00006928
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 10, 2014
• Last updated: January 19, 2017
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30000
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Pneumococcal
• Influenza
• Influenza, Human
• Pneumococcal Infections

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Reliant Medical Group	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Pfizer, Reliant Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of RMG patients with EHR documentation of influenza vaccine completion	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	Months 11-16
Primary	Rate of RMG patients with EHR documentation of pneumococcal vaccine completion	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	Months 11-16
Secondary	Percent of intervention patients with self-reported influenza vaccinations documented in Electronic Health Record (EHR)		Months 11-16
Secondary	Number of vaccinations reported via electronic Health Information Exchange (HIE)	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.	Months 18-30