Trial Outcomes & Findings for System Alignment for VaccinE Delivery (SAVED): Improving Rates of Influenza and Pneumococcal Vaccination Through Patient Outreach, Improved Medical Record Accuracy and Targeted Physician Alerts (NCT NCT02266277)

Last Updated: 2017-05-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30000 participants

Primary outcome timeframe

Months 11-16

Results posted on

2017-05-31

Participant Flow

Cycle 1 Outreach

Participant milestones

Participant milestones
Measure	Arm 1: E-portal Message With IVR Call Patients identified as e-portal users will receive an e-portal message with Interactive Voice Recognition (IVR) call 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 Patients identified as e-portal users will receive an e-portal message only 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 Patients identified as e-portal users will receive an IVR call only 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 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	Arm 5: IVR Call Patients identified as non e-portal users will receive an IVR call only 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.	Arm 6: No IVR Call Patients identified as non e-portal users will not receive any outreach
Overall Study STARTED	5000	5000	5000	5000	5000	5000
Overall Study COMPLETED	5000	5000	5000	5000	5000	5000
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: E-portal Message With IVR Call n=5000 Participants Patients identified as e-portal users will receive an e-portal message with IVR call 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 n=5000 Participants Patients identified as e-portal users will receive an e-portal message only 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 n=5000 Participants Patients identified as e-portal users will receive an IVR call only 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 4: No E-portal Message With no IVR Call n=5000 Participants Patients identified as e-portal users will receive neither an e-portal message nor an IVR call	Arm 5: IVR Call n=5000 Participants Patients identified as non e-portal users will receive an IVR call only 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.	Arm 6: No IVR Call n=5000 Participants Patients identified as non e-portal users will not receive any outreach	Total n=30000 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	4444 Participants n=5 Participants	4416 Participants n=7 Participants	4403 Participants n=5 Participants	4360 Participants n=4 Participants	4320 Participants n=21 Participants	4303 Participants n=8 Participants	26246 Participants n=8 Participants
Age, Categorical >=65 years	556 Participants n=5 Participants	584 Participants n=7 Participants	597 Participants n=5 Participants	640 Participants n=4 Participants	680 Participants n=21 Participants	697 Participants n=8 Participants	3754 Participants n=8 Participants
Sex: Female, Male Female	3111 Participants n=5 Participants	3179 Participants n=7 Participants	3166 Participants n=5 Participants	3132 Participants n=4 Participants	2497 Participants n=21 Participants	2531 Participants n=8 Participants	17616 Participants n=8 Participants
Sex: Female, Male Male	1889 Participants n=5 Participants	1821 Participants n=7 Participants	1834 Participants n=5 Participants	1868 Participants n=4 Participants	2503 Participants n=21 Participants	2469 Participants n=8 Participants	12384 Participants n=8 Participants
Race/Ethnicity, Customized White	4031 Participants n=5 Participants	4105 Participants n=7 Participants	4022 Participants n=5 Participants	4125 Participants n=4 Participants	3519 Participants n=21 Participants	3554 Participants n=8 Participants	23356 Participants n=8 Participants
Race/Ethnicity, Customized Black	150 Participants n=5 Participants	145 Participants n=7 Participants	153 Participants n=5 Participants	113 Participants n=4 Participants	234 Participants n=21 Participants	230 Participants n=8 Participants	1025 Participants n=8 Participants
Race/Ethnicity, Customized Asian	252 Participants n=5 Participants	212 Participants n=7 Participants	248 Participants n=5 Participants	211 Participants n=4 Participants	189 Participants n=21 Participants	200 Participants n=8 Participants	1312 Participants n=8 Participants
Race/Ethnicity, Customized Other	86 Participants n=5 Participants	72 Participants n=7 Participants	81 Participants n=5 Participants	84 Participants n=4 Participants	138 Participants n=21 Participants	161 Participants n=8 Participants	622 Participants n=8 Participants
Race/Ethnicity, Customized Missing	481 Participants n=5 Participants	466 Participants n=7 Participants	496 Participants n=5 Participants	467 Participants n=4 Participants	920 Participants n=21 Participants	855 Participants n=8 Participants	3685 Participants n=8 Participants

PRIMARY outcome

Timeframe: Months 11-16

Population: Using computer-generated random number assignments, we selected 20,000 portal users and 10,000 non portal users (total of 30,000 patients) from the eligible population.

Outcome measures

Outcome measures
Measure	Arm 1: E-portal Message With IVR Call n=5000 Participants Patients identified as e-portal users will receive an e-portal message with IVR call 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 n=5000 Participants Patients identified as e-portal users will receive an e-portal message only 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 n=5000 Participants Patients identified as e-portal users will receive an IVR call only 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 4: No E-portal Message With no IVR Call n=5000 Participants Patients identified as e-portal users will receive neither an e-portal message nor an IVR call	Arm 5: IVR Call n=5000 Participants Patients identified as non e-portal users will receive an IVR call only 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.	Arm 6: No IVR Call n=5000 Participants Patients identified as non e-portal users will not receive any outreach
Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season	702 Participants	669 Participants	642 Participants	582 Participants	427 Participants	430 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1: E-portal Message With IVR Call n=1122 Participants Patients identified as e-portal users will receive an e-portal message with IVR call 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 n=1164 Participants Patients identified as e-portal users will receive an e-portal message only 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 n=1176 Participants Patients identified as e-portal users will receive an IVR call only 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 4: No E-portal Message With no IVR Call n=1183 Participants Patients identified as e-portal users will receive neither an e-portal message nor an IVR call	Arm 5: IVR Call n=1580 Participants Patients identified as non e-portal users will receive an IVR call only 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.	Arm 6: No IVR Call n=1562 Participants Patients identified as non e-portal users will not receive any outreach
Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion	153 Participants	155 Participants	176 Participants	178 Participants	161 Participants	154 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).