Infections, Pneumococcal, Influenza
Conditions
Keywords
electronic health record, utilization, randomized controlled trial, pragmatic clinical trial, influenza, prevention and control, pneumococcal vaccines, qualitative research
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)
Interventions
OTHERArm 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.
OTHERArm 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.
OTHERArm 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.
OTHERArm 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.
Sponsors
Reliant Medical Group
Pfizer
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR) | 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). |
Countries
United States
Participant flow
Recruitment details
Cycle 1 Outreach
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: E-portal Message With IVR Call 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. | 5,000 |
| 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. | 5,000 |
| 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. | 5,000 |
| 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 | 5,000 |
| 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. | 5,000 |
| Arm 6: No IVR Call Patients identified as non e-portal users will not receive any outreach | 5,000 |
| Total | 30,000 |
Baseline characteristics
| Characteristic | Arm 1: E-portal Message With IVR Call | Arm 2: E-portal Message With no IVR Call | Arm 3: No E-portal Message With IVR Call | Arm 4: No E-portal Message With no IVR Call | Arm 5: IVR Call | Arm 6: No IVR Call | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 556 Participants | 584 Participants | 597 Participants | 640 Participants | 680 Participants | 697 Participants | 3754 Participants |
| Age, Categorical Between 18 and 65 years | 4444 Participants | 4416 Participants | 4403 Participants | 4360 Participants | 4320 Participants | 4303 Participants | 26246 Participants |
| Race/Ethnicity, Customized Asian | 252 Participants | 212 Participants | 248 Participants | 211 Participants | 189 Participants | 200 Participants | 1312 Participants |
| Race/Ethnicity, Customized Black | 150 Participants | 145 Participants | 153 Participants | 113 Participants | 234 Participants | 230 Participants | 1025 Participants |
| Race/Ethnicity, Customized Missing | 481 Participants | 466 Participants | 496 Participants | 467 Participants | 920 Participants | 855 Participants | 3685 Participants |
| Race/Ethnicity, Customized Other | 86 Participants | 72 Participants | 81 Participants | 84 Participants | 138 Participants | 161 Participants | 622 Participants |
| Race/Ethnicity, Customized White | 4031 Participants | 4105 Participants | 4022 Participants | 4125 Participants | 3519 Participants | 3554 Participants | 23356 Participants |
| Sex: Female, Male Female | 3111 Participants | 3179 Participants | 3166 Participants | 3132 Participants | 2497 Participants | 2531 Participants | 17616 Participants |
| Sex: Female, Male Male | 1889 Participants | 1821 Participants | 1834 Participants | 1868 Participants | 2503 Participants | 2469 Participants | 12384 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: E-portal Message With IVR Call | Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season | 702 Participants |
| Arm 2: E-portal Message With no IVR Call | Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season | 669 Participants |
| Arm 3: No E-portal Message With IVR Call | Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season | 642 Participants |
| Arm 4: No E-portal Message With no IVR Call | Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season | 582 Participants |
| Arm 5: IVR Call | Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season | 427 Participants |
| Arm 6: No IVR Call | Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season | 430 Participants |
p-value: 0.000195% CI: [1.15, 1.47]Regression, Logistic
p-value: 0.002695% CI: [1.07, 1.36]Regression, Logistic
p-value: 0.020695% CI: [1.02, 1.31]Regression, Logistic
p-value: 0.23395% CI: [0.96, 1.21]Regression, Logistic
p-value: 0.057995% CI: [0.996, 1.26]Regression, Logistic
p-value: 0.8795% CI: [0.86, 1.14]Regression, Logistic
Secondary
Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion
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.
Time frame: Months 11-16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: E-portal Message With IVR Call | Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion | 153 Participants |
| Arm 2: E-portal Message With no IVR Call | Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion | 155 Participants |
| Arm 3: No E-portal Message With IVR Call | Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion | 176 Participants |
| Arm 4: No E-portal Message With no IVR Call | Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion | 178 Participants |
| Arm 5: IVR Call | Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion | 161 Participants |
| Arm 6: No IVR Call | Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion | 154 Participants |
p-value: 0.8295% CI: [0.81, 1.31]Regression, Logistic
p-value: 0.3695% CI: [0.71, 1.13]Regression, Logistic
p-value: 0.3395% CI: [0.71, 1.13]Regression, Logistic
p-value: 0.2395% CI: [0.69, 1.09]Regression, Logistic
p-value: 0.9695% CI: [0.79, 1.25]Regression, Logistic
p-value: 0.7695% CI: [0.82, 1.31]Regression, Logistic
Other Pre-specified
Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR)
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).
Time frame: Months 11-16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: E-portal Message With IVR Call | Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR) | 1527 Participants |
| Arm 2: E-portal Message With no IVR Call | Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR) | 6774 Participants |