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| ID | Type | Description | Link |
|---|---|---|---|
| H00006928 | Other Identifier | University of Massachusetts Medical School IRB |
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| Name | Class |
|---|---|
| Reliant Medical Group | OTHER |
| Pfizer | INDUSTRY |
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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:
Non e-portal users will be randomized to receive either:
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:
To improve rates of influenza and pneumococcal vaccination in eligible patient populations via:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: E-portal message with IVR call | Active Comparator | Patients identified as e-portal users will receive an e-portal message with IVR call |
|
| Arm 2: E-portal message with no IVR call | Active Comparator | Patients identified as e-portal users will receive an e-portal message only |
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| Arm 3: No e-portal message with IVR call | Active Comparator | Patients identified as e-portal users will receive an IVR call only |
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| Arm 4: No E-portal message with no IVR call | No Intervention | Patients identified as e-portal users will receive neither an e-portal message nor an IVR call | |
| Arm 5: IVR call | Active Comparator | Patients identified as non e-portal users will receive an IVR call only |
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| Arm 6: No IVR call |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1: E-portal message with IVR call | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Months 11-16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Months 11-16 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah L Cutrona, MD, MPH | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reliant Medical Group | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32975529 | Derived | Wijesundara JG, Ito Fukunaga M, Ogarek J, Barton B, Fisher L, Preusse P, Sundaresan D, Garber L, Mazor KM, Cutrona SL. Electronic Health Record Portal Messages and Interactive Voice Response Calls to Improve Rates of Early Season Influenza Vaccination: Randomized Controlled Trial. J Med Internet Res. 2020 Sep 25;22(9):e16373. doi: 10.2196/16373. | |
| 29383550 |
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Cycle 1 Outreach
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients identified as non e-portal users will not receive any outreach |
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| Arm 2: E-portal message with no IVR call | Other | 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. |
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| Arm 3: No e-portal message with IVR call | Other | 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 | Other | 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. |
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| Months 11-16 |
| Cutrona SL, Golden JG, Goff SL, Ogarek J, Barton B, Fisher L, Preusse P, Sundaresan D, Garber L, Mazor KM. Improving Rates of Outpatient Influenza Vaccination Through EHR Portal Messages and Interactive Automated Calls: A Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):659-667. doi: 10.1007/s11606-017-4266-9. Epub 2018 Jan 30. |
| 27153752 | Derived | Cutrona SL, Sreedhara M, Goff SL, Fisher LD, Preusse P, Jackson M, Sundaresan D, Garber LD, Mazor KM. 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. JMIR Res Protoc. 2016 May 6;5(2):e56. doi: 10.2196/resprot.5478. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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 |
| FG004 | 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. |
| FG005 | Arm 6: No IVR Call | Patients identified as non e-portal users will not receive any outreach |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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 |
| BG004 | 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. |
| BG005 | Arm 6: No IVR Call | Patients identified as non e-portal users will not receive any outreach |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Months 11-16 |
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| 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. | Posted | Count of Participants | Participants | Months 11-16 |
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| 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). | Posted | Count of Participants | Participants | Months 11-16 |
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All-Cause Mortality, Serious, and Other (not including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Arm 6: No IVR Call | Patients identified as non e-portal users will not receive any outreach | 0 | 0 | 0 | 0 | 0 | 0 |
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It is possible that our findings are not generalizable to patients in other parts of the country or to those without regular access to primary care.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Cutrona | University of Massachusetts Medical School | 508-856-3086 | sarah.cutrona@umassmed.edu |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D011008 | Pneumococcal Infections |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Black |
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| Asian |
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| Other |
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| Missing |
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| OG005 | Arm 6: No IVR Call | Patients identified as non e-portal users will not receive any outreach |
| Regression, Logistic | .0026 | Odds Ratio (OR) | 1.20 | 2-Sided | 95 | 1.07 | 1.36 | Superiority | We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses. With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates 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). |
| Regression, Logistic | .0206 | Odds Ratio (OR) | 1.16 | 2-Sided | 95 | 1.02 | 1.31 | Superiority | We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses. With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates 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). |
| Regression, Logistic | .2330 | Odds Ratio (OR) | 1.07 | 2-Sided | 95 | .96 | 1.21 | Superiority | We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses. With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates 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). |
| Regression, Logistic | .0579 | Odds Ratio, log | 1.12 | 2-Sided | 95 | .996 | 1.26 | Superiority | We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses. With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates 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). |
| Regression, Logistic | .87 | Odds Ratio (OR) | .99 | 2-Sided | 95 | .86 | 1.14 | Superiority | We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses. With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates 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). |
| OG002 | 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. |
| OG003 | 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 |
| OG004 | 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. |
| OG005 | Arm 6: No IVR Call | Patients identified as non e-portal users will not receive any outreach |
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