Influenza Vaccination
Conditions
Keywords
education, vaccination, preventive service, Prevention & Control
Brief summary
The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants.
Interventions
BEHAVIORALFact Only Education Message
Participants randomized to this intervention will receive an educational brochure listing the facts of the influenza vaccine.
BEHAVIORALFact and Myth Educational Message
Participants randomized to this intervention will receive an educational brochure listing the facts and myths of the influenza vaccine.
BEHAVIORALFact, Myth, Why Educational Message
Participants randomized to this intervention will receive an educational brochure listing the facts, myths, and refutation of the myths of the influenza vaccine.
BEHAVIORALControl Educational Message
Participants randomized to this intervention will receive an educational brochure created and used by the CDC in a previous influenza season.
Sponsors
National Institute on Aging (NIA)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must have a scheduled appointment at least 6 weeks in advance in either the GIM or Geriatrics clinics at NMFF. * Participant must be a patient of Northwestern Medical Faculty Foundation. * Participant does not intend to receive the influenza vaccine.
Exclusion criteria
* Participant has a diagnosis of Alzheimer's Disease or Dementia * Participant has received an influenza vaccination during either the last influenza season or the current. * The scheduled visit is the participant's first time being seen by this doctor (appointment is to establish care in the clinic).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influenza Vaccination | 1 week following randomization | The primary outcome is receipt of influenza vaccination at appointment directly following the post-test. A pre-test was completed by participants during a telephone interview that occurred approximately two weeks prior to a scheduled clinic appointment. The post-test was completed via an in-person interview by participants immediately prior to their scheduled appointment. That is, the participants met with the Research Assistant, completed the post-test, and then proceeded to see their physician for a previously scheduled office visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recall Accuracy | 1 week following receipt of message | Participants were given 8 statements about the flu/flu shot and asked to recall if they had seen the statement on the message they received via FedEx. Participants responded that statement had been presented as a fact, presented as a myth, presented, but I don't recall if it was a fact or a myth, or not presented. Participants scored 1 for each correct answer; 0 for each incorrect answer or for response I don't recall. Recall accuracy was calculated among each message format, range for recall accuracy was 0 - 8 with 0 indicating no correct answers and 8 representing 100% accuracy. Thus units of measurement are units on a scale to represent participant scores out of 8 on the recall items. |
Countries
United States
Participant flow
Recruitment details
Eligible participants had scheduled appointments in a private medical clinic during October 2009 - March 2010. Potential participants were sent an opt-out letter indicating that they would be receiving a phone call to invite them to participate in a study if interested; those not opting out were contacted and asked to participate.
Pre-assignment details
If potential participants had already received the seasonal influenza vaccination for 2009 - 2010 or responded on the phone that they definitely intended to receive the vaccine, they were excluded from the study. These screening questions were asked prior to enrollment into the study.
Participants by arm
| Arm | Count |
|---|---|
| Fact Only The educational message used will contain facts only. | 31 |
| Fact and Myth The educational material seen by this arm will contain facts and myths only. | 31 |
| Fact, Myth, Why The educational material seen by this arm will contain myths, facts, and refutations of the myths. | 32 |
| Control This arm will receive fact/myth educational materials originally developed and used by the CDC. | 31 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 8 | 4 | 5 |
Baseline characteristics
| Characteristic | Fact and Myth | Fact, Myth, Why | Fact Only | Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 9 Participants | 13 Participants | 15 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 23 Participants | 18 Participants | 16 Participants | 77 Participants |
| Age, Continuous | 61.13 years STANDARD_DEVIATION 7.46 | 63.34 years STANDARD_DEVIATION 9.64 | 62.8 years STANDARD_DEVIATION 11.27 | 65.35 years STANDARD_DEVIATION 8.4 | 63.16 years STANDARD_DEVIATION 9.43 |
| Region of Enrollment United States | 31 participants | 32 participants | 31 participants | 31 participants | 125 participants |
| Sex: Female, Male Female | 24 Participants | 23 Participants | 27 Participants | 24 Participants | 98 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 4 Participants | 7 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 31 | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 32 | 0 / 31 |
Outcome results
Primary
Influenza Vaccination
The primary outcome is receipt of influenza vaccination at appointment directly following the post-test. A pre-test was completed by participants during a telephone interview that occurred approximately two weeks prior to a scheduled clinic appointment. The post-test was completed via an in-person interview by participants immediately prior to their scheduled appointment. That is, the participants met with the Research Assistant, completed the post-test, and then proceeded to see their physician for a previously scheduled office visit.
Time frame: 1 week following randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fact Only | Influenza Vaccination | 4 participants |
| Fact and Myth | Influenza Vaccination | 1 participants |
| Fact, Myth, Why | Influenza Vaccination | 3 participants |
| Control | Influenza Vaccination | 4 participants |
Comparison: Contrast analysis was used to assess difference in vaccination status. The first contrast assessed whether or not the three newly created messages (Fact Only (FO), Fact/Myth (FM), and Fact/Myth/Refutation (FMR)) were as a group significantly different than the control message.p-value: <0.05Contrast Analysis
Comparison: Contrast analysis was used to assess difference in vaccination status. The second contrast assessed whether the FO and FMR conditions were significantly different from the FM message.p-value: <0.05Contrast Analysis
Comparison: Contrast analysis was used to assess difference in vaccination status. The third contrast assessed whether the FO and the FMR message conditions were significantly different.p-value: <0.05Contrast Analysis
Secondary
Recall Accuracy
Participants were given 8 statements about the flu/flu shot and asked to recall if they had seen the statement on the message they received via FedEx. Participants responded that statement had been presented as a fact, presented as a myth, presented, but I don't recall if it was a fact or a myth, or not presented. Participants scored 1 for each correct answer; 0 for each incorrect answer or for response I don't recall. Recall accuracy was calculated among each message format, range for recall accuracy was 0 - 8 with 0 indicating no correct answers and 8 representing 100% accuracy. Thus units of measurement are units on a scale to represent participant scores out of 8 on the recall items.
Time frame: 1 week following receipt of message
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fact Only | Recall Accuracy | 3.13 units on a scale | Standard Deviation 1.66 |
| Fact and Myth | Recall Accuracy | 4.52 units on a scale | Standard Deviation 1.96 |
| Fact, Myth, Why | Recall Accuracy | 5.67 units on a scale | Standard Deviation 1.65 |
| Control | Recall Accuracy | 4.77 units on a scale | Standard Deviation 1.82 |
p-value: <0.05ANOVA