InfluenzaNCT03950986
Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System
A study testing Modified clinical reminders in people with Influenza and Tetanus, run by Atlanta VA Medical Center at 1 site in United States.
Trial summary
The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza, Tetanus, Diphtheria
- What is being tested?
- Modified clinical reminders
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients must have appointments with active primary care providers (physicians, physician assistants and nurse practitioners) in the Atlanta VA Health Care System
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System Through a Randomized Trial
The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the VA electronic health record system. The team will evaluate the intervention using a randomized controlled trial.
Read the detailed description
The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the VA electronic health record system.
The intervention includes a bundled vaccination reminder for influenza, pneumococcal and TDap vaccines, an immunization dashboard that relays a patient's vaccination status and history, and talking points for providers to use in their dialogues with patients. This intervention was designed to mitigate potential bottlenecks to vaccination, based on conversations and observations with facility clinicians.
The team will evaluate the intervention using a randomized controlled trial.
- Conditions
- Influenza, Tetanus, Diphtheria, Pertussis, Pneumonia
- Being tested
- Modified clinical reminders
- Keywords
- Vaccination, EHR Reminders, Nudge, Electronic Medical Records, Behavioral Economics
- Medical subject headings
- Influenza, Human, Tetanus, Diphtheria, Whooping Cough, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified clinical remindersOther
Clinical reminders for the vaccines of interest will be bundled into a single reminder, and other changes made to streamline the design and reduce provider burden. Other changes include an immunization dashboard that relays a patient's vaccination status and talking points for providers to use in their dialogues with patients.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Providers assigned to the control group will receive unmodified vaccine reminders (as they already appear in the VA EHR system). Separate reminders will appear for the different vaccines of interest. |
| Treatment | Experimental | Providers in the treatment group will receive modified clinical reminders for the vaccines of interest. Reminders for the different vaccines of interest will be bundled into a single reminder, and other changes made to streamline the design and reduce provider burden. Other changes include an immunization dashboard that relays a patient's vaccination status and talking points for providers to use in their dialogues with patients. Receives: Other: Modified clinical reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients receiving one of more vaccines of interest when due for these vaccines
Percent of patients receiving of one or more of the influenza, pneumococcal (PCV13 or PPSV23) or Tdap/Td vaccines during the observation period, conditional on the patient being due for at least one of these vaccines at any appointment during the observation period
Measured: 6 months
Percent of patients receiving the influenza vaccine when due for the vaccine
Percent of patients receiving the influenza vaccine during the observation period, conditional on the patient being due for the influenza vaccine at any appointment during the observation period
Measured: 6 months
Secondary outcomes (2)
Percent of patients receiving Tdap/Td or pneumococcal vaccines when due
Percent of patients receiving Tdap/Td or pneumococcal vaccines during the observation period, conditional on the patient being due for at least one of these vaccines at any appointment during the observation period
Measured: 6 months
Cost per additional individual vaccinated
Should these data be available, will assess the cost per additional individual vaccinated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start15 Oct 2018
- Primary completion30 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention is designed to target patients of primary care providers (physicians, physician assistants and nurse practitioners) in the Atlanta VA Medical System. Primary care providers will be assigned to a provider-side treatment (modified vaccine reminders in the electronic health record (EHR) system) or to control (existing vaccine reminders). Outcomes will be tracked for patients who have appointments with these providers.
- Masking
- None (open label)
- Enrolment
- 67,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlanta VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- General Services Administration (GSA), Emory University
- Responsible party
- Principal investigator, Vincent Marconi, Atlanta VA Medical Center
- Investigators
- Pompa Debroy, MS, Principal investigator, Office of Evaluation Sciences, U.S. General Services AdministrationRuss Burnett, PhD, Principal investigator, Office of Evaluation Sciences, U.S. General Services AdministrationSaad Omer, MBBS, MPH, PhD, Principal investigator, Emory UniversityJoseph M Wallace, Principal investigator, Atlanta VA Health Care SystemVincent Marconi, MD, Principal investigator, Atlanta VA Health Care System, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950986
- Sponsor's protocol ID
- AtlantaVAMC
- Status last verified
- Jan 2020
- First submitted
- 25 Apr 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Debroy P, Balu R, Burnett R, Johnson RA, Kappes HB, Wallace JM, Marconi VC. A cluster randomized controlled trial of a modified vaccination clinical reminder for primary care providers. Health Psychol. 2023 Mar;42(3):195-204. doi: 10.1037/hea0001218. Epub 2022 Oct 13.
PubMed 36227309
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System Through a Randomized Trial
- ClinicalTrials.gov ID
- NCT03950986
- Acronym / sponsor ID
- AtlantaVAMC
- Conditions
- Influenza, Tetanus, Diphtheria, Pertussis, Pneumonia
- Keywords
- Vaccination, EHR Reminders, Nudge, Electronic Medical Records, Behavioral Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67,000 participants (actual)
- Lead sponsor
- Atlanta VA Medical CenterUS federal agency
- Collaborators
- General Services Administration (GSA), Emory University
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the VA electronic health record system. The team will evaluate the intervention using a randomized controlled trial.
Detailed description
The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the VA electronic health record system.
The intervention includes a bundled vaccination reminder for influenza, pneumococcal and TDap vaccines, an immunization dashboard that relays a patient's vaccination status and history, and talking points for providers to use in their dialogues with patients. This intervention was designed to mitigate potential bottlenecks to vaccination, based on conversations and observations with facility clinicians.
The team will evaluate the intervention using a randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention is designed to target patients of primary care providers (physicians, physician assistants and nurse practitioners) in the Atlanta VA Medical System. Primary care providers will be assigned to a provider-side treatment (modified vaccine reminders in the electronic health record (EHR) system) or to control (existing vaccine reminders). Outcomes will be tracked for patients who have appointments with these providers.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Providers assigned to the control group will receive unmodified vaccine reminders (as they already appear in the VA EHR system). Separate reminders will appear for the different vaccines of interest. |
| Treatment | Experimental | Other: Modified clinical remindersProviders in the treatment group will receive modified clinical reminders for the vaccines of interest. Reminders for the different vaccines of interest will be bundled into a single reminder, and other changes made to streamline the design and reduce provider burden. Other changes include an immunization dashboard that relays a patient's vaccination status and talking points for providers to use in their dialogues with patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients must have appointments with active primary care providers (physicians, physician assistants and nurse practitioners) in the Atlanta VA Health Care System
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified clinical remindersClinical reminders for the vaccines of interest will be bundled into a single reminder, and other changes made to streamline the design and reduce provider burden. Other changes include an immunization dashboard that relays a patient's vaccination status and talking points for providers to use in their dialogues with patients. | Other | Treatment |
Primary outcome
Percent of patients receiving one of more vaccines of interest when due for these vaccines
Time frame: 6 months
Percent of patients receiving of one or more of the influenza, pneumococcal (PCV13 or PPSV23) or Tdap/Td vaccines during the observation period, conditional on the patient being due for at least one of these vaccines at any appointment during the observation period
Percent of patients receiving the influenza vaccine when due for the vaccine
Time frame: 6 months
Percent of patients receiving the influenza vaccine during the observation period, conditional on the patient being due for the influenza vaccine at any appointment during the observation period
2 secondary outcomes
Percent of patients receiving Tdap/Td or pneumococcal vaccines when due
Time frame: 6 months
Cost per additional individual vaccinated
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Derived from this study: PubMed 36227309Debroy P, Balu R, Burnett R, Johnson RA, Kappes HB, Wallace JM, Marconi VC. A cluster randomized controlled trial of a modified vaccination clinical reminder for primary care providers. Health Psychol. 2023 Mar;42(3):195-204. doi: 10.1037/hea0001218. Epub 2022 Oct 13.
- Project Analysis PlanLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pompa Debroy, MS principal investigator
Office of Evaluation Sciences, U.S. General Services Administration
Russ Burnett, PhD principal investigator
Office of Evaluation Sciences, U.S. General Services Administration
Saad Omer, MBBS, MPH, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified clinical reminders in people with Influenza and Tetanus, run by Atlanta VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients receiving one of more vaccines of interest when due for these vaccines (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.