PharmacyImmuSMARTNCT02609035
Immunization Services Model for Adult Rate Improvement
A study testing Telephonic prompt in people with Pharmacy and Immunization, run by Pharmacy Quality Alliance.
Trial summary
ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to improve adult vaccination rates for pneumococcal and herpes zoster vaccines. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pharmacy, Immunization, Vaccines
- What is being tested?
- Telephonic prompt
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,301 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2016to 31 Mar 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at least 19 years of age at date of enrollment
- Patient not in long-term care, hospice or otherwise identified as unable to come to pharmacy for receipt of vaccine
- Patient currently missing a record of receipt of at least one of three vaccinations: flu, pneumonia, or shingles
- Patient enrolled in telephonic pharmacy reminder service
Who cannot join
None listed.
About this study
ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to improve adult vaccination rates for pneumococcal and herpes zoster vaccines.
Read the detailed description
This study will investigate immunization rate improvement among adult patients in 250 northeastern US community pharmacies as a result of telephonic prompts during regular automated outbound communiqués. There will be three projects assessing different forms of these appended prompts-appointment-based medication synchronization automated prompts, refill ready automated prompts, and refill reminder automated prompts. Each intervention will occur in one of three pharmacy chains, each with approximately 10,000 patients randomized to control or intervention (receive prompt or no).
Prior to the outbound automated call to the patient, a third-party technology vendor (Scientific Technologies Corporation) will perform an automated immunization status assessment of the patient by submitting a query the state immunization registry to compare the adult patient's existing immunization record to the CDC Recommended Adult Immunization Schedule. Gaps in immunizations that fall within pharmacy scope of practice will be identified. During the automated call (performed by VoicePort, a pharmacy telephonic support vendor) to the patient, they will be prompted to receive identified immunization gap vaccines upon their next pharmacy visit, with priority on pneumococcal, influenza, and herpes zoster vaccinations. If the patient accepts, the vaccination will be delivered when next the patient comes to visit the pharmacy.
After 6 months of running the trial, statistical modeling will be employed to assess vaccination rate differences between control and intervention patients.
- Conditions
- Pharmacy, Immunization, Vaccines
- Being tested
- Telephonic prompt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic promptBehavioural
Also called Appended message
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients who are either appointment-based medication synchronization calls, refill ready calls, or refill reminder calls at the pharmacy who have been identified as missing at least one vaccination. These patients will receive a telephonic prompt to get a vaccination. Receives: Behavioral: Telephonic prompt |
| Control | No intervention | Patients who are either appointment-based medication synchronization calls, refill ready calls, or refill reminder calls at the pharmacy who have been identified as missing at least one vaccination. These patients will receive usual pharmacy care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination rates
Administration of vaccine will be assessed at 3 months after patient receives the prompt
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start31 Mar 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22,301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacy Quality Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Stolpe, Pharmacy Quality Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609035
- Sponsor's protocol ID
- Pro00014163
- Acronym
- ImmuSMART
- Status last verified
- Apr 2017
- First submitted
- 17 Nov 2015
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunization Services Model for Adult Rate Improvement
- ClinicalTrials.gov ID
- NCT02609035
- Acronym / sponsor ID
- ImmuSMART / Pro00014163
- Conditions
- Pharmacy, Immunization, Vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22,301 participants (actual)
- Lead sponsor
- Pharmacy Quality AllianceUniversity, hospital or other
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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.
ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to improve adult vaccination rates for pneumococcal and herpes zoster vaccines.
Detailed description
This study will investigate immunization rate improvement among adult patients in 250 northeastern US community pharmacies as a result of telephonic prompts during regular automated outbound communiqués. There will be three projects assessing different forms of these appended prompts-appointment-based medication synchronization automated prompts, refill ready automated prompts, and refill reminder automated prompts. Each intervention will occur in one of three pharmacy chains, each with approximately 10,000 patients randomized to control or intervention (receive prompt or no).
Prior to the outbound automated call to the patient, a third-party technology vendor (Scientific Technologies Corporation) will perform an automated immunization status assessment of the patient by submitting a query the state immunization registry to compare the adult patient's existing immunization record to the CDC Recommended Adult Immunization Schedule. Gaps in immunizations that fall within pharmacy scope of practice will be identified. During the automated call (performed by VoicePort, a pharmacy telephonic support vendor) to the patient, they will be prompted to receive identified immunization gap vaccines upon their next pharmacy visit, with priority on pneumococcal, influenza, and herpes zoster vaccinations. If the patient accepts, the vaccination will be delivered when next the patient comes to visit the pharmacy.
After 6 months of running the trial, statistical modeling will be employed to assess vaccination rate differences between control and intervention patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Telephonic promptPatients who are either appointment-based medication synchronization calls, refill ready calls, or refill reminder calls at the pharmacy who have been identified as missing at least one vaccination. These patients will receive a telephonic prompt to get a vaccination. |
| Control | No intervention | –Patients who are either appointment-based medication synchronization calls, refill ready calls, or refill reminder calls at the pharmacy who have been identified as missing at least one vaccination. These patients will receive usual pharmacy care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient at least 19 years of age at date of enrollment
- Patient not in long-term care, hospice or otherwise identified as unable to come to pharmacy for receipt of vaccine
- Patient currently missing a record of receipt of at least one of three vaccinations: flu, pneumonia, or shingles
- Patient enrolled in telephonic pharmacy reminder service
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 |
|---|---|---|
| Telephonic promptAlso: Appended message | Behavioural | Intervention |
Primary outcome
Vaccination rates
Time frame: 3 months
Administration of vaccine will be assessed at 3 months after patient receives the prompt
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 27 Apr 2017.
Related trials for Pharmacy
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
Recruiting
Community Pharmacies as Social Determinant of Health Navigators
Social Needs Status
Recruiting
Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Physiotherapy
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Not yet recruiting
The PharmFIT Study
Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Telephonic prompt in people with Pharmacy and Immunization, run by Pharmacy Quality Alliance.
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 4 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 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Vaccination rates (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2017.