ImmunizationNCT03796585
Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies
A study testing Immunization Registry Training and Informational flyer in people with Immunization, run by Auburn University at 1 site in United States.
Trial summary
The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information into a novel immunization registry training program. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunization
- What is being tested?
- Immunization Registry Training and Informational flyer
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2019to 15 Sep 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- not currently enrolled in ImmPRINT
- currently provide at least one type of vaccination in addition to influenza
- independently owned
- agree to provide requested data for assessment
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies: A Randomized Controlled Trial
The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information into a novel immunization registry training program.
Read the detailed description
The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information learned about barriers into a novel immunization registry training program with strategies specific to individual subsets of pharmacies, independent pharmacies in rural areas. Doing so will help achieve the long-term goal which is to increase the use of immunization registries in community pharmacies in Alabama.
The specific aims are to
- identify barriers and best practices of immunization registry implementation,
- use a participatory design approach to develop an immunization registry training program, and
- disseminate and assess the impact of the immunization registry training program among community pharmacies' registry participation rates.
The impact of the training program on registry participation rates will be assessed using a randomized controlled trial design comparing Alabama community pharmacies' registry data as well as intention to participate.
- Conditions
- Immunization
- Being tested
- Immunization Registry Training, Informational flyer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunization Registry TrainingBehavioural
Education highlighting practical strategies to improve pharmacies' willingness to adopt the immunization registry and improve their ability to integrate the immunization registry into their pharmacy workflow.
Informational flyerBehavioural
Informational flyer with ImmPRINT contact information
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pharmacists assigned to this group will receive an immunization registry training program and informational flyer. Receives: Behavioral: Immunization Registry Training; Behavioral: Informational flyer |
| Control | Active comparator | Pharmacists assigned to this group will receive an informational flyer. They will not receive training. Receives: Behavioral: Informational flyer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pharmacies enrolled in the Alabama Immunization Registry
The change in the number of participant pharmacies enrolled in the Alabama immunization registry from baseline to 3 months.
Measured: 3 months
Secondary outcomes (6)
Level of Immunization Registry Participation
Proportion of self-reported doses administered that are verified in the immunization registry.
Measured: 3 months
Change in awareness
The change in participant awareness of immunization registries from baseline to 3 months assessed by online questionnaire at baseline, one month, and three months. Awareness will be measured using three true or false items. Each item will be scored, 0 for an incorrect answer and 1 for a correct answer. Awareness index is the sum of the 3 items and could range from 0-3 with higher values representing greater awareness.
Measured: 1 month and 3 months
Change in knowledge
The extent to which participant is familiar with and understands immunization registries will be assessed via online questionnaire at baseline, one month, and three months. Eight true or false and multiple answer items will be used to measure knowledge. Each item will be scored, 0 for an incorrect answer and 1 for a correct answer. Knowledge is the sum of the 8 items and could range from 0-8 with higher values representing greater knowledge.
Measured: 1 month and 3 months
Change in attitudes
Participant's perceptions toward attributes of the immunization registry assessed via online questionnaire at baseline, one month, and three months. A scale including 25 Likert-type items will be used to measure attitudes. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated for the 25 items in the scale so that attitudes score range from 0 to 6 with higher values indicating greater positive attitudes.
Measured: 1 month and 3 months
Change in intention to enroll in immunization registry
Participant's likelihood to enroll their pharmacy in the immunization registry assessed via online questionnaire at baseline and one month. A scale including 3 Likert-type items will be used to measure intention. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated for the three items in the scale so that intention score ranges from 0 to 6 with higher values indicating greater intention.
Measured: 1 month and 3 months
Change in Implementation Factors
Implementation factors informed by the Consolidated Framework for Implementation Research (CFIR) including innovation characteristics, characteristics of individuals, inner setting, outer setting, and process will be assessed via online questionnaire at baseline and three months. A scale including 42 Likert-type items will be used to measure Implementation Factors. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated so that the implementation factors score ranges from 0 to 6 with higher values indicating greater positive influence of CFIR implementation factors.
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 posted8 Jan 2019
- Study start10 Jan 2019
- Primary completion15 Sep 2019
- Study completion15 Sep 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 ImmunizationStudies 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Tessa Hastings, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796585
- Sponsor's protocol ID
- 1R36HS026093-01A1
- Status last verified
- Oct 2019
- First submitted
- 3 Jan 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hastings TJ, Ha D, Fox BI, Qian J, Lakin J, Westrick SC. Increasing use of immunization information systems for routine vaccinations in independent community pharmacies: A randomized controlled trial. J Am Pharm Assoc (2003). 2022 Jul-Aug;62(4):1270-1279.e2. doi: 10.1016/j.japh.2022.02.010. Epub 2022 Feb 19.
PubMed 35292212
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03796585
- Acronym / sponsor ID
- 1R36HS026093-01A1
- Conditions
- Immunization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 8 Jan 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 purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information into a novel immunization registry training program.
Detailed description
The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information learned about barriers into a novel immunization registry training program with strategies specific to individual subsets of pharmacies, independent pharmacies in rural areas. Doing so will help achieve the long-term goal which is to increase the use of immunization registries in community pharmacies in Alabama.
The specific aims are to
- identify barriers and best practices of immunization registry implementation,
- use a participatory design approach to develop an immunization registry training program, and
- disseminate and assess the impact of the immunization registry training program among community pharmacies' registry participation rates.
The impact of the training program on registry participation rates will be assessed using a randomized controlled trial design comparing Alabama community pharmacies' registry data as well as intention to participate.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Immunization Registry Training, Behavioral: Informational flyerPharmacists assigned to this group will receive an immunization registry training program and informational flyer. |
| Control | Active comparator | Behavioral: Informational flyerPharmacists assigned to this group will receive an informational flyer. They will not receive training. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- not currently enrolled in ImmPRINT
- currently provide at least one type of vaccination in addition to influenza
- independently owned
- agree to provide requested data for assessment
Key exclusion criteria (1 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 |
|---|---|---|
| Immunization Registry TrainingEducation highlighting practical strategies to improve pharmacies' willingness to adopt the immunization registry and improve their ability to integrate the immunization registry into their pharmacy workflow. | Behavioural | Intervention |
| Informational flyerInformational flyer with ImmPRINT contact information | Behavioural | Control, Intervention |
Primary outcome
Number of pharmacies enrolled in the Alabama Immunization Registry
Time frame: 3 months
The change in the number of participant pharmacies enrolled in the Alabama immunization registry from baseline to 3 months.
6 secondary outcomes
Level of Immunization Registry Participation
Time frame: 3 months
Change in awareness
Time frame: 1 month and 3 months
Change in knowledge
Time frame: 1 month and 3 months
Change in attitudes
Time frame: 1 month and 3 months
Change in intention to enroll in immunization registry
Time frame: 1 month and 3 months
Change in Implementation Factors
Time frame: 3 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 30 Oct 2019.
- Derived from this study: PubMed 35292212Hastings TJ, Ha D, Fox BI, Qian J, Lakin J, Westrick SC. Increasing use of immunization information systems for routine vaccinations in independent community pharmacies: A randomized controlled trial. J Am Pharm Assoc (2003). 2022 Jul-Aug;62(4):1270-1279.e2. doi: 10.1016/j.japh.2022.02.010. Epub 2022 Feb 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunization Registry Training and Informational flyer in people with Immunization, run by Auburn University 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 4 inclusion and 1 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 30 Oct 2019. 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?
Number of pharmacies enrolled in the Alabama Immunization Registry (time frame: 3 months). 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 NCT03796585, 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 30 Oct 2019.