Project IMPACT Immunizations (IMProving America's Communities Together)

July 11, 2016 updated by: American Pharmacists Association Foundation
The primary objective of this study is to evaluate how implementing an innovative care model that provides the pharmacist access to a patient's vaccine history at the point-of-care impacts the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-site, observational study investigating the impact of implementing an innovative care model on the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations. The innovative care model enables the pharmacist to utilize a bi-directional IIS to assess patients' vaccination histories, identify unmet vaccination needs, and document the care provided. Data will be collected in the bi-directional IIS. Aggregate de-identified data will be reported to the researchers at the midpoint and conclusion of the study. The project duration has been established to allow sufficient time for each pharmacy to implement the innovative care model and monitor each pharmacy for a 6-month study period. The American Pharmacists Association (APhA) Foundation has an a priori intent to publish the project results.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1080

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Belfair, Washington, United States, 98528
        • Quality Food Centers #101
      • Cheney, Washington, United States, 99004
        • Cheney-Owl Pharmacy
      • Eatonville, Washington, United States, 98328
        • Kirk's Pharmacy
      • Edmonds, Washington, United States, 98020
        • Quality Food Centers #851
      • Lopez Island, Washington, United States, 98261
        • Lopez Island Pharmacy
      • Seattle, Washington, United States, 98104
        • Kelley-Ross Pharmacy
      • Spokane, Washington, United States, 99207
        • ReliantRx
      • Yakima, Washington, United States, 98902
        • Tieton Village Drug

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving an influenza vaccine

Description

Inclusion Criteria:

  • Individuals eligible to be enrolled in the study include any person at least 18 years of age receiving an influenza vaccination from a participating pharmacy site.

Exclusion Criteria:

  • n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Receiving Influenza Vaccine
Patients who receive an influenza vaccine at a participating pharmacy site will be eligible to: a) receive a vaccination forecast review, b) be evaluated for unmet vaccination needs, c) receive patient education, and d) have vaccination needs met.
Biological: Vaccine administration by a pharmacist
Administration, number and types, of vaccine(s) by a pharmacist
Behavioral: Unmet vaccination needs identified and met
Identification of unmet vaccination needs and having those needs met
Behavioral: Vaccination forecast review and patient education
Pharmacist review of the vaccination forecast and patient education on his/her vaccine needs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number and types of vaccines administered
Time Frame: Change from baseline rates at 6 months
Change from baseline rates at 6 months
Number of unmet vaccination needs identified and met
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Number of times the pharmacist reviewed the vaccination forecast and educated the patient on his/her vaccine needs
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American Pharmacists Association Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benjamin M Bluml, BPharm, American Pharmacists Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 015 (Other Identifier: Nahrain Medical Research Collective (NMRC))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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