Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies

• ClinicalTrials.gov Identifier: NCT03796585
• Recruitment Status: Completed
• First Posted: January 8, 2019
• Last Update Posted: October 30, 2019
• Sponsor: Auburn University
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Tessa Hastings, Auburn University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Immunization	Behavioral: Immunization Registry Training; Behavioral: Informational flyer	Not Applicable

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

1. identify barriers and best practices of immunization registry implementation,
2. use a participatory design approach to develop an immunization registry training program, and
3. 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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies: A Randomized Controlled Trial
• Actual Study Start Date: January 10, 2019
• Actual Primary Completion Date: September 15, 2019
• Actual Study Completion Date: September 15, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Pharmacists assigned to this group will receive an immunization registry training program and informational flyer.	Behavioral: Immunization Registry Training; 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.; Behavioral: Informational flyer; Informational flyer with ImmPRINT contact information
Active Comparator: Control; Pharmacists assigned to this group will receive an informational flyer. They will not receive training.	Behavioral: Informational flyer; Informational flyer with ImmPRINT contact information

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Level of Immunization Registry Participation [ Time Frame: 3 months ]
   Proportion of self-reported doses administered that are verified in the immunization registry.
2. Change in awareness [ Time Frame: 1 month and 3 months ]
   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.
3. Change in knowledge [ Time Frame: 1 month and 3 months ]
   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.
4. Change in attitudes [ Time Frame: 1 month and 3 months ]
   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.
5. Change in intention to enroll in immunization registry [ Time Frame: 1 month and 3 months ]
   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.
6. Change in Implementation Factors [ Time Frame: 3 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Contacts and Locations

Locations

United States, Alabama

Auburn University

Auburn, Alabama, United States, 36849

Sponsors and Collaborators

Auburn University

Agency for Healthcare Research and Quality (AHRQ)

More Information

• Responsible Party: Tessa Hastings, Principal Investigator, Auburn University
• ClinicalTrials.gov Identifier: NCT03796585
• Other Study ID Numbers: 1R36HS026093-01A1 ( U.S. AHRQ Grant/Contract )
• First Posted: January 8, 2019
• Last Update Posted: October 30, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Vaccines; Immunologic Factors; Physiological Effects of Drugs