Improving Pneumococcal Vaccination Rates in an Ambulatory Pre-surgical Testing Setting

Sponsor
Carilion Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01787838
Collaborator
Merck Sharp & Dohme LLC (Industry)
2,509
1
1
12
209.2

Study Details

Study Description

Brief Summary

The purpose of this quality improvement project is to improve the immunization rates of an at-risk adult population seen in an ambulatory healthcare environment, through the use of targeted health education messages regarding pneumococcal immunization. Patients seen in an out-patient pre-surgical testing center will receive 1) a one-page written information sheet that outlines the benefits of pneumococcal immunization and 2) verbal reinforcement of this message, provided by the clinical staff, during the patient's interview.

At-risk adult patients (as defined by Centers for Disease Control) seen in an ambulatory healthcare environment (a pre-surgical testing center) will receive a one page, "gain-framed" message that emphasizes the benefits of pneumococcal vaccinations. This educational material will be reviewed and reinforced by clinical staff during the assessment phase of the clinical visit. Among this group, there will be increased vaccination rate compared with at-risk adult patients who did not receive this communication (prospective vs retrospective data).

Condition or Disease Intervention/Treatment Phase
  • Other: Focused Health Education
N/A

Detailed Description

The purpose of this project was to improve the immunization rates of an at-risk adult population seen in an ambulatory environment, through the use of targeted and evidence-based health education messages regarding pneumococcal immunization and staff training on the use of gain-framed messaging.

We hypothesized that there would be an increase in immunization rates for at-risk adults following implementation of the intervention.

The objective of the project was to increase our local immunization rate by 30% (from 20% to 50%) and to provide tools and processes that can be utilized in other ambulatory healthcare settings.

Study Design

Study Type:
Interventional
Actual Enrollment :
2509 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Quality Improvement Study to Improve Pneumococcal Vaccination Rates Through Targeted Health Education for Patients in an Ambulatory Pre-surgical Testing Setting
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: health education, audit and feedback

Focused health education for staff and patients.

Other: Focused Health Education
A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education. The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it.
Other Names:
  • Patient literature and staff education, reinforcement
  • Outcome Measures

    Primary Outcome Measures

    1. Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients [12 Months]

      Pneumococcal vaccination rates, tracked biweekly, following 1) staff education, audit and feedback of rates and 2) patient education

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patient seen in out-patient pre-surgical testing center

    • At-risk adult patient as defined by the Centers for Disease Control (CDC)

    Exclusion Criteria:
    • Minors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Carilion Clinic Roanoke Virginia United States 24014

    Sponsors and Collaborators

    • Carilion Clinic
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Rebecca C Clark, PhD, Carilion Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carilion Clinic
    ClinicalTrials.gov Identifier:
    NCT01787838
    Other Study ID Numbers:
    • Clark_Merck_2.4.2013
    First Posted:
    Feb 11, 2013
    Last Update Posted:
    Jul 19, 2017
    Last Verified:
    Jul 1, 2017
    Keywords provided by Carilion Clinic
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details All patients seen in the presurgical testing center who were eligible were offered the pneumococcal vaccine.
    Pre-assignment Detail
    Arm/Group Title Health Education, Audit and Feedback
    Arm/Group Description Prospective single group intervention with retrospective control group with no intervention. Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education. The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it.
    Period Title: Overall Study
    STARTED 2509
    COMPLETED 1096
    NOT COMPLETED 1413

    Baseline Characteristics

    Arm/Group Title Health Education, Audit and Feedback
    Arm/Group Description Prospective single group intervention with retrospective control group with no intervention. Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education. The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it.
    Overall Participants 2509
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    57
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    1757
    70%
    >=65 years
    752
    30%
    Sex: Female, Male (Count of Participants)
    Female
    1531
    61%
    Male
    978
    39%
    Region of Enrollment (participants) [Number]
    United States
    2509
    100%

    Outcome Measures

    1. Primary Outcome
    Title Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients
    Description Pneumococcal vaccination rates, tracked biweekly, following 1) staff education, audit and feedback of rates and 2) patient education
    Time Frame 12 Months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Health Education, Audit and Feedback
    Arm/Group Description Prospective single group intervention Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education. The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about immunizations.
    Measure Participants 2509
    Number [participants]
    1096
    43.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Health Education, Audit and Feedback
    Comments Prospective data from 12 months were compared to data that had been collected for the previous 12 month period to determine statistical significance and trended outcomes for comparative periods. Patients were screened for eligibility during the first 12 months, and staff and patients received the interventions during the second 12 month period.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.80
    Confidence Interval (2-Sided) 95%
    1.65 to 1.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Time of visit to presurgical center
    Adverse Event Reporting Description
    Arm/Group Title Health Education, Audit and Feedback
    Arm/Group Description Prospective single group intervention with retrospective control group with no intervention. Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education. The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it.
    All Cause Mortality
    Health Education, Audit and Feedback
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Health Education, Audit and Feedback
    Affected / at Risk (%) # Events
    Total 0/2509 (0%)
    Other (Not Including Serious) Adverse Events
    Health Education, Audit and Feedback
    Affected / at Risk (%) # Events
    Total 0/2509 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Rebecca Culver Clark
    Organization Carilion Clinic
    Phone 540-588-8184
    Email rcclark@carilionclinic.org
    Responsible Party:
    Carilion Clinic
    ClinicalTrials.gov Identifier:
    NCT01787838
    Other Study ID Numbers:
    • Clark_Merck_2.4.2013
    First Posted:
    Feb 11, 2013
    Last Update Posted:
    Jul 19, 2017
    Last Verified:
    Jul 1, 2017