NCT01787838

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,509

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 26, 2014

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

February 4, 2013

Results QC Date

May 21, 2014

Last Update Submit

July 17, 2017

Conditions

Keywords

Pneumococcal vaccination rates, ambulatory settings

Outcome Measures

Primary Outcomes (1)

  • Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients

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

    12 Months

Study Arms (1)

health education, audit and feedback

OTHER

Focused health education for staff and patients.

Other: Focused Health Education

Interventions

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.

Also known as: Patient literature and staff education, reinforcement
health education, audit and feedback

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient seen in out-patient pre-surgical testing center
  • At-risk adult patient as defined by the Centers for Disease Control (CDC)

You may not qualify if:

  • Minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Results Point of Contact

Title
Rebecca Culver Clark
Organization
Carilion Clinic

Study Officials

  • Rebecca C Clark, PhD

    Carilion Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 11, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 19, 2017

Results First Posted

August 26, 2014

Record last verified: 2017-07

Locations