Community Acquired PneumoniaNCT01787838
Improving Pneumococcal Vaccination Rates in an Ambulatory Pre-surgical Testing Setting
A study testing Focused Health Education in people with Community Acquired Pneumonia, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Focused Health Education
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,509 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient seen in out-patient pre-surgical testing center
- At-risk adult patient as defined by the Centers for Disease Control (CDC)
Who cannot join
- Minors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Quality Improvement Study to Improve Pneumococcal Vaccination Rates Through Targeted Health Education for Patients in an Ambulatory Pre-surgical Testing Setting
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).
Read the 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.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Focused Health Education
- Keywords
- Pneumococcal vaccination rates, ambulatory settings
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Health EducationOther
Also called Patient literature and staff education, reinforcement
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.
| Study group | Role | What they receive |
|---|---|---|
| health education, audit and feedback | Other | Focused health education for staff and patients. Receives: Other: Focused Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Community Acquired PneumoniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Rebecca C Clark, PhD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787838
- Sponsor's protocol ID
- Clark_Merck_2.4.2013
- Status last verified
- Jul 2017
- First submitted
- 4 Feb 2013
- Last updated
- 19 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality Improvement Study to Improve Pneumococcal Vaccination Rates Through Targeted Health Education for Patients in an Ambulatory Pre-surgical Testing Setting
- ClinicalTrials.gov ID
- NCT01787838
- Acronym / sponsor ID
- Clark_Merck_2.4.2013
- Conditions
- Community Acquired Pneumonia
- Keywords
- Pneumococcal vaccination rates, ambulatory settings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,509 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Posted 26 Aug 2014
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 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).
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| health education, audit and feedback | Other | Other: Focused Health EducationFocused health education for staff and patients. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient seen in out-patient pre-surgical testing center
- At-risk adult patient as defined by the Centers for Disease Control (CDC)
Key exclusion criteria (1 listed)
- Minors
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 |
|---|---|---|
| Focused Health EducationAlso: Patient literature and staff education, reinforcementA 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 | health education, audit and feedback |
Primary outcome
Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients
Time frame: 12 Months
Pneumococcal vaccination rates, tracked biweekly, following 1) staff education, audit and feedback of rates and 2) patient education
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Community Acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
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.
Rebecca C Clark, PhD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Health Education in people with Community Acquired Pneumonia, run by Carilion Clinic 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 2 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 19 Jul 2017. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2017.