Pneumococcal Disease PreventionNCT00229762
Racial Disparities in Pneumococcal Vaccination in Managed Care
A study testing phone call from nurses - informational only in people with Pneumococcal Disease Prevention, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The goal of the study was to determine effectiveness of a telephone reminder to increase pneumococcal vaccination in a managed care population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease Prevention
- What is being tested?
- phone call from nurses - informational only
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- recommended for pneumococcal vaccination according to age or medical comorbidity
Who cannot join
- already known to have received pneumococcal vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Racial Disparities in Pneumococcal Vaccination in Managed Care: the Effects of Randomized Telephone Outreach
The goal of the study was to determine effectiveness of a telephone reminder to increase pneumococcal vaccination in a managed care population.
Read the detailed description
Patients randomized to the intervention arm received a telephone call from managed care nurses asking about their pneumococcal vaccination status and whether they would like to be vaccinated. We compared six month follow-up of pneumococcal vaccination in electronic medical records for the intervention versus control group. We tested the percent vaccinated in each randomization arm using chi-square tests for proportions.
- Conditions
- Pneumococcal Disease Prevention
- Being tested
- phone call from nurses - informational only
- Keywords
- pneumococcal vaccination coverage with no disease or efficacy outcomes recorded
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone call from nurses - informational onlyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
pneumococcal vaccination coverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startMar 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal Disease PreventionStudies 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 7,000 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Kaiser Permanente
- Investigators
- Carla A Winston, PhD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229762
- Sponsor's protocol ID
- CDC-NIP-4252
- Other IDs
- 000HCJ4-2004-07797
- Status last verified
- Sep 2005
- First submitted
- 28 Sep 2005
- Last updated
- 30 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Disparities in Pneumococcal Vaccination in Managed Care: the Effects of Randomized Telephone Outreach
- ClinicalTrials.gov ID
- NCT00229762
- Acronym / sponsor ID
- CDC-NIP-4252
- Conditions
- Pneumococcal Disease Prevention
- Keywords
- pneumococcal vaccination coverage with no disease or efficacy outcomes recorded
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,000 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Kaiser Permanente
- Study start
- Mar 2004
- Study completion
- Jun 2005
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study was to determine effectiveness of a telephone reminder to increase pneumococcal vaccination in a managed care population.
Detailed description
Patients randomized to the intervention arm received a telephone call from managed care nurses asking about their pneumococcal vaccination status and whether they would like to be vaccinated. We compared six month follow-up of pneumococcal vaccination in electronic medical records for the intervention versus control group. We tested the percent vaccinated in each randomization arm using chi-square tests for proportions.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- recommended for pneumococcal vaccination according to age or medical comorbidity
Key exclusion criteria (1 listed)
- already known to have received pneumococcal vaccine
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 |
|---|---|---|
| phone call from nurses - informational only | Behavioural | – |
Primary outcome
pneumococcal vaccination coverage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2005.
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Pneumococcal Polysaccharide Vaccine, Influenza Vaccines
Not yet recruiting
A Study on the Immunization Schedule for the 13-Valent Pneumococcal Polysaccharide-Conjugate Vaccine in Healthy Infants
Pneumococcal Disease Prevention
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.
Carla A Winston, PhD principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phone call from nurses - informational only in people with Pneumococcal Disease Prevention, run by Centers for Disease Control and Prevention 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 1 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 30 Sep 2005. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pneumococcal vaccination coverage. 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 30 Sep 2005.