Improve Childhood Immunization RatesImmProveNCT01794286
Improving Childhood Immunization
A study testing Provider bulletins and Trigger alerts in people with Improve Childhood Immunization Rates, run by Johns Hopkins University at 1 site in United States.
Trial summary
Specific Aim: To improve childhood immunization rates by utilizing automated Electronic Health Record-derived provider-specific performance feedback reports, coupled with automated Electronic Health Record-derived trigger alerts. Read more about this study
- Who is it for?
- Ages 28 to 40 years
- Conditions the study is for
- Improve Childhood Immunization Rates
- What is being tested?
- Provider bulletins and Trigger alerts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2011
- 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 28 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all pediatric resident providers in Harriet Lane Clinic at Johns Hopkins University
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Childhood Immunization Compliance Using Electronic Health Records
Specific Aim: To improve childhood immunization rates by utilizing automated Electronic Health Record-derived provider-specific performance feedback reports, coupled with automated Electronic Health Record-derived trigger alerts.
Hypothesis: The automated Electronic Health Record-derived provider-specific performance feedback reports will result in a 50% decrease in unimmunized children ages 0-13 years of age, when coupled with automated Electronic Health Record-derived trigger alerts, compared with trigger alerts alone.
- Conditions
- Improve Childhood Immunization Rates
- Being tested
- Provider bulletins, Trigger alerts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider bulletinsOther
Trigger alertsOther
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Trigger alerts only Receives: Other: Trigger alerts |
| Intervention Group | Experimental | Trigger alerts + provider bulletins Receives: Other: Provider bulletins; Other: Trigger alerts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of missing immunization
Measured: Time to event analyses, with events measured across 7 quarters (21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improve Childhood Immunization RatesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlene Miller, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794286
- Sponsor's protocol ID
- RC1LM010512
- Acronym
- ImmProve
- Status last verified
- Feb 2013
- First submitted
- 13 Feb 2013
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Childhood Immunization Compliance Using Electronic Health Records
- ClinicalTrials.gov ID
- NCT01794286
- Acronym / sponsor ID
- ImmProve / RC1LM010512
- Conditions
- Improve Childhood Immunization Rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Feb 2013 (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.
Specific Aim: To improve childhood immunization rates by utilizing automated Electronic Health Record-derived provider-specific performance feedback reports, coupled with automated Electronic Health Record-derived trigger alerts.
Hypothesis: The automated Electronic Health Record-derived provider-specific performance feedback reports will result in a 50% decrease in unimmunized children ages 0-13 years of age, when coupled with automated Electronic Health Record-derived trigger alerts, compared with trigger alerts alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Trigger alertsTrigger alerts only |
| Intervention Group | Experimental | Other: Provider bulletins, Other: Trigger alertsTrigger alerts + provider bulletins |
Who may qualify
- Ages
- 28 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all pediatric resident providers in Harriet Lane Clinic at Johns Hopkins University
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Provider bulletins | Other | Intervention Group |
| Trigger alerts | Other | Control Group, Intervention Group |
Primary outcome
Receipt of missing immunization
Time frame: Time to event analyses, with events measured across 7 quarters (21 months)
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 18 Feb 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider bulletins and Trigger alerts in people with Improve Childhood Immunization Rates, run by Johns Hopkins University 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 18 Feb 2013. 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?
Receipt of missing immunization (time frame: Time to event analyses, with events measured across 7 quarters (21 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 18 Feb 2013.