Vaccine Preventable DiseasesAIMHiNCT01984125
Testing the Use of Prompts to Increase Adolescent Immunization Rates
A study testing Point-of-Care Prompt in people with Vaccine Preventable Diseases and Meningococcal Disease, run by University of California, Los Angeles at 22 sites in United States.
Trial summary
Although most US adolescents visit their primary care doctor, their immunization rates are low. Primary care practices from two networks, one in upstate New York as well as a national network of pediatric clinics were surveyed to ask what they thought was the best strategy to increase immunization rates. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Vaccine Preventable Diseases, Meningococcal Disease, Human Papillomavirus
- What is being tested?
- Point-of-Care Prompt
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,040 participants
- Where
- 22 sitesUnited States
- Study dates
- Apr 2011to Dec 2013
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged 11 - 18 who had a visit to their primary care provider during the 12 month intervention period
Who cannot join
- Adolescent is pregnant during intervention time period
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Michigan
Ann Arbor, Michigan, 48109
Boston Children's
Boston, Massachusetts, 02115
Oak Orchard Community Health Center
Brockport, New York, 14420
Children's Memorial Hospital - Northwestern University
Chicago, Illinois, 60611
Nationwide Children's Hospital
Columbus, Ohio, 42338
University of Florida
Gainesville, Florida, 32608
Honeoye Falls Family Medicine
Honeoye Falls, New York, 14472
Baylor College of Medicine, Texas Children's Hospital
Houston, Texas, 77030
University of Texas - Houston
Houston, Texas, 77030
University of Iowa Hospital
Iowa City, Iowa, 52242
University of Arkansas - Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Mendon Pediatrics
Mendon, New York, 14506
Long Pond Pediatrics
Rochester, New York, 14606
Goodman Pediatrics
Rochester, New York, 14609
Parkway Pediatrics
Rochester, New York, 14612
English Road Pediatrics
Rochester, New York, 14616
12 Corner Pediatrics
Rochester, New York, 14618
Westside Pediatrics
Rochester, New York, 14624
Ridgewood Med-Peds
Rochester, New York, 14626
University of Washington Medical Center
Seattle, Washington, 98105
St. Louis University - School of Medicine
St Louis, Missouri, 63104
Wilmington Hospital Health Center
Wilmington, Delaware, 19801
About this study
Official title: Adolescent Vaccination in the Medical Home
Although most US adolescents visit their primary care doctor, their immunization rates are low. Primary care practices from two networks, one in upstate New York as well as a national network of pediatric clinics were surveyed to ask what they thought was the best strategy to increase immunization rates. Point-of-care prompts (either by an electronic health record message or by a nurse) when an adolescent patient comes in for any type of visit and is due for a vaccine was chosen. This study will determine if these prompts will increase immunization rates after a 12-month intervention period.
- Conditions
- Vaccine Preventable Diseases, Meningococcal Disease, Human Papillomavirus, Pertussis, Influenza
- Being tested
- Point-of-Care Prompt
- Keywords
- Adolescent Immunization Rates, Provider prompts
- Medical subject headings
- Vaccine-Preventable Diseases, Meningococcal Infections, Whooping Cough, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care PromptOther
| Study group | Role | What they receive |
|---|---|---|
| Point-of-Care Prompt | Experimental | A prompt, either electronically or by a nurse, will notify a provider if an adolescent is due for a vaccination. This prompt will appear at any type of visit where the patient is seen by a health provider. Receives: Other: Point-of-Care Prompt |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Immunization Rates
Bivariate analysis will measure the overall change between the control and intervention groups. Vaccination rates will be summarized using descriptive statistics. As appropriate, two sample t-test or chi-square tests will be used to summarize patient level data. Odds ratio with associated 95% confidence interval will be reported within each of the 2 networks.
Measured: One Year
Secondary outcomes (1)
Missed Opportunities
A hierarchical logistic regression model will evaluate the intervention effect on rates of missed opportunities.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine Preventable DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Peter G Szilagyi, MD MPH, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984125
- Sponsor's protocol ID
- IP000312
- Acronym
- AIMHi
- Status last verified
- Apr 2017
- First submitted
- 7 Nov 2013
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Szilagyi PG, Serwint JR, Humiston SG, Rand CM, Schaffer S, Vincelli P, Dhepyasuwan N, Blumkin A, Albertin C, Curtis CR. Effect of provider prompts on adolescent immunization rates: a randomized trial. Acad Pediatr. 2015 Mar-Apr;15(2):149-57. doi: 10.1016/j.acap.2014.10.006.
PubMed 25748976
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Vaccination in the Medical Home
- ClinicalTrials.gov ID
- NCT01984125
- Acronym / sponsor ID
- AIMHi / IP000312
- Conditions
- Vaccine Preventable Diseases, Meningococcal Disease, Human Papillomavirus, Pertussis, Influenza
- Keywords
- Adolescent Immunization Rates, Provider prompts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,040 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Nov 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.
Although most US adolescents visit their primary care doctor, their immunization rates are low. Primary care practices from two networks, one in upstate New York as well as a national network of pediatric clinics were surveyed to ask what they thought was the best strategy to increase immunization rates. Point-of-care prompts (either by an electronic health record message or by a nurse) when an adolescent patient comes in for any type of visit and is due for a vaccine was chosen. This study will determine if these prompts will increase immunization rates after a 12-month intervention period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-Care Prompt | Experimental | Other: Point-of-Care PromptA prompt, either electronically or by a nurse, will notify a provider if an adolescent is due for a vaccination. This prompt will appear at any type of visit where the patient is seen by a health provider. |
| Control | No intervention | – |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents aged 11 - 18 who had a visit to their primary care provider during the 12 month intervention period
Key exclusion criteria (1 listed)
- Adolescent is pregnant during intervention time period
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 |
|---|---|---|
| Point-of-Care Prompt | Other | Point-of-Care Prompt |
Primary outcome
Adolescent Immunization Rates
Time frame: One Year
Bivariate analysis will measure the overall change between the control and intervention groups. Vaccination rates will be summarized using descriptive statistics. As appropriate, two sample t-test or chi-square tests will be used to summarize patient level data. Odds ratio with associated 95% confidence interval will be reported within each of the 2 networks.
1 secondary outcome
Missed Opportunities
Time frame: One Year
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 2 May 2017.
- Results publication: PubMed 25748976Szilagyi PG, Serwint JR, Humiston SG, Rand CM, Schaffer S, Vincelli P, Dhepyasuwan N, Blumkin A, Albertin C, Curtis CR. Effect of provider prompts on adolescent immunization rates: a randomized trial. Acad Pediatr. 2015 Mar-Apr;15(2):149-57. doi: 10.1016/j.acap.2014.10.006.
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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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-Care Prompt in people with Vaccine Preventable Diseases and Meningococcal Disease, run by University of California, Los Angeles at 22 sites 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 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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?
Adolescent Immunization Rates (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01984125, which also lists 1 linked publication.
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 2 May 2017.