Health Services ResearchNCT01296906
Population Versus Practice-based Interventions to Increase Immunizations
A study testing Recall conducted by private practices and Recall conducted centrally by local health department in people with Health Services Research and Comparative Effectiveness, run by University of Colorado, Denver at 1 site in United States.
Trial summary
One of the nation's major health priorities, as outlined in Healthy People 2010, is to increase the proportion of children aged 19 to 35 months who have received all universally recommended vaccines. Read more about this study
- Who is it for?
- Ages 19 months and older
- Conditions the study is for
- Health Services Research, Comparative Effectiveness, Immunization
- What is being tested?
- Recall conducted by private practices and Recall conducted centrally by local health department
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31,567 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2012
- 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 19 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- child between the age of 19-35 months
- has an address in a specified study county in the state immunization registry
- child is in need of at least one recommended immunization
Who cannot join
- child has opted out of the state immunization registry
- child is up-to-date on all recommended immunizations
Trial locations and contacts
1 site in 1 country.
About this study
One of the nation's major health priorities, as outlined in Healthy People 2010, is to increase the proportion of children aged 19 to 35 months who have received all universally recommended vaccines. This study will compare two interventions for increasing immunization rates in this age group, one using well-studied primary care practice-based methods and the other using innovative technologies to increase immunization rates at the population-level. Results of this study will provide data that will be relevant nationally in guiding future investment of resources to increase up-to-date rates in young children prior to school entry.
Hypothesis: Population-based approaches will be more effective than practice-based interventions at increasing immunizations among 19-35 month olds.
- Being tested
- Recall conducted by private practices, Recall conducted centrally by local health department
- Keywords
- Reminder/recall messages, reminders, recall, immunizations, immunization information systems, effectiveness of reminder/recall, population-based reminder/recall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recall conducted by private practicesBehavioural
All practices in these counties will receive training on practice-based R/R using the Colorado Immunization Information System (CIIS or immunization registry). Practices will receive a recommended schedule for conducting recall in 19-35 month children and educational materials to use within their practices to promote compliance with the infant vaccination schedule. Individual practices will make their own decisions about the extent to which they follow the recommendations and implement recall within their practice. Although the study team will not provide them with any additional interventions, we will track any other interventions they independently do (websites, newsletters, telephone informational systems) in order to assess the effect of these additional interventions.
Recall conducted centrally by local health departmentBehavioural
A centralized recall of children 19-35 months will be conducted through local health departments. CIIS will identify a cohort of 19-35 month olds with an who are in need of an immunization and will coordinate up to 3 mailers to children who are not current for recommended immunizations.
| Study group | Role | What they receive |
|---|---|---|
| Population-based Reminder/Recall | Experimental | Recall is performed centrally by public health departments for all children in need of immunizations in a geographic area. Receives: Behavioral: Recall conducted centrally by local health department |
| Practice-based Reminder/Recall | Experimental | Reminder/Recall is performed by individual private practices for their patients who appear in need of immunizations. Receives: Behavioral: Recall conducted by private practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate effectiveness of population-based reminder/recall methods versus practice-based reminder/recall methods in 14 Colorado counties (rural and urban)
The primary outcome measures will be: 1) change in up-to-date rates from baseline levels 6 months after the intervention (T-1) for 19-35 month olds in population-based compared to practice-based intervention counties and 2) percent of children who were not up-to-date prior to recall (T-0) who received any additional new vaccine in each type of intervention county.
Measured: 6 months post-intervention (December 2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Health Services ResearchStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 31,567 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Sponsor
- Investigators
- Allison Kempe, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296906
- Sponsor's protocol ID
- 10-0823
- Other IDs
- 1RC1LM010513-01
- Status last verified
- Jun 2013
- First submitted
- 14 Feb 2011
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Briss PA, Rodewald LE, Hinman AR, Shefer AM, Strikas RA, Bernier RR, Carande-Kulis VG, Yusuf HR, Ndiaye SM, Williams SM. Reviews of evidence regarding interventions to improve vaccination coverage in children, adolescents, and adults. The Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):97-140. doi: 10.1016/s0749-3797(99)00118-x.
PubMed 10806982Recommendations regarding interventions to improve vaccination coverage in children, adolescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):92-6. No abstract available.
PubMed 10806981Tierney CD, Yusuf H, McMahon SR, Rusinak D, O' Brien MA, Massoudi MS, Lieu TA. Adoption of reminder and recall messages for immunizations by pediatricians and public health clinics. Pediatrics. 2003 Nov;112(5):1076-82. doi: 10.1542/peds.112.5.1076.
PubMed 14595049Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health. 2004 Mar;94(3):423-32. doi: 10.2105/ajph.94.3.423.
PubMed 14998806Kempe A, Saville A, Dickinson LM, Eisert S, Reynolds J, Herrero D, Beaty B, Albright K, Dibert E, Koehler V, Lockhart S, Calonge N. Population-based versus practice-based recall for childhood immunizations: a randomized controlled comparative effectiveness trial. Am J Public Health. 2013 Jun;103(6):1116-23. doi: 10.2105/AJPH.2012.301035. Epub 2012 Dec 13.
PubMed 23237154
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Versus Practice-based Interventions to Increase Immunizations
- ClinicalTrials.gov ID
- NCT01296906
- Acronym / sponsor ID
- 10-0823
- Keywords
- Reminder/recall messages, reminders, recall, immunizations, immunization information systems, effectiveness of reminder/recall, population-based reminder/recall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31,567 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Feb 2011 (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.
One of the nation's major health priorities, as outlined in Healthy People 2010, is to increase the proportion of children aged 19 to 35 months who have received all universally recommended vaccines. This study will compare two interventions for increasing immunization rates in this age group, one using well-studied primary care practice-based methods and the other using innovative technologies to increase immunization rates at the population-level. Results of this study will provide data that will be relevant nationally in guiding future investment of resources to increase up-to-date rates in young children prior to school entry.
Hypothesis: Population-based approaches will be more effective than practice-based interventions at increasing immunizations among 19-35 month olds.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population-based Reminder/Recall | Experimental | Behavioral: Recall conducted centrally by local health departmentRecall is performed centrally by public health departments for all children in need of immunizations in a geographic area. |
| Practice-based Reminder/Recall | Experimental | Behavioral: Recall conducted by private practicesReminder/Recall is performed by individual private practices for their patients who appear in need of immunizations. |
Who may qualify
- Ages
- 19 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- child between the age of 19-35 months
- has an address in a specified study county in the state immunization registry
- child is in need of at least one recommended immunization
Key exclusion criteria (2 listed)
- child has opted out of the state immunization registry
- child is up-to-date on all recommended immunizations
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 |
|---|---|---|
| Recall conducted by private practicesAll practices in these counties will receive training on practice-based R/R using the Colorado Immunization Information System (CIIS or immunization registry). Practices will receive a recommended schedule for conducting recall in 19-35 month children and educational materials to use within their practices to promote compliance with the infant vaccination schedule. Individual practices will make their own decisions about the extent to which they follow the recommendations and implement recall within their practice. Although the study team will not provide them with any additional interventions, we will track any other interventions they independently do (websites, newsletters, telephone informational systems) in order to assess the effect of these additional interventions. | Behavioural | Practice-based Reminder/Recall |
| Recall conducted centrally by local health departmentA centralized recall of children 19-35 months will be conducted through local health departments. CIIS will identify a cohort of 19-35 month olds with an who are in need of an immunization and will coordinate up to 3 mailers to children who are not current for recommended immunizations. | Behavioural | Population-based Reminder/Recall |
Primary outcome
Evaluate effectiveness of population-based reminder/recall methods versus practice-based reminder/recall methods in 14 Colorado counties (rural and urban)
Time frame: 6 months post-intervention (December 2010)
The primary outcome measures will be: 1) change in up-to-date rates from baseline levels 6 months after the intervention (T-1) for 19-35 month olds in population-based compared to practice-based intervention counties and 2) percent of children who were not up-to-date prior to recall (T-0) who received any additional new vaccine in each type of intervention county.
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 21 Jun 2013.
- Background: PubMed 10806982Briss PA, Rodewald LE, Hinman AR, Shefer AM, Strikas RA, Bernier RR, Carande-Kulis VG, Yusuf HR, Ndiaye SM, Williams SM. Reviews of evidence regarding interventions to improve vaccination coverage in children, adolescents, and adults. The Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):97-140. doi: 10.1016/s0749-3797(99)00118-x.
- Background: PubMed 10806981Recommendations regarding interventions to improve vaccination coverage in children, adolescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):92-6. No abstract available.
- Background: PubMed 14595049Tierney CD, Yusuf H, McMahon SR, Rusinak D, O' Brien MA, Massoudi MS, Lieu TA. Adoption of reminder and recall messages for immunizations by pediatricians and public health clinics. Pediatrics. 2003 Nov;112(5):1076-82. doi: 10.1542/peds.112.5.1076.
- Background: PubMed 14998806Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health. 2004 Mar;94(3):423-32. doi: 10.2105/ajph.94.3.423.
- Derived from this study: PubMed 23237154Kempe A, Saville A, Dickinson LM, Eisert S, Reynolds J, Herrero D, Beaty B, Albright K, Dibert E, Koehler V, Lockhart S, Calonge N. Population-based versus practice-based recall for childhood immunizations: a randomized controlled comparative effectiveness trial. Am J Public Health. 2013 Jun;103(6):1116-23. doi: 10.2105/AJPH.2012.301035. Epub 2012 Dec 13.
Related trials for Health Services Research
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Recruiting
Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement
Methamphetamine Use, Heart Failure
Active, not recruiting
Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease
Recruiting
Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Interstitial Lung Disease (ILD), Suspected Interstitial Lung Disease
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.
Allison Kempe, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recall conducted by private practices and Recall conducted centrally by local health department in people with Health Services Research and Comparative Effectiveness, run by University of Colorado, Denver 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 3 inclusion and 2 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 21 Jun 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?
Evaluate effectiveness of population-based reminder/recall methods versus practice-based reminder/recall methods in 14 Colorado counties (rural and urban) (time frame: 6 months post-intervention (December 2010)). 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 NCT01296906, which also lists 5 linked publications.
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 21 Jun 2013.