Immunization Reminder SystemACO/PHNCT02133391
Accountable Care Organizations/ Public Health Collaborative
A study testing Centralized Reminder/Recall (R/R) and Practice-based Reminder/Recall in people with Immunization Reminder System, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study focuses on implementing and evaluating an evidence-based collaborative method of increasing immunization rates among preschool children, adolescents and adults within an Accountable Care Organization-Public Health collaborative. Read more about this study
- Who is it for?
- Ages 19 months and older
- Conditions the study is for
- Immunization Reminder System
- What is being tested?
- Centralized Reminder/Recall (R/R) and Practice-based Reminder/Recall
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78,354 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2015to 14 Jul 2017
- 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
- Patients enrolled in Regional Care Collaborative Organizations (RCCOs) study practices in the regions covered by Colorado Access,
- Age 19-35 months,
- Age 11-17 years, or
- Age 18 years and older.
- Require an immunization according to Advisory Committee on Immunization Practices (ACIP) guidelines,
- Adult (18 and older) patients at 8 primary care sites who are enrolled in Denver Health and patients at 6 primary care RCCO study practices
Who cannot join
- Any child whose parents have requested removal from the immunization registry;
- Any adult who has requested removal from the immunization registry;
- Any child or adult with hypersensitivity to any component of one of the recommended vaccines;
- Any child or adult who has moved to a primary care provider other than one at the study practices.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Outcomes Research Program, University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Agency for Healthcare Research and Quality R18: Accountable Care Organizations (ACO)/ Public Health Collaborative Preventive Care Delivery to Priority Populations
This study focuses on implementing and evaluating an evidence-based collaborative method of increasing immunization rates among preschool children, adolescents and adults within an Accountable Care Organization-Public Health collaborative. The infrastructure we will create through this project will serve as the framework for future collaborative delivery of other preventive services.
Read the detailed description
The current project leverages newly formed Regional Care Collaborative Organizations (RCCO) in Colorado that are charged with providing comprehensive care for children and adults insured by Medicaid. With a new RCCO-public health collaborative we will implement a randomized controlled trial to test the effectiveness of 1) evidence-based collaborative centralized method of increasing immunization delivery using reminder/recall techniques versus 2) traditional practice-based reminder/recall techniques that are done by individual practices (not centrally) or usual care from their provider. These interventions have been previously developed by the study team in different clinical settings. The project will examine the collaborative centralized approach, implemented within the new RCCO-public health collaborative first among preschool children, the group in which it has been previously studied. We will then extend the method to new populations, including adolescents and adults within the RCCO and Denver Health (adults only), and will evaluate the effectiveness of the intervention in each population.
- Conditions
- Immunization Reminder System
- Being tested
- Centralized Reminder/Recall (R/R), Practice-based Reminder/Recall
- Keywords
- Accountable Care Organization, Comparative Effectiveness Research, Immunization/statistics & numerical data, Medicaid, Reminder Systems/economics, Reminder Systems/statistics & numerical data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centralized Reminder/Recall (R/R)Other
Method of increasing immunization delivery using reminder/recall techniques, which are implemented centrally.
Practice-based Reminder/RecallOther
Method of increasing immunization delivery using reminder/recall techniques, which are implemented at the practice level.
| Study group | Role | What they receive |
|---|---|---|
| Practice-based reminder/recall or Usual care arm | Active comparator | Practices participating in state immunization registry invited to reminder/recall (R/R) webinar trainings and provided educational materials to encourage immunization within their practices (child and adolescent trials only)
Patients not randomized to the collaborative centralized R/R arm will receive usual care from their provider, which does not include R/R (adult trials only) Receives: Other: Practice-based Reminder/Recall |
| Collaborative centralized R/R | Experimental | Collaborative centralized reminder/recall (R/R) effort will be conducted by state immunization registry in collaboration with accountable care organizations and practices Receives: Other: Centralized Reminder/Recall (R/R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Vaccination Reminder/Recall
- Comparisons of receipt of any recommended vaccine and all recommended vaccines by study arm
- Comparisons of receipt of all needed vaccines
- Comparisons of receipt of specific targeted vaccines
Measured: 2015-2017 (Year 2-4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study start18 Feb 2015
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immunization Reminder SystemStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78,354 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Allison Kempe, MD, MPH, Principal investigator, University of Colorado School of Medicine, Children's Outcomes Research Program, Children's Hospital of Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133391
- Sponsor's protocol ID
- 13-2395
- Acronym
- ACO/PH
- Status last verified
- Sep 2017
- First submitted
- 16 Dec 2013
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hurley LP, Beaty B, Lockhart S, Gurfinkel D, Dickinson LM, Roth H, Kempe A. Randomized controlled trial of centralized vaccine reminder/recall to improve adult vaccination rates in an accountable care organization setting. Prev Med Rep. 2019 May 22;15:100893. doi: 10.1016/j.pmedr.2019.100893. eCollection 2019 Sep.
PubMed 31193580Hurley LP, Beaty B, Lockhart S, Gurfinkel D, Breslin K, Dickinson M, Whittington MD, Roth H, Kempe A. RCT of Centralized Vaccine Reminder/Recall for Adults. Am J Prev Med. 2018 Aug;55(2):231-239. doi: 10.1016/j.amepre.2018.04.022. Epub 2018 Jun 15.
PubMed 29910118
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agency for Healthcare Research and Quality R18: Accountable Care Organizations (ACO)/ Public Health Collaborative Preventive Care Delivery to Priority Populations
- ClinicalTrials.gov ID
- NCT02133391
- Acronym / sponsor ID
- ACO/PH / 13-2395
- Conditions
- Immunization Reminder System
- Keywords
- Accountable Care Organization, Comparative Effectiveness Research, Immunization/statistics & numerical data, Medicaid, Reminder Systems/economics, Reminder Systems/statistics & numerical data
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78,354 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 18 Feb 2015 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 8 May 2014 (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.
This study focuses on implementing and evaluating an evidence-based collaborative method of increasing immunization rates among preschool children, adolescents and adults within an Accountable Care Organization-Public Health collaborative. The infrastructure we will create through this project will serve as the framework for future collaborative delivery of other preventive services.
Detailed description
The current project leverages newly formed Regional Care Collaborative Organizations (RCCO) in Colorado that are charged with providing comprehensive care for children and adults insured by Medicaid. With a new RCCO-public health collaborative we will implement a randomized controlled trial to test the effectiveness of 1) evidence-based collaborative centralized method of increasing immunization delivery using reminder/recall techniques versus 2) traditional practice-based reminder/recall techniques that are done by individual practices (not centrally) or usual care from their provider. These interventions have been previously developed by the study team in different clinical settings. The project will examine the collaborative centralized approach, implemented within the new RCCO-public health collaborative first among preschool children, the group in which it has been previously studied. We will then extend the method to new populations, including adolescents and adults within the RCCO and Denver Health (adults only), and will evaluate the effectiveness of the intervention in each population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Practice-based reminder/recall or Usual care arm | Active comparator | Other: Practice-based Reminder/RecallPractices participating in state immunization registry invited to reminder/recall (R/R) webinar trainings and provided educational materials to encourage immunization within their practices (child and adolescent trials only) Patients not randomized to the collaborative centralized R/R arm will receive usual care from their provider, which does not include R/R (adult trials only) |
| Collaborative centralized R/R | Experimental | Other: Centralized Reminder/Recall (R/R)Collaborative centralized reminder/recall (R/R) effort will be conducted by state immunization registry in collaboration with accountable care organizations and practices |
Who may qualify
- Ages
- 19 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients enrolled in Regional Care Collaborative Organizations (RCCOs) study practices in the regions covered by Colorado Access,
- Age 19-35 months,
- Age 11-17 years, or
- Age 18 years and older.
- Require an immunization according to Advisory Committee on Immunization Practices (ACIP) guidelines,
Key exclusion criteria (4 listed)
- Any child whose parents have requested removal from the immunization registry;
- Any adult who has requested removal from the immunization registry;
- Any child or adult with hypersensitivity to any component of one of the recommended vaccines;
- Any child or adult who has moved to a primary care provider other than one at the study practices.
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 |
|---|---|---|
| Centralized Reminder/Recall (R/R)Method of increasing immunization delivery using reminder/recall techniques, which are implemented centrally. | Other | Collaborative centralized R/R |
| Practice-based Reminder/RecallMethod of increasing immunization delivery using reminder/recall techniques, which are implemented at the practice level. | Other | Practice-based reminder/recall or Usual care arm |
Primary outcome
Effectiveness of Vaccination Reminder/Recall
Time frame: 2015-2017 (Year 2-4)
1. Comparisons of receipt of any recommended vaccine and all recommended vaccines by study arm 2. Comparisons of receipt of all needed vaccines 3. Comparisons of receipt of specific targeted vaccines
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 29 Sep 2017.
- Derived from this study: PubMed 31193580Hurley LP, Beaty B, Lockhart S, Gurfinkel D, Dickinson LM, Roth H, Kempe A. Randomized controlled trial of centralized vaccine reminder/recall to improve adult vaccination rates in an accountable care organization setting. Prev Med Rep. 2019 May 22;15:100893. doi: 10.1016/j.pmedr.2019.100893. eCollection 2019 Sep.
- Derived from this study: PubMed 29910118Hurley LP, Beaty B, Lockhart S, Gurfinkel D, Breslin K, Dickinson M, Whittington MD, Roth H, Kempe A. RCT of Centralized Vaccine Reminder/Recall for Adults. Am J Prev Med. 2018 Aug;55(2):231-239. doi: 10.1016/j.amepre.2018.04.022. Epub 2018 Jun 15.
- Individual participant dataSharing planned: No
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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.
Allison Kempe, MD, MPH principal investigator
University of Colorado School of Medicine, Children's Outcomes Research Program, Children's Hospital of Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centralized Reminder/Recall (R/R) and Practice-based Reminder/Recall in people with Immunization Reminder System, 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 6 inclusion and 4 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 29 Sep 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?
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?
Effectiveness of Vaccination Reminder/Recall (time frame: 2015-2017 (Year 2-4)). 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 NCT02133391, which also lists 2 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 29 Sep 2017.