Human Papilloma Virus (HPV)NCT00715234
Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
A study testing Reminder/recall notices for vaccines in people with Human Papilloma Virus (HPV) and Tetanus-diphtheria-acellular Pertussis (Tdap), run by University of Colorado, Denver.
Trial summary
A study team with extensive experience in immunization delivery research will evaluate the effectiveness of vaccination reminder/recall systems for adolescent patients in five types of clinical settings including: urban pediatric, urban family medicine and rural family medicine practices, public pediatric clinics, and… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Human Papilloma Virus (HPV), Tetanus-diphtheria-acellular Pertussis (Tdap), Meningococcal Infection
- What is being tested?
- Reminder/recall notices for vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,807 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Sep 2010
- 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
- children ages 11-18
- seen in practice in last 2 years
- not up-to-date on any or all shots (Tdap, HPV, meningococcal)
- parents agree to participate in Colorado Immunization and Information System registry
Who cannot join
- up-to-date on all vaccines
- under age 11 over age 18
- patients who have moved or gone elsewhere at each practice setting
About this study
A study team with extensive experience in immunization delivery research will evaluate the effectiveness of vaccination reminder/recall systems for adolescent patients in five types of clinical settings including: urban pediatric, urban family medicine and rural family medicine practices, public pediatric clinics, and school-based health centers. Randomized controlled trials of reminder/recall for adolescents will be conducted at each type of site, with randomization at the level of the patient.
Read the detailed description
Although patient reminder/recall systems have been shown to be effective at improving vaccination coverage levels for infants and younger children, little is known about the effectiveness of such systems for increasing immunization rates in adolescent populations. The process of reminder/recall in adolescents, and vaccination of adolescents overall, presents particular challenges. Adolescents are less likely to routinely access health care compared to younger children and adults. In addition, other obstacles such as lack of health insurance, missed opportunities for vaccination during health care visits, and the scattering of immunization records across multiple providers have posed major challenges in the vaccination of adolescents. Issues of parental consent for vaccination can also be problematic, given that adolescents may present for care without their parents accompanying them. These and other barriers to immunization may reduce the effectiveness of reminder/recall for adolescents. In the current research study, a study team with extensive experience in immunization delivery research will investigate the ability of pediatricians and family physicians in a number of different practice settings to implement a reminder/recall system for their adolescent patient populations. In addition, we will be able to examine the effectiveness of reminder/recall originating at public school-based health centers, an innovative strategy that has not previously been reported. Randomized controlled trials of reminder/recall for adolescents will be conducted at each type of site. The study team will track important process measures during reminder/recall including the percentage of the eligible population who actually received intervention; percentage with incorrect addresses; percentage with incorrect or disconnected phones; percentage actually up-to-date but incorrectly recalled; missed vaccination opportunities; and invalid doses of vaccines administered. In this way, we will be able to not only determine the degree to which reminder/recall was successful for adolescents, but also identify impediments to success, which will provide a foundation for future efforts. Our study will also investigate the cost of establishing and operating a reminder/recall system for adolescents in each type of clinical setting.
Major Hypotheses
- Reminder/recall of adolescents will result in an increased rate of receipt of immunizations in private settings of approximately 10 percentage points
- Reminder/recall will result in a greater rate of receipt of immunizations when patients in public settings have access to a school-based health center (SBHC) compared to when they do not have access to a SBHC
- Reminder/recall originating at SBHC sites will result in the highest efficacy of reminder/recall among all the types of clinical sites
- Conditions
- Human Papilloma Virus (HPV), Tetanus-diphtheria-acellular Pertussis (Tdap), Meningococcal Infection, Varicella
- Being tested
- Reminder/recall notices for vaccines
- Keywords
- adolescent reminder/recall, adolescent vaccines, Tdap, Meningococcal, HPV, Reminder cards, Recall messages, vaccine, conjugate
- Medical subject headings
- Meningococcal Infections, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder/recall notices for vaccinesOther
- Receive a generic letter reminding them to make an appointment to get vaccines.
- Receive a computer-generated telephone message at 1 week post initial letter.
- Receive a computer-generated telephone message at 2 months post initial letter.
- Receive a letter at 3 months post initial letter.
| Study group | Role | What they receive |
|---|---|---|
| Reminder/recall notices for vaccines | Experimental | This group will receive up to 4 recall messages (both letters and computer-generated phone messages) reminding them to get their vaccines. There are 4 separate study groups: 1) private pediatric patients 2) public pediatric patients 3) school-based health center patients and 4) family medicine patients. Receives: Other: Reminder/recall notices for vaccines |
| Usual Care | No intervention | This group will receive usual care. There are 4 separate study groups: 1) private pediatric patients 2) public pediatric patients 3) school-based health center patients and 4) family medicine patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) the percentage receiving any vaccine after the baseline time point
Measured: 6 months after intervention
The percentage of adolescents becoming up-to-date on all needed immunizations
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma Virus (HPV)Studies 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
- 4,807 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Allison Kempe, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715234
- Sponsor's protocol ID
- 07-0763
- Other IDs
- U01IP000129
- Status last verified
- Jun 2013
- First submitted
- 10 Jul 2008
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ziv A, Boulet JR, Slap GB. Utilization of physician offices by adolescents in the United States. Pediatrics. 1999 Jul;104(1 Pt 1):35-42. doi: 10.1542/peds.104.1.35.
PubMed 10390257Schaffer SJ, Humiston SG, Shone LP, Averhoff FM, Szilagyi PG. Adolescent immunization practices: a national survey of US physicians. Arch Pediatr Adolesc Med. 2001 May;155(5):566-71. doi: 10.1001/archpedi.155.5.566.
PubMed 11343499Briss 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 10806982Humiston SG, Rosenthal SL. Challenges to vaccinating adolescents: vaccine implementation issues. Pediatr Infect Dis J. 2005 Jun;24(6 Suppl):S134-40. doi: 10.1097/01.inf.0000166161.12087.94.
PubMed 15931141Szilagyi PG, Bordley C, Vann JC, Chelminski A, Kraus RM, Margolis PA, Rodewald LE. Effect of patient reminder/recall interventions on immunization rates: A review. JAMA. 2000 Oct 11;284(14):1820-7. doi: 10.1001/jama.284.14.1820.
PubMed 11025835Kempe A, Lowery NE, Pearson KA, Renfrew BL, Jones JS, Steiner JF, Berman S. Immunization recall: effectiveness and barriers to success in an urban teaching clinic. J Pediatr. 2001 Nov;139(5):630-5. doi: 10.1067/mpd.2001.117069.
PubMed 11713438Suh CA, Saville A, Daley MF, Glazner JE, Barrow J, Stokley S, Dong F, Beaty B, Dickinson LM, Kempe A. Effectiveness and net cost of reminder/recall for adolescent immunizations. Pediatrics. 2012 Jun;129(6):e1437-45. doi: 10.1542/peds.2011-1714. Epub 2012 May 7.
PubMed 22566415
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
- ClinicalTrials.gov ID
- NCT00715234
- Acronym / sponsor ID
- 07-0763
- Conditions
- Human Papilloma Virus (HPV), Tetanus-diphtheria-acellular Pertussis (Tdap), Meningococcal Infection, Varicella
- Keywords
- adolescent reminder/recall, adolescent vaccines, Tdap, Meningococcal, HPV, Reminder cards, Recall messages, vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,807 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Jul 2008 (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.
A study team with extensive experience in immunization delivery research will evaluate the effectiveness of vaccination reminder/recall systems for adolescent patients in five types of clinical settings including: urban pediatric, urban family medicine and rural family medicine practices, public pediatric clinics, and school-based health centers. Randomized controlled trials of reminder/recall for adolescents will be conducted at each type of site, with randomization at the level of the patient.
Detailed description
Although patient reminder/recall systems have been shown to be effective at improving vaccination coverage levels for infants and younger children, little is known about the effectiveness of such systems for increasing immunization rates in adolescent populations. The process of reminder/recall in adolescents, and vaccination of adolescents overall, presents particular challenges. Adolescents are less likely to routinely access health care compared to younger children and adults. In addition, other obstacles such as lack of health insurance, missed opportunities for vaccination during health care visits, and the scattering of immunization records across multiple providers have posed major challenges in the vaccination of adolescents. Issues of parental consent for vaccination can also be problematic, given that adolescents may present for care without their parents accompanying them. These and other barriers to immunization may reduce the effectiveness of reminder/recall for adolescents. In the current research study, a study team with extensive experience in immunization delivery research will investigate the ability of pediatricians and family physicians in a number of different practice settings to implement a reminder/recall system for their adolescent patient populations. In addition, we will be able to examine the effectiveness of reminder/recall originating at public school-based health centers, an innovative strategy that has not previously been reported. Randomized controlled trials of reminder/recall for adolescents will be conducted at each type of site. The study team will track important process measures during reminder/recall including the percentage of the eligible population who actually received intervention; percentage with incorrect addresses; percentage with incorrect or disconnected phones; percentage actually up-to-date but incorrectly recalled; missed vaccination opportunities; and invalid doses of vaccines administered. In this way, we will be able to not only determine the degree to which reminder/recall was successful for adolescents, but also identify impediments to success, which will provide a foundation for future efforts. Our study will also investigate the cost of establishing and operating a reminder/recall system for adolescents in each type of clinical setting.
Major Hypotheses
- Reminder/recall of adolescents will result in an increased rate of receipt of immunizations in private settings of approximately 10 percentage points
- Reminder/recall will result in a greater rate of receipt of immunizations when patients in public settings have access to a school-based health center (SBHC) compared to when they do not have access to a SBHC
- Reminder/recall originating at SBHC sites will result in the highest efficacy of reminder/recall among all the types of clinical sites
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reminder/recall notices for vaccines | Experimental | Other: Reminder/recall notices for vaccinesThis group will receive up to 4 recall messages (both letters and computer-generated phone messages) reminding them to get their vaccines. There are 4 separate study groups: 1) private pediatric patients 2) public pediatric patients 3) school-based health center patients and 4) family medicine patients. |
| Usual Care | No intervention | –This group will receive usual care. There are 4 separate study groups: 1) private pediatric patients 2) public pediatric patients 3) school-based health center patients and 4) family medicine patients. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- children ages 11-18
- seen in practice in last 2 years
- not up-to-date on any or all shots (Tdap, HPV, meningococcal)
- parents agree to participate in Colorado Immunization and Information System registry
Key exclusion criteria (3 listed)
- up-to-date on all vaccines
- under age 11 over age 18
- patients who have moved or gone elsewhere at each practice setting
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 |
|---|---|---|
| Reminder/recall notices for vaccines1. Receive a generic letter reminding them to make an appointment to get vaccines. 2. Receive a computer-generated telephone message at 1 week post initial letter. 3. Receive a computer-generated telephone message at 2 months post initial letter. 4. Receive a letter at 3 months post initial letter. | Other | Reminder/recall notices for vaccines |
Primary outcome
1) the percentage receiving any vaccine after the baseline time point
Time frame: 6 months after intervention
The percentage of adolescents becoming up-to-date on all needed immunizations
Time frame: 6 months post intervention
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 25 Jun 2013.
- Background: PubMed 10390257Ziv A, Boulet JR, Slap GB. Utilization of physician offices by adolescents in the United States. Pediatrics. 1999 Jul;104(1 Pt 1):35-42. doi: 10.1542/peds.104.1.35.
- Background: PubMed 11343499Schaffer SJ, Humiston SG, Shone LP, Averhoff FM, Szilagyi PG. Adolescent immunization practices: a national survey of US physicians. Arch Pediatr Adolesc Med. 2001 May;155(5):566-71. doi: 10.1001/archpedi.155.5.566.
- 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 15931141Humiston SG, Rosenthal SL. Challenges to vaccinating adolescents: vaccine implementation issues. Pediatr Infect Dis J. 2005 Jun;24(6 Suppl):S134-40. doi: 10.1097/01.inf.0000166161.12087.94.
- Background: PubMed 11025835Szilagyi PG, Bordley C, Vann JC, Chelminski A, Kraus RM, Margolis PA, Rodewald LE. Effect of patient reminder/recall interventions on immunization rates: A review. JAMA. 2000 Oct 11;284(14):1820-7. doi: 10.1001/jama.284.14.1820.
- Background: PubMed 11713438Kempe A, Lowery NE, Pearson KA, Renfrew BL, Jones JS, Steiner JF, Berman S. Immunization recall: effectiveness and barriers to success in an urban teaching clinic. J Pediatr. 2001 Nov;139(5):630-5. doi: 10.1067/mpd.2001.117069.
- Derived from this study: PubMed 22566415Suh CA, Saville A, Daley MF, Glazner JE, Barrow J, Stokley S, Dong F, Beaty B, Dickinson LM, Kempe A. Effectiveness and net cost of reminder/recall for adolescent immunizations. Pediatrics. 2012 Jun;129(6):e1437-45. doi: 10.1542/peds.2011-1714. Epub 2012 May 7.
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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, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Reminder/recall notices for vaccines in people with Human Papilloma Virus (HPV) and Tetanus-diphtheria-acellular Pertussis (Tdap), run by University of Colorado, Denver.
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 4 inclusion and 3 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 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
1) the percentage receiving any vaccine after the baseline time point (time frame: 6 months after intervention). The study lists 2 primary outcomes in all. 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 NCT00715234, which also lists 7 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 25 Jun 2013.