Immunization RateNCT01577979
Adolescent Vaccination in the Medical Home: Established and Innovative Strategies
A study testing Text Message Reminder/Recall and Parent Preference in people with Immunization Rate, run by University of Colorado, Denver at 1 site in United States.
Trial summary
In this project, the investigators will develop, implement, and evaluate an adolescent vaccination quality improvement program, with the program designed to encourage adolescents to visit their usual primary care provider to receive vaccinations and other recommended preventive health services. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Immunization Rate
- What is being tested?
- Text Message Reminder/Recall and Parent Preference
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34,581 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Sep 2014
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 11-17 years old
- Active patient (visit in last 2 years) of clinics in study
- Need one or more vaccines or well-care visit
Who cannot join
- Up to date on vaccines and well-care
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
In this project, the investigators will develop, implement, and evaluate an adolescent vaccination quality improvement program, with the program designed to encourage adolescents to visit their usual primary care provider to receive vaccinations and other recommended preventive health services. This study will be conducted in different types of primary care settings, such as public, private, and managed care clinics serving adolescent patients of diverse backgrounds, and will provide important information to help guide future public health efforts to achieve high rates of immunization in adolescents.
Read the detailed description
Specific Aim 1: Within different types of primary care practices (pediatric practices in public, private, and managed care settings) serving adolescent patients of diverse socioeconomic and racial/ethnic backgrounds, to assess provider and staff attitudes regarding the desirability, feasibility, and potential sustainability of evidence-based and innovative strategies to promote adolescent vaccination in primary care practices.
Specific Aim 2: Among parents of adolescents (and/or adolescent patients) seen at primary care practices, to assess knowledge of existing national and state programs to promote vaccination, and to assess attitudes regarding, perceived barriers to, and acceptability of various practice-based strategies to promote adolescent vaccination.
Specific Aim 3: To implement and evaluate the effectiveness of a multi-faceted quality improvement program to promote adolescent vaccination within the medical home.
- Based upon findings from Specific Aims 1 and 2, develop a quality improvement program containing two or more interventions to promote adolescent vaccination.
- Select intervention patients to receive a multi-faceted vaccination quality improvement program and usual care patients which will continue receiving usual care.
- Compare the following primary outcome measure between intervention and usual care patients, overall and stratified by the type of practice setting: 1)percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
- Compare the following secondary outcome measures between intervention and usual care patients, overall and stratified by practice setting: 1) percent of adolescent patients with ≥ 1 Tdap vaccine; 2) percent of adolescent patients with ≥ 1 meningococcal (MCV4) vaccine; 3) percent of adolescent patients with ≥ 1 HPV vaccine; 4) percent of adolescent patients with ≥ 3 HPV vaccines; 5) percent of adolescent patients receiving ≥ 1 influenza vaccine during the preceding influenza season; 6) percent of adolescent patients with either a documented history of varicella disease or ≥ 2 varicella vaccines; 7) percent of adolescent patients with ≥ 2 MMR vaccines; 8) percent of adolescent patients with ≥ 3 hepatitis B vaccines; 9) percent of adolescent patients with ≥ 3 poliovirus vaccines; and 10) percent of adolescent patients with ≥ 1 missed vaccination opportunity, defined as having a patient visit to a primary care practice, being eligible for vaccination, and not receiving needed vaccines.
Specific Aim 3 (Kaiser Only): Design, implement and evaluate an HPV reminder/recall intervention based on obtaining the parents' and adolescents' preferences for reminder method and recipient at the time of the first dose of HPV.
- Compare 2nd and 3rd dose HPV vaccination rates among adolescents age 11-17 between intervention and usual care patients.
- Assess process measures related to feasibility and fidelity of implementation
Specific Aim 4: Evaluate the effect of a multi-faceted vaccination quality improvement program on the receipt of non-vaccination clinical preventive services recommended for adolescents.
- Compare the following outcome measures between intervention and usual care patients, overall and stratified by the type of practice setting: 1) receipt of ≥ 1 health maintenance visits within a 12 month interval; 2) receipt of blood pressure screening; and 3) growth assessment, as documented by the measurement of weight and height and calculation of body mass index at a clinic visit.
Specific Aim 5: Assess the cost to participating practices of implementing a multi-faceted vaccination quality improvement program designed to promote adolescent vaccination.
Specific Aim 6: After conducting a multi-faceted quality improvement program to promote adolescent vaccination, to assess provider and staff attitudes about the program, in particular the perceived benefits of the program and factors which may facilitate or hamper the sustainability of the program within study practices.
- Conditions
- Immunization Rate
- Being tested
- Text Message Reminder/Recall, Parent Preference
- Keywords
- Vaccination, Medical Home, Adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message Reminder/RecallBehavioural
Also called Text Messaging
Adolescents will be randomly selected from the participating private practices and safety net organization clinics. Parents of selected adolescents will receive a text message to alert them that their child is due for a vaccine or well-care visit. The text message will provide response instructions. The responses can be one of three options: 1) the parent will call the clinic to schedule a visit, 2) the parent would like the clinic to call them to schedule a visit, or 3) the parent would like to stop any future text message reminders. Parents who would like the clinic to call them to schedule an appointment will be contacted by their child's provider to set up a visit. Parents may receive up to 3 text message reminders, unless they chose to stop any future messages.
Parent PreferenceBehavioural
Parents of adolescents being seen within the managed care organization's intervention clinics will be asked about their reminder method preference at their child's 1st HPV immunization. The preference options include phone call, text message, or email. The preference for contact method will be recorded and utilized for the 2nd and 3rd dose reminders. The clinics' usual method of reminder will be used for all other parents.
| Study group | Role | What they receive |
|---|---|---|
| Reminder/Recall Strategy | Experimental | The experimental group will consist of patients randomly selected from participating clinics. Patients from private practices and the safety net provider may be exposed to a reminder/recall strategy involving text messaging. Text messages will be used to notify parents that their child is due for an immunization or well-care visit. Parents will be able to reply with one of three response options. Patients presenting to the randomly selected experimental managed care clinics for the first HPV vaccination dose will be offered the ability to provide the clinic with their preferred contact method. The preferred method of contact will be used for the second and third HPV dose reminder/recalls. Receives: Behavioral: Text Message Reminder/Recall; Behavioral: Parent Preference |
| Usual Care | No intervention | The patients in the usual care group will receive the clinic's usual care in terms of immunization and well-care reminder/recall. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
Percent of adolescents who received ANY needed vaccine or well-care visit
Measured: 6 months
Secondary outcomes (10)
Percent of adolescent patients with 1 or more Tdap vaccine
Measured: 6 months
Percent of adolescent patients with 1 or more meningococcal (MCV4) vaccine
Measured: 6 months
Percent of adolescent patients with 1 or more HPV vaccine
Measured: 6 months
Percent of adolescent patients with 3 or more HPV vaccines
Measured: 6 months
Percent of adolescent patients receiving 1 or more influenza vaccine during the preceding influenza season
Measured: 6 months
Percent of adolescent patients with either a documented history of varicella disease or 2 or more varicella vaccines
Measured: 6 months
Percent of adolescent patients with 2 or more MMR vaccines
Measured: 6 months
Percent of adolescent patients with 3 or more hepatitis B vaccines
Measured: 6 months
Percent of adolescent patients with 3 or more poliovirus vaccines
Measured: 6 months
Percent of adolescent patients with 1 or more missed vaccination opportunity, defined as having a patient visit to a primary care practice, being eligible for vaccination, and not receiving needed vaccines
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionSep 2014
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 RateStudies 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
- 34,581 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, The Children's Hospital of Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577979
- Sponsor's protocol ID
- 10-1209
- Other IDs
- U01IP000310
- Status last verified
- Feb 2015
- First submitted
- 12 Apr 2012
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kempe A, O'Leary ST, Shoup JA, Stokley S, Lockhart S, Furniss A, Dickinson LM, Barnard J, Daley MF. Parental Choice of Recall Method for HPV Vaccination: A Pragmatic Trial. Pediatrics. 2016 Mar;137(3):e20152857. doi: 10.1542/peds.2015-2857. Epub 2016 Feb 26.
PubMed 26921286O'Leary ST, Lee M, Lockhart S, Eisert S, Furniss A, Barnard J, Eblovi DE, Shmueli D, Stokley S, Dickinson LM, Kempe A. Effectiveness and Cost of Bidirectional Text Messaging for Adolescent Vaccines and Well Care. Pediatrics. 2015 Nov;136(5):e1220-7. doi: 10.1542/peds.2015-1089. Epub 2015 Oct 5.
PubMed 26438703
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Vaccination in the Medical Home: Established and Innovative Strategies
- ClinicalTrials.gov ID
- NCT01577979
- Acronym / sponsor ID
- 10-1209
- Conditions
- Immunization Rate
- Keywords
- Vaccination, Medical Home, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34,581 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Apr 2012 (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.
In this project, the investigators will develop, implement, and evaluate an adolescent vaccination quality improvement program, with the program designed to encourage adolescents to visit their usual primary care provider to receive vaccinations and other recommended preventive health services. This study will be conducted in different types of primary care settings, such as public, private, and managed care clinics serving adolescent patients of diverse backgrounds, and will provide important information to help guide future public health efforts to achieve high rates of immunization in adolescents.
Detailed description
Specific Aim 1: Within different types of primary care practices (pediatric practices in public, private, and managed care settings) serving adolescent patients of diverse socioeconomic and racial/ethnic backgrounds, to assess provider and staff attitudes regarding the desirability, feasibility, and potential sustainability of evidence-based and innovative strategies to promote adolescent vaccination in primary care practices.
Specific Aim 2: Among parents of adolescents (and/or adolescent patients) seen at primary care practices, to assess knowledge of existing national and state programs to promote vaccination, and to assess attitudes regarding, perceived barriers to, and acceptability of various practice-based strategies to promote adolescent vaccination.
Specific Aim 3: To implement and evaluate the effectiveness of a multi-faceted quality improvement program to promote adolescent vaccination within the medical home.
- Based upon findings from Specific Aims 1 and 2, develop a quality improvement program containing two or more interventions to promote adolescent vaccination.
- Select intervention patients to receive a multi-faceted vaccination quality improvement program and usual care patients which will continue receiving usual care.
- Compare the following primary outcome measure between intervention and usual care patients, overall and stratified by the type of practice setting: 1)percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
- Compare the following secondary outcome measures between intervention and usual care patients, overall and stratified by practice setting: 1) percent of adolescent patients with ≥ 1 Tdap vaccine; 2) percent of adolescent patients with ≥ 1 meningococcal (MCV4) vaccine; 3) percent of adolescent patients with ≥ 1 HPV vaccine; 4) percent of adolescent patients with ≥ 3 HPV vaccines; 5) percent of adolescent patients receiving ≥ 1 influenza vaccine during the preceding influenza season; 6) percent of adolescent patients with either a documented history of varicella disease or ≥ 2 varicella vaccines; 7) percent of adolescent patients with ≥ 2 MMR vaccines; 8) percent of adolescent patients with ≥ 3 hepatitis B vaccines; 9) percent of adolescent patients with ≥ 3 poliovirus vaccines; and 10) percent of adolescent patients with ≥ 1 missed vaccination opportunity, defined as having a patient visit to a primary care practice, being eligible for vaccination, and not receiving needed vaccines.
Specific Aim 3 (Kaiser Only): Design, implement and evaluate an HPV reminder/recall intervention based on obtaining the parents' and adolescents' preferences for reminder method and recipient at the time of the first dose of HPV.
- Compare 2nd and 3rd dose HPV vaccination rates among adolescents age 11-17 between intervention and usual care patients.
- Assess process measures related to feasibility and fidelity of implementation
Specific Aim 4: Evaluate the effect of a multi-faceted vaccination quality improvement program on the receipt of non-vaccination clinical preventive services recommended for adolescents.
- Compare the following outcome measures between intervention and usual care patients, overall and stratified by the type of practice setting: 1) receipt of ≥ 1 health maintenance visits within a 12 month interval; 2) receipt of blood pressure screening; and 3) growth assessment, as documented by the measurement of weight and height and calculation of body mass index at a clinic visit.
Specific Aim 5: Assess the cost to participating practices of implementing a multi-faceted vaccination quality improvement program designed to promote adolescent vaccination.
Specific Aim 6: After conducting a multi-faceted quality improvement program to promote adolescent vaccination, to assess provider and staff attitudes about the program, in particular the perceived benefits of the program and factors which may facilitate or hamper the sustainability of the program within study practices.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reminder/Recall Strategy | Experimental | Behavioral: Text Message Reminder/Recall, Behavioral: Parent PreferenceThe experimental group will consist of patients randomly selected from participating clinics. Patients from private practices and the safety net provider may be exposed to a reminder/recall strategy involving text messaging. Text messages will be used to notify parents that their child is due for an immunization or well-care visit. Parents will be able to reply with one of three response options. Patients presenting to the randomly selected experimental managed care clinics for the first HPV vaccination dose will be offered the ability to provide the clinic with their preferred contact method. The preferred method of contact will be used for the second and third HPV dose reminder/recalls. |
| Usual Care | No intervention | –The patients in the usual care group will receive the clinic's usual care in terms of immunization and well-care reminder/recall. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 11-17 years old
- Active patient (visit in last 2 years) of clinics in study
- Need one or more vaccines or well-care visit
Key exclusion criteria (1 listed)
- Up to date on vaccines and well-care
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 |
|---|---|---|
| Text Message Reminder/RecallAlso: Text MessagingAdolescents will be randomly selected from the participating private practices and safety net organization clinics. Parents of selected adolescents will receive a text message to alert them that their child is due for a vaccine or well-care visit. The text message will provide response instructions. The responses can be one of three options: 1) the parent will call the clinic to schedule a visit, 2) the parent would like the clinic to call them to schedule a visit, or 3) the parent would like to stop any future text message reminders. Parents who would like the clinic to call them to schedule an appointment will be contacted by their child's provider to set up a visit. Parents may receive up to 3 text message reminders, unless they chose to stop any future messages. | Behavioural | Reminder/Recall Strategy |
| Parent PreferenceParents of adolescents being seen within the managed care organization's intervention clinics will be asked about their reminder method preference at their child's 1st HPV immunization. The preference options include phone call, text message, or email. The preference for contact method will be recorded and utilized for the 2nd and 3rd dose reminders. The clinics' usual method of reminder will be used for all other parents. | Behavioural | Reminder/Recall Strategy |
Primary outcome
Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
Time frame: 6 months
Percent of adolescents who received ANY needed vaccine or well-care visit
10 secondary outcomes
Percent of adolescent patients with 1 or more Tdap vaccine
Time frame: 6 months
Percent of adolescent patients with 1 or more meningococcal (MCV4) vaccine
Time frame: 6 months
Percent of adolescent patients with 1 or more HPV vaccine
Time frame: 6 months
Percent of adolescent patients with 3 or more HPV vaccines
Time frame: 6 months
Percent of adolescent patients receiving 1 or more influenza vaccine during the preceding influenza season
Time frame: 6 months
Percent of adolescent patients with either a documented history of varicella disease or 2 or more varicella vaccines
Time frame: 6 months
Percent of adolescent patients with 2 or more MMR vaccines
Time frame: 6 months
Percent of adolescent patients with 3 or more hepatitis B vaccines
Time frame: 6 months
Percent of adolescent patients with 3 or more poliovirus vaccines
Time frame: 6 months
Percent of adolescent patients with 1 or more missed vaccination opportunity, defined as having a patient visit to a primary care practice, being eligible for vaccination, and not receiving needed vaccines
Time frame: 6 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 26 Feb 2015.
- Derived from this study: PubMed 26921286Kempe A, O'Leary ST, Shoup JA, Stokley S, Lockhart S, Furniss A, Dickinson LM, Barnard J, Daley MF. Parental Choice of Recall Method for HPV Vaccination: A Pragmatic Trial. Pediatrics. 2016 Mar;137(3):e20152857. doi: 10.1542/peds.2015-2857. Epub 2016 Feb 26.
- Derived from this study: PubMed 26438703O'Leary ST, Lee M, Lockhart S, Eisert S, Furniss A, Barnard J, Eblovi DE, Shmueli D, Stokley S, Dickinson LM, Kempe A. Effectiveness and Cost of Bidirectional Text Messaging for Adolescent Vaccines and Well Care. Pediatrics. 2015 Nov;136(5):e1220-7. doi: 10.1542/peds.2015-1089. Epub 2015 Oct 5.
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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, The 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 Text Message Reminder/Recall and Parent Preference in people with Immunization Rate, 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 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 26 Feb 2015. 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?
Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits (time frame: 6 months). 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 NCT01577979, 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 26 Feb 2015.