AsthmaNCT01852656
Effectiveness of Influenza Vaccine Reminder Systems
A study testing Postcard and IVR Reminder Group, Postcard Only Reminder Group and IVR Only Reminder Group in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Kaiser Permanente at 1 site in United States.
Trial summary
Influenza disease causes significant morbidity and mortality in the Unites States each year. Although influenza can cause morbidity in otherwise healthy individuals, adults with chronic lung disease have significantly increased rates of hospitalization from influenza-related illnesses compared to healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Postcard and IVR Reminder Group, Postcard Only Reminder Group and IVR Only Reminder Group
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,255 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 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 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 19 to 64 years
- Enrolled in Kaiser Permanente Colorado health plan
- Diagnosis of asthma and/or chronic obstructive pulmonary disease
Who cannot join
- Subjects living in households with other individuals in high-risk categories for influenza morbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness and Cost of Different Methods of Reminders for Annual Influenza Immunization Among Adults With Asthma and Chronic Obstructive Pulmonary Disease
Influenza disease causes significant morbidity and mortality in the Unites States each year. Although influenza can cause morbidity in otherwise healthy individuals, adults with chronic lung disease have significantly increased rates of hospitalization from influenza-related illnesses compared to healthy adults. Influenza vaccination is the primary means of preventing influenza disease. Annual influenza vaccination is recommended for all individuals 6 months of age and older in the United States. Influenza vaccination rates are sub-optimal, however. Patient reminder/recall has been shown, in multiple studies across a variety of age groups and health conditions, to increase immunization rates. However, the effectiveness and cost-effectiveness of different types of reminder/recall has not been well-studied, particularly in adults. In the fall of 2012, the Population and Prevention Services (PPS) Department at Kaiser Permanente Colorado (KPCO) is using 3 different reminder strategies for influenza vaccination among adults with asthma and chronic obstructive pulmonary disease (COPD). The objective of this study is to provide a rigorous evaluation of which strategy is more effective and more cost-effective, to promote influenza vaccination.
Read the detailed description
At KPCO, postcards are typically sent to members each fall, to remind members to receive their annual influenza vaccine. At KPCO, interactive voice response (IVR) systems have been utilized for a number of prevention reminders, but have not in the past been used for influenza vaccination reminders. For the 2012-2013 influenza season, the PPS department is going to send three different types of reminders to their adult patients with certain chronic lung diseases (specifically, adults with asthma and COPD): postcards only; IVR reminders only; postcards plus IVR reminders. This study seeks to evaluate the effectiveness, and cost-effectiveness, of an already-finalized operational plan for influenza reminders.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- Postcard and IVR Reminder Group, Postcard Only Reminder Group, IVR Only Reminder Group
- Keywords
- Influenza, Human, Immunization
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postcard and IVR Reminder GroupBehavioural
IVR: Subjects in this reminder group will receive an automated telephone call to their primary telephone number. A total of 2 call attempts per member will be made. The IVR system will provide a message about the importance of annual influenza vaccination. The member can also request additional information about influenza vaccination and influenza vaccination locations and times.
Postcard: The postcard will be sent as a single postcard to each individual on the list. The postcard will be sent to the home address of the member. If the postcard is returned, the postcard will not be re-sent. The postcard does not identify that the member has a chronic health condition such as asthma or COPD. The postcard will be mailed during the last two weeks of September, 2012.
Postcard Only Reminder GroupBehavioural
Postcard: The postcard will be sent as a single postcard to each individual on the list. The postcard will be sent to the home address of the member. If the postcard is returned, due to an inaccurate address, the postcard will not be re-sent. The postcard does not identify that the member has a chronic health condition such as asthma or COPD. The postcard will be mailed during the last two weeks of September, 2012.
IVR Only Reminder GroupBehavioural
IVR: Subjects in this reminder group will receive an automated telephone call to their primary telephone number. A total of 2 call attempts per member will be made. The IVR system will provide a message about the importance of annual influenza vaccination. The member can also request additional information about influenza vaccination and influenza vaccination locations and times.
| Study group | Role | What they receive |
|---|---|---|
| Postcard Only Reminder Group | Active comparator | In the postcard reminder intervention, the member will receive a single postcard, addressed to the member with asthma or COPD. Receives: Behavioral: Postcard Only Reminder Group |
| IVR Only Reminder Group | Active comparator | In the IVR reminder intervention, targeted members will be contacted by the interactive voice response system Receives: Behavioral: IVR Only Reminder Group |
| Postcard and IVR Reminder Group | Active comparator | In this group, individuals will receive both a postcard reminder and an IVR reminder. Receives: Behavioral: Postcard and IVR Reminder Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of influenza vaccine
The 2012-2013 influenza season, defined as October to April.
Measured: up to 7 months
Secondary outcomes (1)
Total unit cost per outreach method
The time in months to develop, plan, and implement the intervention arms, as a function of cost.
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- 12,255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew F. Daley, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852656
- Sponsor's protocol ID
- 12010936
- Status last verified
- May 2013
- First submitted
- 8 Oct 2012
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Cost of Different Methods of Reminders for Annual Influenza Immunization Among Adults With Asthma and Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01852656
- Acronym / sponsor ID
- 12010936
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Keywords
- Influenza, Human, Immunization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,255 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 14 May 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.
Influenza disease causes significant morbidity and mortality in the Unites States each year. Although influenza can cause morbidity in otherwise healthy individuals, adults with chronic lung disease have significantly increased rates of hospitalization from influenza-related illnesses compared to healthy adults. Influenza vaccination is the primary means of preventing influenza disease. Annual influenza vaccination is recommended for all individuals 6 months of age and older in the United States. Influenza vaccination rates are sub-optimal, however. Patient reminder/recall has been shown, in multiple studies across a variety of age groups and health conditions, to increase immunization rates. However, the effectiveness and cost-effectiveness of different types of reminder/recall has not been well-studied, particularly in adults. In the fall of 2012, the Population and Prevention Services (PPS) Department at Kaiser Permanente Colorado (KPCO) is using 3 different reminder strategies for influenza vaccination among adults with asthma and chronic obstructive pulmonary disease (COPD). The objective of this study is to provide a rigorous evaluation of which strategy is more effective and more cost-effective, to promote influenza vaccination.
Detailed description
At KPCO, postcards are typically sent to members each fall, to remind members to receive their annual influenza vaccine. At KPCO, interactive voice response (IVR) systems have been utilized for a number of prevention reminders, but have not in the past been used for influenza vaccination reminders. For the 2012-2013 influenza season, the PPS department is going to send three different types of reminders to their adult patients with certain chronic lung diseases (specifically, adults with asthma and COPD): postcards only; IVR reminders only; postcards plus IVR reminders. This study seeks to evaluate the effectiveness, and cost-effectiveness, of an already-finalized operational plan for influenza reminders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postcard Only Reminder Group | Active comparator | Behavioral: Postcard Only Reminder GroupIn the postcard reminder intervention, the member will receive a single postcard, addressed to the member with asthma or COPD. |
| IVR Only Reminder Group | Active comparator | Behavioral: IVR Only Reminder GroupIn the IVR reminder intervention, targeted members will be contacted by the interactive voice response system |
| Postcard and IVR Reminder Group | Active comparator | Behavioral: Postcard and IVR Reminder GroupIn this group, individuals will receive both a postcard reminder and an IVR reminder. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 19 to 64 years
- Enrolled in Kaiser Permanente Colorado health plan
- Diagnosis of asthma and/or chronic obstructive pulmonary disease
Key exclusion criteria (1 listed)
- Subjects living in households with other individuals in high-risk categories for influenza morbidity
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 |
|---|---|---|
| Postcard and IVR Reminder GroupIVR: Subjects in this reminder group will receive an automated telephone call to their primary telephone number. A total of 2 call attempts per member will be made. The IVR system will provide a message about the importance of annual influenza vaccination. The member can also request additional information about influenza vaccination and influenza vaccination locations and times. Postcard: The postcard will be sent as a single postcard to each individual on the list. The postcard will be sent to the home address of the member. If the postcard is returned, the postcard will not be re-sent. The postcard does not identify that the member has a chronic health condition such as asthma or COPD. The postcard will be mailed during the last two weeks of September, 2012. | Behavioural | Postcard and IVR Reminder Group |
| Postcard Only Reminder GroupPostcard: The postcard will be sent as a single postcard to each individual on the list. The postcard will be sent to the home address of the member. If the postcard is returned, due to an inaccurate address, the postcard will not be re-sent. The postcard does not identify that the member has a chronic health condition such as asthma or COPD. The postcard will be mailed during the last two weeks of September, 2012. | Behavioural | Postcard Only Reminder Group |
| IVR Only Reminder GroupIVR: Subjects in this reminder group will receive an automated telephone call to their primary telephone number. A total of 2 call attempts per member will be made. The IVR system will provide a message about the importance of annual influenza vaccination. The member can also request additional information about influenza vaccination and influenza vaccination locations and times. | Behavioural | IVR Only Reminder Group |
Primary outcome
Receipt of influenza vaccine
Time frame: up to 7 months
The 2012-2013 influenza season, defined as October to April.
1 secondary outcome
Total unit cost per outreach method
Time frame: up to 10 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 14 May 2013.
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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.
Matthew F. Daley, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postcard and IVR Reminder Group, Postcard Only Reminder Group and IVR Only Reminder Group in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Kaiser Permanente 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 14 May 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?
Receipt of influenza vaccine (time frame: up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2013.