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Effectiveness of Influenza Vaccine Reminder Systems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01852656
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Asthma Chronic Obstructive Pulmonary Disease Behavioral: Postcard and IVR Reminder Group Behavioral: Postcard Only Reminder Group Behavioral: IVR Only Reminder Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effectiveness and Cost of Different Methods of Reminders for Annual Influenza Immunization Among Adults With Asthma and Chronic Obstructive Pulmonary Disease
Study Start Date : September 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Postcard Only Reminder Group
In the postcard reminder intervention, the member will receive a single postcard, addressed to the member with asthma or COPD.
Behavioral: Postcard Only Reminder Group
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.

Active Comparator: IVR Only Reminder Group
In the IVR reminder intervention, targeted members will be contacted by the interactive voice response system
Behavioral: IVR Only Reminder Group
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.

Active Comparator: Postcard and IVR Reminder Group
In this group, individuals will receive both a postcard reminder and an IVR reminder.
Behavioral: Postcard and IVR Reminder Group

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.





Primary Outcome Measures :
  1. Receipt of influenza vaccine [ Time Frame: up to 7 months ]
    The 2012-2013 influenza season, defined as October to April.


Secondary Outcome Measures :
  1. Total unit cost per outreach method [ Time Frame: up to 10 months ]
    The time in months to develop, plan, and implement the intervention arms, as a function of cost.



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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 19 to 64 years
  • Enrolled in Kaiser Permanente Colorado health plan
  • Diagnosis of asthma and/or chronic obstructive pulmonary disease

Exclusion Criteria:

  • Subjects living in households with other individuals in high-risk categories for influenza morbidity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852656


Locations
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United States, Colorado
Kaiser Permanente Colorado
Denver, Colorado, United States, 80237
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: Matthew F. Daley, MD Kaiser Permanente
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01852656    
Other Study ID Numbers: 12010936
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013
Keywords provided by Kaiser Permanente:
Influenza, Human
Immunization
Additional relevant MeSH terms:
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Influenza, Human
Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections