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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01852656
Other study ID # 12010936
Secondary ID
Status Completed
Phase N/A
First received October 8, 2012
Last updated May 9, 2013
Start date September 2012
Est. completion date April 2013

Study information

Verified date May 2013
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12255
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States Kaiser Permanente Colorado Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Receipt of influenza vaccine The 2012-2013 influenza season, defined as October to April. up to 7 months No
Secondary Total unit cost per outreach method The time in months to develop, plan, and implement the intervention arms, as a function of cost. up to 10 months No
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