NCT01852656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,255

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

7 months

First QC Date

October 8, 2012

Last Update Submit

May 9, 2013

Conditions

Keywords

Influenza, HumanImmunization

Outcome Measures

Primary Outcomes (1)

  • Receipt of influenza vaccine

    The 2012-2013 influenza season, defined as October to April.

    up to 7 months

Secondary Outcomes (1)

  • Total unit cost per outreach method

    up to 10 months

Study Arms (3)

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.

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

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.

Behavioral: Postcard and IVR Reminder Group

Interventions

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 and IVR 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.

Postcard 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.

IVR Only Reminder Group

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Colorado

Denver, Colorado, 80237, United States

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveInfluenza, Human

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus Diseases

Study Officials

  • Matthew F. Daley, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2012

First Posted

May 14, 2013

Study Start

September 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations