RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening
November 13, 2008 updated by: Harvard Pilgrim Health Care
Automated Telephone Outreach With Speech Recognition to Improve Colorectal Cancer Screening: A Randomized Controlled Trial
This large randomized controlled trial is testing the effectiveness of automated telephone outreach with speech recognition to improve rates of screening for colorectal cancer.
The hypothesis is that the intervention improves rates of screening overall and specifically rates of colonoscopy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer (CRC) is the second leading cause of cancer-related mortality in the United States.
Despite widespread dissemination of evidence-based guidelines recommending CRC screening, a large proportion of eligible individuals do not undergo screening.
A variety of interventions have been tested to increase screening in primary care, but there remains an urgent imperative to develop and evaluate cost-effective and widely applicable approaches to promoting screening.
In March 2005, Harvard Pilgrim Health Care, a large non-profit HMO in New England, carried out an internally funded program to increase CRC screening.
The HMO randomized 80,000 members aged 50 to 64 years to receive automated telephone outreach with speech recognition or usual care.
The intervention entailed the telephone engagement of members in a dialogue with a computer-programmed, responsive human voice about the importance of CRC screening, the options for undergoing screening, and encouragement to follow-up with their primary care physicians.
The present study involves a 12-month follow-up of all eligible members randomized to intervention or usual care in March 2005, with assessment of the effect of the intervention on rates of CRC screening.
This study has important implications for increasing CRC screening.
With health plans expanding efforts to screen large populations for CRC and other malignancies, automated telephone outreach with speech recognition can reach large numbers of individuals with educational and reminder messages.
It is important to know whether these efforts to promote screening are effective in overcoming known disparities in screening for CRC.
If proven effective and cost-effective, this technology has the potential for widespread adoption and population-wide improvements in CRC screening and other prevention-related behaviors, with the ultimate public health goal of reducing the burden of suffering attributable to cancer and its complications.
Study Type
Interventional
Enrollment (Actual)
80000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Harvard Pilgrim Health Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 50-64 at baseline
- Continuous enrollment in health plan
Exclusion Criteria:
- Prior request for exclusion from research or quality improvement
- No telephone number on file
- Enrolled in other telephone-based outreach program of the health plan
- Share household with another eligible member
- Evidence of colorectal cancer or polyps at baseline
- Evidence of prior screening at baseline such that screening is not due at time of intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
|
|
|
Experimental: Automated Telephone Outreach
Automated Telephone Outreach with Speech Recognition
|
Automated Telephone Outreach with Speech Recognition calls to health plan members to promote screening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
colorectal cancer screening
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
colonoscopy screening
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven R Simon, MD, Harvard Pilgrim Health Care
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
November 13, 2008
First Submitted That Met QC Criteria
November 13, 2008
First Posted (Estimate)
November 17, 2008
Study Record Updates
Last Update Posted (Estimate)
November 17, 2008
Last Update Submitted That Met QC Criteria
November 13, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATO-SR CRC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.