RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated Telephone Outreach with Speech Recognition
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Colon cancer, Prevention, Screening, Telephone
Eligibility Criteria
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
Sites / Locations
- Harvard Pilgrim Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Automated Telephone Outreach
Usual Care
Arm Description
Automated Telephone Outreach with Speech Recognition
Usual Care
Outcomes
Primary Outcome Measures
colorectal cancer screening
Secondary Outcome Measures
colonoscopy screening
Full Information
NCT ID
NCT00792285
First Posted
November 13, 2008
Last Updated
November 13, 2008
Sponsor
Harvard Pilgrim Health Care
1. Study Identification
Unique Protocol Identification Number
NCT00792285
Brief Title
RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening
Official Title
Automated Telephone Outreach With Speech Recognition to Improve Colorectal Cancer Screening: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Harvard Pilgrim Health Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colon cancer, Prevention, Screening, Telephone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Automated Telephone Outreach
Arm Type
Experimental
Arm Description
Automated Telephone Outreach with Speech Recognition
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Automated Telephone Outreach with Speech Recognition
Intervention Description
Automated Telephone Outreach with Speech Recognition calls to health plan members to promote screening
Primary Outcome Measure Information:
Title
colorectal cancer screening
Time Frame
one year
Secondary Outcome Measure Information:
Title
colonoscopy screening
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Simon, MD
Organizational Affiliation
Harvard Pilgrim Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Pilgrim Health Care
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20142572
Citation
Simon SR, Zhang F, Soumerai SB, Ensroth A, Bernstein L, Fletcher RH, Ross-Degnan D. Failure of automated telephone outreach with speech recognition to improve colorectal cancer screening: a randomized controlled trial. Arch Intern Med. 2010 Feb 8;170(3):264-70. doi: 10.1001/archinternmed.2009.522.
Results Reference
derived
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RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening
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