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RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening

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. Identifier: NCT00792285
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : November 17, 2008
Information provided by:
Harvard Pilgrim Health Care

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Automated Telephone Outreach with Speech Recognition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Automated Telephone Outreach With Speech Recognition to Improve Colorectal Cancer Screening: A Randomized Controlled Trial
Study Start Date : March 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Arm Intervention/treatment
Experimental: Automated Telephone Outreach
Automated Telephone Outreach with Speech Recognition
Behavioral: Automated Telephone Outreach with Speech Recognition
Automated Telephone Outreach with Speech Recognition calls to health plan members to promote screening

No Intervention: Usual Care
Usual Care

Primary Outcome Measures :
  1. colorectal cancer screening [ Time Frame: one year ]

Secondary Outcome Measures :
  1. colonoscopy screening [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00792285

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United States, Massachusetts
Harvard Pilgrim Health Care
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Harvard Pilgrim Health Care
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Principal Investigator: Steven R Simon, MD Harvard Pilgrim Health Care
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Steven R. Simon, MD / Principal Investigator, Harvard Pilgrim Health Care Identifier: NCT00792285    
Other Study ID Numbers: ATO-SR CRC
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: November 17, 2008
Last Verified: November 2008
Keywords provided by Harvard Pilgrim Health Care:
Colon cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases