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RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening

This study has been completed.
Sponsor:
Information provided by:
Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:
NCT00792285
First received: November 13, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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 Intervention
Colorectal Cancer
 Behavioral: Automated Telephone Outreach with Speech Recognition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Automated Telephone Outreach With Speech Recognition to Improve Colorectal Cancer Screening: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harvard Pilgrim Health Care:

Primary Outcome Measures:
  • colorectal cancer screening [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • colonoscopy screening [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 80000
Study Start Date: March 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792285

Locations
United States, Massachusetts
Harvard Pilgrim Health Care
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Harvard Pilgrim Health Care
Investigators
Principal Investigator: Steven R Simon, MD Harvard Pilgrim Health Care
  More Information

No publications provided by Harvard Pilgrim Health Care

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven R. Simon, MD / Principal Investigator, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT00792285     History of Changes
Other Study ID Numbers: ATO-SR CRC
Study First Received: November 13, 2008
Last Updated: November 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard Pilgrim Health Care:
Colon cancer
Prevention
Screening
Telephone

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013