RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

Official title:

Automated Telephone Outreach With Speech Recognition to Improve Colorectal Cancer Screening: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792285
• Other study ID #: ATO-SR CRC
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: November 13, 2008
• Start date: March 2005
• Est. completion date: March 2006

Study information

• Verified date: November 2008
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80000
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Automated Telephone Outreach with Speech Recognition
Automated Telephone Outreach with Speech Recognition calls to health plan members to promote screening

Locations

Country	Name	City	State
United States	Harvard Pilgrim Health Care	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard Pilgrim Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colorectal cancer screening		one year	No
Secondary	colonoscopy screening		one year	No