RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening

NCT ID: NCT00792285

Last Updated: 2008-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-03-31

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.

Conditions

Colorectal Cancer

Keywords

Colon cancer; Prevention; Screening; Telephone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Automated Telephone Outreach

Automated Telephone Outreach with Speech Recognition

Group Type: EXPERIMENTAL

Automated Telephone Outreach with Speech Recognition

Intervention Type: BEHAVIORAL

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

Usual Care

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Automated Telephone Outreach with Speech Recognition

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard Pilgrim Health Care

OTHER

Sponsor Role: lead

Responsible Party

Harvard Pilgrim Health Care

Principal Investigators

Steven R Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Pilgrim Health Care

Locations

Harvard Pilgrim Health Care

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20142572 (View on PubMed)

Other Identifiers

ATO-SR CRC

Identifier Type: -

Identifier Source: org_study_id