Colorectal CancerNCT00792285
RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening
A study testing Automated Telephone Outreach with Speech Recognition in people with Colorectal Cancer, run by Harvard Pilgrim Health Care at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Automated Telephone Outreach with Speech Recognition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 50-64 at baseline
- Continuous enrollment in health plan
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Pilgrim Health Care
Boston, Massachusetts, 02215
About this study
Official title: Automated Telephone Outreach With Speech Recognition to Improve Colorectal Cancer Screening: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Automated Telephone Outreach with Speech Recognition
- Keywords
- Colon cancer, Prevention, Screening, Telephone
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Telephone Outreach with Speech RecognitionBehavioural
Automated Telephone Outreach with Speech Recognition calls to health plan members to promote screening
| Study group | Role | What they receive |
|---|---|---|
| Automated Telephone Outreach | Experimental | Automated Telephone Outreach with Speech Recognition Receives: Behavioral: Automated Telephone Outreach with Speech Recognition |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
colorectal cancer screening
Measured: one year
Secondary outcomes (1)
colonoscopy screening
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startMar 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Investigators
- Steven R Simon, MD, Principal investigator, Harvard Pilgrim Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792285
- Sponsor's protocol ID
- ATO-SR CRC
- Status last verified
- Nov 2008
- First submitted
- 13 Nov 2008
- Last updated
- 17 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20142572
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Telephone Outreach With Speech Recognition to Improve Colorectal Cancer Screening: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00792285
- Acronym / sponsor ID
- ATO-SR CRC
- Conditions
- Colorectal Cancer
- Keywords
- Colon cancer, Prevention, Screening, Telephone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80,000 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated Telephone Outreach | Experimental | Behavioral: Automated Telephone Outreach with Speech RecognitionAutomated Telephone Outreach with Speech Recognition |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 50-64 at baseline
- Continuous enrollment in health plan
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Telephone Outreach with Speech RecognitionAutomated Telephone Outreach with Speech Recognition calls to health plan members to promote screening | Behavioural | Automated Telephone Outreach |
Primary outcome
colorectal cancer screening
Time frame: one year
1 secondary outcome
colonoscopy screening
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2008.
- Derived from this study: PubMed 20142572Simon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Simon, MD principal investigator
Harvard Pilgrim Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Telephone Outreach with Speech Recognition in people with Colorectal Cancer, run by Harvard Pilgrim Health Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colorectal cancer screening (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00792285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2008.