Diabetes MellitusATO-SR-DMNCT00790530
Automated Telephone Outreach With Speech Recognition to Improve Diabetes Care: A Randomized Controlled Study
A study testing Automated Telephone Outreach with Speech Recognition in people with Diabetes Mellitus, run by Harvard Pilgrim Health Care at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of automated telephone outreach with speech recognition to improve diabetes care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- 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
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2007
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diabetes, defined as either 1) filled a prescription for insulin or an oral hypoglycemic agent; or, 2) had two outpatient or one inpatient or two outpatients encounter claims with an ICD9-CM or CPT code indicating diabetes.
- Gap in a key diabetes management metric as evidenced by no claim for a dilated eye examination in the prior 15 months and no claim for one or more of the following tests: glycated hemoglobin, LDL-cholesterol, or microalbumin. (Individuals with evidence of having received ACE-inhibitors or angiotensin receptor blockers were considered to have had a microalbumin test.)
Who cannot join
- No primary care clinician in the data base
- Those who had previously asked the health plan to exclude them from research or quality improvement
- Women whose claim records contained diagnoses suggesting gestational diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Pilgrim Health Care
Boston, Massachusetts, 02215
About this study
The purpose of this study is to evaluate the effectiveness of automated telephone outreach with speech recognition to improve diabetes care.
Read the detailed description
Randomly allocate a total of 1200 health plan members with diabetes to automated telephone outreach with speech recognition (ATO-SR; N = 600) or usual care (N = 600). The intervention is a series of three calls, using automated calls, originating from the health plan, using interactive speech recognition technology, spaced approximately 4-6 weeks apart, to encourage participants to fulfill the recommended testing (dilated eye examinations, glycated hemoglobin, LDL-cholesterol, microalbumin) that had not been performed received in the preceding year.
- Conditions
- Diabetes Mellitus
- Being tested
- Automated Telephone Outreach with Speech Recognition, Usual Care
- Keywords
- Diabetes, Information Technology, Health Plans
- Medical subject headings
- Diabetes Mellitus
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
Usual CareOther
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| ATO-SR | Experimental | Automated Telephone Outreach with Speech Recognition Receives: Behavioral: Automated Telephone Outreach with Speech Recognition |
| Usual Care | No intervention | Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of dilated eye examination
Measured: 12-months following intervention
Secondary outcomes (3)
Completion of glycated hemoglobin testing (HbA1c)
Measured: one-year following intervention
Completion of LDL-cholesterol testing
Measured: one year following intervention
Completion of microalbumin testing
Measured: one-year following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startJun 2006
- Primary completionOct 2007
- Study completionOct 2007
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 Diabetes MellitusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Investigators
- Steven R Simon, MD, Principal investigator, Harvard Pilgrim Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790530
- Sponsor's protocol ID
- 1-05-JF-40
- Acronym
- ATO-SR-DM
- Status last verified
- Nov 2008
- First submitted
- 11 Nov 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Simon SR, Trinacty CM, Soumerai SB, Piette JD, Meigs JB, Shi P, Ensroth A, Ross-Degnan D. Improving diabetes care among patients overdue for recommended testing: a randomized controlled trial of automated telephone outreach. Diabetes Care. 2010 Jul;33(7):1452-3. doi: 10.2337/dc09-2332. Epub 2010 Mar 31.
PubMed 20357376
Study at a glance
From the registry record, last updated by the sponsor on 13 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 Diabetes Care: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00790530
- Acronym / sponsor ID
- ATO-SR-DM / 1-05-JF-40
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Information Technology, Health Plans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jun 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 13 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.
The purpose of this study is to evaluate the effectiveness of automated telephone outreach with speech recognition to improve diabetes care.
Detailed description
Randomly allocate a total of 1200 health plan members with diabetes to automated telephone outreach with speech recognition (ATO-SR; N = 600) or usual care (N = 600). The intervention is a series of three calls, using automated calls, originating from the health plan, using interactive speech recognition technology, spaced approximately 4-6 weeks apart, to encourage participants to fulfill the recommended testing (dilated eye examinations, glycated hemoglobin, LDL-cholesterol, microalbumin) that had not been performed received in the preceding year.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATO-SR | Experimental | Behavioral: Automated Telephone Outreach with Speech RecognitionAutomated Telephone Outreach with Speech Recognition |
| Usual Care | No intervention | Other: Usual CareUsual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Diabetes, defined as either 1) filled a prescription for insulin or an oral hypoglycemic agent; or, 2) had two outpatient or one inpatient or two outpatients encounter claims with an ICD9-CM or CPT code indicating diabetes.
- Gap in a key diabetes management metric as evidenced by no claim for a dilated eye examination in the prior 15 months and no claim for one or more of the following tests: glycated hemoglobin, LDL-cholesterol, or microalbumin. (Individuals with evidence of having received ACE-inhibitors or angiotensin receptor blockers were considered to have had a microalbumin test.)
Key exclusion criteria (3 listed)
- No primary care clinician in the data base
- Those who had previously asked the health plan to exclude them from research or quality improvement
- Women whose claim records contained diagnoses suggesting gestational diabetes
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 | Behavioural | ATO-SR |
| Usual CareUsual Care | Other | Usual Care |
Primary outcome
Completion of dilated eye examination
Time frame: 12-months following intervention
3 secondary outcomes
Completion of glycated hemoglobin testing (HbA1c)
Time frame: one-year following intervention
Completion of LDL-cholesterol testing
Time frame: one year following intervention
Completion of microalbumin testing
Time frame: one-year following intervention
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 13 Nov 2008.
- Derived from this study: PubMed 20357376Simon SR, Trinacty CM, Soumerai SB, Piette JD, Meigs JB, Shi P, Ensroth A, Ross-Degnan D. Improving diabetes care among patients overdue for recommended testing: a randomized controlled trial of automated telephone outreach. Diabetes Care. 2010 Jul;33(7):1452-3. doi: 10.2337/dc09-2332. Epub 2010 Mar 31.
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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 Diabetes Mellitus, 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 3 inclusion and 3 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 13 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?
Completion of dilated eye examination (time frame: 12-months following intervention). 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 NCT00790530, 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 13 Nov 2008.