DiabetesNCT01023243
Natural Language Processing and Quality Assessment in Primary Care
A study testing Brochure: Care of the Feet for Those at Risk and Quality Survey: foot exam, tobacco and aspirin use in people with Diabetes, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators propose to use a Natural Language Processing System (NLP) to provide an initial baseline report for primary care patients at risk for diabetes and cardiovascular complications that will include: a) evidence of foot exam documentation in the previous year; b) use of aspirin for cardiovascular risk… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Brochure: Care of the Feet for Those at Risk and Quality Survey: foot exam, tobacco and aspirin use
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 389 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- primary care patients with diagnosis of diabetes
Who cannot join
- unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Use of Natural Language Processing and Targeted Patient Education Information Regarding the Process for Completion of the Foot Examination in Primary Care
The investigators propose to use a Natural Language Processing System (NLP) to provide an initial baseline report for primary care patients at risk for diabetes and cardiovascular complications that will include: a) evidence of foot exam documentation in the previous year; b) use of aspirin for cardiovascular risk reduction; and c) tobacco use. As part of a randomized trial, we plan to use a previously validated mailed survey (NCQA Provider Recognition Program) that requests information on the last foot exam, use of aspirin and tobacco. Patients who have been identified by NLP as not having had a foot exam will be randomized into treatment and control arms. Both arms will receive an informational letter; with a second mailing to nonresponders after one month, describing the key strategies for effective patient-physician communication during the clinical encounter. The treatment arm will also receive an informational letter and patient education brochure containing key messages about the importance of regular foot examinations. NLP will be repeated after 6 months to compare the impact of the patient education materials.
- Conditions
- Diabetes
- Being tested
- Brochure: Care of the Feet for Those at Risk, Quality Survey: foot exam, tobacco and aspirin use
- Keywords
- foot exam, health services, practice improvement, quality, preventive services, Natural Language Processing
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brochure: Care of the Feet for Those at RiskOther
Also called Care of the Feet For Those at Risk
Patient education materials and key messages for care of the feet for those patients at risk
Quality Survey: foot exam, tobacco and aspirin useOther
Also called Care of the Feet For Those at Risk
NCQA Patient Survey
| Study group | Role | What they receive |
|---|---|---|
| 1 CAre of the Feet for Those at Risk | Placebo comparator | secular trends for physician documentation in the medical record for care of the feet for high risk patients Receives: Other: Brochure: Care of the Feet for Those at Risk; Other: Quality Survey: foot exam, tobacco and aspirin use |
| Care of the feet for those at risk | Active comparator | the impact of 1) patient survey regarding last foot exam, tobacco and aspirin use on documentation of foot exam and 2) patient education material: Care of the Foot For Those at Risk, on documentation of foot examination in the medical record Receives: Other: Quality Survey: foot exam, tobacco and aspirin use |
| Impact of Quality Survey | Active comparator | Impact of patient survey regarding last foot exam, tobacco and aspirin use on documentation of foot exam in the medical record Receives: Other: Brochure: Care of the Feet for Those at Risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of foot exam
Measured: 6 months post intervention
Secondary outcomes (1)
Patient report in validation of Natural Language Processing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionApr 2011
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Smith, Mayo Clinic
- Investigators
- Gregory a Bartel, MD, Principal investigator, Mayo ClinicSteven A Smith, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023243
- Sponsor's protocol ID
- 08-002255
- Status last verified
- Jan 2016
- First submitted
- 9 Dec 2008
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pakhomov S, Bjornsen S, Hanson P, Smith S. Quality performance measurement using the text of electronic medical records. Med Decis Making. 2008 Jul-Aug;28(4):462-70. doi: 10.1177/0272989X08315253. Epub 2008 May 13.
PubMed 18480037
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Use of Natural Language Processing and Targeted Patient Education Information Regarding the Process for Completion of the Foot Examination in Primary Care
- ClinicalTrials.gov ID
- NCT01023243
- Acronym / sponsor ID
- 08-002255
- Conditions
- Diabetes
- Keywords
- foot exam, health services, practice improvement, quality, preventive services, Natural Language Processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Dec 2009 (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 investigators propose to use a Natural Language Processing System (NLP) to provide an initial baseline report for primary care patients at risk for diabetes and cardiovascular complications that will include: a) evidence of foot exam documentation in the previous year; b) use of aspirin for cardiovascular risk reduction; and c) tobacco use. As part of a randomized trial, we plan to use a previously validated mailed survey (NCQA Provider Recognition Program) that requests information on the last foot exam, use of aspirin and tobacco. Patients who have been identified by NLP as not having had a foot exam will be randomized into treatment and control arms. Both arms will receive an informational letter; with a second mailing to nonresponders after one month, describing the key strategies for effective patient-physician communication during the clinical encounter. The treatment arm will also receive an informational letter and patient education brochure containing key messages about the importance of regular foot examinations. NLP will be repeated after 6 months to compare the impact of the patient education materials.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 CAre of the Feet for Those at Risk | Placebo comparator | Other: Brochure: Care of the Feet for Those at Risk, Other: Quality Survey: foot exam, tobacco and aspirin usesecular trends for physician documentation in the medical record for care of the feet for high risk patients |
| Care of the feet for those at risk | Active comparator | Other: Quality Survey: foot exam, tobacco and aspirin usethe impact of 1) patient survey regarding last foot exam, tobacco and aspirin use on documentation of foot exam and 2) patient education material: Care of the Foot For Those at Risk, on documentation of foot examination in the medical record |
| Impact of Quality Survey | Active comparator | Other: Brochure: Care of the Feet for Those at RiskImpact of patient survey regarding last foot exam, tobacco and aspirin use on documentation of foot exam in the medical record |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary care patients with diagnosis of diabetes
Key exclusion criteria (1 listed)
- unwilling to give informed consent
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 |
|---|---|---|
| Brochure: Care of the Feet for Those at RiskAlso: Care of the Feet For Those at RiskPatient education materials and key messages for care of the feet for those patients at risk | Other | 1 CAre of the Feet for Those at Risk, Impact of Quality Survey |
| Quality Survey: foot exam, tobacco and aspirin useAlso: Care of the Feet For Those at RiskNCQA Patient Survey | Other | 1 CAre of the Feet for Those at Risk, Care of the feet for those at risk |
Primary outcome
Completion of foot exam
Time frame: 6 months post intervention
1 secondary outcome
Patient report in validation of Natural Language Processing
Time frame: 6 months
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 6 Jan 2016.
- Background: PubMed 18480037Pakhomov S, Bjornsen S, Hanson P, Smith S. Quality performance measurement using the text of electronic medical records. Med Decis Making. 2008 Jul-Aug;28(4):462-70. doi: 10.1177/0272989X08315253. Epub 2008 May 13.
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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.
Gregory a Bartel, MD principal investigator
Mayo Clinic
Steven A Smith, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brochure: Care of the Feet for Those at Risk and Quality Survey: foot exam, tobacco and aspirin use in people with Diabetes, run by Mayo Clinic 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 1 inclusion and 1 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 6 Jan 2016. 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. Some participants in this study may receive a placebo. 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 foot exam (time frame: 6 months post 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 NCT01023243, 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 6 Jan 2016.