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Natural Language Processing and Quality Assessment in Primary Care

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ClinicalTrials.gov Identifier: NCT01023243
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Steven Smith, Mayo Clinic

Brief 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 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.

Condition or disease Intervention/treatment Phase
Diabetes Other: Brochure: Care of the Feet for Those at Risk Other: Quality Survey: foot exam, tobacco and aspirin use Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
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
Study Start Date : January 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
Drug Information available for: Aspirin

Arm Intervention/treatment
Placebo Comparator: 1 CAre of the Feet for Those at Risk
secular trends for physician documentation in the medical record for care of the feet for high risk patients
Other: Brochure: Care of the Feet for Those at Risk
Patient education materials and key messages for care of the feet for those patients at risk
Other Name: Care of the Feet For Those at Risk

Other: Quality Survey: foot exam, tobacco and aspirin use
NCQA Patient Survey
Other Name: Care of the Feet For Those at Risk

Active Comparator: Care of the feet for those at risk
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
Other: Quality Survey: foot exam, tobacco and aspirin use
NCQA Patient Survey
Other Name: Care of the Feet For Those at Risk

Active Comparator: Impact of Quality Survey
Impact of patient survey regarding last foot exam, tobacco and aspirin use on documentation of foot exam in the medical record
Other: Brochure: Care of the Feet for Those at Risk
Patient education materials and key messages for care of the feet for those patients at risk
Other Name: Care of the Feet For Those at Risk




Primary Outcome Measures :
  1. Completion of foot exam [ Time Frame: 6 months post intervention ]

Secondary Outcome Measures :
  1. Patient report in validation of Natural Language Processing [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary care patients with diagnosis of diabetes

Exclusion Criteria:

  • unwilling to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023243


Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Gregory a Bartel, MD Mayo Clinic
Principal Investigator: Steven A Smith, MD Mayo Clinic

Additional Information:
Publications:
Responsible Party: Steven Smith, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01023243     History of Changes
Other Study ID Numbers: 08-002255
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016

Keywords provided by Steven Smith, Mayo Clinic:
foot exam
health services
practice improvement
quality
preventive services
Natural Language Processing

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics