Natural Language Processing and Quality Assessment in Primary Care

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01023243
First received: December 9, 2008
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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 Intervention
Diabetes
Other: Brochure: Care of the Feet for Those at Risk
Other: Quality Survey: foot exam, tobacco and aspirin use

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Completion of foot exam [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient report in validation of Natural Language Processing [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 389
Study Start Date: January 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary care patients with diagnosis of diabetes

Exclusion Criteria:

  • unwilling to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Responsible Party: Steven A. Smith M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01023243     History of Changes
Other Study ID Numbers: 08-002255
Study First Received: December 9, 2008
Last Updated: December 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014