Natural Language Processing and Quality Assessment in Primary Care

January 5, 2016 updated by: Steven Smith, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary care patients with diagnosis of diabetes

Exclusion Criteria:

  • unwilling to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Care of the Feet For Those at Risk
Other: Quality Survey: foot exam, tobacco and aspirin use
NCQA Patient Survey
Other Names:
  • 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 Names:
  • 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 Names:
  • Care of the Feet For Those at Risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion of foot exam
Time Frame: 6 months post intervention
6 months post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient report in validation of Natural Language Processing
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Gregory a Bartel, MD, Mayo Clinic
  • Principal Investigator: Steven A Smith, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 9, 2008

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-002255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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