Natural Language Processing and Quality Assessment in Primary Care

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023243
• Other study ID #: 08-002255
• Status: Completed
• Phase: N/A
• First received: December 9, 2008
• Last updated: January 5, 2016
• Start date: January 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• primary care patients with diagnosis of diabetes

Exclusion Criteria:

• unwilling to give informed consent

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes

Intervention

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
• Quality Survey: foot exam, tobacco and aspirin use
NCQA Patient Survey

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of foot exam		6 months post intervention	No
Secondary	Patient report in validation of Natural Language Processing		6 months	No

External Links

•   Mayo Clinic Clinical Trials