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Natural Language Processing and Quality Assessment in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 9, 2008
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date January 6, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Completion of foot exam [ Time Frame: 6 months post intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Patient report in validation of Natural Language Processing [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Natural Language Processing and Quality Assessment in Primary Care
Official Title  ICMJE Novel Use of Natural Language Processing and Targeted Patient Education Information Regarding the Process for Completion of the Foot Examination in Primary Care
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Condition  ICMJE Diabetes
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: Brochure: Care of the Feet for Those at Risk
    • Other: Quality Survey: foot exam, tobacco and aspirin use
  • 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
    Intervention: Other: Quality Survey: foot exam, tobacco and aspirin use
  • 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
    Intervention: Other: Brochure: Care of the Feet for Those at Risk
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2011)
389
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
450
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • primary care patients with diagnosis of diabetes

Exclusion Criteria:

  • unwilling to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01023243
Other Study ID Numbers  ICMJE 08-002255
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Smith, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory a Bartel, MD Mayo Clinic
Principal Investigator: Steven A Smith, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP