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Trial record 5 of 8 for:    CARISOPRODOL

Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic

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: NCT02244099
Recruitment Status : Completed
First Posted : September 18, 2014
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Jared Moore, Ohio State University

Tracking Information
First Submitted Date  ICMJE September 16, 2014
First Posted Date  ICMJE September 18, 2014
Last Update Posted Date September 24, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
Percentage of Patients Adhering to Controlled Substance Agreement [ Time Frame: 18 months ]
To measure the adherence to a controlled substance treatment agreement (CSTA) before and after implementation of a population management intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
  • Discrepancy on urine drug screen [ Time Frame: 18 months ]
    To determine the number of patients on a CSTA with a discrepancy identified on a urine drug screen or an Ohio Automated Rx Reporting System (OARRS) report
  • Morphine Equivalent Review [ Time Frame: 18 months ]
    To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day before and after implementation of a review intervention
  • Healthcare Utilization [ Time Frame: 18 months ]
    To characterize the healthcare utilization of patients taking controlled substances, carisoprodol, or tramadol by tracking the mean number of ED visits, hospital admissions, telephone calls, and clinic office visits during a 6 month period
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 Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic
Official Title  ICMJE Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic
Brief Summary

The purpose of this study is to characterize and improve controlled substance, carisoprodol and tramadol use in an internal medicine residents' clinic. Specific objectives of this study include:

  • To measure the adherence to a controlled substance treatment agreement (CSTA) before and after implementation of a population management intervention
  • To determine the number of patients on a CSTA with a discrepancy identified on a urine drug screen or an Ohio Automated Rx Reporting System (OARRS) report
  • To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day before and after implementation of a review intervention
  • To characterize the healthcare utilization of patients taking controlled substances, carisoprodol, or tramadol by tracking the mean number of ED visits, hospital admissions, telephone calls, and clinic office visits during a 6 month period
Detailed Description

Reporting workbench will be used to generate a report from the EMR of all patients of consenting physicians prescribed a controlled substance, carisoprodol, or tramadol at least 3 times in the past 6 months. This report will also include demographics, number of ED visits in the last 6 months, hospital admissions in the last 6 months, the number of telephone calls documented in the last 6 months, the number of clinic visits in the last 6 months, the number of missed clinic visits in the last 6 months, controlled substance prescribed, directions for use, number of tabs of medication prescribed, number of refills given, order date and date of completion of urine drug screen if in last 6 months, if chronic pain is listed as a medical problem, and if controlled substance treatment agreement has been signed and scanned into EMR. For each patient of the consenting physicians, the EMR will be reviewed to track next clinic visit date, urine toxicology screen results, and if there is documentation of an Ohio Automated Rx Reporting System (OARRS) review. The MED for each patient will be obtained from the OARRS report and included on the data collection form. For any patients taking opioid substances at MED ≥ 80 mg/day a review of the appropriateness of this medication and dose based on EMR documentation will be conducted by clinic physicians and/or pharmacists. This will all be done in order to make recommendations to the resident physician based on our best practice recommended controlled substance agreement.

For all patients of the consenting physicians who have an upcoming office visit scheduled, any recommendations for improved adherence to the CSTA or change in controlled substance, carisoprodol, or tramadol prescribing based on EMR review findings will be given to the patient's physician prior to the office visit. Because this intervention is a quality improvement intervention and studies physician decision making but no direct interaction with the patient, the patient will not know this study is occurring. An EMR review after the patient's visit will be completed to track the acceptance of these recommendations leading to changes in the parameters listed in the data analysis section. Additionally, a second report will be generated from the reporting workbence 6 months after implementation of this workflow which includes all patients of the consenting physicians prescribed controlled substances, tramadol, and carisoprodol (including those on the initial report and those who are now new patients controlled substances since the time the report was generated) to characterize the improvement in these parameters for patients in clinic as a whole to track the improvement in adherence to a controlled substance treatment agreement. See study procedures in Figure 1. Data Collection will start on 8/1/14 and continue until 12/31/15.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Anxiety
  • Chronic Pain
  • Opioid Use, Unspecified
Intervention  ICMJE Other: Controlled Substance
Patients will be identified using the reporting workbench in the EMR if they have been prescribed a controlled substance, carisoprodol, or tramadol at least 3 times in the last 6 months by one of the consenting resident physicians from Martha Morehouse General Internal Medicine Resident Continuity Clinic. Once identified, a comprehensive chart review for other important parameters based on best practice recommendations as described in the research protocol will be conducted in order to characterize the patient population for which the recommendations are being made to the physicians. Improvement in controlled substance, carisoprodol, and tramadol prescribing and adherence to the CSTA by the resident physicians will be tracked using a pre/post intervention comparison.
Study Arms  ICMJE Experimental: Controlled Substance
Consenting physicians who care for patients who have been prescribed a controlled substance, carisoprodol, or tramadol at least 3 times in the last 6 months in Martha Morehouse General Internal Medicine Resident Continuity Clinic.
Intervention: Other: Controlled Substance
Publications * Not Provided

*   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: September 22, 2015)
96
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2014)
500
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years and older
  • Residents and attending physicians who work in the resident continuity practice

Exclusion Criteria:

  • Age < 18 years of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT02244099
Other Study ID Numbers  ICMJE 2014H0102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jared Moore, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kelli D Barnes, PharmD Ohio State University
PRS Account Ohio State University
Verification Date September 2015

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