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Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic

Primary Purpose

Anxiety, Chronic Pain, Opioid Use, Unspecified

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled Substance
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety focused on measuring Controlled substance prescribing, Controlled substance treatment agreements, Opioid use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Controlled Substance

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Patients Adhering to Controlled Substance Agreement
To measure the adherence to a controlled substance treatment agreement (CSTA) before and after implementation of a population management intervention

Secondary Outcome Measures

Discrepancy on urine drug screen
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
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
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

Full Information

First Posted
September 16, 2014
Last Updated
September 22, 2015
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT02244099
Brief Title
Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic
Official Title
Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Chronic Pain, Opioid Use, Unspecified
Keywords
Controlled substance prescribing, Controlled substance treatment agreements, Opioid use

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controlled Substance
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Controlled Substance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients Adhering to Controlled Substance Agreement
Description
To measure the adherence to a controlled substance treatment agreement (CSTA) before and after implementation of a population management intervention
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Discrepancy on urine drug screen
Description
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
Time Frame
18 months
Title
Morphine Equivalent Review
Description
To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day before and after implementation of a review intervention
Time Frame
18 months
Title
Healthcare Utilization
Description
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
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli D Barnes, PharmD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic

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