Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02244099
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2014-09-16
Brief Title:
Controlled Substance Treatment Agreements in an Internal Medicine Residents Clinic
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Controlled Substance Treatment Agreements in an Internal Medicine Residents Clinic
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday 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
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 mgday 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 mgday a review of the appropriateness of this medication and dose based on EMR documentation will be conducted by clinic physicians andor 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 patients 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 patients 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 8114 and continue until 123115
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 patients 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 patients 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 8114 and continue until 123115
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None