NCT02244099

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

September 16, 2014

Last Update Submit

September 22, 2015

Conditions

AnxietyChronic PainOpioid Use, Unspecified

Keywords

Controlled substance prescribingControlled substance treatment agreementsOpioid use

Outcome Measures

Primary Outcomes (1)

  • 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

    18 months

Secondary Outcomes (3)

  • Discrepancy on urine drug screen

    18 months

  • Morphine Equivalent Review

    18 months

  • Healthcare Utilization

    18 months

Study Arms (1)

Controlled Substance

EXPERIMENTAL

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.

Other: Controlled Substance

Interventions

Controlled SubstanceOTHER

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.

Controlled Substance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Anxiety DisordersChronic Pain

Interventions

Controlled Substances

Condition Hierarchy (Ancestors)

Mental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

  • Kelli D Barnes, PharmD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Clinical

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 18, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations

US(1)