Electronic Pharmacotherapy Risk Management (ePRM)

March 21, 2010 updated by: University of Utah

Developing a Utah Pharmacotherapy Risk Management System With an Electronic Surveillance Tool (Utah ePRM)

The purpose of the Utah ePRM (electronic Pharmacotherapy Risk Management) project is to improve quality and safety of medication use while simultaneously controlling costs and detecting fraud and abuse.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The ePRM project has two objectives:

  1. Refine and implement a computerized surveillance and trigger tool to support medication therapy and risk management services. The ePRM tool will be used to (1) identify potential drug-therapy problems, which include quality, safety and cost-related problems; (2) select patients and providers for in-depth clinical reviews and possibly direct intervention (i.e., letter, phone call, Medication Therapy Management Services (MTMS), or Academic Detailing); (3) identify potential fraud and diversion of controlled substances; and (4) track patterns of medication use and evaluate ePRM performance, identify improvements, and direct policy change.
  2. Conduct innovative multi-pronged interventions that are guided by the ePRM trigger tool. Clinical areas chosen for review include diabetes therapy, hypertension, asthma, antipsychotic therapy, pain management (opioid narcotics and anticonvulsants) and anticoagulation/antiplatelet drugs. Interventions in these areas will address potential under and overuse, or patient safety concerns. Clinical pharmacists and physicians will implement five types of inter-related interventions: a) provider level reviews, which includes prescribers' profiling and feedback for outlier prescribers; b) patient level reviews and letters to prescribers for high-risk patients; c) phone consultation and Academic Detailing with outlier prescribers; d) MTMS; and e) detecting and pursuing suspected fraud and abuse cases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States
        • Multi-clinic site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all medicaid recipients in the salt lake area

Description

Inclusion Criteria:

  • All medicaid recipients and providers with in the salt lake area

Exclusion Criteria:

  • each participant much be a Medicaid recipient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pediatric Asthmatics
Medicaid beneficiaries ≤21 years of age who meet the HEDIS criteria for persistent asthma
Behavioral: provider feedback
The provider-level intervention includes a targeted review of trigger-flagged beneficiaries' drug utilization history and an information packet sent to providers which includes patient-specific pharmacy and medical claims history, patient specific recommendations, and provider comparative profiling.
Behavioral: patient intervention
The patient intervention arm includes the provider-level intervention mentioned above in addition to Medication Therapy Management Services (MTMS), a program that provides patients one-on-one therapy counseling administered by community pharmacists who have completed an MTMS certificate program.
Behavioral: Process-level
The process-level intervention includes the provider-level intervention plus in-clinic evidence-based quality improvement workshops with opportunity for CME credit
Antipsychotic Therapy
Medicaid beneficiaries ≥18 years of age and enrolled ≥6 months of the past 12 months with enrollment in at least one of the past 3 months and ≥3 antipsychotic Rx within past 12 months
Behavioral: provider feedback
The provider-level intervention includes a targeted review of trigger-flagged beneficiaries' drug utilization history and an information packet sent to providers which includes patient-specific pharmacy and medical claims history, patient specific recommendations, and provider comparative profiling.
Behavioral: patient intervention
The patient intervention arm includes the provider-level intervention mentioned above in addition to Medication Therapy Management Services (MTMS), a program that provides patients one-on-one therapy counseling administered by community pharmacists who have completed an MTMS certificate program.
Behavioral: Process-level
The process-level intervention includes the provider-level intervention plus in-clinic evidence-based quality improvement workshops with opportunity for CME credit
Bipolar Therapy
Medicaid beneficiaries ≥18 years of age and enrolled ≥6 months of the past 12 months with enrollment in at least one of the past 3 months and a diagnosis of Bipolar in past 3 years, and ≥ 1 antidepressant Rx in past 6 months, and no mood stabilizer in past 6 months.
Behavioral: provider feedback
The provider-level intervention includes a targeted review of trigger-flagged beneficiaries' drug utilization history and an information packet sent to providers which includes patient-specific pharmacy and medical claims history, patient specific recommendations, and provider comparative profiling.
Behavioral: patient intervention
The patient intervention arm includes the provider-level intervention mentioned above in addition to Medication Therapy Management Services (MTMS), a program that provides patients one-on-one therapy counseling administered by community pharmacists who have completed an MTMS certificate program.
Behavioral: Process-level
The process-level intervention includes the provider-level intervention plus in-clinic evidence-based quality improvement workshops with opportunity for CME credit
Opioid Therapy

Medicaid beneficiaries ≥18 years and enrolled ≥6 of prior 12 months with enrollment in ≥1 of prior 3 months and ≥1 opioid fill in prior 3 months and none of the following in prior 12 months:

Hospice CPT code or Primary diagnosis of cancer or Oncology CPT code
Behavioral: Process-level
The process-level intervention includes the provider-level intervention plus in-clinic evidence-based quality improvement workshops with opportunity for CME credit
Fraud and Abuse
Medicaid beneficiaries who filled at least 3 opioid Rx in the last 12 months
Pediatric Antipsychtotic Therapy
Medicaid beneficiaries <18 years of age with at least 3 antipsychotic Rx's in the past year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Utah Department of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan R Nebeker, M.D., M.S., VASLCHCS
  • Principal Investigator: Gary Oderda, PharmD, M.P.H., University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24987
  • 7570516-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on provider feedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings