- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00828490
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
Completed
Conditions
Intervention / Treatment
Detailed Description
The ePRM project has two objectives:
- 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.
- 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
Observational
Enrollment (Actual)
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Pediatric Asthmatics
Medicaid beneficiaries ≤21 years of age who meet the HEDIS criteria for persistent asthma
|
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.
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.
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
|
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.
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.
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.
|
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.
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.
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 |
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
Collaborators
Investigators
- 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
July 1, 2007
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
January 23, 2009
First Submitted That Met QC Criteria
January 23, 2009
First Posted (Estimate)
January 26, 2009
Study Record Updates
Last Update Posted (Estimate)
March 23, 2010
Last Update Submitted That Met QC Criteria
March 21, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID 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
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on provider feedback
-
Dallas VA Medical CenterRecruitingPeripheral Arterial DiseaseUnited States
-
Cook County HealthCompletedMetabolic Syndrome | Type 2 Diabetes | Pre-DiabetesUnited States
-
The University of Texas Health Science Center,...Baylor College of Medicine; Cancer Prevention Research Institute of TexasCompletedHuman Papillomavirus (HPV)United States
-
University of ChicagoNorthwestern University; Ann & Robert H Lurie Children's Hospital of Chicago; Howard Brown Health Center and other collaboratorsCompleted
-
US Department of Veterans AffairsCompletedAdverse Drug EventsUnited States
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR)CompletedQuality of Life | Pediatric Cancer | Symptom ScreeningCanada
-
University of NottinghamHeartlight Systems LimitedCompletedInfant, Newborn, Diseases | Infant, Premature, Diseases | Fetus or Neonate Affected by Cesarean SectionUnited Kingdom
-
University of PittsburghCompletedQuality of Life | Bladder CancerUnited States
-
University of California, Los AngelesRAND; Olive View-UCLA Education & Research InstituteActive, not recruitingCardiovascular Diseases | HIVUnited States
-
UConn HealthAgency for Healthcare Research and Quality (AHRQ)Completed