AsthmaePRMNCT00828490
Electronic Pharmacotherapy Risk Management
An observational study of Asthma and Mental Health, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma, Mental Health, Pain
- What is being tested?
- provider feedback, patient intervention and Process-level
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 174,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all medicaid recipients in the salt lake area
Who may be able to join
- All medicaid recipients and providers with in the salt lake area
Who cannot join
- each participant much be a Medicaid recipient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma, Mental Health, Pain
- Being tested
- provider feedback, patient intervention, Process-level
- Keywords
- Fraud and Abuse, opioids
- Medical subject headings
- Asthma, Psychological Well-Being, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
provider feedbackBehavioural
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.
patient interventionBehavioural
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.
Process-levelBehavioural
The process-level intervention includes the provider-level intervention plus in-clinic evidence-based quality improvement workshops with opportunity for CME credit
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Asthmatics | Medicaid beneficiaries ≤21 years of age who meet the HEDIS criteria for persistent asthma Receives: Behavioral: provider feedback; Behavioral: patient intervention; Behavioral: Process-level | |
| 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 Receives: Behavioral: provider feedback; Behavioral: patient intervention; Behavioral: Process-level | |
| 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. Receives: Behavioral: provider feedback; Behavioral: patient intervention; Behavioral: Process-level | |
| 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 Receives: Behavioral: Process-level | |
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJul 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 174,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Utah Department of Health
- Investigators
- Jonathan R Nebeker, M.D., M.S., Principal investigator, VASLCHCSGary Oderda, PharmD, M.P.H., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828490
- Sponsor's protocol ID
- 24987
- Other IDs
- 7570516-1
- Acronym
- ePRM
- Status last verified
- Mar 2010
- First submitted
- 23 Jan 2009
- Last updated
- 23 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Utah Pharmacotherapy Risk Management System With an Electronic Surveillance Tool (Utah ePRM)
- ClinicalTrials.gov ID
- NCT00828490
- Acronym / sponsor ID
- ePRM / 24987
- Conditions
- Asthma, Mental Health, Pain
- Keywords
- Fraud and Abuse, opioids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174,000 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Utah Department of Health
- Study start
- Jul 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pediatric Asthmatics | – | Behavioral: provider feedback, Behavioral: patient intervention, Behavioral: Process-levelMedicaid beneficiaries ≤21 years of age who meet the HEDIS criteria for persistent asthma |
| Antipsychotic Therapy | – | Behavioral: provider feedback, Behavioral: patient intervention, Behavioral: Process-levelMedicaid 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 |
| Bipolar Therapy | – | Behavioral: provider feedback, Behavioral: patient intervention, Behavioral: Process-levelMedicaid 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. |
| Opioid Therapy | – | Behavioral: Process-levelMedicaid 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 |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all medicaid recipients in the salt lake area
Key inclusion criteria (1 listed)
- All medicaid recipients and providers with in the salt lake area
Key exclusion criteria (1 listed)
- each participant much be a Medicaid recipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| provider feedbackThe 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. | Behavioural | Antipsychotic Therapy, Bipolar Therapy, Pediatric Asthmatics |
| patient interventionThe 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. | Behavioural | Antipsychotic Therapy, Bipolar Therapy, Pediatric Asthmatics |
| Process-levelThe process-level intervention includes the provider-level intervention plus in-clinic evidence-based quality improvement workshops with opportunity for CME credit | Behavioural | Antipsychotic Therapy, Bipolar Therapy, Opioid Therapy, Pediatric Asthmatics |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2010.
Related trials for Asthma
RecruitingObservational study
Swiss Severe Asthma Register
Severe Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan R Nebeker, M.D., M.S. principal investigator
VASLCHCS
Gary Oderda, PharmD, M.P.H. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Mental Health, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2010; AzTrials last refreshed its copy on 3 Nov 2026.