PolypharmacyNCT02077725
Measuring the Impact of an Interdisciplinary Polypharmacy Clinic Within a Patient-centered Medical Home
An observational study of Polypharmacy, run by Ohio State University at 1 site in United States.
Trial summary
Title: Measuring the impact of an interdisciplinary polypharmacy clinic within a patient-centered medical home Objectives: The primary objective of this project will be to track the types of interventions made in an interdisciplinary polypharmacy clinic to improve medication regimens and medication burden. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy
- What is being tested?
- interdisciplinary polypharmacy clinic visit
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients within the general internal medicine patient-centered medical homes of The Ohio State University Division of General Internal Medicine
Who may be able to join
- Patients on 10 or more chronic medications
- Age 18 or older
Who cannot join
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Division of General Internal Medicine Martha Morehouse
Columbus, Ohio, 43221
About this study
Official title: Measure the Impact of an Interdisciplinary Polypharmacy Clinic Within a Patient-entered Medical Home
Title: Measuring the impact of an interdisciplinary polypharmacy clinic within a patient-centered medical home
Objectives:
Read more
The primary objective of this project will be to track the types of interventions made in an interdisciplinary polypharmacy clinic to improve medication regimens and medication burden. Polypharmacy has been well documented in the literature as a risk for medication errors, adverse drug events, and morbidity. Team visits, including complete medication reviews, by pharmacists and physicians within a National Committee for Quality Assurance (NCQA) tier 3 patient-centered medical home (PCMH) at an academic medical center, can improve medication regimens. Secondary objectives include (1) measuring each patient's quality of life at baseline and one month post-intervention and (2) tracking the cost of medication additions and discontinuations.
Methods:
Patients taking ten or more chronic medications will be identified for referral to the polypharmacy clinic from a report generated from the electronic medical record. The polypharmacy clinic will be staffed by a pharmacist and medical resident with oversight from an attending physician who specializes in geriatrics. Drug-related problems identified during the visit will be resolved and categorized based upon indication, efficacy, cost, safety, and compliance. The numbers and types of interventions made, both during the primary visit and anticipated in the future, will be tracked. The 12-item short form (SF-12) survey will also be administered at baseline and one month post intervention. The increase or decrease in cost for medications added and removed during these visits will be captured using the average wholesale prices.
Preliminary Results Using descriptive statistics, the types of drug-related problems identified and interventions made will be reported. Changes in quality of life and monthly medication costs will also be described.
- Conditions
- Polypharmacy
- Being tested
- interdisciplinary polypharmacy clinic visit
- Keywords
- drug related problems, comprehensive medication review, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdisciplinary polypharmacy clinic visitOther
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary polypharmacy clinic | Patients will be seen in the interdisciplinary polypharmacy clinic for a complete comprehensive medication review Receives: Other: interdisciplinary polypharmacy clinic visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and types of drug related problems identified
Measured: 1 year
Secondary outcomes (2)
Assess quality of life at baseline and one month post polypharmacy clinic visit
Measured: 1 month
Cost of medication additions and discontinuations
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Beatty, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077725
- Sponsor's protocol ID
- 2012H0067
- Status last verified
- Sep 2022
- First submitted
- 2 Mar 2014
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measure the Impact of an Interdisciplinary Polypharmacy Clinic Within a Patient-entered Medical Home
- ClinicalTrials.gov ID
- NCT02077725
- Acronym / sponsor ID
- 2012H0067
- Conditions
- Polypharmacy
- Keywords
- drug related problems, comprehensive medication review, quality of life
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 4 Mar 2014 (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.
Title: Measuring the impact of an interdisciplinary polypharmacy clinic within a patient-centered medical home
Objectives:
The primary objective of this project will be to track the types of interventions made in an interdisciplinary polypharmacy clinic to improve medication regimens and medication burden. Polypharmacy has been well documented in the literature as a risk for medication errors, adverse drug events, and morbidity. Team visits, including complete medication reviews, by pharmacists and physicians within a National Committee for Quality Assurance (NCQA) tier 3 patient-centered medical home (PCMH) at an academic medical center, can improve medication regimens. Secondary objectives include (1) measuring each patient's quality of life at baseline and one month post-intervention and (2) tracking the cost of medication additions and discontinuations.
Methods:
Patients taking ten or more chronic medications will be identified for referral to the polypharmacy clinic from a report generated from the electronic medical record. The polypharmacy clinic will be staffed by a pharmacist and medical resident with oversight from an attending physician who specializes in geriatrics. Drug-related problems identified during the visit will be resolved and categorized based upon indication, efficacy, cost, safety, and compliance. The numbers and types of interventions made, both during the primary visit and anticipated in the future, will be tracked. The 12-item short form (SF-12) survey will also be administered at baseline and one month post intervention. The increase or decrease in cost for medications added and removed during these visits will be captured using the average wholesale prices.
Preliminary Results Using descriptive statistics, the types of drug-related problems identified and interventions made will be reported. Changes in quality of life and monthly medication costs will also be described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary polypharmacy clinic | – | Other: interdisciplinary polypharmacy clinic visitPatients will be seen in the interdisciplinary polypharmacy clinic for a complete comprehensive medication review |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients within the general internal medicine patient-centered medical homes of The Ohio State University Division of General Internal Medicine
Key inclusion criteria (2 listed)
- Patients on 10 or more chronic medications
- Age 18 or older
Key exclusion criteria (1 listed)
- Non-English speaking patients
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 |
|---|---|---|
| interdisciplinary polypharmacy clinic visit | Other | Interdisciplinary polypharmacy clinic |
Primary outcome
Number and types of drug related problems identified
Time frame: 1 year
2 secondary outcomes
Assess quality of life at baseline and one month post polypharmacy clinic visit
Time frame: 1 month
Cost of medication additions and discontinuations
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Polypharmacy, run by Ohio State University 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 2 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: withdrawn, as of the sponsor's last update on 30 Sep 2022. 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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Number and types of drug related problems identified (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 30 Sep 2022.