PolypharmacyCOMETNCT02501967
Care Planning for Older Persons With Multiple Conditions: Encouraging a Tailored Approach (COMET): Stage II
A study testing COMET in people with Polypharmacy, run by Yale University at 1 site in United States.
Trial summary
The purpose of the proposed project is to pilot-test in the clinic setting a computer-based clinical decision support system (CDSS) designed to optimize medication prescribing for older persons with multiple chronic conditions and polypharmacy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy
- What is being tested?
- COMET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2016
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Veterans age 65 years and older.
- Patients should be diagnosed with diabetes and hypertension and be prescribed five or more medications.
- Patients receiving primary care at the West Haven campus of VA Connecticut Healthcare System.
Who cannot join
- Unable to manage own medications because of cognitive impairment.
- Medications prescribed by physician outside of the VA.
- Severe vision or hearing impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare
West Haven, Connecticut, 06516
About this study
The purpose of the proposed project is to pilot-test in the clinic setting a computer-based clinical decision support system (CDSS) designed to optimize medication prescribing for older persons with multiple chronic conditions and polypharmacy.
- Conditions
- Polypharmacy
- Being tested
- COMET
- Keywords
- multiple chronic conditions
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMETOther
The intervention consists of completion of the tool by means of a telephone interview prior to the primary care visit and provision of the tool's output to the patient and PCP.
| Study group | Role | What they receive |
|---|---|---|
| COMET | Experimental | The intervention consists of completion of the tool (COMET) by means of a 30 minute telephone interview prior to the primary care visit and provision of the tool's output to the patient and primary care physician. The COMET tool takes information about the patient's medications and chronic conditions from the electronic health record, and then supplements this with information obtained by a telephone interview assessing the patient's cognition, social supports, medication adherence, home medication regimen, medication side effects, and health status. In addition, there is a chart review screen to record renal function, blood pressure, and hemoglobin A1C. All of this information is run through a set of algorithms to identify medication reconciliation errors and potentially inappropriate medications. Receives: Other: COMET |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Assessment of Care for Chronic Conditions (PACIC)
A modified version of the Patient Assessment of Care for Chronic Conditions (PACIC) will be used. The original tool is a 20 item instrument (100 points total) designed to assess a patients perception of one's health care (for chronic conditions). A higher score indicates a more favorable rating.
Measured: Immediately following the primary care visit at which the patient is enrolled in the study
Secondary outcomes (2)
Number of changes made to the medication regimen
A chart review will be completed of the 3 months following the clinic appointment at which the patient is enrolled in the study to document any changes that were made to the medication regimen.
Measured: 3 Month Follow Up
Coding of audiotapes of primary care visit
The Active Patient Participation Coding Scheme (APPC) is a validated instrument to assess indicators and facilitators of patient participation. Audio recordings will also be coded for evidence of providers' partnership building in the form of verbal encouragement to ask questions, express opinions, talk about their feelings, and participate in decision making.
Measured: The primary care visit at which the patient is enrolled in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionMay 2016
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 Yale 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Responsible party
- Sponsor
- Investigators
- Terri R Fried, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501967
- Sponsor's protocol ID
- 1410014812
- Acronym
- COMET
- Status last verified
- Aug 2016
- First submitted
- 8 Jul 2015
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Planning for Older Persons With Multiple Conditions: Encouraging a Tailored Approach (COMET): Stage II
- ClinicalTrials.gov ID
- NCT02501967
- Acronym / sponsor ID
- COMET / 1410014812
- Conditions
- Polypharmacy
- Keywords
- multiple chronic conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jul 2015 (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 proposed project is to pilot-test in the clinic setting a computer-based clinical decision support system (CDSS) designed to optimize medication prescribing for older persons with multiple chronic conditions and polypharmacy.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMET | Experimental | Other: COMETThe intervention consists of completion of the tool (COMET) by means of a 30 minute telephone interview prior to the primary care visit and provision of the tool's output to the patient and primary care physician. The COMET tool takes information about the patient's medications and chronic conditions from the electronic health record, and then supplements this with information obtained by a telephone interview assessing the patient's cognition, social supports, medication adherence, home medication regimen, medication side effects, and health status. In addition, there is a chart review screen to record renal function, blood pressure, and hemoglobin A1C. All of this information is run through a set of algorithms to identify medication reconciliation errors and potentially inappropriate medications. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Veterans age 65 years and older.
- Patients should be diagnosed with diabetes and hypertension and be prescribed five or more medications.
- Patients receiving primary care at the West Haven campus of VA Connecticut Healthcare System.
Key exclusion criteria (3 listed)
- Unable to manage own medications because of cognitive impairment.
- Medications prescribed by physician outside of the VA.
- Severe vision or hearing impairment.
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 |
|---|---|---|
| COMETThe intervention consists of completion of the tool by means of a telephone interview prior to the primary care visit and provision of the tool's output to the patient and PCP. | Other | COMET |
Primary outcome
Patient Assessment of Care for Chronic Conditions (PACIC)
Time frame: Immediately following the primary care visit at which the patient is enrolled in the study
A modified version of the Patient Assessment of Care for Chronic Conditions (PACIC) will be used. The original tool is a 20 item instrument (100 points total) designed to assess a patients perception of one's health care (for chronic conditions). A higher score indicates a more favorable rating.
2 secondary outcomes
Number of changes made to the medication regimen
Time frame: 3 Month Follow Up
Coding of audiotapes of primary care visit
Time frame: The primary care visit at which the patient is enrolled in the study
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 24 Aug 2016.
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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.
Terri R Fried, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMET in people with Polypharmacy, run by Yale 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 3 inclusion and 3 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 24 Aug 2016. 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.
What does the primary outcome measure?
Patient Assessment of Care for Chronic Conditions (PACIC) (time frame: Immediately following the primary care visit at which the patient is enrolled in the study). 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 24 Aug 2016.