Heart Failure，CongestiveNCT03519477
Comprehensive Medication Monitoring on Heart Failure Patient Outcomes
A study testing Sano Patient Medication Profile in people with Heart Failure，Congestive, run by Precera Bioscience, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical utility of comprehensive medication monitoring using the Patient Medication Profile to improve heart failure patient medication therapy and associated outcomes relative to usual care in a hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure，Congestive
- What is being tested?
- Sano Patient Medication Profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2018to 21 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a regularly scheduled visit to a University of Pittsburgh Medical Center (UPMC) cardiology clinic in Oakland
- Patients must have Heart Failure with Reduced Ejection Fraction (≤40%)
- Patients have admitted to UPMC hospital facility between one and five times in past 12 months
- Patients must be able to provide informed consent for present study
- Patient age > 18 years
Who cannot join
- Enrolled in Hospice
- Patient on home inotrope (Dobutamine or milrinone)
- World Health Organization (WHO) Group 1 or Group 5 pulmonary hypertension
- Patient with current ventricular assist device (VAD)
- Not able to communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Pilot Prospective, Randomized Controlled Trial Assessing the Impact of Clinical Decision Support Using Comprehensive Medication Monitoring on Heart Failure Patient Outcomes
The purpose of this study is to evaluate the clinical utility of comprehensive medication monitoring using the Patient Medication Profile to improve heart failure patient medication therapy and associated outcomes relative to usual care in a hospital setting.
Read the detailed description
Congestive heart failure has an exceptionally high rate of hospital admission and is responsible for more re-admissions (23.5% at 30 days) in the United States than the 2nd and 3rd leading causes combined. Inadequate medication reconciliation both on admission and discharge from the hospital is a significant cause of medical error. In one study of cardiovascular patients, 44% believed they were taking a medication they were not, and 96% were unable to recall at least one medication they were taking. In the same study patients omitted on average 6.8 medications from their medication list. Medication optimization through improved adherence and reconciled medical records has been postulated to significantly improve admission and 30-day hospital readmission rates.
Sano has developed a blood-based comprehensive medication monitoring tool that identifies and quantitates 235 prescription drugs and drug metabolites. It does not detect illicit drugs. This tool, which produces an output report designated the 'Patient Medication Profile', is designed to be used with clinical decision support to improve medication adherence, reduce medication errors, and optimize medication therapy. For heart failure patients, the investigators hypothesize that deploying the Patient Medication Profile with clinical decision support at key points of treatment intervention will A) improve medication adherence, B) identify and reconcile significant discrepancies in the medication list, C) result in reduced hospital admissions, and D) result in better overall patient outcomes. These outcome expectations are relative to usual care for heart failure patients.
- Conditions
- Heart Failure，Congestive
- Being tested
- Sano Patient Medication Profile
- Keywords
- clinical decision support, drug levels in blood, therapeutic drug monitoring, medication adherence, medication therapy management
- Medical subject headings
- Heart Failure, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sano Patient Medication ProfileDiagnostic test
The Sano Patient Medication Profile (PMP) is a graphical report comparing prescribed medications to liquid (chromatography/tandem mass-spectrometry) LC/MS/MS-detected drugs from patient blood samples
| Study group | Role | What they receive |
|---|---|---|
| Heart failure care with Sano test | Experimental | Scheduled outpatient care for patients at high risk of admission for heart failure, supplemented with the Sano Patient Medication Profile Receives: Diagnostic Test: Sano Patient Medication Profile |
| Heart failure care as-usual | No intervention | Scheduled outpatient care for patients at high risk of admission for heart failure, care as-usual (i.e. without the Sano Patient Medication Profile). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence to prescribed cardiology medications
For each patient, the proportion of prescribed medications that are detected using the baseline and final PMP will be calculated; change in adherence will be defined as proportion using final PMP, minus proportion using baseline PMP. Compare adherence difference in intervention vs. control groups.
Measured: 30 days
Secondary outcomes (3)
Number of hospital admissions per patient within 90 days of enrollment in intervention vs. control group
Measured: 90 days
Baseline adherence to prescribed cardiology medications as a predictor of hospital admission for heart failure within 90 days
Baseline adherence to prescribed cardiology medications as a predictor of hospital admission for heart failure within 90 days. This endpoint will use baseline adherence and the Patient Medication Profile will not have been discussed with the care team in the intervention group, therefore both intervention and control groups will be pooled
Measured: 90 days
Drug Related Problem identification and resolution
Documented drug related problems identified by medication reconciliation will be compared between the intervention and control groups. The number of changes in medications to resolve drug related problems, such as medication additions, terminations, dosage or frequency changes will be compared between the intervention and control groups.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study startSep 2018 (estimated)
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Why it stopped: Study terminated by sponsor for commercial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure，CongestiveStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precera Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519477
- Sponsor's protocol ID
- SAN_UPMC_CV_001
- Status last verified
- Aug 2018
- First submitted
- 26 Apr 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cumbler E, Wald H, Kutner J. Lack of patient knowledge regarding hospital medications. J Hosp Med. 2010 Feb;5(2):83-6. doi: 10.1002/jhm.566.
PubMed 20013875Gupta P, Patel P, Strauch B, Lai FY, Akbarov A, Maresova V, White CMJ, Petrak O, Gulsin GS, Patel V, Rosa J, Cole R, Zelinka T, Holaj R, Kinnell A, Smith PR, Thompson JR, Squire I, Widimsky J Jr, Samani NJ, Williams B, Tomaszewski M. Risk Factors for Nonadherence to Antihypertensive Treatment. Hypertension. 2017 Jun;69(6):1113-1120. doi: 10.1161/HYPERTENSIONAHA.116.08729. Epub 2017 May 1.
PubMed 28461599
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Prospective, Randomized Controlled Trial Assessing the Impact of Clinical Decision Support Using Comprehensive Medication Monitoring on Heart Failure Patient Outcomes
- ClinicalTrials.gov ID
- NCT03519477
- Acronym / sponsor ID
- SAN_UPMC_CV_001
- Conditions
- Heart Failure，Congestive
- Keywords
- clinical decision support, drug levels in blood, therapeutic drug monitoring, medication adherence, medication therapy management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated by sponsor for commercial reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Precera Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Study start
- Sep 2018 (estimated)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 9 May 2018 (actual)
- 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 this study is to evaluate the clinical utility of comprehensive medication monitoring using the Patient Medication Profile to improve heart failure patient medication therapy and associated outcomes relative to usual care in a hospital setting.
Detailed description
Congestive heart failure has an exceptionally high rate of hospital admission and is responsible for more re-admissions (23.5% at 30 days) in the United States than the 2nd and 3rd leading causes combined. Inadequate medication reconciliation both on admission and discharge from the hospital is a significant cause of medical error. In one study of cardiovascular patients, 44% believed they were taking a medication they were not, and 96% were unable to recall at least one medication they were taking. In the same study patients omitted on average 6.8 medications from their medication list. Medication optimization through improved adherence and reconciled medical records has been postulated to significantly improve admission and 30-day hospital readmission rates.
Sano has developed a blood-based comprehensive medication monitoring tool that identifies and quantitates 235 prescription drugs and drug metabolites. It does not detect illicit drugs. This tool, which produces an output report designated the 'Patient Medication Profile', is designed to be used with clinical decision support to improve medication adherence, reduce medication errors, and optimize medication therapy. For heart failure patients, the investigators hypothesize that deploying the Patient Medication Profile with clinical decision support at key points of treatment intervention will A) improve medication adherence, B) identify and reconcile significant discrepancies in the medication list, C) result in reduced hospital admissions, and D) result in better overall patient outcomes. These outcome expectations are relative to usual care for heart failure patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure care with Sano test | Experimental | Diagnostic Test: Sano Patient Medication ProfileScheduled outpatient care for patients at high risk of admission for heart failure, supplemented with the Sano Patient Medication Profile |
| Heart failure care as-usual | No intervention | –Scheduled outpatient care for patients at high risk of admission for heart failure, care as-usual (i.e. without the Sano Patient Medication Profile). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have a regularly scheduled visit to a University of Pittsburgh Medical Center (UPMC) cardiology clinic in Oakland
- Patients must have Heart Failure with Reduced Ejection Fraction (≤40%)
- Patients have admitted to UPMC hospital facility between one and five times in past 12 months
- Patients must be able to provide informed consent for present study
- Patient age > 18 years
Key exclusion criteria (5 listed)
- Enrolled in Hospice
- Patient on home inotrope (Dobutamine or milrinone)
- World Health Organization (WHO) Group 1 or Group 5 pulmonary hypertension
- Patient with current ventricular assist device (VAD)
- Not able to communicate in English
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 |
|---|---|---|
| Sano Patient Medication ProfileThe Sano Patient Medication Profile (PMP) is a graphical report comparing prescribed medications to liquid (chromatography/tandem mass-spectrometry) LC/MS/MS-detected drugs from patient blood samples | Diagnostic test | Heart failure care with Sano test |
Primary outcome
Change in adherence to prescribed cardiology medications
Time frame: 30 days
For each patient, the proportion of prescribed medications that are detected using the baseline and final PMP will be calculated; change in adherence will be defined as proportion using final PMP, minus proportion using baseline PMP. Compare adherence difference in intervention vs. control groups.
3 secondary outcomes
Number of hospital admissions per patient within 90 days of enrollment in intervention vs. control group
Time frame: 90 days
Baseline adherence to prescribed cardiology medications as a predictor of hospital admission for heart failure within 90 days
Time frame: 90 days
Drug Related Problem identification and resolution
Time frame: 30 days
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 25 Jan 2019.
- Background: PubMed 20013875Cumbler E, Wald H, Kutner J. Lack of patient knowledge regarding hospital medications. J Hosp Med. 2010 Feb;5(2):83-6. doi: 10.1002/jhm.566.
- Background: PubMed 28461599Gupta P, Patel P, Strauch B, Lai FY, Akbarov A, Maresova V, White CMJ, Petrak O, Gulsin GS, Patel V, Rosa J, Cole R, Zelinka T, Holaj R, Kinnell A, Smith PR, Thompson JR, Squire I, Widimsky J Jr, Samani NJ, Williams B, Tomaszewski M. Risk Factors for Nonadherence to Antihypertensive Treatment. Hypertension. 2017 Jun;69(6):1113-1120. doi: 10.1161/HYPERTENSIONAHA.116.08729. Epub 2017 May 1.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Sano Patient Medication Profile in people with Heart Failure，Congestive, run by Precera Bioscience, Inc. 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 5 inclusion and 5 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 25 Jan 2019. 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?
Change in adherence to prescribed cardiology medications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03519477, which also lists 2 linked publications.
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 25 Jan 2019.