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Mental DisordersNCT03169868

Enhanced Medication Reconciliation For Serious Mental Illness

A study testing Sano Patient Medication Profile in people with Mental Disorders, run by Precera Bioscience, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the clinical utility of a decision support tool, the Patient Medication Profile(TM), developed by Sano Informed Prescribing on medication reconciliation and identification of drug-related problems in patients with serious mental illness. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Mental Disorders
What is being tested?
Sano Patient Medication Profile
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
27 Feb 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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current insurer is UPMC Health Plan
  • Currently active in CRS clinic
  • Prescribed four or more medications as indicated by pre-study Health Plan Medication List
  • Able to provide informed consent for present study

Who cannot join

  • Not competent to give informed consent in the opinion of the investigator
  • Having had a previous medication reconciliation by the clinical pharmacist

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Western Psychiatric Institute and Clinic of UPMC

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Pilot Prospective, Randomized Controlled Trial Assessing Enhanced Medication Reconciliation With a Clinical Decision Support Tool in Patients With Serious Mental Illness.

The purpose of this study is to evaluate the clinical utility of a decision support tool, the Patient Medication Profile(TM), developed by Sano Informed Prescribing on medication reconciliation and identification of drug-related problems in patients with serious mental illness.

Read the detailed description

Lack of adherence to medications is an identifiable and growing problem in the United States and can result in disease progression, disease complications, treatment failure, a lower quality of life, and increased morbidity and mortality. Medication-related problems and medication nonadherence have been estimated to cost $177 billion annually in total direct and indirect U.S. health care costs. Moreover, medication adherence rates are poor for individuals diagnosed with chronic conditions such as diabetes, depression, and schizophrenia, which require long-term therapy. Recent publications have estimated that nearly 50% of patients in the U.S. being treated for chronic conditions are non-adherent to their medication regimens. Although increased medication adherence may lead to increased spending on drug therapy, it is associated with greatly reduced total health care costs and usage, and better patient outcomes.

Persons diagnosed with serious mental illness (SMI) such as schizophrenia and bipolar disorder are at higher risk than the general population for medication nonadherence, cardiovascular mortality, and medical co-morbidities such as diabetes, hypertension, dyslipidemia, obesity, nicotine dependence, and coronary heart disease. Poor adherence to complex medication regimens, decreased access to care, and uncoordinated care between psychiatry and medical care teams, have been identified as key contributors to the disparities experienced by this patient population.

The United States healthcare system is complex and healthcare is fragmented, particularly for those with serious mental illness who are often prescribed multiple medications from numerous providers. One unifying piece of information that is of critical importance for optimizing patient care is the patient medication list. Unfortunately, appropriate medication reconciliation to obtain the correct medication list and information about medication adherence is a complex and imperfect process. Using patient pharmacy records, electronic health record (EHR), and patient interviews, discrepancies have been found with over one third of patients upon hospital admission. Therefore, it can be expected that most polypharmacy patients (defined as taking five or more medications) have errors in their medical record.

National and world health associations have identified several opportunities for health professionals to provide services that aim to increase medication adherence and decrease medication related problems. Several of the recommendations emphasize the use of coordinated multidisciplinary efforts to provide patients with the most access to care and the highest quality education about their medications. Pharmacists are among the most accessible health care professionals and have specialized training to identify, prevent, and resolve drug-related problems (DRPs). As medication experts, pharmacists are important members of the multidisciplinary team and are uniquely positioned to impact medication-related health outcomes through accurate medication reconciliation, comprehensive mediation reviews (CMR), and interventions to improve medication safety and adherence.

An objective measure of what medications patients are actually taking would enable healthcare teams to better identify and tailor interventions to each specific patient situation. Using a novel therapeutic drug monitoring assay and empirical clinical decision support tool, Sano has shown that errors in patient medication lists are prevalent and poorly reflect patient adherence to the intended medication regimen and actual medication exposure. For example, in a cohort of psychiatry patients, only 37% were fully adherent to all medications in their treatment regimen and roughly one in five medications detected was not in the medical record. We anticipate that when medication reconciliation is performed by a pharmacist using Sano's clinical decision support tool, medication adherence will improve and more drug therapy problems will be identified and resolved. As a result, we expect to see an improvement in patient outcomes and a reduction in healthcare spending (i.e. post-hospitalization unplanned healthcare utilization).

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
Mental Disorders, 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 LC/MS/MS-detected drugs from patient blood samples

Study groups in NCT03169868
Study groupRoleWhat they receive
Enhanced Medication reconciliationExperimentalMedication reconciliation with pharmacist using electronic health records, pharmacy dispensing data and Sano Patient Medication Profile(TM)
Receives: Diagnostic Test: Sano Patient Medication Profile
Standard Medication reconciliationNo interventionMedication reconciliation with pharmacist using electronic health records and pharmacy dispensing data only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medical record accuracy

    The "Final Medication List" (medications in EHR at final visit) will be compared to the detected medications as summarized in the Patient Medication Profile at final visit (approx 3 months). For each patient, the proportion of detected medications that are not in the medication list will be calculated, excluding OTC medications from the analysis. Medical record accuracy in the intervention and control groups will be compared.

    Measured: 3 months

Secondary outcomes (3)
  1. Automated vs. manual pharmacist-led medication reconciliation

    Compare automated Sano Patient Medication Profile medication list to the manual pharmacist-led reconciliation which includes review of medication lists from available EHRs, pharmacy dispensing data and patient interview. For each patient in the control group, calculate the number of drug additions and/or subtractions to arrive at the "Informed Medication List" (review of EHR and pharmacy dispensing during patient interview with/without the Sano test) from the "Reconciled Medication List" (EHR, pharmacy dispensing) vs. the number of additions / subtractions to arrive at the Informed Medication List from the Patient Medication Profile.

    Measured: 0 months

  2. Drug Related Problem Identification and resolution

    Documented drug related problems identified by the pharmacist will be compared between the intervention and control groups at baseline and final visit. 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: 3 months

  3. Adherence to prescribed medications

    For each patient, the proportion of medications that are in the "Optimized Medication List" (medications that patient should be taking after pharmacist medication reconciliation and interview) and detected as summarized in the Patient Medication Profile will be calculated. Medications with half-life < three hours will be excluded, as will be medications prescribed "as needed" (PRN).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start27 Feb 2018
  3. Primary completion21 Jan 2019
  4. Study completion21 Jan 2019

Why it stopped: Enrollment rate insufficient to fully enroll study within the planned timeline.

Resources

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03169868
Sponsor's protocol ID
SAN_UPMC_Psych_001
Status last verified
Jan 2019
First submitted
25 May 2017
Last updated
25 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Sano Patient Medication Profile in people with Mental Disorders, 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 4 inclusion and 2 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: stopped early, 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 stopped early (reason given: Enrollment rate insufficient to fully enroll study within the planned timeline.). Results are not available in the source record.

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?

Medical record accuracy (time frame: 3 months). 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 25 Jan 2019.

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