Clinical trial NCT03169868: Enhanced Medication Reconciliation For Serious Mental Illness
Official title: A Pilot Prospective, Randomized Controlled Trial Assessing Enhanced Medication Reconciliation With a Clinical Decision Support Tool in Patients With Serious Mental Illness.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mental Disorders
Keywords: clinical decision support
drug levels in blood
therapeutic drug monitoring
medication adherence
medication therapy management
Lead sponsor: Precera Bioscience, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Pittsburgh Medical Center
First posted: 2017-05-30
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Medical record accuracy
timeFrame: 3 months
Secondary outcomes:
measure: Automated vs. manual pharmacist-led medication reconciliation
timeFrame: 0 months
measure: Drug Related Problem Identification and resolution
timeFrame: 3 months
measure: Adherence to prescribed medications
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic of UPMC
state: Pennsylvania
Study officials:
References: