Reducing Post-discharge Potentially Inappropriate Medications Among Older Adults
Condition: Polypharmacy; Deprescription; Aged
Study type: Interventional

Summary: 
      Potentially inappropriate medications (PIMs) can lead to adverse drug events (ADEs) among
      older adults and especially those classified as frail. ADEs are responsible for nearly 27,000
      hospital admissions in Canada annually. Within 30 days of discharge, medications contribute
      to two-thirds of adverse events, with nearly 60% being preventable or ameliorable. MedSafer
      is software product that guides patients and physicians in the community through the process
      of deprescribing. MedSafer electronically cross-references patient comorbidities with the
      most recent evidence-based PIMs, as of the study date, in order to generate a
      patient-tailored deprescribing care plan. This study will evaluate whether this application,
      when applied at hospitalization, leads to a reduction in the proprotion of patients with PIMs
      prescribed at discharge, by highlighting harmful medications for deprescription to treating
      physicians. This study will take place on the clinical teaching units (CTUs) at four
      hospitals. Based on historical records, the investigators estimate enrolling 480 patients
      aged 65 or older over three months. A trained research assistant will identify eligible
      patients, and will enter their medications, comorbidities, and an estimate of frailty into
      MedSafer. A deprescribing plan will be generated for the CTU team containing rationale for
      suggested medication changes and strategies for safe and successful deprescription. The CTU
      team will then decide in conjunction with the patient or proxy, and with relevant
      consultants, which medications can rationally be stopped or tapered at discharge.
    

Detailed description: 
      Deprescribing during hospitalization can be achieved through the concerted effort of expert
      clinicians. A single-centre randomized controlled trial (400 patients) demonstrated that by
      having a dedicated geriatrician apply the STOPP/START criteria [screening tool of older
      people's prescriptions (STOPP) and screening tool to alert to right treatment (START)] to
      screen for PIM use on admission could improve prescribing appropriateness by providing
      recommendations for medication management; these changes were shown to persist for at least
      six months post discharge. Recommendations were made in 58% of intervention patients, and
      these were accepted in greater than 90% of cases. At discharge the proportion of patients
      taking "unnecessary" therapy was 20% in the control group and 5.2% in the intervention arm.
      This study was underpowered to show meaningful differences in ADEs and was entirely dependent
      on a dedicated expert physician whose full time job was to provide this service; despite
      this, medications were discontinued in nearly 1 in 5 patients with a sustained post-discharge
      effect.

      This catalyst program will build on the Canadian Frailty Network-funded Catalyst Research
      Program Grant (MEdication RAtionalization or MERA) by Co-Investigator James Downar. MERA
      identifies medication for deprescribing by combining STOPP/START, the Beers criteria, and
      Choosing Wisely Canada recommendations. A multidisciplinary case team then guides elderly
      patients and their caregivers through deprescription during their hospitalization. Both the
      Gallagher and MERA approaches are intensive in terms of human resources and are challenging
      to generalize, implement and sustain nationwide. Furthermore, the current lack of firm
      evidence on the risks and benefits of systemic deprescribing has limited the implementation
      of these concepts into routine medical practice. A technological solution that facilitates
      deprescribing and with proven effectiveness and safety would be a tremendous step forward for
      the deprescribing movement.

      Research Objectives: The investigators will adapt and implement an electronic tool called
      MedSafer to identify PIMs within 72 hours of hospitalization and prioritize medications for
      deprescription. The tool will use three key criteria for deprescription: the potential for a
      drug to improve symptoms, the potential to reduce the risk of future illness, and the
      likelihood of causing harm. The recommendations from MedSafer will cue the treating team to
      consider deprescribing PIMs after taking into consideration their knowledge of the individual
      patient comorbidities, along with an understanding of patient values and goals of care.

      The primary goal of this pilot study is to demonstrate that MedSafer can facilitate
      deprescription (beyond usual care) in a diverse population of elderly patients. This pilot
      will serve as the proof of concept for a larger multicenter RCT looking at the impact of this
      process on adverse drug events. This pilot will facilitate: 1) estimates of the frequency of
      PIMs; 2) adverse drug event rates; 3) rates of recruitment, refusal and loss to follow up; 4)
      refinement of MedSafer based on real world user feedback; and 6) refinement of the adverse
      drug event endpoint adjudication and health-related quality of life interview process. The
      study will be conducted at the Ottawa Hospital, the Toronto General Hospital and two
      hospitals at the McGill University Health Centre, in Montreal (Royal Victoria and Montreal
      General Hospitals).

      Primary objective: The primary outcome is the proportion of patients for whom 1 or more PIMs
      are stopped at discharge. We hypothesize that MedSafer will facilitate deprescription of PIMs
      compared to usual practice.

      Secondary objectives: To determine if this intervention leads to demonstrable improvements
      in: a) Proportion of PIMs at 30-days post hospital discharge; b) adverse drug events within
      30 days of hospital discharge; c) falls in hospital; d) length of stay; e) in-hospital
      mortality; f) the overall number of any medications the average patient receives at discharge
      and 30 days post; g) post-discharge self-reported health-related quality of life (HRQOL); h)
      emergency department visits and readmissions within 30 days; i) 30-day all cause mortality.

      This intervention is a novel electronic tool that combines the newly refined version of the
      STOPP/START criteria, the 2015 Beers criteria, and applicable recommendations from Choosing
      Wisely Canada to guide and facilitate deprescribing. To the investigator's knowledge, this is
      the first electronic intervention to be implemented among heterogeneous at-risk, frail
      elderly, hospitalized patients. This trial will test a tool that could lead to a
      transformative change in medication appropriateness.

      2.2 Methodological Approach Study design: The study design is a before-after intervention
      study. All hospitals will participate in six weeks of baseline measurement followed by six
      weeks of intervention. The primary outcome is the proportion of patients who have 1 or more
      PIM discontinued at discharge.

      Study Setting: This study will take place on the clinical teaching units where patients are
      cared for by teams composed of medical students, junior and senior residents in internal
      medicine and other specialties, and attending physicians. The CTUs where this study will take
      place admits complex elderly patients with multiple comorbidities where the majority are
      non-surgical frail elderly and are most likely to benefit from a medication stewardship
      intervention. Most medical trainees will spend weeks to months on these units each year,
      yielding high exposure to the intervention. The investigators have shown that medication
      stewardship projects can be successful on the CTU and that changes taking place on the CTU
      can continue after discharge.

      Planned trial interventions: Within 72 hours of admission (excluding weekends and holidays)
      to both control and intervention units, each patient's documented medical history and
      medication list will be manually extracted by a trained research assistant.

      Intervention: Participants in the intervention phase will be electronically screened using
      MedSafer which will cross-reference this information to automatically identify and prioritize
      "deprescribing opportunities" for further expert evaluation by the CTU team.

      In this intervention, PIMs that are electronically identified will be communicated to the
      treating medical team through MedSafer generated evidence-based recommendations including how
      to safely deprescribe or taper medications as necessary. In the case of multiple
      recommendations, they will be limited and prioritized in order to avoid overwhelming the
      treating team. The doctors caring for the hospitalized patient will receive the information.
      At that point, based on expert medical judgement, in collaboration with the patient/caregiver
      and other relevant physicians (i.e. consultants and the community physician), a decision will
      be made to deprescribe if appropriate.

      Control: all participants will receive medication reconciliation by the unit pharmacist, a
      review of medical history and medication use, and identical follow up, but no prioritized
      list will be generated for the treating team to systematically trigger deprescribing.

      The results of this catalyst study will ideally establish the safety and efficacy of MedSafer
      to electronically facilitate the inpatient application of criteria based on STOPP/START,
      Beers and Choosing Wisely recommendations to identity and prioritize PIMs for deprescribing.
      Based on a positive outcome of this study, the investigators would plan to implement the tool
      in a larger study at multiple hospitals across Canada to determine its effectiveness at
      reducing ADEs among a similar frail and elderly population.
    

Intervention name(s): MedSafer
Intervention type(s): Other
Intervention description(s): MedSafer is an electronic tool for the treating team (physician and pharmacists) to facilitate medication deprescription. MedSafer can identify potentially inappropriate medication use and communicate the risk of adverse drug events to the treating team.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Frailty; Deprescription