The Influence of Clinical Pharmacist on the Quality of Drug Prescribing and Rehabilitation Outcomes in Post-acute Hip Fractured Patients
Condition: Hip Fractures; Clinical Pharmacists; Rehabilitation Outcome
MeSH terms: Hip Fractures
Study type: Interventional

Summary: 
      The influence of clinical pharmacist on various drug related outcomes was reported in
      different healthcare setting including the community, long term care and during acute
      hospitalization. Nevertheless, data on the influence of clinical pharmacist intervention on
      the quality of drug prescribing and rehabilitation outcomes in post-acute hip fractured
      patients is scarce.

      The aims of the current study are to evaluate the contribution of a clinical pharmacist on
      the appropriateness of drug prescribing among post-acute geriatric hip fractured patients and
      to investigate whether this involvement can improve rehabilitation outcomes.

      The investigators hypothesis is that early review of geriatric hip fractured patients medical
      record by a clinical pharmacist will improve the appropriateness of drug treatment and the
      rehabilitation outcomes among this population.
    

Detailed description: 
      An Open label randomized prospective study of elderly patients (65 years old and above)
      admitted for rehabilitation after hip fracture. All study participants will be admitted in
      the same geriatric-rehabilitation department specialized in the rehabilitation of geriatric
      patients after hip fracture ("D" ward). This department is divided into 2 subunits (D1 and
      D2) with the same patient population but a different medical and nursing staff.

      Randomization in this study will be based upon the admission subunit. The intervention group
      will include all hip fractured patients admitted to D1 subunit. This group will get a
      clinical pharmacist review of their medication and a pharmaceutical counseling to the medical
      staff in the first few days of admission (1-5 days post admission). The control group will
      include all hip fractured patients admitted to D2 subunit. This group will not receive any
      pharmacist intervention during their rehabilitation, unless the pharmacist will be asked
      directly to review a patient medical record by the medical or nursing staff. In this case the
      specific patient will be excluded from the study.

      Pharmaceutical intervention will include a complete medication review by a clinical
      pharmacist with the following process: medication reconciliation, medication indication and
      dosage check, medication effectiveness and appropriateness assessment, drug-drug or
      drug-disease interactions check, medication duplications check, length and cost of treatment
      evaluation.

      The pharmacist will use the following tools:

      Medication appropriateness evaluation Medication appropriateness will be evaluated based upon
      the MAI (medication appropriateness index) score - an implicit (judgment-based) outcome
      measure. The MAI is a measure of prescribing appropriateness that assesses ten elements of
      prescribing: indication, effectiveness, dose, correct directions, practical directions,
      drug-drug interactions, drug-disease interactions, duplication, duration, and cost. Although
      based on implicit criteria, the index has operational definitions and explicit instructions,
      which standardize the rating process. Each medication can get a score between 0-18, with a
      higher score indicating inappropriateness of more drug elements. The ratings generate a
      weighted score that serves as a summary measure of prescribing appropriateness.

      The clinical pharmacist will calculate the MAI score upon admission and discharge for each
      study participant.

      Anticholinergic drug burden Anticholinergic drug burden will be assessed by a common
      anticholinergic drug scale. The medical literature describes several anticholinergic drug
      scales. Most of those scales were built by experts in order to generate an anticholinergic
      burden for a specific patient based upon his current drug treatment. Evaluation of the
      anticholinergic burden may predict the risk for an anticholinergic side effect in that
      patient.

      the ACB (Anticholinergic cognitive burden) score will determine the anticholinergic burden
      for each patient. The ACB score was developed in order to evaluate the cognitive effects of
      anticholinergic medications. The tool gives points for each medication based on an ordinal
      scale. Each medication can get the following score: 0 = no potential for anticholinergic
      effect, 1 = slight anticholinergic effects, based on Evidence from in vitro data that
      chemical entity has antagonist activity at muscarinic receptor, 2 = moderate anticholinergic
      effects, based on evidence from literature, prescriber's information, or expert opinion of
      clinical anticholinergic effect, 3 = strong anticholinergic effects, based on evidence from
      literature, expert opinion, or prescribers information that medication may cause delirium.

      The total ACB score will be calculated upon admission and discharge for each patient.

      Underuse of medications Underuse of medications refers to the omission of a drug when there
      is a clear indication and no contraindications. The evaluation of underuse will be through a
      medication reconciliation process and by using the assessment of underutilization (AOU)
      index.

      In the process of medication reconciliation the pharmacist will compare the current patient
      drug regimen to the recommended medications in the general hospital discharge letter and to
      the drugs prescribed/dispensed in the community. The purpose of this process is to trace any
      medication that was unintentionally omitted from the patient current drug list.

      Drug Underutilizion will be assessed by the AOU tool. This instrument is intended for the
      evaluation of medications that should have been prescribed by a health care provider but were
      omitted. The pharmacist will review the medical file of each patient in search for any
      omission of a needed drug for an established active disease/condition.

      A needed drug is defined as a drug that is indicated or recommended based on current practice
      guidelines or evidence available.

      The study will involve pharmacist review of patient electronic medical records in order to
      collect the following data for each patient: the MAI and ACB at admission and discharge, the
      number of drugs added or stopped during the rehabilitation period, demographic data,
      functional level including pre-rehabilitation functional levels, cognitive function (via the
      mini-mental status exam) and clinical data including the metabolic state (admission albumin
      level), chronic diseases.

      Likewise, other operation related factors will be collected, including: type of fracture,
      operation latency period, rehabilitation latency period and rehabilitation length of stay
      (LOS).

      the rehabilitation outcomes for each patient will be register including the FIM score at
      admission and discharge, motor FIM , MRFS scores and the destination of the patient at the
      end of the rehabilitation period.

      The same data for the control group will be collected retrospectively at the end of the study
      period.
    

Intervention name(s): Pharmaceutical intervention; Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Pharmaceutical intervention will include a complete medication review by a clinical pharmacist with the following process: medication reconciliation, medication indication and dosage check, medication effectiveness and appropriateness assessment, drug-drug or drug-disease interactions check, medication duplications check, length and cost of treatment evaluation. The pharmacist will use the following tools: Medication appropriateness index (MAI), ACB (Anticholinergic cognitive burden) score and the using the assessment of underutilization (AOU) index.; A multidisciplinary team provided medical, nursing, physical, occupational, and social work interventions. Rehabilitation care include: (a) individual physical therapy (PT), 2 to 3 times a week; (b) 30 to 40 min of PT in an adapted fitness room, aerobic training on a treadmill with and without partial weight support and stationary bicycles, 2 to 3 times a week ; (c) 30 to 40 min of virtual reality training by performing challenging functional tasks, 2 times a week and (d) 30 to 45 min of individual occupational therapy (OT), cognitive evaluation and stimulation, safety education, and learning to use assistive devices, 3 times a week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research