The Influence of Clinical Pharmacist on the Quality of Drug Prescribing and Rehabilitation Outcomes in Post-acute Hip Fractured Patients

April 9, 2023 updated by: AVITAL HERSHKOVITZ, Rabin Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petah Tikva, Israel
        • Beit Rivka geriatric rehabilitation center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 120 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elderly patient (65 years of older) who were admitted for rehabilitation after hip fracture at "D" ward in beit rivka post-acute geriatric center.

Exclusion Criteria:

  • Patient that did not complete the rehabilitation period due the following causes: death, acute care hospitalization or severe medical deterioration.
  • In the case of D2 sub unit hospitalized patient - any request by the sub unit medical or nursing staff for pharmacist consultation/intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clinical pharmacist intervention group
all hip fractured patients admitted to D1 subunit in "Beit rivka" geriatric rehabilitation center. 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)
Other: Pharmaceutical intervention
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.
Other: Rehabilitation
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.
Other: control group
The control group will include all hip fractured patients admitted to D2 subunit in "Beit rivka" geriatric rehabilitation center. This group will not receive any pharmacist intervention during their rehabilitation.
Other: Rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summated Medication Appropriateness Index (MAI) score
Time Frame: Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change from admission to discharge in the summated medication appropriateness index score. Each medication can get a score between 0-18, with a higher score indicating inappropriateness of more drug elements.
Admission (baseline value) and at discharge (approximately 5 weeks post admission)
Anticholinergic Cognitive Burden (ACB) score
Time Frame: Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change from admission to discharge in the anticholinergic cognitive burden score. Each medication can get a score between 0-3, with a higher score indicating a higher anticholinergic burden.
Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change in medication discrepancy
Time Frame: Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The number of medication discrepancy and underuse of drugs
Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change in overused drugs
Time Frame: Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The number of overused or misused drugs
Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change in Functional Independence measure (FIM) score
Time Frame: Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change from admission to discharge in the Functional Independence measure score. the score is calculated for each patient and can be between 18-126, with a higher score indicating a better functional independence status.
Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change in motor functional independence measure (mFIM)
Time Frame: Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change from admission to discharge in motor functional independence measure score. the score is calculated for each patient and can be between 18-91, with a higher score indicating a better motor functional independence status.
Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change in Montebello Rehabilitation Factor Score (MRFS)
Time Frame: Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The relative functional gain (motor functional independence measure effectiveness) achieved on the motor functional independence measure score. The Montebello Rehabilitation Factor Score (MRFS) is calculated as the motor functional independence measure score change (discharge score minus admission score) divided by the motor functional independence measure maximum score (a score of 91) minus the motor functional independence measure admission score. The Montebello Rehabilitation Factor Score can be between -80 to 100 with a higher score indicating a better motor functional independence measure effectiveness (a higher relative functional gain during rehabilitation).
Admission (baseline value) and at discharge (approximately 5 weeks post admission)
LOS (Length Of Stay)
Time Frame: Through study completion, an average of 1 year
Length of rehabilitation center stay
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0832-19-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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