NCT04360746

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

2.2 years

First QC Date

April 16, 2020

Last Update Submit

April 9, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • Summated Medication Appropriateness Index (MAI) score

    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

    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

    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

    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

    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)

    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)

    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)

    Length of rehabilitation center stay

    Through study completion, an average of 1 year

Study Arms (2)

Clinical pharmacist intervention group

ACTIVE COMPARATOR

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 interventionOther: Rehabilitation

control group

OTHER

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

Interventions

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.

Clinical pharmacist intervention group

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.

Clinical pharmacist intervention groupcontrol group

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beit Rivka geriatric rehabilitation center

Petah Tikva, Israel

Location

Related Publications (24)

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    PMID: 21748749BACKGROUND
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    PMID: 30429122BACKGROUND
  • Iaboni A, Rawson K, Burkett C, Lenze EJ, Flint AJ. Potentially Inappropriate Medications and the Time to Full Functional Recovery After Hip Fracture. Drugs Aging. 2017 Sep;34(9):723-728. doi: 10.1007/s40266-017-0482-6.

    PMID: 28776209BACKGROUND
  • Kragh Ekstam A, Elmstahl S. Do fall-risk-increasing drugs have an impact on mortality in older hip fracture patients? A population-based cohort study. Clin Interv Aging. 2016 Apr 29;11:489-96. doi: 10.2147/CIA.S101832. eCollection 2016.

    PMID: 27199553BACKGROUND
  • Lee JK, Alshehri S, Kutbi HI, Martin JR. Optimizing pharmacotherapy in elderly patients: the role of pharmacists. Integr Pharm Res Pract. 2015 Aug 11;4:101-111. doi: 10.2147/IPRP.S70404. eCollection 2015.

    PMID: 29354524BACKGROUND
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    PMID: 18248511BACKGROUND
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    PMID: 23796001BACKGROUND
  • Hanlon JT, Schmader KE, Samsa GP, Weinberger M, Uttech KM, Lewis IK, Cohen HJ, Feussner JR. A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992 Oct;45(10):1045-51. doi: 10.1016/0895-4356(92)90144-c.

    PMID: 1474400BACKGROUND
  • Samsa GP, Hanlon JT, Schmader KE, Weinberger M, Clipp EC, Uttech KM, Lewis IK, Landsman PB, Cohen HJ. A summated score for the medication appropriateness index: development and assessment of clinimetric properties including content validity. J Clin Epidemiol. 1994 Aug;47(8):891-6. doi: 10.1016/0895-4356(94)90192-9.

    PMID: 7730892BACKGROUND
  • Somers A, Mallet L, van der Cammen T, Robays H, Petrovic M. Applicability of an adapted medication appropriateness index for detection of drug-related problems in geriatric inpatients. Am J Geriatr Pharmacother. 2012 Apr;10(2):101-9. doi: 10.1016/j.amjopharm.2012.01.003. Epub 2012 Feb 1.

    PMID: 22304791BACKGROUND
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    PMID: 17630041BACKGROUND
  • Salahudeen MS, Duffull SB, Nishtala PS. Anticholinergic burden quantified by anticholinergic risk scales and adverse outcomes in older people: a systematic review. BMC Geriatr. 2015 Mar 25;15:31. doi: 10.1186/s12877-015-0029-9.

    PMID: 25879993BACKGROUND
  • Ottenbacher KJ, Mann WC, Granger CV, Tomita M, Hurren D, Charvat B. Inter-rater agreement and stability of functional assessment in the community-based elderly. Arch Phys Med Rehabil. 1994 Dec;75(12):1297-301.

    PMID: 7993167BACKGROUND
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    PMID: 8305182BACKGROUND
  • Heruti RJ, Lusky A, Barell V, Ohry A, Adunsky A. Cognitive status at admission: does it affect the rehabilitation outcome of elderly patients with hip fracture? Arch Phys Med Rehabil. 1999 Apr;80(4):432-6. doi: 10.1016/s0003-9993(99)90281-2.

    PMID: 10206606BACKGROUND
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    PMID: 15204479BACKGROUND
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    PMID: 22414793BACKGROUND
  • Bulloch MN, Olin JL. Instruments for evaluating medication use and prescribing in older adults. J Am Pharm Assoc (2003). 2014 Sep-Oct;54(5):530-7. doi: 10.1331/JAPhA.2014.13244.

    PMID: 25216883BACKGROUND
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    PMID: 1202204BACKGROUND
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    PMID: 17493184BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Rehabilitation Department D, 'Beit Rivka' Geriatric Rehabilitation Center

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 24, 2020

Study Start

March 1, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations