Hip FracturesNCT04360746
The Influence of Clinical Pharmacist on the Quality of Drug Prescribing and Rehabilitation Outcomes in Post-acute Hip Fractured Patients
A study testing Pharmaceutical intervention and Rehabilitation in people with Hip Fractures and Clinical Pharmacists, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Hip Fractures, Clinical Pharmacists, Rehabilitation Outcome
- What is being tested?
- Pharmaceutical intervention and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patient (65 years of older) who were admitted for rehabilitation after hip fracture at "D" ward in beit rivka post-acute geriatric center.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hip Fractures, Clinical Pharmacists, Rehabilitation Outcome
- Being tested
- Pharmaceutical intervention, Rehabilitation
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical interventionOther
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.
RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Pharmaceutical intervention; Other: 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. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Admission (baseline value) and at discharge (approximately 5 weeks post admission)
The change in overused drugs
The number of overused or misused drugs
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Admission (baseline value) and at discharge (approximately 5 weeks post admission)
LOS (Length Of Stay)
Length of rehabilitation center stay
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Mar 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AVITAL HERSHKOVITZ, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360746
- Sponsor's protocol ID
- 0832-19-RMC
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2020
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boparai MK, Korc-Grodzicki B. Prescribing for older adults. Mt Sinai J Med. 2011 Jul-Aug;78(4):613-26. doi: 10.1002/msj.20278.
PubMed 21748749Spinewine A, Fialova D, Byrne S. The role of the pharmacist in optimizing pharmacotherapy in older people. Drugs Aging. 2012 Jun 1;29(6):495-510. doi: 10.2165/11631720-000000000-00000.
PubMed 22642783Walsh KA, O'Riordan D, Kearney PM, Timmons S, Byrne S. Improving the appropriateness of prescribing in older patients: a systematic review and meta-analysis of pharmacists' interventions in secondary care. Age Ageing. 2016 Mar;45(2):201-9. doi: 10.1093/ageing/afv190. Epub 2016 Jan 10.
PubMed 26755524Geller AI, Nopkhun W, Dows-Martinez MN, Strasser DC. Polypharmacy and the role of physical medicine and rehabilitation. PM R. 2012 Mar;4(3):198-219. doi: 10.1016/j.pmrj.2012.02.012.
PubMed 22443958Perez T, Moriarty F, Wallace E, McDowell R, Redmond P, Fahey T. Prevalence of potentially inappropriate prescribing in older people in primary care and its association with hospital admission: longitudinal study. BMJ. 2018 Nov 14;363:k4524. doi: 10.1136/bmj.k4524.
PubMed 30429122Iaboni 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.
PubMed 28776209Kragh 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.
PubMed 27199553Lee 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.
PubMed 29354524Gillespie U, Alassaad A, Hammarlund-Udenaes M, Morlin C, Henrohn D, Bertilsson M, Melhus H. Effects of pharmacists' interventions on appropriateness of prescribing and evaluation of the instruments' (MAI, STOPP and STARTs') ability to predict hospitalization--analyses from a randomized controlled trial. PLoS One. 2013 May 17;8(5):e62401. doi: 10.1371/journal.pone.0062401. Print 2013.
PubMed 23690938Viktil KK, Blix HS. The impact of clinical pharmacists on drug-related problems and clinical outcomes. Basic Clin Pharmacol Toxicol. 2008 Mar;102(3):275-80. doi: 10.1111/j.1742-7843.2007.00206.x. Epub 2008 Jan 30.
PubMed 18248511Lee JK, Slack MK, Martin J, Ehrman C, Chisholm-Burns M. Geriatric patient care by U.S. pharmacists in healthcare teams: systematic review and meta-analyses. J Am Geriatr Soc. 2013 Jul;61(7):1119-27. doi: 10.1111/jgs.12323. Epub 2013 Jun 24.
PubMed 23796001Hanlon 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.
PubMed 1474400Samsa 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.
PubMed 7730892Somers 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.
PubMed 22304791Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, Hanlon JT. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007 Jul 14;370(9582):173-184. doi: 10.1016/S0140-6736(07)61091-5.
PubMed 17630041
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Clinical Pharmacist on the Quality of Drug Prescribing and Rehabilitation Outcomes in Post-acute Hip Fractured Patients
- ClinicalTrials.gov ID
- NCT04360746
- Acronym / sponsor ID
- 0832-19-RMC
- Conditions
- Hip Fractures, Clinical Pharmacists, Rehabilitation Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical pharmacist intervention group | Active comparator | Other: Pharmaceutical intervention, Other: Rehabilitationall 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) |
| control group | Other | Other: RehabilitationThe 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. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderly patient (65 years of older) who were admitted for rehabilitation after hip fracture at "D" ward in beit rivka post-acute geriatric center.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical interventionPharmaceutical 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 | Clinical pharmacist intervention group |
| RehabilitationA 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 | Clinical pharmacist intervention group, control group |
Primary outcome
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.
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.
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
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
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.
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.
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).
LOS (Length Of Stay)
Time frame: Through study completion, an average of 1 year
Length of rehabilitation center stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Background: PubMed 21748749Boparai MK, Korc-Grodzicki B. Prescribing for older adults. Mt Sinai J Med. 2011 Jul-Aug;78(4):613-26. doi: 10.1002/msj.20278.
- Background: PubMed 22642783Spinewine A, Fialova D, Byrne S. The role of the pharmacist in optimizing pharmacotherapy in older people. Drugs Aging. 2012 Jun 1;29(6):495-510. doi: 10.2165/11631720-000000000-00000.
- Background: PubMed 26755524Walsh KA, O'Riordan D, Kearney PM, Timmons S, Byrne S. Improving the appropriateness of prescribing in older patients: a systematic review and meta-analysis of pharmacists' interventions in secondary care. Age Ageing. 2016 Mar;45(2):201-9. doi: 10.1093/ageing/afv190. Epub 2016 Jan 10.
- Background: PubMed 22443958Geller AI, Nopkhun W, Dows-Martinez MN, Strasser DC. Polypharmacy and the role of physical medicine and rehabilitation. PM R. 2012 Mar;4(3):198-219. doi: 10.1016/j.pmrj.2012.02.012.
- Background: PubMed 30429122Perez T, Moriarty F, Wallace E, McDowell R, Redmond P, Fahey T. Prevalence of potentially inappropriate prescribing in older people in primary care and its association with hospital admission: longitudinal study. BMJ. 2018 Nov 14;363:k4524. doi: 10.1136/bmj.k4524.
- Background: PubMed 28776209Iaboni 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.
- Background: PubMed 27199553Kragh 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.
- Background: PubMed 29354524Lee 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.
- Background: PubMed 23690938Gillespie U, Alassaad A, Hammarlund-Udenaes M, Morlin C, Henrohn D, Bertilsson M, Melhus H. Effects of pharmacists' interventions on appropriateness of prescribing and evaluation of the instruments' (MAI, STOPP and STARTs') ability to predict hospitalization--analyses from a randomized controlled trial. PLoS One. 2013 May 17;8(5):e62401. doi: 10.1371/journal.pone.0062401. Print 2013.
- Background: PubMed 18248511Viktil KK, Blix HS. The impact of clinical pharmacists on drug-related problems and clinical outcomes. Basic Clin Pharmacol Toxicol. 2008 Mar;102(3):275-80. doi: 10.1111/j.1742-7843.2007.00206.x. Epub 2008 Jan 30.
- Background: PubMed 23796001Lee JK, Slack MK, Martin J, Ehrman C, Chisholm-Burns M. Geriatric patient care by U.S. pharmacists in healthcare teams: systematic review and meta-analyses. J Am Geriatr Soc. 2013 Jul;61(7):1119-27. doi: 10.1111/jgs.12323. Epub 2013 Jun 24.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical intervention and Rehabilitation in people with Hip Fractures and Clinical Pharmacists, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summated Medication Appropriateness Index (MAI) score (time frame: Admission (baseline value) and at discharge (approximately 5 weeks post admission)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360746, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.