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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025495
Receipt No. R000029339
Scientific Title Intervention to improve the appropriate use of polypharmacy for older patients with hip fracture: an observational study
Date of disclosure of the study information 2017/01/02
Last modified on 2018/01/09

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Basic information
Public title Intervention to improve the appropriate use of polypharmacy for older patients with hip fracture: an observational study
Acronym Intervention to improve the appropriate use of polypharmacy for older patients with hip fracture
Scientific Title Intervention to improve the appropriate use of polypharmacy for older patients with hip fracture: an observational study
Scientific Title:Acronym Intervention to improve the appropriate use of polypharmacy for older patients with hip fracture
Region
Japan

Condition
Condition Hip fracture
Classification by specialty
Geriatrics Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the effectiveness of an intervention to improve appropriate polypharmacy for elderly patients with hip fracture.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary composite outcome was death or the first occurrence of any new fracture
Key secondary outcomes Secondary outcomes were death, any new fractures, cardiovascular events, delirium, adverse drug events, in-hospital infections, or unplanned hospital admission for any reason.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The intervention consisted of an assessment of the appropriateness of polypharmacy and deprescribing any unnecessary medications by internal medicine physicians during the patients' hospital stay
Interventions/Control_2 We used hip fracture patients prescribed five or more medications at admission who pharmacist could not contact or rejected to receive the intervention for polypharmacy as a control group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
120 years-old >=
Gender Male and Female
Key inclusion criteria all consecutive patients aged 65 years or more who were admitted to the hospital for hip fracture and who were prescribed five or more than medications at admission
Key exclusion criteria Patients with hip fracture due to metastatic bone cancer were excluded
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junpei Komagamine
Organization Tochigi Medical Center
Division name Internal medicine
Zip code
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi 320-8580, Japan
TEL 028-622-5241
Email jkomagamine@tochigi-mc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junpei Komagamine
Organization Tochigi Medical Center
Division name Internal medicine
Zip code
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi 320-8580, Japan
TEL 028-622-5241
Homepage URL
Email jkomagamine@tochigi-mc.jp

Sponsor
Institute Tochigi Medical Center
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-017-0681-3
Number of participants that the trial has enrolled
Results
A total of 164 patients were included in the study. The primary composite outcome occurred in 35 patients. No significant differences in the primary composite outcome were found between the intervention and usual care groups (7 in the intervention group and 28 in the usual care group, odds ratio 1.04, 95% CI 0.41-2.65; p?=?1.00).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cases will be included retrospectively if the admission date of patients was after 1 January 2015

Management information
Registered date
2017 Year 01 Month 02 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029339

Research Plan
Registered date File name
2017/01/02 polypharmacyと股関節骨折 研究計画書 20160926改訂.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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