UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025495
Receipt number 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 13:51:07

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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 or person

Institute

Tochigi Medical Center

Institute

Department

Personal name



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

Value
https://center6.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