UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035265
Receipt number R000040177
Scientific Title Efficacy of medication optimization protocol for older inpatients: a randomized controlled trial
Date of disclosure of the study information 2018/12/21
Last modified on 2022/06/01 14:54:46

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Basic information

Public title

Efficacy of medication optimization protocol for older inpatients: a randomized controlled trial

Acronym

Efficacy of medication optimization protocol for older inpatients

Scientific Title

Efficacy of medication optimization protocol for older inpatients: a randomized controlled trial

Scientific Title:Acronym

Efficacy of medication optimization protocol for older inpatients

Region

Japan


Condition

Condition

Polypharmacy among older adults

Classification by specialty

Medicine in general Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this trial is to evaluate the effect of multidisciplinary team-based deprescribing intervention on survival, re-hospitalization and unscheduled visits among older inpatients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Composite of death, unscheduled visits, and re-hospitalization until 12 months after randomization.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

A multidisciplinary team-based medication review and deprescribing proposal based on STOPP/START criteria and a medication optimization protocol.

Interventions/Control_2

Usual care

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients admitted to the internal medicine department of Kawasaki Municipal Tama Hospital (general internal medicine, gastroenterology, cardiology, respiratory medicine, endocrinology, nephrology, and neurology)
2) Patients aged 65 years or older at the time of enrollment
3) Patients who are confirmed to have 5 or more regular medications at the time of admission
4) Patients with expected hospitalization duration of 1 week or longer
5) Patients who are permitted to be given oral medication by the attending physician at the time of the trial participation
6) Patients with written agreement for study participation by themselves or by the substitute person with sufficient understanding

Key exclusion criteria

1) Patients whose attending physician do not agree to participate in the study

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Kenya
Middle name
Last name Ie

Organization

St. Marianna university school of medicine/Kawasaki Municipal Tama Hospital

Division name

Department of internal medicine, division of general internal medicine

Zip code

214-8525

Address

1-30-37 Shukugawara, Tama-ku, Kawasaki city, Kanagawa, Japan

TEL

044-933-8111

Email

iekenya0321@gmail.com


Public contact

Name of contact person

1st name Satomi
Middle name
Last name Tsuchiya

Organization

Kawasaki Municipal Tama Hospital

Division name

General Affairs Section

Zip code

214-8525

Address

1-30-37 Shukugawara, Tama-ku, Kawasaki city, Kanagawa, Japan

TEL

044-933-8111

Homepage URL


Email

s-tsuchiya@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Marianna University

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan

Tel

044-977-8111

Email

noriko.matsuda@marianna-u.ac.jp


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

2018 Year 12 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

No longer recruiting

Date of protocol fixation

2018 Year 11 Month 23 Day

Date of IRB

2019 Year 03 Month 01 Day

Anticipated trial start date

2019 Year 03 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 15 Day

Last modified on

2022 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040177


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name