UMIN-CTR Clinical Trial

Basic information
Public title	Multidisciplinary team intervention for elderly orthopedic inpatients and its impact on polypharmacy
Acronym	Multidisciplinary team intervention for elderly orthopedic inpatients and its impact on polypharmacy
Scientific Title	Multidisciplinary team intervention for elderly orthopedic inpatients and its impact on polypharmacy
Scientific Title:Acronym	Multidisciplinary team intervention for elderly orthopedic inpatients and its impact on polypharmacy
Region	Japan

Condition
Condition	polypharmacy
Classification by specialty	Geriatrics Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of the study is to evaluate the effectiveness of multidisciplinary team intervention to reduce polypharmacy and potentially inappropriate medications (PIMs) in elderly patients admitted to our orthopedic department.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcomes were changes in the mean number of regular medicines and PIMs during hospitalization.
Key secondary outcomes	Secondary outcomes included falls, delirium, and any adverse events during hospitalization, and emergency department visits and unplanned hospital admissions for any reason within six months after discharge.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who meet all the following criteria were included; 1) patients aged 75 years and older who were admitted to the orthopedic ward of Akashi Medical Center 2) patients with hospitalization duration of 1 week or longer 3) patients who were confirmed to have 6 or more regular medications at the time of admission
Key exclusion criteria	1) Patients who received end of life care or palliative care 2) Patients who died during hospitalization
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Seto
Organization	Akashi Medical Center
Division name	Department of General Internal Medicine
Zip code	674-0063
Address	743-33 Yagi, Okubo-Cho, Akashi, Hyogo
TEL	078-936-1101
Email	h.seto1981@gmail.com

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Seto
Organization	Akashi Medical Center
Division name	Department of General Internal Medicine
Zip code	674-0063
Address	743-33 Yagi, Okubo-Cho, Akashi, Hyogo
TEL	078-936-1101
Homepage URL
Email	h.seto1981@gmail.com

Sponsor
Institute	Akashi Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Akashi Medical Center
Address	743-33 Yagi, Okubo-Cho, Akashi, Hyogo
Tel	078-936-1101
Email	kawata@amc1.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	2020 Year 03 Month 25 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	276
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	Completed
Date of protocol fixation	2018 Year 10 Month 22 Day
Date of IRB	2018 Year 10 Month 31 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We compare the outcomes of patients receiving intervention vs. patients not receiving intervention in this single-center retrospective observational study. Intervention comprised polypharmacy screening and deprescription of any unnecessary medications during hospital stays. Our multidisciplinary team included general internal medicine physicians, pharmacists and nurses. Control group received usual care. Comparisons between the intervention and usual care groups were analyzed using propensity score matching.

Management information
Registered date	2020 Year 03 Month 24 Day
Last modified on	2020 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045498