UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039920 |
|---|---|
| Receipt number | R000045498 |
| Scientific Title | Multidisciplinary team intervention for elderly orthopedic inpatients and its impact on polypharmacy |
| Date of disclosure of the study information | 2020/03/25 |
| Last modified on | 2020/03/22 02:01:41 |
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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
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
h.seto1981@gmail.com
Sponsor or person
Institute
Akashi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045498
