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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029404
Receipt No. R000033602
Scientific Title A Single-center, Prospective, Non-blinded, Randomized, 12-month, Parallel-group, Superiority Study to Compare the Efficacy of Pharmacist Intervention versus Usual Care for Older Patients Hospitalized in the Orthopedic Ward
Date of disclosure of the study information 2017/10/03
Last modified on 2018/03/11

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Basic information
Public title A Single-center, Prospective, Non-blinded, Randomized, 12-month, Parallel-group, Superiority Study to Compare the Efficacy of Pharmacist Intervention versus Usual Care for Older Patients Hospitalized in the Orthopedic Ward
Acronym Efficacy of Pharmacist Intervention for Older Patients Hospitalized in the Orthopedic Ward
Scientific Title A Single-center, Prospective, Non-blinded, Randomized, 12-month, Parallel-group, Superiority Study to Compare the Efficacy of Pharmacist Intervention versus Usual Care for Older Patients Hospitalized in the Orthopedic Ward
Scientific Title:Acronym Efficacy of Pharmacist Intervention for Older Patients Hospitalized in the Orthopedic Ward
Region
Japan

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

Objectives
Narrative objectives1 To evaluate whether a pharmacist intervention for older orthopedic patients with polypharmacy improves patient outcomes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the readmission rate within one year after randomization.
Key secondary outcomes Secondary outcomes are the proportion of patients who undergo Emergency Department (ED) visits, all-cause death, a new fracture, acute myocardial infarction, and ischemic stroke. Other outcomes include the number of medications, potentially inappropriate medications, and potential prescribing omissions.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Usual care includes medication reconciliation, patient education, monitoring, and providing information about discharge medications.
Interventions/Control_2 Pharmacist interventions include medication reconciliation, advice to patients' physician in stopping unnecessary or inappropriate medications and starting necessary medications, patient education, monitoring, and providing written summary information about discharge medications to patients, primary care physicians and community pharmacists from admission to discharge.
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Aged more or 70 years
2) Polypharmacy (defined as 5 or more medications) or at least one potentially inappropriate medication (defined by 2015 STOPP criteria8) at admission
Key exclusion criteria 1)Elective admission
2)Inability to contact patients within 72 hours after their admission
3)Expected duration of hospital stay of < one week
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Sugawara
Organization National Hospital Organization Tochigi Medical Center
Division name Department of Pharmacy
Zip code
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
TEL 028-622-5241
Email ksuga1@tochigi-mc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Sugawara
Organization National Hospital Organization Tochigi Medical Center
Division name Department of Pharmacy
Zip code
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
TEL 028-622-5241
Homepage URL
Email ksuga1@tochigi-mc.jp

Sponsor
Institute National Hospital Organization Tochigi Medical Center
Institute
Department

Funding Source
Organization None
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 独立行政法人国立病院機構栃木医療センター

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 03 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 06 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 01 Month 31 Day
Date analysis concluded
2021 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 03 Day
Last modified on
2018 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033602

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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