UMIN-CTR Clinical Trial

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 Kenichi Middle name Last name Sugawara
Organization	National Hospital Organization Tochigi Medical Center
Division name	Department of Pharmacy
Zip code	3208580
Address	1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
TEL	028-622-5241
Email	ksuga1@tochigi-mc.jp

Public contact
Name of contact person	1st name Kenichi Middle name Last name Sugawara
Organization	National Hospital Organization Tochigi Medical Center
Division name	Department of Pharmacy
Zip code	3208580
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	National Hospital Organization Tochigi Medical Center
Address	1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
Tel	028-622-5241
Email	atamura@tochigi-mc.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	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	No longer recruiting
Date of protocol fixation	2017 Year 09 Month 21 Day
Date of IRB	2017 Year 09 Month 21 Day
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	2021 Year 09 Month 02 Day

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