UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029404 |
|---|---|
| Receipt number | 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 | 2021/09/02 21:25:43 |
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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 | 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
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
ksuga1@tochigi-mc.jp
Sponsor or person
Institute
National Hospital Organization Tochigi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033602
