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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024250
Receipt No. R000027692
Scientific Title SADA-5 (Strategy of Assessment for Drug Appropriateness) Criteria as a Powerful Tool for Detecting Potentially Inappropriate Medications with Using Another Explicit Criteria; a Randomized Control Trial
Date of disclosure of the study information 2016/10/11
Last modified on 2018/02/11

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Basic information
Public title SADA-5 (Strategy of Assessment for Drug Appropriateness) Criteria as a Powerful Tool for Detecting Potentially Inappropriate Medications with Using Another Explicit Criteria; a Randomized Control Trial
Acronym SADA-5 trial
Scientific Title SADA-5 (Strategy of Assessment for Drug Appropriateness) Criteria as a Powerful Tool for Detecting Potentially Inappropriate Medications with Using Another Explicit Criteria; a Randomized Control Trial
Scientific Title:Acronym SADA-5 trial
Region
Japan

Condition
Condition The patients who are just admitted in Kameda rehabilitation hospital and have one or more prescription drugs.
Classification by specialty
Medicine in general Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There are two major methods for the evaluation of potentially inappropriate drugs (PIMs). First, implicit criteria can evaluate overall drugs by point-rating system. However, implicit criteria cannot provide doctors with confident decision making for deprescribing because implicit criteria does not have a specific cut-off for the judgment of deprescribing. Second, explicit criteria can identify high-risk drugs using a list of PIMs that have been identified through expert panel review. However, the explicit criteria cannot evaluate all of drugs because only a small portion of drug-related problems are described in the explicit criteria. We want establishment of a new criteria for deprescribing, which contains elements of both implicit and explicit criteria by evaluating the appropriateness of all of drugs as implicit criteria and by providing a decision making for deprescribing as explicit criteria.
We developed a new criteria SADA-5 (Strategy of Assessment for Drug Appropriateness) criteria for resolving these problems. This criteria evaluates the appropriateness of prescription drugs in five points
as follows;
1) Does this drug have an evidence-based clinical indication of treatment and prevention for this patient or not?
2) Does this drug have an evidence-based demerit for this patient or not?
3) Is this drug useful to be continued although the targeting symptom of the drug is already improved?
4) Is this drug useful to be continued although the diagnostic process is unclear?
5) Is this drug a part of prescribing cascade?
(Prescribing cascade is a process in which a drug causes an adverse effect, leading to a prescription of another drug.)

SADA-5 criteria has two strong points; First, SADA-5 criteria can evaluate the appropriateness of prescribing in all of drugs. Second, SADA-5 criteiria can provide appropriate decision making to stop the drugs.
Our aim is to conduct a randomized controlled study to evaluate the safety and efficacy of SADA-5 criteria.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of potentially inappropriate medications (PIMs) whichI is evaluated in each criteria.
Key secondary outcomes 1) The appropriateness of prescribing as measured by the Medicine Appropriateness Index
2) The number of all prescribing drugs at discharge
3) Reduced cost by deprescribing drugs
4) Adverse events by deprescribing drugs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In an intervention group, the evaluators evaluate the appropriateness of drugs using Screening Tool for Older Persons' Appropriate Prescriptions in Japanese (STOPP-J) and SADA (Strategy of Assessment for Drug Appropriateness)-5 criteria. Two senior residents in the Department of General Internal Medicine of Kameda Medical Center are protocol evaluators. They decide PIMs with discussion and tell the decision to a pharmacist in Kameda Rehabilitation Hospital. Then the pharmacist tells the result of the evaluation to each attending physician, who determines to stop medications or not, which are evaluated as PIMs.
Interventions/Control_2 In a comparison group, the evaluator evaluates the appropriateness of drugs using Screening Tool for Older Persons' Appropriate Prescriptions in Japanese (STOPP-J). One senior resident in the Department of General Internal Medicine of Kameda Medical Center is the protocol evaluator.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patient who are 65 years old and older, admitted to Kameda Rehabilitation Hospital under the care of rehabilitation physicians, and have one or more oral prescription drugs.
Key exclusion criteria 1) unwillingness of the patient to participate in the study.
2) a patient who have no oral prescription drug.
3) a patient under 65 years old.
Target sample size 154

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuichi Sada
Organization Kameda Medical Center
Division name Department of General Internal Medicine
Zip code
Address 929 Higashi-cho, Kamogawa, Chiba, Japan
TEL 81-4-7092-2211
Email sada.ryuichi@kameda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryuichi Sada
Organization Kameda Medical Center
Division name Department of General Internal Medicine
Zip code
Address 929 Higashi-cho, Kamogawa, Chiba, Japan
TEL 81-4-7092-2211
Homepage URL
Email sada.ryuichi@kameda.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kameda Rehabilitation Hospital
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 亀田リハビリテーション病院

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 11 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
2016 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 11 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 01 Day
Last modified on
2018 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027692

Research Plan
Registered date File name
2017/10/02 polypharmacy研究:研究計画書(H28.9.28 sada-revised) .pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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