Unique ID issued by UMIN | UMIN000024250 |
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Receipt number | 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 | 2023/05/19 12:30:59 |
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
SADA-5 trial
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
SADA-5 trial
Japan |
The patients who are just admitted in Kameda rehabilitation hospital and have one or more prescription drugs.
Medicine in general | Geriatrics |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
The number of potentially inappropriate medications (PIMs) whichI is evaluated in each criteria.
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
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
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.
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.
65 | years-old | <= |
Not applicable |
Male and Female
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.
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.
154
1st name | Sada |
Middle name | Minoda |
Last name | Ryuichi |
Kameda Medical Center
Department of General Internal Medicine
296-8602
929 Higashi-cho, Kamogawa, Chiba, Japan
81-4-7092-2211
sada.ryuichi@kameda.jp
1st name | Sada |
Middle name | Minoda |
Last name | Ryuichi |
Kameda Medical Center
Department of General Internal Medicine
296-8602
929 Higashi-cho, Kamogawa, Chiba, Japan
81-4-7092-2211
sada.ryuichi@kameda.jp
Kameda Medical Center
Self-funding
Self funding
Kameda Rehabilitation Hospital
Kameda medical center
929 Higashi-cho, Kamogawa City, Chiba 296-8602, Japan
04-7092-2211
sadametal@gmail.com
NO
亀田リハビリテーション病院
2016 | Year | 10 | Month | 11 | Day |
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000027692
Partially published
https://jpca2023.org
156
In the primary endpoint, PIMs were significantly more in the SADA-5 plus STOPP-J group than in the STOPP-J group (2.35 vs 0.77, P<0.0001). In the secondary endpoint, summated MAI per medication at discharge was significantly lower in the SADA-5 plus STOPP-J group than in the STOPP-J group (1.53 vs. 2.38, P=0.005). The mean number of drugs stopped at discharge was also lower in the SADA-5 plus STOPP-J group than in the STOPP-J group. (1.68 vs 1.10, P=0.016.)
2023 | Year | 05 | Month | 19 | Day |
Delay expected |
Delayed reporting due to complexity of data analysis.
2023 | Year | 05 | Month | 13 | Day |
The median age was 78.9 years in the SADA-5 plus STOPP-J group and 79.2 years in the STOPP-J group. The female sex was 61.0% and 59.5%. The background rehabilitation disease was neurological or orthopaedic in 95% of the SADA-5 plus STOPP-J group and 99% of the control group.
Between October 11th, 2016 and December 20th, 2017, 351 patients were screened. and 177 patients were excluded (Figure 1). A total of 176 patients were randomized. 77 were randomized to the SADA-5 plus STOPP-J group and 79 to the STOPP-J group. A total of 18 patients were excluded due to early discharge before evaluation, consent withdrawal, protocol violation, or incorrect allocation. Finally, 156 patients completed the trial.
There were no relevant adverse events caused by deprescribing drugs in both groups.
The primary endpoint was the number of potentially inappropriate medications (PIMs) which is evaluated in each criterion. The secondary outcomes included 1) The appropriateness of prescribing as measured by the summated MAI, 2) The number of all prescribing drugs at discharge, and 3) Adverse events by deprescribing drugs. The summated MAI was measured and the mean MAI in both groups was compared. The MAI in each drug was calculated by RS and TM independently, and the final value was determined by a consensus of the authors.
No longer recruiting
2016 | Year | 10 | Month | 04 | Day |
2016 | Year | 10 | Month | 04 | Day |
2016 | Year | 10 | Month | 11 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
2016 | Year | 10 | Month | 01 | Day |
2023 | Year | 05 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027692
Research Plan | |
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Registered date | File name |
2017/10/02 | polypharmacy研究:研究計画書(H28.9.28 sada-revised) .pdf |
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