UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024250
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

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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 Sada
Middle name Minoda
Last name Ryuichi

Organization

Kameda Medical Center

Division name

Department of General Internal Medicine

Zip code

296-8602

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 Sada
Middle name Minoda
Last name Ryuichi

Organization

Kameda Medical Center

Division name

Department of General Internal Medicine

Zip code

296-8602

Address

929 Higashi-cho, Kamogawa, Chiba, Japan

TEL

81-4-7092-2211

Homepage URL


Email

sada.ryuichi@kameda.jp


Sponsor or person

Institute

Kameda Medical Center

Institute

Department

Personal name



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

Kameda medical center

Address

929 Higashi-cho, Kamogawa City, Chiba 296-8602, Japan

Tel

04-7092-2211

Email

sadametal@gmail.com


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

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000027692

Publication of results

Partially published


Result

URL related to results and publications

https://jpca2023.org

Number of participants that the trial has enrolled

156

Results

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.)

Results date posted

2023 Year 05 Month 19 Day

Results Delayed

Delay expected

Results Delay Reason

Delayed reporting due to complexity of data analysis.

Date of the first journal publication of results

2023 Year 05 Month 13 Day

Baseline Characteristics

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.

Participant flow

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.

Adverse events

There were no relevant adverse events caused by deprescribing drugs in both groups.

Outcome measures

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.

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

2016 Year 10 Month 04 Day

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

2018 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 01 Day

Last modified on

2023 Year 05 Month 19 Day



Link to view the page

Value
https://center6.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