UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035265
Receipt number R000040177
Scientific Title Efficacy of medication optimization protocol for older inpatients: a randomized controlled trial
Date of disclosure of the study information 2018/12/21
Last modified on 2024/12/19 19:34:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Efficacy of medication optimization protocol for older inpatients: a randomized controlled trial

Acronym

Efficacy of medication optimization protocol for older inpatients

Scientific Title

Efficacy of medication optimization protocol for older inpatients: a randomized controlled trial

Scientific Title:Acronym

Efficacy of medication optimization protocol for older inpatients

Region

Japan


Condition

Condition

Polypharmacy among older adults

Classification by specialty

Medicine in general Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this trial is to evaluate the effect of multidisciplinary team-based deprescribing intervention on survival, re-hospitalization and unscheduled visits among older inpatients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Composite of death, unscheduled visits, and re-hospitalization until 12 months after randomization.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

A multidisciplinary team-based medication review and deprescribing proposal based on STOPP/START criteria and a medication optimization protocol.

Interventions/Control_2

Usual care

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

1) Patients admitted to the internal medicine department of Kawasaki Municipal Tama Hospital (general internal medicine, gastroenterology, cardiology, respiratory medicine, endocrinology, nephrology, and neurology)
2) Patients aged 65 years or older at the time of enrollment
3) Patients who are confirmed to have 5 or more regular medications at the time of admission
4) Patients with expected hospitalization duration of 1 week or longer
5) Patients who are permitted to be given oral medication by the attending physician at the time of the trial participation
6) Patients with written agreement for study participation by themselves or by the substitute person with sufficient understanding

Key exclusion criteria

1) Patients whose attending physician do not agree to participate in the study

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Kenya
Middle name
Last name Ie

Organization

St. Marianna university school of medicine/Kawasaki Municipal Tama Hospital

Division name

Department of internal medicine, division of general internal medicine

Zip code

214-8525

Address

1-30-37 Shukugawara, Tama-ku, Kawasaki city, Kanagawa, Japan

TEL

044-933-8111

Email

iekenya0321@gmail.com


Public contact

Name of contact person

1st name Satomi
Middle name
Last name Tsuchiya

Organization

Kawasaki Municipal Tama Hospital

Division name

General Affairs Section

Zip code

214-8525

Address

1-30-37 Shukugawara, Tama-ku, Kawasaki city, Kanagawa, Japan

TEL

044-933-8111

Homepage URL


Email

s-tsuchiya@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Marianna University

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan

Tel

044-977-8111

Email

noriko.matsuda@marianna-u.ac.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



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 21 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040177

Publication of results

Published


Result

URL related to results and publications

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821656

Number of participants that the trial has enrolled

442

Results

Between May 21, 2019, and March 14, 2022, 442 participants were randomly assigned to the intervention (n=215) and usual care (n=227) groups. The intervention group had a lower percentage of patients with potentially inappropriate medications at discharge (26.2% vs 33.0%; OR 0.56 [95% CI 0.33-0.94]) and at 12 months (26.7% vs 37.4%; OR 0.45 [95% CI 0.25-0.80]). The primary outcome occurred in 49.3% of the intervention group and 51.5% of the usual care group (HR 0.98 [95% CI 0.75-1.27]).

Results date posted

2024 Year 12 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Baseline characteristics were similar in both groups, with the exception of a higher prevalence of smoking among participants in the usual care group. At baseline, the participants had a mean (SD) of 4.2 (1.7) diagnoses, used a median (IQR) of 8 (7-10) regular medications, 187 (42.3%) had been prescribed 1 or more PIMs, and 109 (24.7%) had fallen at least once during the previous 3 months prior to study participation. Total medication counts, PIM use, and the distribution of drug class at baseline were similar between the groups.

Participant flow

Given the medical risk of older patients, who are at a higher risk of medication-related adverse events, we deemed it ethically unacceptable to withhold medication reconciliation. Therefore, usual care included medication reconciliation conducted by ward-based pharmacists at admission. For participants in the intervention group, a multidisciplinary deprescribing team, composed of a physician and a pharmacist, promptly initiated the intervention within 48 hours of allocation. All members of the intervention team underwent standardized guidance and training in advance. The structure of the intervention included: 1. baseline data collection, including age, sex, previous medical history, comorbid conditions, smoking status, physical measurements on admission height, weight and vital signs, eGFR, serum sodium and potassium level, and regularly prescribed medications, conducted through medical record review; 2. preliminary medication optimization proposal using a clinical-decision support system; baseline data were entered into a computer-based clinical-decision support system developed specifically for this trial by the deprescribing team using a Microsoft Excel spreadsheet. Using these data, the clinical-decision support system generated a preliminary list of potentially inappropriate prescriptions as well as prescribing omissions in line with STOPP START criteria; and 3. medication optimization protocol-based team discussion; the deprescribing team reviewed the draft proposal and embarked on a step-by-step discussion, adhering to the medication optimization protocol; this discussion followed a specific algorithm, as proposed by Scott et al: assessment of medication indication; balancing benefits and harms; evaluation of symptomatic medications; and evaluation of preventive medications.

Following these steps, the medication optimization plan was explained and discussed with the participant or their next of kin. With the participant's consent, the team recommended the medication optimization plan, including its rationale, to the attending physician. The decision to accept or decline the proposal was at the discretion of their attending physician. A summary of the medication optimization, including reasons for modifications and relevant precautions, was conveyed to the participant's primary care physician and community pharmacists upon discharge, ensuring continuity of care.

Adverse events

Adverse events occurred in 123 participants (57.2%) in the intervention group and 135 participants (59.5%) in the control group. Overall, adverse events were similar between groups, and there were no safety events related to the study intervention.

Outcome measures

The primary outcome was a composite of all-cause death, unscheduled hospital visits, and rehospitalization within 48 weeks of enrollment. Secondary outcomes included each of the primary outcome, number of regular medications and PIMs based on STOPP START criteria version 2, level of long-term care required, EQ5D-3L, adverse events, falls, and all-cause death during initial hospitalization. Events were tracked in regular follow-up telephone interviews performed by trained research assistants masked to group allocation. Number of regular medications and PIMs at discharge, 24 weeks, and 48 weeks were collected using medication lists included in the participant's medical record handbook or electronic medical record and consecutively adjudicated with medication lists sent from the relevant community pharmacist. Level of long-term care required and health-related quality of life were assessed at baseline, hospital discharge, 24 weeks, and 48 weeks based on the follow-up telephone interview according to the prespecified questionnaire. All adverse events, regardless of their potential relevance to the intervention, were recorded during initial hospital admission and follow-up period. Serious adverse events included all-cause death and events that resulted in persistent disability or hospital admission. The relevance to the intervention was assessed by consensus among the deprescribing team and reviewed by the institutional data and safety monitoring board.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 23 Day

Date of IRB

2019 Year 03 Month 01 Day

Anticipated trial start date

2019 Year 03 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 15 Day

Last modified on

2024 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040177