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 |
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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
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
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
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
