UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047912 |
|---|---|
| Receipt number | R000054619 |
| Scientific Title | Development of a novel deprescribing protocol focused on improving patient proactiveness |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/12/02 18:55:26 |
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Basic information
Public title
Development of a novel deprescribing protocol focused on improving patient proactiveness
Acronym
Development of a novel deprescribing protocol focused on improving patient proactiveness
Scientific Title
Development of a novel deprescribing protocol focused on improving patient proactiveness
Scientific Title:Acronym
Development of a novel deprescribing protocol focused on improving patient proactiveness
Region
| Japan |
Condition
Condition
Polypharmacy
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will develop a patient proactiveness evaluation scale that can be used with Japanese patients and verify the indirect effects of comprehensive prescription optimization from polypharmacy through comparisons between Japan and the United States.
Basic objectives2
Others
Basic objectives -Others
We will develop a prescription optimization protocol with high clinical usefulness focusing on indirect effects, and establish a foundation for future effectiveness verification and clinical application.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Self-reported hospitalizations, emergency department visits, and falls in the past 12 months
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) 65 years of age or older 2) A history of visits to the relevant medical institution within 6 months 3) Able to communicate in Japanese and have written consent to participate in the study 4) Prescription drug information from either a medication diary, medical record information, or receipt data that confirms at least 5 regular medications that have been ongoing for at least 4 weeks
Key exclusion criteria
1) Has a diagnosis of dementia 2) Has a history of hospitalization with a change of prescription within 30 days 3) Any other person deemed inappropriate by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Ie |
Organization
St. Mariannna University School of Medicine
Division name
Department of General Internal Medicine
Zip code
214-8525
Address
1-30-37 Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL
044-933-8111
iekenya0321@gmail.com
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Machino |
Organization
St. Mariannna University School of Medicine
Division name
Department of General Internal Medicine
Zip code
214-8525
Address
1-30-37 Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL
044-933-8111
Homepage URL
tama-soushinnaika-002@marianna-u.ac.jp
Sponsor or person
Institute
St. Mariannna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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. Mariannna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
Tel
044-977-8111
daigakuin-kenkyu-001@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
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
265
Results
Phase 1: Confirmed two-factor validity and reliability https://onlinelibrary.wiley.com/doi/10.1002/jgf2.733
Phase 2: Identified factors via the theory of planned behavior https://pubmed.ncbi.nlm.nih.gov/36834238/
Phase 3: Key concepts extracted. Manuscript under submission.
Phase 4: Evaluated 24-week health indicators. Data under analysis.
Results date posted
| 2024 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 02 | Month | 17 | Day |
Baseline Characteristics
The 196 patients analyzed in Phase 1 and Phase 4 were the same.
Phase1 Participant Background
Cognitive Interviews: 10 patients aged 60 years or older.
Survey Participants: 196 older adults aged 65 years or older taking five or more regular medications. The mean age was 79.2 years, with 118 males and 78 females. The study was conducted at regional clinics and hospitals.
Phase2 Participant Background
Participants were 35 physicians and pharmacists working in hospitals, clinics, and community pharmacies. This included 22 physicians and 13 pharmacists, with years of experience ranging from less than 5 years to over 20 years. Each focus group interview included 4 to 6 participants.
Phase3 Participant Background
Participants were 20 outpatients aged 65 years or older taking five or more regular medications. The mean age was 78 years, with an approximately equal gender distribution. Most participants had multiple chronic conditions and regularly visited medical facilities.
Phase4 Participant Background
Participants were 200 outpatients aged 65 years or older attending primary care clinics and a community hospital in Kanagawa, Japan, with 196 included in the analysis. All participants were taking five or more regular medications. The mean age was 77.5 years, with a nearly equal gender distribution. Most participants had multiple chronic conditions.
Participant flow
Adverse events
None
Outcome measures
Phase1. Outcome Measures
Structural Validity: Confirmation of the two-factor structure of the Japanese version of SF-PPoD through factor analysis.
Internal Consistency: Evaluation using Cronbach's alpha.
Test-Retest Reliability: Assessment using the intraclass correlation coefficient (ICC) based on repeated responses from the same participants.
Phase2. Outcome Measures
Identification of decision-making processes for deprescribing based on healthcare providers' attitudes, beliefs, subjective norms, and perceived behavioral control.
Extraction of factors influencing deprescribing, such as drug types, patient characteristics, environment, and educational experiences.
Identification of facilitators and barriers to deprescribing behavior guided by the theory of planned behavior.
Phase3. Outcome Measures
Extraction of patients' perceptions, experiences, proactiveness, barriers, and enablers related to deprescribing.
Development of patient typologies based on attitudes and behaviors toward deprescribing.
Phase4. Outcome Measures
Changes in the number of medications and subjective health status (including EQ-5D-5L scores) after 24 weeks.
Self-reported frequency of hospitalizations, emergency department visits, and falls.
Associations between baseline SF-PPoD scores and health outcomes, adjusted for covariates using multivariate regression analysis.
Plan to share IPD
N/A
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Phase 1: Translation and validation of PPoD-SF
Translation, back-translation, and revision by researchers including the original author. Pre- and post-test interviews will be conducted with approximately 10 patients aged 65 years or older with at least 5 medications, and revisions will be made.
Phase 2: Experience with deprescribing and effective approaches for physicians and pharmacists (focus group interviews) 20 physicians and pharmacists at Kawasaki City Tama Hospital, Tama Family Clinic, Tochigi Medical Center, and Nanohana Pharmacy Noborito.
Phase 3: Factors related to the experience of deprescribing and its usefulness (semi-structured individual interviews) with patients visiting Kawasaki City Tama Hospital and Tama Family Clinic.
Eligibility: 1) 65 years or older 2) visits to the institution within 6 months 3) talked about deprescribing within the past year 4) At least 5 regular medications that have been ongoing for at least 4 weeks.
Exclusion: 1) Dementia 2) hospitalization with prescription change within 30 days
Phase 4: Development and implementation of a survey on the acceptance of deprescribing and health outcomes among the elderly
200 patients visiting Kawasaki City Tama Hospital and Tama Family Clinic who meet the eligibility criteria.
Eligibility criteria: 1) 65 years or older; 2) visited the institution within 6 months; 3) able to confirm that they have at least 5 regular medications that they have been using for at least 4 weeks
Exclusion: 1) Dementia 2) hospitalization with prescription change within 30 days
Main explanatory variables: Japanese PPoD-SF total/subscale scores.
Covariates: age, gender, Japanese EQ-5D-5L, drug information, comorbidity, and history of deprescribing.
Outcome: hospitalizations, emergency visits, and falls in the past 12 months
Analyses: Covariance structure analysis and mediation analysis to identify associations between medication reduction, Japanese PPoD-SF subscale/total scores, and outcomes.
Management information
Registered date
| 2022 | Year | 06 | Month | 01 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054619
