UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027189 |
|---|---|
| Receipt number | R000031157 |
| Scientific Title | Impact of hospitalization due to medical illness on inappropriate prescribing in elderly patients: a prospective observational study. |
| Date of disclosure of the study information | 2017/04/29 |
| Last modified on | 2020/02/01 23:41:11 |
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Basic information
Public title
Impact of hospitalization due to medical illness on inappropriate prescribing in elderly patients: a prospective observational study.
Acronym
Impact of hospitalization on inappropriate prescribing in elderly patients
Scientific Title
Impact of hospitalization due to medical illness on inappropriate prescribing in elderly patients: a prospective observational study.
Scientific Title:Acronym
Impact of hospitalization on inappropriate prescribing in elderly patients
Region
| Japan |
Condition
Condition
Geriatrics
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of hospitalizations for medical illness on potentially inappropriate medications in elderly patients from admission to discharge. The other is to investigate the association between PIMs and unplanned readmission.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between PIMs and unplanned readmission.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The temporal change in the proportion of patients taking any PIMs from admission to discharge.
Key secondary outcomes
The association between PIMs at discharge and unplanned readmission (30-day and 90-day).
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years or older admitted to the internal medicine ward
Key exclusion criteria
1) A second admission to a medical ward during the study period
2) Death during the hospitalization
3) Transfer to other hospitals or other wards in our hospital
4) Hospitalization for diagnostic testing only
5) Missing data
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Internal medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi, Japan
TEL
028-622-5241
jkomagamine@tochigi-mc.jp
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Internal medicine
Zip code
320-8580
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi, Japan
TEL
028-622-5241
Homepage URL
jkomagamine@tochigi-mc.jp
Sponsor or person
Institute
National Hospital Organization Tochigi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tochigi Medical Center
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi 320-8580, Japan
Tel
028-622-5241
web-info@tochigi-mc.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
| 2017 | Year | 04 | Month | 29 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/9/11/e032574.info
Publication of results
Published
Result
URL related to results and publications
https://bmjopen.bmj.com/content/9/11/e032574.info
Number of participants that the trial has enrolled
739
Results
The proportions of patients taking any PIMs at admission and discharge were 47.2% and 32.2%, respectively. Of all the patients, 39 (5.3%) were readmitted within 30 days after discharge for the index hospitalisation. The use of PIMs at discharge was not associated with an increased risk of 30-day readmission (OR 0.93; 95% CI 0.46 to 1.87). This result did not change after adjusting for patient age, sex, number of medications, duration of hospital stay and comorbidities (OR 0.78; 95% CI 0.36 to 1.66).
Results date posted
| 2020 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 11 | Month | 07 | Day |
Baseline Characteristics
Seven hundred thirty-nine patients were included in this study. The median patient age was 82 years (IQR 74-88); 389 (52.6%) were women, and the median Charlson Comorbidity Index was 2 (IQR 0-3).
Participant flow
Of all the patients, 39 (5.3%) were readmitted within 30 days after discharge for the index hospitalisation.
Adverse events
Of all the patients, 39 (5.3%) were readmitted within 30 days after discharge for the index hospitalisation.
Outcome measures
The primary outcome was 30-day unplanned readmissions. The secondary outcome was the prevalence of any PIM use at admission and discharge. PIMs were defined based on the Beers Criteria.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 04 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:
Prospective observational study
Setting/Participants:
Community general hospital (1 site) with inpatient care.
To evaluate the effect of hospitalizations for medical illness on inappropriate prescribing in elderly patients, 130 consecutive hospitalized patients aged 65 or older who survive to discharge will be included.
To evaluate the association between PIMs at discharge and 30-day unplanned readmission, approximately 550 consecutive hospitalized patients aged 65 or older who survive to discharge will be included.
Measures:
Review of medical records in Tochigi Medical Center. The primary outcome is the change in the proportion of patients taking any PIMs from admission to discharge. PIMs will be defined based on 2015 AGS Beers criteria. The secondary outcome is the association between PIMs at discharge and unplanned readmission (30-day and 90-day). Fisher's exact test will be used to compare the proportion of patients taking any PIMs between admission and discharge. Logistic regression analysis for binary responses using odds ratios will be employed to evaluate the association between PIMs at discharge and 30-day unplanned readmission.
Management information
Registered date
| 2017 | Year | 04 | Month | 29 | Day |
Last modified on
| 2020 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031157
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/04/29 | PIM hispitalization prospective cohort study protocol 20170422.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
