UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026528 |
|---|---|
| Receipt number | R000030461 |
| Scientific Title | Intervention study on improvement of care transition process using standardized care information sheet in home-bound frail elderly admission |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2023/10/30 10:42:43 |
* 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
Intervention study on improvement of care transition process using standardized care information sheet in home-bound frail elderly admission
Acronym
Care transition process study using standardized care information sheet
Scientific Title
Intervention study on improvement of care transition process using standardized care information sheet in home-bound frail elderly admission
Scientific Title:Acronym
Care transition process study using standardized care information sheet
Region
| Japan |
Condition
Condition
Geriatric syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether treatment is conducted according to the needs of patients and patient families, unnecessary use of medical resources after discharge is reduced, and communication between hospital staff and the primary care physician is promoted, by attaching a standardized care information sheet in addition to ordinary patient referral letter when a home-bound frail elderly who is undergoing home care with long-term care level two or more receives referrals to an acute care hospital and receives hospitalized care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hospitalization experience reflecting the patient's recuperation environment and caregiver's expectation
Patient satisfaction with hospital
Key secondary outcomes
Readmission rate within 30 days after discharge
Health care utilization
Communication between hospital staff and primary care physician
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
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
| Other |
Interventions/Control_1
Ordinary referral letter
Interventions/Control_2
Ordinary referral letter with standardized care information sheet
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
65 years old or older
Long term care level two or higher on Long term care insurance
Provided home-visit care in the last two months or longer
Key exclusion criteria
Interval of home-visit care is three months or longer
Patients that their primary care physician judged that the clinical situation is not suitable for the investigation.
Patients that their primary care physician judged that the main caregiver is unable to fill in the questionnaire due to dementia or physical condition, or not suitable for the investigation.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Matsumura |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division of Clinical Epidemiology
Zip code
1520092
Address
2-5-1 Higashigaoka Meguro-ku Tokyo Japan
TEL
03-3411-0111
shin-mat@nifty.com
Public contact
Name of contact person
| 1st name | Yachie |
| Middle name | |
| Last name | Hayashi |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division of Clinical Epidemiology
Zip code
1520092
Address
2-5-1 Higashigaoka Meguro-ku Tokyo Japan
TEL
03-3411-0111
Homepage URL
hayashiyachie@kankakuki.go.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center, Division of clinical epidemiology
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C) 15K08864
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Oraganization Tokyo Medical Center
Address
2-5-1 Higashigaoka Meguro-ku Tokyo Japan
Tel
03-3411-0111
auchimura@ntmc.hosp.go.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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.sagepub.com/doi/10.1177/20534345231208295
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/10.1177/20534345231208295
Number of participants that the trial has enrolled
764
Results
No significant differences were found in the experience of hospitalization by caregivers. No significant differences in hospitalization satisfaction as measured by the HPSQ-13 were found. No significant differences were found in communication between the primary caregiver and the hospital during hospitalization for the items "inquiries during hospitalization," "goal achievement during hospitalization," and "information sharing with hospital staff. "
Results date posted
| 2023 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age of the subjects was 86.4 years, and 70 (62.5%) were women, of whom 61 (54.5%) needed care four or more. Eight (7.1%) lived alone.
These background factors did not differ significantly between the groups.
Participant flow
Of the total 764 patients (289 in the intervention group and 475 in the control group) who ultimately met the inclusion criteria and provided consent, a total of 177 patients (99 in the control group and 78 in the intervention group) were referred and admitted to acute care hospitals during the study period. Of these subjects, 140 (58 in the intervention group and 82 in the control group), excluding those who died during hospitalization, were admitted for more than 90 days or otherwise dropped out of the study, of which 112 (45 in the intervention group and 67 in the control group) ultimately obtained valid responses and were included in the analysis.
Adverse events
None
Outcome measures
Quality of care transition
Hospital Patient Satisfaction (HPSQ-13)
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 14 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030461
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
