UMIN-CTR Clinical Trial

Basic information
Public title	The Development of Psychometric Property of Japanese version of Scale of Attitudes Toward Pharmacist-Physician Collaboration
Acronym	The Development of Psychometric Property of Japanese version of Scale of Attitudes Toward Pharmacist-Physician Collaboration
Scientific Title	The Development of Psychometric Property of Japanese version of Scale of Attitudes Toward Pharmacist-Physician Collaboration
Scientific Title:Acronym	The Development of Psychometric Property of Japanese version of Scale of Attitudes Toward Pharmacist-Physician Collaboration
Region	Japan

Condition
Condition	students
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to develop the Japanese version of scale of attitudes toward pharmacist-physician collaboration (SATP2C) and to assess the reliability and validity of SATP2C.
Basic objectives2	Others
Basic objectives -Others	The ability to detect change is assessed by comparing SATP2C score before and after school joint curriculum intended for the medical students and pharmacy students.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The Psychometric Property of Japanese version of SATP2C
Key secondary outcomes	Changes in the score of SATP2C through interprofessional education

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Physician, pharmacist, medical student, or pharmacy student 2. Native Japanese speaker
Key exclusion criteria	None
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Kanayuki Middle name Last name Kitahara
Organization	Showa University
Division name	School of pharmacy
Zip code	1428666
Address	Hatanodai 1-5-8, Shinagawa-ku, Tokyo
TEL	03-3784-8467
Email	k.kitahara@cmed.showa-u.ac.jp

Public contact
Name of contact person	1st name Kanayuki Middle name Last name Kitahara
Organization	Showa University
Division name	School of pharmacy
Zip code	1428666
Address	Hatanodai 1-5-8, Shinagawa-ku, Tokyo
TEL	03-3784-8467
Homepage URL
Email	k.kitahara@cmed.showa-u.ac.jp

Sponsor
Institute	Showa university
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo University of Pharmacy and Life Sciences, Department of Practical Pharmacy Tohoku University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	School of Medicine, Showa University ETHICAL COMMITTEE
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
Tel	03-3784-8022
Email	gakuji@ofc.showa-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	2016 Year 10 Month 24 Day

Related information
URL releasing protocol	https://www.tandfonline.com/doi/abs/10.1080/13561820.2020.1834369?journalCode=ijic20
Publication of results	Published

Result
URL related to results and publications	https://www.tandfonline.com/doi/abs/10.1080/13561820.2020.1834369?journalCode=ijic20
Number of participants that the trial has enrolled	137
Results	The scale showed confirmed reliability; Cronbach's alphas were 0.79 for Responsibility and Accountability, 0.68 for Shared Authority, and 0.67 for Interdisciplinary Education. Pre and post-IPE, each mean subscale score increased: Responsibility and Accountability, 0.7+/-0.4, Shared Authority, 0.2+/- 0.3; and Interdisciplinary Education, 0.3+/-0.2. Although the total score increased (1.2+/-0.7), this was non-significant.
Results date posted	2021 Year 03 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 11 Month 15 Day
Baseline Characteristics	The participants in Cohort 1 were 21 physicians and 62 pharmacists. The participants in Cohort 2 were 25 medical students and 29 pharmacy students.
Participant flow	The IPE program in this research was a five-day program in which students in the fifth grade of pharmacy school, dental school, and medical school, and fourth grade nursing students cooperated with each other to care for one patient in each ward in eight Showa University-branched hospitals. For students who had not experienced IPE, conducting only one day of IPE may change their attitude toward other professions; therefore, it is difficult to implement test and retest reliability to verify replicability. Consequently, in this study, two cohorts were established. Cohort 1 evaluated replicability, and Cohort 2 assessed criterion-related validity and responsiveness. In Cohort 1, replicability was assessed for physicians and pharmacists using test-retest reliability. Physicians and pharmacists completed background survey items and the SATP2C on the first day and then completed the SATP2C again on the second day. In Cohort 2, we evaluated responsiveness, internal consistency, and validity among medical and pharmacy students, who answered the SATP2C and RIPLS on the first day. After the end of IPE, the medical and pharmacy students answered the SATP2C, RIPLS, and global impression scale again.
Adverse events	none
Outcome measures	pre-and post IPE SATP2C score, post IPE Global impression
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 22 Day
Date of IRB	2016 Year 09 Month 30 Day
Anticipated trial start date	2016 Year 10 Month 24 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry	2017 Year 03 Month 01 Day
Date trial data considered complete	2017 Year 03 Month 01 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Other
Other related information	Reliability of SATP2C is assessed in the cohort of physicians and pharmacists by measuring two pointson the first day and the second day. Response is assessed by comparing SATP2C score before and after multi-school joint curriculum in Showa university intended for medical students and pharmacy students. Criterion-related validity is evaluated by applying RIPLS.

Management information
Registered date	2016 Year 10 Month 23 Day
Last modified on	2021 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028223