Clinical Trial: A Randomized Study Comparing Opt-In and Opt-Out Consent Models for Resident Physician Consultations and Case Report Publication in General Internal Medicine Outpatient Clinics (Japan)

Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062324) titled 'A Randomized Study Comparing Opt-In and Opt-Out Consent Models for Resident Physician Consultations and Case Report Publication in General Internal Medicine Outpatient Clinics' on July 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Chiba Central Medical Center

Condition: Condition - Not applicable (study of consent procedures in general internal medicine outpatients) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate whether the consent model (opt-in vs. opt-out) differentially affects patient consent rates for resident physician consultations and case report publication in a general internal medicine outpatient setting. Basic objectives2 - Others

Intervention: Interventions/Control_1 - An opt-in consent form was distributed by administrative staff prior to the clinical encounter at first visit. The form addressed two items: (1) consent to be initially examined by a resident physician under the supervision of an attending physician, and (2) consent for their clinical case to be used in a published case report. Patients were required to actively indicate consent by checking a box for each item. Interventions/Control_2 - An opt-out consent form was distributed by administrative staff prior to the clinical encounter at first visit. The form addressed two items: (1) consent to be initially examined by a resident physician under the supervision of an attending physician, and (2) consent for their clinical case to be used in a published case report. Consent was presumed unless patients actively declined by checking a box for each item.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - New outpatients aged 18 years or older attending the general internal medicine outpatient clinic of Chiba Central Medical Center during the 15-month resident physician training period between April 2021 and January 2023 Key exclusion criteria - Patients were excluded if their consent form contained insufficient information to determine their response, if they declined participation in the study, or if written consent could not be obtained due to severe communication difficulties without a proxy available. Target Size - 178

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2021 Year 02 Month 24 Day Date of IRB - 2021 Year 02 Month 24 Day Anticipated trial start date - 2021 Year 04 Month 01 Day Last follow-up date - 2023 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071268

Disclaimer: Curated by HT Syndication.