YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey

Completed

• Conditions: Advanced Melanoma
• Interventions: Drug: Ipilimumab

• Registration Number: NCT02224768
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in terms of awareness about these tools, their utilization, knowledge and comprehension of Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional (HCP)s and patients

Detailed Description

A total sample size of 160 to 200 HCPs and 160 to 200 patients

Study Timeline

• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Study Start: 2015-07
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-18
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• HCP experienced in the treatment of patients with the research compound and patients that have received at least one dose

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCP and Patient inclusion	Ipilimumab	HCP inclusion - HCP Experience with treatment of patients with study compound who have been exposed to risk minimization tools Patient inclusion - Patients treated with study compound as per label who have been exposed to the risk minimization materials

Primary Outcome Measures

Name	Time	Method
The proportion of YERVOY HCPs that are aware of the existence of the risk communications tools and how the tools were accessed (i.e. paper or electronic versions)	6 months	Distribution metrics and awareness of the tools from responses through the survey will be analysed and descriptive statistics will be used within the different participant groups
Questionnaire: "Who uses the RM communication tools, how, when they are used and how often they are used"	6 months	Web downloads metrics will be collected and the usage of tools from responses in the survey will be analysed, and descriptive statistics will be used within the participant groups
Level of knowledge and comprehension of the key elements of important identified risks associated with YERVOY treatment based on the scores obtained from the Questionnaire Surveys	6 months	Knowledge and comprehension in HCPs and patients, the knowledge surveys will provide the following data; 1. Total number of responses to the question including the proportions of correct answers to questions where appropriate; 2. Number or frequency and proportion of response options selected; 3. Percentage of responses/total responses per option; 4. Mean value and standard deviation (for appropriate questions); From the obtained data, Acceptable levels of correct responses will be determined, post data analysis, reporting and discussion with EMA, to set baseline levels for potential future evaluations and then the scores will be assessed
HCP and patient behaviours via behavioural questions and scenarios based on the scores obtained from the Questionnaire Surveys	6 months	For determining appropriate behaviours in HCPs and patients, ideal expected behaviours will be mapped to the ideal care pathway from the Failure Modes and Effects Analysis (FMEA) as described in the RMP. The metrics will show: 1. Total of number of participants answering the question.; 2. Proportions of participants providing correct answers (to identify knowledge and comprehension); 3. Proportion of participants showing expected (ideal) behaviour - i.e. correct answers to individual questions.; 4. Proportion of participants showing non-ideal behaviour - i.e. partially correct or incorrect answers to individual questions.; Analysis will examine knowledge, comprehension and behaviours for different participant types (HCP, Hospital type and Country)

Trial Locations

Locations (2)

Local Institution; 🇬🇧 St. Ives, Cambridgeshire, United Kingdom

Bristol-Myers Squibb; 🇺🇸 Princeton, New Jersey, United States