Clinical trial NCT04938440: Assessment of Updated Educational Materials for Instanyl®
Official title: Assessment of the Effectiveness of Updated Educational Materials on Prescribers' Knowledge and Behavior With Respect to Risks Associated With INSTANYL® Off-Label Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Cancer Pain
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-06-24
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prescribers of Instanyl® will be assessed before and after the distribution of the updated EMs.

Brief summary: The purpose of the Instanyl study is to learn how much doctors know and understand about Instanyl® before and after they receive updated educational information, including the risks of its unapproved use. In this study, the doctors will complete two surveys: one three months before they receive the updated educational information, and one about six months after they receive this information. They will answer questions about their prescribing behavior plus their knowledge of Instanyl® including any risks.

Detailed description: This is a non-interventional, observational, cross-sectional study of prescribers of Instanyl®.

This study will assess the prescribers' awareness of the updated EMs and changes in prescribers' knowledge and understanding of the key information contained in the updated EMs. The study will enroll approximately 259 prescribers. The first survey (pre-EM survey) will be conducted three months before the distribution of updated EMs, second survey (post-EM survey) will be conducted six months following the distribution of updated EMs.

The data will be collected, through a self-administered web-based questionnaire. All participants will be enrolled in a single observational group:

• Prescriber of Instanyl®

This multi-center study will be conducted in France, the Netherlands, and Poland. The overall duration of the study will be approximately 22 months.

Eligibility criteria: Inclusion Criteria:

1. Specialists of any of those medical specialties targeted for the EMs as agreed with each national competent authority. The foreseen specialties include the following (subject to changes after the EM distribution plan is completed and agreed with national competent authorities):

   * Oncologists and oncoradiologists
   * Anaesthesiologists
   * Pain management prescribers
   * Palliative care prescribers
   * Internal medicine prescribers
   * General practitioner (GPs)
   * Other specialties may be locally included such as hematology. Current and potential prescribers may vary between country; thus, some countries may have modified lists of target specialties.
2. Physicians who have prescribed Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs (post-EM survey) and who intend to prescribe Instanyl® in the following months after each survey.

Exclusion Criteria:

1. Physicians who may have a conflict of interest (that is, prescribers employed by regulatory bodies, pharmaceutical industries).
2. Inactive or retired prescribers.
3. Physicians who did not prescribe Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs are distributed (post-EM survey) and do not foresee treating a participants with Instanyl® in the following 12 months, regardless of whether they have prescribed Instanyl® before.

Primary outcomes:
measure: Percentage of Prescribers With Awareness of Updated Educational Materials (EMs) Based on Post-EM Questionnaire Survey
timeFrame: Up to 6 months (Post-EM Survey)
measure: Percentage of Prescribers With Change in Knowledge and Understanding of Key Safety Information Contained in Updated EMs Based on Pre-EM to Post-EM Questionnaire Survey
timeFrame: Up to 9 months (Pre-EM to Post-EM survey)
measure: Percentage of Prescribers With Change in Self-Reported Behavior Prescribing Based on Pre-EM to Post-EM Questionnaire Survey
timeFrame: Up to 9 months (Pre-EM to Post-EM survey)
measure: Number of Reasons for Off-label Prescription
timeFrame: Up to 3 months (Pre-EM survey)
measure: Number of Prescribers With Awareness of the Profile of Patients at Risk of Misuse and Addiction
timeFrame: Up to 6 months (Post-EM Survey)
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Central Contact
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: