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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05035225
Other study ID # IRB00277792
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 31, 2023
Est. completion date November 30, 2024

Study information

Verified date May 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Specialty medications often have dispensing restrictions which can be dictated by manufacturer limited distribution strategies, narrow insurance networks, or a combination of both. Unfortunately, this may result in patients being required to use 2 or more pharmacies to fill their prescription medications; this is referred to as multiple pharmacy use (MPU). The investigators' plan is to administer a survey to patients who have been prescribed one or more specialty medications to evaluate the prevalence of MPU in this population as well as to investigate patients' attitudes about MPU and potential factors increasing the likelihood of MPU


Description:

The investigators will identify patients from participating member sites via a review of prescribing records for specific specialty medications. Patients will be contacted via telephone to explain the purpose and risk of the study. Consented patients will then be asked a series of 11 questions about their attitudes and experience with taking and obtaining their specialty medication(s). Additional demographic and clinical information about patients will be collected via chart review.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 800
Est. completion date November 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects 18 years of age or older - English-speakers - An active patient of a performance institution and ability to provide informed consent to participate with the survey - Electronically prescribed at least one specialty medication by a performance site provider, which can be either a new or renewed order, within the last 3 months Exclusion Criteria: - Subjects less than 18 years of age - Non-English speakers - Patients that cannot or are unwilling to provide consent - Patients who have not had a new or renewed specialty medication prescription order placed electronically within the last 3 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
Multiple Pharmacy Use Survey

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (5)

Lead Sponsor Collaborator
Johns Hopkins University The Cleveland Clinic, University of California, Los Angeles, University of Illinois at Chicago, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Patients using Multiple Pharmacies Of all patients consented, the percentage of patients using more than one pharmacy to obtain their medications Within one year of study initiation
Secondary Self-reported adherence and barriers Patient response to questions about having missed doses in the past month Within one year of study initiation
Secondary Method of obtaining medications Patient response to questions about distance from pharmacy and how prescriptions are primarily obtained Within one year of study initiation
Secondary Experience with obtaining and administering medications Patient response to questions about how easy it is for patients to obtain and administer medication Within one year of study initiation
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