Impacts of a Physician-targeted Price Transparency Tool on Medication Out-of-pocket Costs

September 14, 2021 updated by: NYU Langone Health

Impacts of a Physician-targeted Price Transparency Real Time Prescription Benefits Tool on Medication Out-of-pocket Costs

The goal of this study is to evaluate whether presenting patient out-of-pocket cost information to the provider at the time of prescribing leads to orders for medications with lower out-of-pocket costs. The Real-Time Prescription Benefits (RTPB) tool has been implemented to randomly selected providers across NYU Langone Health's outpatient physician practices. The RTPB tool provides physicians with information about patient out-of-pocket (OOP) cost for medications at the point of outpatient prescribing. OOP is inclusive of any copay, coinsurance, and deductible that the patient owes given their prescription drug benefit plan. If the physician is submitting a prescription order and a clinically-appropriate alternative with a lower OOP cost is available, an alert with OOP cost information for the drug being initially ordered as well as up to three lower-cost alternatives will be displayed. Implementation of this tool will be analyzed to see if it will lead to reduced out-of-pocket costs on ordered medications when alternatives were available. Because effects could vary along many dimensions (e.g., specialty, drug class, insurance type), secondary analyses will be conducted and stratified along such dimensions. Analyses will be conducted at the prescription order level.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21401

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The intervention group refers to medication orders placed by prescribers when practicing in an outpatient department randomly assigned to receive the intervention, which is implementation of the RTPB tool. The control group refers to medication orders placed by prescribers when practicing in an outpatient department randomly selected to not receive the intervention.

Description

Inclusion Criteria:

  • Medication orders for which this match and query was successful and outcomes data was available.

Exclusion Criteria:

  • No patient-level exclusion criteria will be imposed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
See alert
The intervention group refers to medication orders placed by prescribers when practicing in an outpatient department randomly assigned to receive the intervention, which is implementation of the RTPB tool.
Other: Real-time benefits check
Prescribers practicing in outpatient departments assigned to the intervention arm will be shown popup alerts with their patient's insurance benefit design-specific out-of-pocket cost for the drug being ordered as well as out-of-pocket costs for up to 3 lower-cost alternatives if available. Alternatives will only be shown when available and when the patient and his or her benefit design information can be matched by the electronic health record system to accurately query out-of-pocket cost information.
Other Names:
  • Physician-focused medication price transparency
Do not see alert
The non intervention group refers to medication orders placed by prescribers when practicing in an outpatient department randomly selected to not receive the intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medication out of pocket cost per day
Time Frame: Through study completion, an average of 1 year
The primary outcome, which will be measured at the medication-order level is out-of-pocket cost per day for a drug ordered. It will be computed by dividing the out-of-pocket cost of a drug by the days supply. Data will be collected through the electronic health record.
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Whether an order was placed for a mail-order pharmacy
Time Frame: Through study completion, an average of 1 year
A secondary outcome, also specified at the order level, is whether a drug prescription was ordered from a mail-order pharmacy, since switching to a mail-order pharmacy often presents an opportunity for savings. Data will be collected through the electronic health record.
Through study completion, an average of 1 year
Days supply
Time Frame: Through study completion, an average of 1 year
A secondary outcome, also specified at the order level, is the days supply. Data will be collected through the electronic health record.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QI-RTPB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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