NCT04940988

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

March 18, 2021

Last Update Submit

September 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medication out of pocket cost per day

    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 Outcomes (2)

  • Whether an order was placed for a mail-order pharmacy

    Through study completion, an average of 1 year

  • Days supply

    Through study completion, an average of 1 year

Study Arms (2)

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

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.

Interventions

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.

Also known as: Physician-focused medication price transparency
See alert

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

  • Desai SM, Chen AZ, Wang J, Chung WY, Stadelman J, Mahoney C, Szerencsy A, Anzisi L, Mehrotra A, Horwitz LI. Effects of Real-time Prescription Benefit Recommendations on Patient Out-of-Pocket Costs: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2022 Nov 1;182(11):1129-1137. doi: 10.1001/jamainternmed.2022.3946.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2021

First Posted

June 28, 2021

Study Start

November 18, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations