Evaluating the Impact of a Value-based Prescription Drug Formulary

NCT ID: NCT04904055

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

36333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to evaluate the impact of the value-based formulary on patient out-of-pocket spending and health plan spending as well as the impact of the value-based formulary on medication use, emergency department visits, hospitalizations, and outpatient office visits.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Value-Based Health Insurance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Value-based Formulary Beneficiaries

enrolled in the value-based formulary

Value-based Formulary

Intervention Type OTHER

Prescription drug formulary tiers informed by estimated value

Standard Formulary Beneficiaries

enrolled in a standard (i.e., non-value-based formulary)

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Value-based Formulary

Prescription drug formulary tiers informed by estimated value

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Individuals:

* aged 0-64
* Continuously enrolled in an employer-sponsored health plan for at least 12 months (with one-month allowable gap) prior to the index date

* For individuals in the exposed group, the index date is defined as the start date of value-based formulary implementation at the employer group level
* For individuals in the control group, the index date is defined as the index date of the matched exposed individual
* Employer groups:

* that transition to the value-based formulary if they transitioned all enrollees in that employer group (no individual selection)

Exclusion Criteria

\- Individuals with:

* missing gender information
* missing zip code level demographics at all member months
Minimum Eligible Age

0 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Donaghue Medical Research Foundation

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kai Yeung, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaiser Permanente

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Yeung K, Cruz M, Tsiao E, Watkins JB, Sullivan SD. Drug use and spending under a formulary informed by cost-effectiveness. J Manag Care Spec Pharm. 2023 Nov;29(11):1175-1183. doi: 10.18553/jmcp.2023.29.11.1175.

Reference Type DERIVED
PMID: 37889867 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

218066

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Community Pharmacy Produce Prescriptions
NCT06920355 NOT_YET_RECRUITING NA
Anticoagulation Adherence Measurement Strategies
NCT07129395 ACTIVE_NOT_RECRUITING