Topical Corticosteroid App

NCT ID: NCT02921503

Last Updated: 2018-08-15

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

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2018-06-01

Brief Summary

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

The study aims to evaluate the effectiveness of a mobile application to assist in the prescription of topical corticosteroids (TCS), focusing on best fit choices of potency, vehicle and volume. The mobile application will be developed from the results obtained in a systematic literature review and quality assessment of clinical practice guidelines for topical corticosteroid use. The quality of the guidelines will be assessed using the AGREE II tool. After the app user enters in information concerning patients' rash location and desired treatment duration, the app will generate a list of recommended topical steroids (focusing on specific quantity and potency) for the patient's particular area of need. The objective of the study is to evaluate whether the use of a standardized application will change prescribing practices for primary care physicians, physician assistants and nurse practitioners.

Detailed Description

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

Primary Study Endpoints The primary endpoint of this study to be measured would be topical steroid prescription records (including unit sizes, potencies, and number of prescriptions) from study participants before and during use of this app.

Secondary Study Endpoints The study participants will also be asked to take surveys to rate user satisfaction and clinical utility.

2.1 Scientific Background and Gaps The literature has shown that patients with dermatologic conditions may not receive appropriate management by PCPs. Dermatologic conditions are common, affecting 20-36% of patients in PCP offices; however PCPs report diagnostic and management uncertainty.1,2 PCPs have been shown to prescribe either inappropriately high-potency TCS or, conversely, inappropriately low-potency TCS.3 In addition, it was recently found that drug costs may be higher if multiple small tubes are dispensed over the treatment course.4 Thus, there are opportunities to reduce cost by prescribing larger units, when indicated; however PCPs may not have the knowledge to effectively and cost-efficiently prescribe TCS. Teaching this information is not sufficient, since most (71%) medical schools provided nine or fewer hours of instruction in the first two years.5 Importantly, mobile devices and apps provide significantly increased access to point-of-care tools and, with use by providers, demonstrate better clinical decision-making and improved patient outcomes.6,7 Thus, our goal is to develop a point-of-care decision support app to educate PCPs while facilitating evidence-based care and lower health care costs.

The mobile application will be developed by a team at Penn State Hershey from the results obtained in a systematic literature review and quality assessment of clinical practice guidelines for topical corticosteroid use. The quality of the guidelines will be assessed using the AGREE II tool. After the app user enters in information concerning patients' rash location and desired treatment duration, the app will generate a list of recommended topical steroids (focusing on specific quantity and potency) for the patient's particular area of need. It is ultimately up to the physician whether or not to follow or modify the recommended suggestions.

Study Rationale Smartphone applications are rising rapidly in popularity in the healthcare field. 85% of clinicians are reported as owners of smart phones, with 50% of them using apps in their practice.8 Use of smartphone technology and clinical decision support tools may mean improvements in primary care practices by assisting in the standardization of the prescribing practices for TCS while allowing dermatologists more availability for patients with higher need.

Conditions

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

Topical Corticosteroid, Topical, Medication, Utilization

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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

Topical Corticosteroids App Users

Practitioners will asked to use a novel application during their patient encounters over the next three months. This application should not modify treatment, it will only act as a vehicle to present evidence based research. Patients will not be subjects of this research, as the app is only presenting best practice which the physicians should be aware of.

Group Type EXPERIMENTAL

mobile topical corticosteroid app

Intervention Type OTHER

app used on mobile phones that takes the input of providers and suggests topical corticosteroids with specific information on the ingredient, vehicle, and amount

Interventions

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

mobile topical corticosteroid app

app used on mobile phones that takes the input of providers and suggests topical corticosteroids with specific information on the ingredient, vehicle, and amount

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

1. Primary Care Providers in the Hershey Medical Center network:

1. Attending physicians
2. Physician assistants
3. Nurse practitioners
2. 18 years of age or older
3. English speaking
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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

Joslyn S. Kirby

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Department of Dermatology, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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

United States

Other Identifiers

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

00005201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Methotrexat to Hand Eczema in the BIOSKIN Cohort
NCT07338305 ACTIVE_NOT_RECRUITING
Allergic Disease Onset Prevention Study
NCT05003804 COMPLETED PHASE1/PHASE2