Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video

The primary aim of this study is to evaluate the effects of prospective patient education on patient satisfaction with administration of topical 5% 5-fluorouracil cream for the treatment of actinic keratosis involving the face, scalp, upper chest, dorsal hands and forearms. Specifically, this study aims to determine if prospective patient viewing of an educational video delineating treatment effects and expectations improves patient satisfaction and treatment completion rates.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with a clinical diagnosis of actinic keratoses with at least 6 clinically-diagnosed actinic keratoses on the face, bald scalp, arms, upper chest, OR dorsal hands classified as grade I, mild (slightly palpable actinic keratoses, more easily felt than seen), and II, moderate (moderately thick hyperkeratotic actinic keratoses, easily felt).

Exclusion criteria

Patients using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressor drugs, corticosteroids, retinoids, or investigational drugs within 4 weeks prior to enrollment.
Patients who have been treated with any topical drug for actinic keratoses lesions less than 8 weeks prior to enrollment.
Patients with invasive tumors within the treated area (e.g. invasive squamous cell carcinoma)
Patients who have exhibited any dermatological disease within the treated or adjacent (3 cm distance) area at the time of screening.
Patients who have known allergies to fluorouracil (5-FU).

Treatment and study plan

Video Group

Other

Subjects will view a brief video today (about 5 minutes long) that provides information on the cream medication that will be used for treatment of your actinic keratoses.

Verbal Group

Other

The physician will provide information about the cream medication for the treatment of actinic keratoses through a regular conversation.

Primary outcomes

Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream

Time frame: 4 weeks

The level of patient satisfaction will be assessed via questionnaire and visual analog scale.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

CQI Pilot Study Evaluating the Utility of an Educational Video in the Setting of Topical 5-fluorouracil Therapy to Treat Actinic Keratoses and Its Influence on Patient Satisfaction

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Feb 14, 2014
Registry last updated: Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed