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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Other: Video Group
* Other: Verbal Group


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video Group<br>Subjects view educational video on the use of cream medication for the treatment of actinic keratoses. | Other: Video Group<br>* 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.<br>|
| Active Comparator: Verbal Group<br>Subjects are given verbal instructions on the use of cream medication for the treatment of actinic keratoses. | Other: Verbal Group<br>* The physician will provide information about the cream medication for the treatment of actinic keratoses through a regular conversation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream | The level of patient satisfaction will be assessed via questionnaire and visual analog scale. | 4 weeks |