Over-the-Counter Medication Usage

Not Applicable

Completed

• Conditions: Medication Systems; Drugs, Non-Prescription
• Interventions: Behavioral: Prescription; Behavioral: Verbal advice

• Registration Number: NCT00439348
• Lead Sponsor: AdventHealth

Brief Summary

There are several benefits of over-the-counter medications, yet there is little research evaluating how to increase patient compliance when a health care provider suggests an over-the-counter (OTC) medication. We are evaluating two types of physician directions to see which increases patient compliance with OTC medications.

Detailed Description

Researchers will identify a cohort of gynecologic patients presenting for annual examinations and offer participation in the study. Physician researchers will randomize patients to 2 types of physician directions about OTC medications, then follow compliance over the course of the next 7 months. A total of 123 participants in each arm will undergo recruitment, until a total of 246 participants are recruited.

Inclusion criteria include: female, non-pregnant patients presenting for annual gynecologic examinations between the ages of 19-50.

Exclusion criteria include: outside of study age range, patient taking thyroid medication, history of kidney stones, history of hypercalcemia, non-English speaking.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-21
• Study First Submitted QC: 2007-02-21
• Study First Posted: 2007-02-23
• Primary Completion: 2008-11
• Study Completion: 2009-02
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-20
• Last Update Posted: 2009-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 246

Inclusion Criteria

• Female patients undergoing annual gynecologic examinations.
• Ages 19-50.
• Patients not currently taking certain OTC medications.

Exclusion Criteria

• Pregnancy.
• History of hypercalcemia.
• History of kidney stones.
• Outside study age range of 19-50.
• Patient taking thyroid medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electronic prescription	Prescription	Patients receive a prescription for specific over-the-counter medications.
Verbal advice	Verbal advice	-

Primary Outcome Measures

Name	Time	Method
Determining which of 2 types of physician direction regarding OTC medication usage improves patients compliance, as assessed at 3 and 6 months after enrollment.	3 and 6 months after enrollment.

Trial Locations

Locations (1)

Loch Haven Ob/Gyn Group; 🇺🇸 Orlando, Florida, United States