Over-the-Counter Medication Usage

• Sponsor: AdventHealth (Other)
• Overall Status: Completed
• CT.gov ID: NCT00439348
• Collaborator: (none)
• Enrollment: 246
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 10.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drugs, Non-Prescription; Medication Systems	Behavioral: Verbal advice; Behavioral: Prescription	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 246 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Improving Over-the-counter Medication Compliance.
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electronic prescription Patients receive a prescription for specific over-the-counter medications.	Behavioral: Prescription; Patients receive a prescription for a specific over-the-counter medication.
Active Comparator: Verbal advice	Behavioral: Verbal advice; Patients receive verbal advice regarding specific over-the-counter medications.

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loch Haven Ob/Gyn Group	Orlando	Florida	United States	32804

Sponsors and Collaborators

• AdventHealth

Investigators

• Study Chair: D. A Hill, MD, Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00439348
• Other Study ID Numbers: 07.02.01
• First Posted: Feb 23, 2007
• Last Update Posted: Nov 23, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: Calcium; Compliance; Medication compliance; electronic prescription; over-the-counter medications; OTC medications

Study Results

No Results Posted as of Nov 23, 2009