Over-the-Counter Medication Usage

This study has been completed.
Sponsor:
Information provided by:
Florida Hospital
ClinicalTrials.gov Identifier:
NCT00439348
First received: February 21, 2007
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

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 Intervention
Drugs, Non-Prescription
Medication Systems
Behavioral: Verbal advice
Behavioral: Prescription

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improving Over-the-counter Medication Compliance.

Resource links provided by NLM:


Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • Determining which of 2 types of physician direction regarding OTC medication usage improves patients compliance, as assessed at 3 and 6 months after enrollment. [ Time Frame: 3 and 6 months after enrollment. ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: February 2007
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439348

Locations
United States, Florida
Loch Haven Ob/Gyn Group
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Florida Hospital
Investigators
Study Chair: D. A Hill, MD Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program
  More Information

No publications provided

Responsible Party: D. Ashley Hill, M.D., Florida Hospital Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT00439348     History of Changes
Other Study ID Numbers: 07.02.01
Study First Received: February 21, 2007
Last Updated: November 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Hospital:
Calcium
Compliance
Medication compliance
electronic prescription
over-the-counter medications
OTC medications

ClinicalTrials.gov processed this record on August 21, 2014