- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00393653
Prescription Methods Assessment Project (PMAP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current prescription writing behavior of physicians is largely an informed decision based upon education and experience. The physician typically assesses the signs and symptoms of a patient presentation, laboratory and other clinical tests, and other factors that may be known to the physician (e.g. an inability to swallow capsules, or a requirement to be in direct sunlight for an extended period), and chooses a drug to prescribe with no evidence of patient response to the agent prescribed. The prescribing physician may or may not decide to validate this decision by additional testing in the form of follow-up visits or other procedures that are designed to assess the effectiveness of the prescription after some arbitrary period of time, but not comparatively with other available agents.
Other influences may impact the decision including aggressive promotions by pharmaceutical companies in support of their latest medication and direct to consumer retail advertising. Studies conducted by the University of Washington Medical School have shown that when patients merely enquire about a drug for which they've seen advertising, that drug is then more frequently prescribed (Hollon 2005). At its best, prescription writing is an educated guess with a scheduled follow-up to verify the results of the decision. At its worst, it may result in all risk with no benefit to the patient if the patient is a non-responder, or if the patient accepts an adverse outcome without informing the physician.
The Opt-e-scrip method for determining prescriptions is virtually the same method that is used to assess new drugs for regulatory approval (i.e.,controlled experiments to reduce systematic error, reduce random variation, increase precision of assessment). However, instead of applying the techniques of scientific investigation to populations, these methods are applied to the individual patient. Opt-e-scrip's proprietary methods are used to assess alternative choices within a therapeutic class for effectiveness and safety before prescribing a specific agent for an individual patient. In this case, however, because the drugs are already marketed and cost information is available, when two or more agents are equally safe and effective, a decision can be made reliably on cost as a relevant factor (2006).
Initial studies indicate that the Opt-e-scrip methodology can distinguish between similar medications based on efficacy and/or side effects at the individual patient level in patients with osteoarthritis, gastroesophageal reflux disease (GERD), and allergic rhinitis (Reitberg, Del Rio et al. 2002; Reitberg, Weiss et al. 2005). It remains to be seen how well this method can be integrated into clinical care and how clinicians and patients respond to the method as part of routine care. This project will assess the integration of Opt-e-scrip method into 20 primary care practices that will each use the method to assist with medication selection in 30 to 40 patients with a new diagnosis or uncontrolled osteoarthritis and GERD.
Specific Aims of Study.
- 1. Evaluate whether the (N-of-1) intervention prescription method can be successfully integrated into primary care practices.
- 2. Determine whether use of the intervention prescription method changes medication selection for patients with osteoarthritis and gastroesophageal reflux disease.
- 3. Examine the effects of the intervention method on medication compliance.
- 4. Examine the effects of the intervention prescription method on medication costs.
References
- Hollon, M. F. (2005). "Direct-to-consumer advertising: a haphazard approach to health promotion." Jama 293(16): 2030-3.
- Opt-e-scrip, I. (2006). Optimizing each prescription to the individual, Opt-e-scrip. 2006.
- Reitberg, D. P., E. Del Rio, et al. (2002). "Single-patient drug trial methodology for allergic rhinitis." Ann Pharmacother 36(9): 1366-74.
- Reitberg, D. P., S. L. Weiss, et al. (2005). "Advances in Single-Patient Trials for Drug Treatment Optimization and Risk Management." Drug Information Journal 39: 119-124.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kansas
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Leawood, Kansas, United States, 66211
- American Academy of Family Physicians National Research Network
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- at least 18 years old
- capable of giving informed consent
- a new diagnosis or uncontrolled symptoms of either osteoarthritis or gastroesophageal reflux disease
- if new diagnosis or uncontrolled osteoarthritis, patient must have condition in knee or hip (need not be isolated)
Exclusion Criteria:
- too ill to participate
- not capable of giving informed consent
- not able to be contacted via phone for study follow-up
- unable to read English, including blindness
- if treating physician considers patient to have medical conditions that would cause the patient to be placed at risk by trial participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Side-effects and adverse events (base-line, 3 and 6 months)
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Secondary Outcome Measures
Outcome Measure |
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Symptoms of condition and health related issues (i.e., satisfaction of doctor visit, self-efficacy)at baseline, 3 and 6 months
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Patient medication information and adherence to prescription(s) at 3 and 6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Wilson D Pace, MD, American Academy of Family Physicians
Publications and helpful links
General Publications
- Wolfe B, Del Rio E, Weiss SL, Mendelson A, Elbaga TA, Huser FJ, Reitberg DP. Validation of a single-patient drug trial methodology for personalized management of gastroesophageal reflux disease. J Manag Care Pharm. 2002 Nov-Dec;8(6):459-68. doi: 10.18553/jmcp.2002.8.6.459.
- Reitberg DP, Del Rio E, Weiss SL, Rebell G, Zaias N. Single-patient drug trial methodology for allergic rhinitis. Ann Pharmacother. 2002 Sep;36(9):1366-74. doi: 10.1345/aph.1C031.
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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