Clinical trial NCT00393653: Prescription Methods Assessment Project (PMAP)
Official title: Prescription Methods Assessment Project (PMAP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Gastroesophageal Reflux Disease
Keywords: osteoarthritis
gastroesophageal reflux disease
practice-based research
N-of-1 trial
prescription
single-patient trial
Lead sponsor: American Academy of Family Physicians
Sponsor class: OTHER
First posted: 2006-10-29
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether a novel prescription method (N-of-1 intervention)can be successfully integrated into primary care practices and to examine the effects of this prescription method on selected patient health outcomes (e.g.., medication compliance, medication costs, symptom management, satisfaction of physician/patient visit, etc.) in patients with a uncontrolled or new diagnosis of Osteoarthritis or Chronic Heartburn (GERD).

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

1. Hollon, M. F. (2005). "Direct-to-consumer advertising: a haphazard approach to health promotion." Jama 293(16): 2030-3.
2. Opt-e-scrip, I. (2006). Optimizing each prescription to the individual, Opt-e-scrip. 2006.
3. Reitberg, D. P., E. Del Rio, et al. (2002). "Single-patient drug trial methodology for allergic rhinitis." Ann Pharmacother 36(9): 1366-74.
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Side-effects and adverse events (base-line, 3 and 6 months)
Secondary outcomes:
measure: Symptoms of condition and health related issues (i.e., satisfaction of doctor visit, self-efficacy)at baseline, 3 and 6 months
measure: Patient medication information and adherence to prescription(s) at 3 and 6 months
Other outcomes:
Locations:
city: Leawood
country: United States
facility: American Academy of Family Physicians National Research Network
state: Kansas
Study officials:
affiliation: American Academy of Family Physicians
name: Wilson D Pace, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.