Deprescribing in Outpatient Internal Medicine Practices
- Conditions
- Deprescribing
- Registration Number
- NCT07226960
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
The purpose of this study is to evaluate the impact of pharmacist-led medication reviews and deprescribing or de-escalation interventions on reducing the number of medications, falls, and hospitalizations, and improvement in quality of life in geriatric patients.
- Detailed Description
With increasing age, key pharmacokinetic processes such as first-pass metabolism, bioavailability, drug distribution, and clearance, are affected, necessitating dose adjustments and careful medication management. Despite these risks, medication regimens in elderly patients are often left unchanged over time. Deprescribing, the intentional reduction or discontinuation of medications, has been shown to improve quality of life, reduce fall risk, minimize cognitive impairment, and decrease adverse drug interactions. In this analysis, the PharmD will perform a comprehensive medication review with the patient and collaborate with the provider and patient through shared decision making to deprescribe and/or dose reduce medication therapy where risks may outweigh benefits for the patient.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 75 years or older
- taking 6 or more medications
- patients in hospice or palliative care
- in Skilled Nursing Facility
- receiving cancer/oncology treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in number of medications Month 3 Change in number of medications
- Secondary Outcome Measures
Name Time Method Change in Medication Appropriateness Index scores Month 3 The Medication Appropriateness Index (MAI) score is a quantitative measure of prescribing appropriateness, where lower scores indicate more appropriate medication use, and higher scores indicate less appropriate use.
Each criterion is rated on a 3-point scale:
Appropriate (score of 0 or a low value) Each criterion is assigned a weight ranging from 1 to 3, with a maximum total score of 18 possible per drug.
A summated score can be calculated for a patient by combining the scores for all their medications. This summated score is not standardized, meaning the potential total score depends on the number of medications the patient is taking. A score of 0 for a medication indicates ideal or appropriate prescribing for that specific criterion. Higher scores are associated with potentially inappropriate medication (PIM) use, increased risk of adverse drug events (ADEs), higher rates of unscheduled ambulatory or emergency department visits, and lower health-related quality of life.Change in Quality of life scores Month 3 The Lübeck Medication Satisfaction Questionnaire (LMSQ) is scored by calculating the average score for each of its six subscales, which are based on three Likert-scale items each. Patients rate their agreement with each statement on a four-point scale (1=strongly disagree, 4=strongly agree), but items phrased negatively must be reverse-scored before calculating the subscale average. To get the subscale score, you sum the three items' scores and divide by three.
Number of documented falls Month 3 Number of documented falls
Number of documented hospitalizations Month 3 Number of documented hospitalizations
Number of documented visits to Primary Care Physician office Month 3 Number of documented visits to Primary Care Physician office
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences🇺🇸Winston-Salem, North Carolina, United StatesAnna Gambrell, PharmDContact980-505-4718anna.gambrell@advocatehealth.org