Deprescribing in Outpatient Internal Medicine Practices

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.

Study Overview

• Status: Completed
• Conditions: Deprescribing
• Intervention / Treatment: Behavioral: medication review

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 75 years or older
• taking 6 or more medications

Exclusion Criteria:

• patients in hospice or palliative care
• in Skilled Nursing Facility
• receiving cancer/oncology treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: medication review - deprescribing / de-escalation may occur; Internal medicine providers and PharmDs will identify patients for whom a medication review and potential deprescribing / de-escalation intervention may be beneficial, and make recommendations to adjust therapy as appropriate.	Behavioral: medication review; Internal medicine providers and PharmDs will identify patients for whom a medication review and potential deprescribing / de-escalation intervention may be beneficial.; Other Names: potential deprescribing / de-escalation
No Intervention: historical controls; No contact or intervention will be made with these patients, only retrospective chart review to gather data such as number of medications, hospitalizations, and falls. Patients included in the historical control arm will be matched to the intervention group based on sex, age, and number of medications as much as possible. The goal will be to include 50 patients in both the intervention and control arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of medications	Change in number of medications	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Medication Appropriateness Index scores	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.	Month 3
Change in Quality of life scores	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.	Month 3
Number of documented falls	Number of documented falls	Month 3
Number of documented hospitalizations	Number of documented hospitalizations	Month 3
Number of documented visits to Primary Care Physician office	Number of documented visits to Primary Care Physician office	Month 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Pharmacist interventions	Documented via Medication therapy problems (MTP) tracking -	Month 3

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Julia Clements, PharmD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2025
• Primary Completion (Actual): May 6, 2026
• Study Completion (Actual): May 6, 2026

Study Registration Dates

• First Submitted: November 10, 2025
• First Submitted That Met QC Criteria: November 10, 2025
• First Posted (Actual): November 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Polypharmacy; geriatric patients; medication regimens; medication reviews
• Additional Relevant MeSH Terms: Organization and Administration; Health Services Administration; Patient Care Management; Medication Systems; Medication Review
• Other Study ID Numbers: IRB00137786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No