Feasibility Pilot Trial of Med Management in COPD

Feasibility Pilot Trial of a Pharmacist-led Medication Management Intervention for Multi-Morbid Adults With Chronic Obstructive Pulmonary Disease

A pilot trial to examine feasibility of a pharmacist-led intervention for patients with COPD (Chronic Obstructive Pulmonary Disease) and multimorbidity to improve medication safety and reduce dyspnea. Patients will receive inhaler teaching and medication optimization counseling. Outcomes include feasibility, acceptability, appropriateness, and exploratory measures such as medication discontinuation and patient-reported symptom burden.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Behavioral: Pharmacist-led Medication Management Intervention

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Hecker, MSN, RN; Phone Number: (919) 660-6612; Email: emily.hecker@duke.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥ 45
• Diagnosis of COPD
• Medicare/Medicaid insured
• Using an inhaler
• Reports dyspnea or suboptimal medication adherence

Exclusion Criteria:

• Under age 18 (caregivers/clinicians)
• Under age 45 (patients)
• Opioid use disorder
• Cognitive impairment
• Unable to communicate in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist-led Medication Management; Pharmacist visit for inhaler teaching and medication optimization with follow-up at weeks 4 and 12.	Behavioral: Pharmacist-led Medication Management Intervention; In-clinic or telehealth pharmacist visit for inhaler teaching, medication optimization, and deprescribing counseling; includes follow-up at weeks 4 and 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible patients recruited to the intervention	A measure of feasibility of the intervention.	Through the end of enrollment period, up to approximately 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM)	The AIM is comprised of 4 items rated on a 5-point Likert scale, where the total score ranges from 4 to 20. A higher score indicates greater acceptability.	Baseline, 4 weeks, 12 weeks
Feasibility of Intervention Measure (FIM)	The FIM is comprised of 4 items rated on a 5-point Likert scale, where the total score ranges from 4 to 20. A higher score indicates greater feasibility.	Baseline, 4 weeks, 12 weeks
Intervention Appropriateness Measure (IAM)	The IAM is comprised of 4 items rated on a 5-point Likert scale, where the total score ranges from 4 to 20. A higher score indicates greater appropriateness.	Baseline, 4 weeks, 12 weeks
Modified Medical Research Council (mMRC) questionnaire to measure dyspnea	The mMRC dyspnea scale is a 5-grade (0 to 4) questionnaire that measures the severity of breathlessness in daily activities, commonly used for assessing functional disability in COPD and other respiratory diseases. A higher score indicates greater, more incapacitating breathlessness.	Baseline, 4 weeks, 12 weeks
Medication side effect burden, measured via Living with Medicines Questionnaire (LMQ-3)	Medication side effect burden refers to the physical, emotional, and practical impact of adverse drug reactions, often causing reduced quality of life, non-adherence, and treatment discontinuation.	Baseline, 4 weeks, 12 weeks
Shared Decision Making (SDM-Q-9) questionnaires	The SDM-Q-9 has a total score range of 0 to 45, where a higher score indicates greater shared decision-making between patients and providers.	Baseline, 4 weeks, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Fall Risk-Increasing Drug (FRID) discontinuation per patient report	FRIDs are medications that heighten the risk of falls in older adults by causing dizziness, sedation, or impaired balance.	At week 4
Perceptions of the intervention via qualitative interviews		At week 12

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Cara McDermott, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Deprescribing; Medication Management
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Pro00118496; K23HL159239 (U.S. NIH Grant/Contract)

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