Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD, Medication Management, Deprescribing
Brief summary
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.
Interventions
BEHAVIORALPharmacist-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.
Sponsors
Duke University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible patients recruited to the intervention | Through the end of enrollment period, up to approximately 1 year | A measure of feasibility of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making (SDM-Q-9) questionnaires | Baseline, 4 weeks, 12 weeks | 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. |
| Medication side effect burden, measured via Living with Medicines Questionnaire (LMQ-3) | Baseline, 4 weeks, 12 weeks | 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. |
| Feasibility of Intervention Measure (FIM) | Baseline, 4 weeks, 12 weeks | 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. |
| Intervention Appropriateness Measure (IAM) | Baseline, 4 weeks, 12 weeks | 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. |
| Modified Medical Research Council (mMRC) questionnaire to measure dyspnea | Baseline, 4 weeks, 12 weeks | 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. |
| Acceptability of Intervention Measure (AIM) | Baseline, 4 weeks, 12 weeks | 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. |
Contacts
CONTACTEmily Hecker, MSN, RN
PRINCIPAL_INVESTIGATORCara McDermott
Duke University
Outcome results
None listed