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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL159239 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist-led Medication Management | Experimental | Pharmacist visit for inhaler teaching and medication optimization with follow-up at weeks 4 and 12. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist-led Medication Management Intervention | Behavioral | In-clinic or telehealth pharmacist visit for inhaler teaching, medication optimization, and deprescribing counseling; includes follow-up at weeks 4 and 12. |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Hecker, MSN, RN | Contact | (919) 660-6612 | emily.hecker@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cara McDermott | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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 |
| At week 12 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |