Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia

Study Overview
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Brief Summary
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The AMOR-Kentucky study will examine the impact of a pharmacist-physician patient-centered medication therapy management deprescribing intervention to address inappropriate medication use in patients with cognitive impairment in underserved, lower socioeconomic populations in rural Appalachian Kentucky. The results of this study will provide valuable insights on how to expand and implement deprescribing interventions using telemedicine to reduce the prevalence and the associated healthcare costs of medication-related problems in patients with mild cognitive impairment, Alzheimer's disease and other dementias in rural areas throughout the US. The investigators will assess the potential use of telemedicine in this population by performing an initial single arm, unblinded study of the medication therapy management (MTM) describing intervention in rural/underserved Kentucky Appalachian populations with cognitive impairment and/or dementia using potentially inappropriate medications (n=50). Following initial recruitment and clinical evaluation, engaged participants will have their medication list reviewed by a pharmacist-clinician team to identify targets for deprescribing intervention. The intervention will be engaged remotely with the participant and their caregiver, and the MTM team at 4 weeks post initial evaluation, and then reinforced at a 3-month timepoint. This approach will be carried forward through a telemedicine practice at University of Kentucky that is comprised of approximately 500 patient-caregiver dyads throughout rural areas of Appalachian Kentucky.

Official Title
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Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia: The AMOR Kentucky Study

Conditions
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Dementia, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Medication therapy management


Participation Criteria
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Eligibility Criteria
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60 years or older, diagnosed with mild cognitive impairment or dementia, using at least one potentially inappropriate medications, living in the community, willing to participate in the study (both the patient and the caregiver)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment optimization<br>Participants will undergo an evaluation of all the medications taken and changes will be proposed for treatment optimization. | Behavioral: Medication therapy management<br>* The proposed deprescribing intervention is using a patient-centered framework by: (1) balancing the risks and benefits, and addressing the specific needs of each individual patient, (2) considering the individual patient and the caregiver's preferences and values, and (3) empowering the patient and the caregiver to take responsibility and fully participate in the decision-making process as equal team players.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medication use | Medication Appropriateness Index (MAI) and change in number of medications (total number and number of PIM)will be measured as change from baseline. | 3 months and 6 months | 
| Participant satisfaction | Patients and caregivers will be asked to provide feedback on participation in the deprescribing process. | 6 months | 
| Connectivity issues | Participants will be asked to report on any connectivity issues that would impact the appropriate delivery of the intervention using the telemedicine approach. | 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deprescribing assessments | The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing | 6 months | 
| Caregiver assessment | The appraisal of self-care will be used to asses additional outcomes in caregiver | 6 months | 
| Cognitive function | The investigators will use the cognitive battery that is incorporated in the telemedicine assessments to explore the impact of the intervention on cognitive function. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rural population, medication optimization, dementia, Alzheimer's disease, telemedicine