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

• Medication therapy management (Behavioral): 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.

Primary outcomes

• Mean Change From Baseline in the Medication Appropriateness Index [Baseline and 3 months]: The Medication Appropriateness Index (MAI) is a score based on 10 criteria used to assess the appropriateness of each medication taken by a study participant. Medications are rated as "appropriate", "marginally appropriate", or "inappropriate" based on these ten criteria. Each medication was scored between 0 (appropriate) and the maximum of 18 (inappropriate for all criteria), then the total MAI was obtained by adding the medication specific MAIs for all medications reported by the participant. For each participant, the total MAI is calculated as the sum of the score for all the medications taken by that participant. The minimum is 0 (all medications are appropriate), but there is no maximum because that depends on the number of medications. A decrease in MAI indicates improvement in medication appropriateness.
• Participant Satisfaction [6 months]: Patients will be asked to provide feedback on participation in the deprescribing process.
• Connectivity Issues [3 months and 6 months]: Participants will be asked to report on any connectivity issues that would impact the appropriate delivery of the intervention using the telemedicine approach. Number of participants that experienced any connectivity issues.

Secondary outcomes

• Deprescribing Assessments [6 months]: The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing
• Caregiver Assessment- Zarit [6 months]: The appraisal of self-care will be used to asses additional outcomes in caregiver. Zarit Burden Interview includes 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
• Cognitive Function- CDR Global Score [6 months]: The investigators will use the cognitive battery that is incorporated in the telemedicine assessments to explore the impact of the intervention on cognitive function. Clinical Dementia Rating (CDR) Global Score 0: Normal (unimpaired) cognition; 0.5: MCI due to AD; 1: Mild AD dementia; 2: Moderate AD dementia; 3: Severe AD dementia

Sex: All, ages: 60 Years to any

1. 60 years or older,
2. diagnosed with mild cognitive impairment or dementia,
3. using at least one potentially inappropriate medications,
4. living in the community,
5. willing to participate in the study (both the patient and the caregiver)

Participant flow

Outcome results

• Mean Change From Baseline in the Medication Appropriateness Index (Primary), Least squares mean, units on a scale: Intervention -5.8 +/- 6.3
• Participant Satisfaction (Primary), Count of participants, Participants: Intervention 10
• Connectivity Issues (Primary), Count of participants, Participants: Treatment Optimization 6
• Deprescribing Assessments (Secondary), Count of participants, Participants: Treatment Optimization 11
• Caregiver Assessment- Zarit (Secondary), Mean, units on a scale: Treatment Optimization 1.3 +/- 6.6
• Cognitive Function- CDR Global Score (Secondary), Mean, score on a scale: Treatment Optimization 0.2 +/- 0.4

Adverse events

Time frame: 6 months

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2020-10-12)
• Informed Consent Form (PDF, 2022-08-31)

NIH grants: R24AG064025