Prediction
**Eligibility Criteria for the Pilot Trial**
### **1.
Patient and Care Partner Dyad**
#### **a.
Eligibility Criteria**
- **Age**: 65 or older.
- **Diagnosis**: MCI or dementia from ICD-9 and ICD-10 codes.
- **Chronic Conditions**: At least one other chronic condition documented on the problem list.
- **Medication List**: Documentation of all prescriptions and over-the-counter medications, both scheduled and as needed.
- **Primary Care Physician**: At the pilot clinic.
- **Routine Visit**: Scheduled visit with a primary care physician during the pilot study period.
- **Care Partners**: Family or other companions age 21 years or older who regularly help the patient with managing medications.
#### **b.
Eligibility Criteria for the MCI/Dementia Cohort**
- **Age**: 65 or older.
- **Diagnosis**: MCI or dementia from ICD-9 and ICD-10 codes.
- **Chronic Conditions**: At least one other chronic condition documented on the problem list.
- **Medication List**: Documentation of all prescriptions and over-the-counter medications, both scheduled and as needed.
- **Primary Care Physician**: At the pilot clinic.
- **Routine Visit**: Scheduled visit with a primary care physician during the pilot study period.
- **Care Partners**: Family or other companions age 21 years or older who regularly help the patient with managing medications.
#### **c.
Eligibility Criteria for the Non-Dementia Cohort**
- **Age**: 75 or older.
- **No MCI or dementia diagnosis**.
- **Chronic Conditions**: At least two chronic conditions documented on the problem list.
- **Medication List**: Documentation of all prescriptions and over-the-counter medications, both scheduled and as needed.
- **Primary Care Physician**: At the pilot clinic.
- **Routine Visit**: Scheduled visit with a primary care physician during the pilot study period.
- **Care Partners**: Family or other companions age 21 years or older who regularly help the patient with managing medications.
### **2.
Drug/ Substance/ Device**
#### **a.
Rationale for Choosing the Drug and Dose**
- **FDA Approved Drugs**: Only selected for non-FDA approved indications or if doses or routes of administration or participant populations are changed.
- **Non-FDA Approved Indications**: Not available for FDA approval.
#### **b.
Justification and Safety Information**
- **Indications**: Non-FDA approved indications.
- **Dosages**: Based on clinical guidelines and patient preference.
- **Routes of Administration**: Oral, intravenous, subcutaneous, etc.
- **Participant Populations**: Long-term care facilities or hospice care at baseline.
### **3.
Study Statistics**
#### **a.
Primary Outcome Variable**
- **Feasibility and Acceptability of the Interventions Among Patients, Care Partners, Clinicians**
- **Secondary Outcomes Variables**
- Proportion of patients who deprescribe 1+ medicine
- Proportion of patients who add 1+ new medicine
- Clinical documentation of deprescribing
- Clinical documentation of a discussion about medication appropriateness, safety or effectiveness (yes/possible vs.
no/absent)
#### **b.
Secondary Outcomes Variables**
- **Prevalence of Deprescribing**
- **Proportion of Patients Who Add New Medicines**
- **Clinical Documentation of Deprescribing**
- **Discussion about Medication Appropriateness, Safety, or Effectiveness**
### **4.
Risks**
#### **a.
Medical Risks**
- **Procedure Details**: Detailed list of procedures, major and minor risks, and expected frequency.
- **Steps Taken to Minimize Risks**: Emphasis on shared-decision-making between patients, care partners, and their primary care physician.
- **Plan for Reporting Unanticipated Problems**: Immediate reporting to the Principal Investigator (Dr.
Green).
#### **b.
Steps Taken to Minimize Risks**
- **Emphasis on Shared-Decision-Making Between Patients, Care Partners, and Their Primary Care Physician**
- **Patient-Centered Education**: Encouraging dialogue about medication management.
- **Use of Language and Approaches for Discussing Deprescribing**: Recommended by patients and care partners.
#### **c.
Plan for Reporting Unanticipated Problems or Study Deviations**
- **Introduction of Gift Cards**: $25 gift cards for participating in the 45-60 minute debriefing interview.
- **Clinicians, Residents, and Medical Assistants**: $25 gift cards for participating in the 30-45 minute debriefing interviews.
#### **d.
Legal Risks**
- **Risk of Breach of Confidentiality**: Small risk of breach of confidentiality.
### **5.
Benefits**
#### **a.
Probable Benefits for the Participant and Society**
- **Patient-Centered, Clinician-Guided Deprescribing**: Safe and effective method for older patients.
- **Improved Outcomes for Older Individuals with Cognitive Impairment**: Taking more medications is associated with greater risk of adverse drug events, drug interactions, treatment burden, and cognitive changes from medication side effects.
- **Educational Brochure**: Provides information on optimal medication management and increases patient/care partner engagement in deprescribing.
#### **b.
Potential Benefits for Society**
- **Improvement in Health Outcomes**: Improved health outcomes for older individuals with cognitive impairment.
- **Enhanced Quality of Life**: Increased quality of life for patients with cognitive impairment and MCC.
- **Reduced Healthcare Costs**: Reduced healthcare costs for patients with cognitive impairment and MCC.
### **6.
Payment and Remuneration**
#### **a.
Compensation for Participants Including Possible Total Compensation, Proposed Bonus, and Any Proposed Reductions or Penalties for Not Completing the Protocol**
- **Participants**: $25 gift card for participating in the 45-60 minute debriefing interview.
- **Clinicians, Residents, and Medical Assistants**: $25 gift card for participating in the 30-45 minute debriefing interviews.
### **7.
Costs**
#### **a.
Cost of Study Procedure(s) or Drug (s) or Substance(s) to Participants and Identify Who Will Pay for Them**
- **No Cost to Participants**.
### **8.
Costs**
#### **b.
Costs of Study Procedure(s) or Drug (s) or Substance(s) to Participants and Identify Who Will Pay for Them**
- **No Cost to Participants**.
### **9.
Costs**
#### **c.
Costs of Study Procedure(s) or Drug (s) or Substance(s) to Participants and Identify Who Will Pay for Them**
- **No Cost to Participants**.
### **10.
Payments and Remuneration**
#### **a.
Detail Compensation for Participants Including Possible Total Compensation, Proposed Bonus, and Any Proposed Reductions or Penalties for Not Completing the Protocol**
- **Participants**: $25 gift card for participating in the 45-60 minute debriefing interview.
- **Clinicians, Residents, and Medical Assistants**: $25 gift card for participating in the 30-45 minute debriefing interviews.
This revised eligibility criteria incorporates the evidence provided, ensuring clinical accuracy and relevance while adhering to the original version.