Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Family Caregiver Medication Administration Hassle Scale, Baseline |
The 24-item Family Caregiver Medication Administration Hassle Scale has four subscales: Information Seeking/Sharing, Safety Issues, Scheduling Logistics, and Polypharmacy. Overall scale reliability is .95. Higher scores indicate greater burden. |
Enrollment |
|
Primary |
Family Caregiver Medication Administration Hassle Scale, Week 2 |
The 24-item Family Caregiver Medication Administration Hassle Scale has four subscales: Information Seeking/Sharing, Safety Issues, Scheduling Logistics, and Polypharmacy. Overall scale reliability is .95. Higher scores indicate greater burden. |
2 weeks post enrollment |
|
Primary |
Family Caregiver Medication Administration Hassle Scale, Week 4 |
The 24-item Family Caregiver Medication Administration Hassle Scale has four subscales: Information Seeking/Sharing, Safety Issues, Scheduling Logistics, and Polypharmacy. Overall scale reliability is .95. Higher scores indicate greater burden. |
4 weeks post enrollment |
|
Primary |
Family Caregiver Medication Administration Hassle Scale, Week 12 |
The 24-item Family Caregiver Medication Administration Hassle Scale has four subscales: Information Seeking/Sharing, Safety Issues, Scheduling Logistics, and Polypharmacy. Overall scale reliability is .95. Higher scores indicate greater burden. |
12 weeks post enrollment |
|
Primary |
Family Caregiver Medication Administration Hassle Scale, Week 24 |
The 24-item Family Caregiver Medication Administration Hassle Scale has four subscales: Information Seeking/Sharing, Safety Issues, Scheduling Logistics, and Polypharmacy. Overall scale reliability is .95. Higher scores indicate greater burden. |
24 weeks post enrollment |
|
Secondary |
Medication Regimen Complexity Index, Baseline |
Medication Regimen Complexity Index (MCRI) will characterize patients' chronic disease and preventive medication regimens (i.e. drugs initiated prior to hospice admission, not End of Life (EOL) symptom medications [e.g. haloperidol] because these increase over time). MRCI score weights dosage form, dosing frequency and administration instructions. Minimum MRCI is 1.5 [a single tablet once a day] and maximum score increases with medication number. Higher scores indicate greater complexity. |
Enrollment |
|
Secondary |
Medication Regimen Complexity Index, Week 2 |
Medication Regimen Complexity Index (MCRI) will characterize patients' chronic disease and preventive medication regimens (i.e. drugs initiated prior to hospice admission, not End of Life (EOL) symptom medications [e.g. haloperidol] because these increase over time). MRCI score weights dosage form, dosing frequency and administration instructions. Minimum MRCI is 1.5 [a single tablet once a day] and maximum score increases with medication number. Higher scores indicate greater complexity. |
2 weeks post enrollment |
|
Secondary |
Medication Regimen Complexity Index, Week 4 |
Medication Regimen Complexity Index (MCRI) will characterize patients' chronic disease and preventive medication regimens (i.e. drugs initiated prior to hospice admission, not End of Life (EOL) symptom medications [e.g. haloperidol] because these increase over time). MRCI score weights dosage form, dosing frequency and administration instructions. Minimum MRCI is 1.5 [a single tablet once a day] and maximum score increases with medication number. Higher scores indicate greater complexity. |
4 weeks post enrollment |
|
Secondary |
Medication Regimen Complexity Index, Week 12 |
Medication Regimen Complexity Index (MCRI) will characterize patients' chronic disease and preventive medication regimens (i.e. drugs initiated prior to hospice admission, not End of Life (EOL) symptom medications [e.g. haloperidol] because these increase over time). MRCI score weights dosage form, dosing frequency and administration instructions. Minimum MRCI is 1.5 [a single tablet once a day] and maximum score increases with medication number. Higher scores indicate greater complexity. |
12 weeks post enrollment |
|
Secondary |
Medication Regimen Complexity Index, Week 24 |
Medication Regimen Complexity Index (MCRI) will characterize patients' chronic disease and preventive medication regimens (i.e. drugs initiated prior to hospice admission, not End of Life (EOL) symptom medications [e.g. haloperidol] because these increase over time). MRCI score weights dosage form, dosing frequency and administration instructions. Minimum MRCI is 1.5 [a single tablet once a day] and maximum score increases with medication number. Higher scores indicate greater complexity. |
24 weeks post enrollment |
|
Secondary |
Potentially Inappropriate Medications (PIM), Baseline |
Number of PIMs is based on STOPPFrail Criteria will be counted. Number of PIMs is based on STOPPFrail Criteria will be counted. High number if PIMs indicates greater burden of inappropriate medications. |
Enrollment |
|
Secondary |
Potentially Inappropriate Medications (PIM), Week 2 |
Number of PIMs is based on STOPPFrail Criteria will be counted. Number of PIMs is based on STOPPFrail Criteria will be counted. High number if PIMs indicates greater burden of inappropriate medications. |
2 weeks post enrollment |
|
Secondary |
Potentially Inappropriate Medications (PIM), Week 4 |
Number of PIMs is based on STOPPFrail Criteria will be counted. Number of PIMs is based on STOPPFrail Criteria will be counted. High number if PIMs indicates greater burden of inappropriate medications. |
4 weeks post enrollment |
|
Secondary |
Potentially Inappropriate Medications (PIM), Week 12 |
Number of PIMs is based on STOPPFrail Criteria will be counted. Number of PIMs is based on STOPPFrail Criteria will be counted. High number if PIMs indicates greater burden of inappropriate medications. |
12 weeks post enrollment |
|
Secondary |
Potentially Inappropriate Medications (PIM), Week 24 |
Number of PIMs is based on STOPPFrail Criteria will be counted. Number of PIMs is based on STOPPFrail Criteria will be counted. High number if PIMs indicates greater burden of inappropriate medications. |
24 weeks post enrollment |
|
Secondary |
Functional status, Baseline |
Karnofsky Performance Status classifies patient's function. The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death. |
Enrollment |
|
Secondary |
Functional status, Week 2 |
Karnofsky Performance Status classifies patient's function. The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death. |
2 weeks post enrollment |
|
Secondary |
Functional status, Week 4 |
Karnofsky Performance Status classifies patient's function. The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death. |
4 weeks post enrollment |
|
Secondary |
Functional status, Week 12 |
Karnofsky Performance Status classifies patient's function. The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death. |
12 weeks post enrollment |
|
Secondary |
Functional status, Week 24 |
Karnofsky Performance Status classifies patient's function. The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death. |
24 weeks post enrollment |
|
Secondary |
Adverse events, Week 2 |
Hospitalizations and Emergency Department (ED) visits will be abstracted from the hospice record. Potential Adverse Drug Event (ADE)s and Adverse Drug Withdrawal Events (ADWEs) will be determined from medical record review using an approach by Hanlon et al. |
2 weeks post enrollment |
|
Secondary |
Adverse events, Week 4 |
Hospitalizations and Emergency Department (ED) visits will be abstracted from the hospice record. Potential Adverse Drug Event (ADE)s and Adverse Drug Withdrawal Events (ADWEs) will be determined from medical record review using an approach by Hanlon et al. |
4 weeks post enrollment |
|
Secondary |
Adverse events, Week 12 |
Hospitalizations and Emergency Department (ED) visits will be abstracted from the hospice record. Potential Adverse Drug Event (ADE)s and Adverse Drug Withdrawal Events (ADWEs) will be determined from medical record review using an approach by Hanlon et al. |
12 weeks post enrollment |
|
Secondary |
Adverse events, week 24 |
Hospitalizations and Emergency Department (ED) visits will be abstracted from the hospice record. Potential Adverse Drug Event (ADE)s and Adverse Drug Withdrawal Events (ADWEs) will be determined from medical record review using an approach by Hanlon et al. |
24 weeks post enrollment |
|