Standardized Patient-Centered Medication Review in Home Hospice

Study Overview
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Brief Summary
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This is a pilot cluster randomized trial that tests the effect of a novel intervention that trains hospice staff to 1. regularly review, simplify, and align patients' prescribed medications with their goals of care as their illness progresses, and 2. support family caregivers with education that empowers them to understand each medication's use, develop skills for safe administration, and 3. understand when stopping medications may be beneficial.

Detailed Description
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A tremendous challenge in home hospice care is ensuring that medication prescribing is appropriately aligned to patients' goals of care and that medications are appropriately managed by family caregivers. Therefore, the Investigators propose a novel intervention that trains hospice staff to 1. regularly review, simplify, and align patients' prescribed medications with their goals of care as their illness progresses, and 2. support family caregivers with education that empowers them to understand each medication's use, develop skills for safe administration, and understand when stopping medications may be beneficial. This program is called Standardized PatiEnt-CenTered medicatiOn Review (SPECTORx) in Home Hospice, and is based on a combination of 3 existing, complementary, educational programs that, together, train hospice staff to create a comprehensive, patient-centered, medication management care plan. The program also creates an online learning community that promotes ongoing education and practice change for hospice clinicians. This pilot study aims to demonstrate the feasibility of conducting a clinical trial to evaluate the efficacy of SPECTORx. The long-term objective is to test the hypothesis that SPECTORx reduces inappropriate medication prescribing and improves family caregiver reported quality of care. However, to accomplish this, the Investigators must first address challenging questions regarding the design, feasibility, and execution of trials in home hospice. The Investigators will accomplish this using a stakeholder engagement process to refine the SPECTORx intervention and trial protocol. The Investigators will then conduct a pilot cluster randomized trial and compare outcomes within and across 2 large, multi-office, hospice agencies from Utah and Massachusetts. Within each hospice agency, the Investigators will randomize 1 office to intervention and 1 office to attention control. Target enrollment is n=60 family caregiver-patient dyads of patients aged ≥65 years with advanced, life-limiting illness. Primary outcomes are acceptability and feasibility of the SPECTORx intervention by hospice stakeholders, and acceptability, burden and completion of family caregiver assessments (Family Caregiver Medication Administration Hassle Scale at baseline, 2 weeks, 4 weeks, 12 weeks, and quarterly). The overarching goal of this research is to align patient's prescribed medications with their goals of care at each stage of their advanced illness and to support family caregivers' medication management challenges. Ultimately, the Investigators want to improve the quality of medication prescribing, reduce treatment complexity and medication-related harm, and improve family caregiver outcomes for the almost 600,000 elderly Americans who receive home hospice services annually.

Official Title
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Standardized PatiEnt-CenTered medicatiOn Review (SPECTORx) in Home Hospice

Conditions
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Hospices, Poly Pharmacy, Deprescriptions, Caregivers, Palliative Care, Prescription Drug Overuse, Interdisciplinary Communication

Intervention / Treatment
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* Behavioral: NIA Medication Management - Active Comparator
* Behavioral: STOPPFrail (Screening Tool of Older Persons Prescriptions)
* Behavioral: Discontinuing Medication Appropriately and Understanding the Art of Communication about Deprescribing
* Behavioral: Key Approaches to Support Informal Family Caregivers in Managing Medications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient - Newly admitted home hospice enrollees, aged ≥65 years old with: 1. advanced life-limiting illness; 2. an estimated life expectancy of >1 month; 3. recent functional status decline (defined as change in Karnofsky Performance Status [KPS] to < 80% in prior 3 months); 4. polypharmacy (defined as ≥ 5 regularly scheduled medications [excluding antimicrobials]); 5. cognitive ability to provide informed consent based on a Short Portable Mental Status Questionnaire (SPMSQ) score ≥6 OR, with a legally authorized representative who is willing and able to provide proxy consent. Family (any relative, partner, friend or neighbor who has a significant personal relationship with, and provides a broad range of assistance) Caregiver - self-identification as usually or always providing care to the eligible patient; English-speaking; telephone access; and cognitive ability to participate. Exclusion Criteria: Patient: Imminent death; pain crisis; no family caregiver or health care proxy Family Caregiver: no telephone access; cognitive impairment.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 110 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Investigators will compare outcomes within and across 2 large hospice agencies using a cluster randomized trial study design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPECTORx Educational Intervention<br>The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan. | Behavioral: STOPPFrail (Screening Tool of Older Persons Prescriptions)<br>* A screening tool used by clinicians with frail older adults with life-limiting illness to review medications<br>Behavioral: Discontinuing Medication Appropriately and Understanding the Art of Communication about Deprescribing<br>* Education resoruce used by clinicians to simplify and align medications with goals of care<br>Behavioral: Key Approaches to Support Informal Family Caregivers in Managing Medications<br>* Education resource used by clinicians to support Family Care Givers (FCGs)<br>|
| Active Comparator: Attention Control<br>As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on Medicines and Medication Management to review content and materials for use in Family Care Giver (FCG) support. | Behavioral: NIA Medication Management - Active Comparator<br>* As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on Medicines and Medication Management to review content and materials for use in Family Care Giver (FCG) support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |