Standardized Patient-Centered Medication Review in Home Hospice

Palliative Care Clinical Trial

— SPECTORx  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03972163
• Other study ID #: H00015417
• Secondary ID: 1R21AG060017
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• NIA Medication Management - Active Comparator
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.
• STOPPFrail (Screening Tool of Older Persons Prescriptions)
A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
• "Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing"
Education resoruce used by clinicians to simplify and align medications with goals of care
• "Key Approaches to Support Informal Family Caregivers in Managing Medications"
Education resource used by clinicians to support Family Care Givers (FCGs)

Locations

Country	Name	City	State
United States	Care Dimensions	Danvers	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Boston College, National Institute on Aging (NIA), University of Utah

Country where clinical trial is conducted

United States, 

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