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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
First received
Last updated
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
Health authority
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.

Study Design


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
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