NCT03972163

Standardized Patient-Centered Medication Review in Home Hospice

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 65 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	STOPPFrail (Screening Tool of Older Persons Prescriptions)	A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
BEHAVIORAL	"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
BEHAVIORAL	"Key Approaches to Support Informal Family Caregivers in Managing Medications"	Education resource used by clinicians to support Family Care Givers (FCGs)

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2019-06-03
• Last updated: 2025-05-21
• Results posted: 2025-05-21

Locations

1 site across 1 country: United States