Standardized Patient-Centered Medication Review in Home Hospice (SPECTORx)

University of Massachusetts, Worcester

Status: Completed

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

Treatments: 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"; Behavioral: NIA Medication Management - Active Comparator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03972163

H00015417

1R21AG060017 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 65 to 110 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

SPECTORx Educational Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: "Key Approaches to Support Informal Family Caregivers in Managing Medications"

Behavioral: "Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing"

Behavioral: STOPPFrail (Screening Tool of Older Persons Prescriptions)

Attention Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: NIA Medication Management - Active Comparator