Standardized Patient-Centered Medication Review in Home Hospice

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

NCT05970315

Dementia

UNKNOWN NA

Deprescribing for Older Adults After Hospital Discharge in Home Health Care

NCT05630144

Polypharmacy

COMPLETED NA

Minimizing Risk and Maximizing Outcomes in Geriatric Patients Through Integrated Clinical Pharmacy Services in an Innovative Model of Community Practice

NCT01351441

Medication Adherence Health Literacy Geriatric Patient Care Improvement +1 more

COMPLETED NA

Hospice Quality Score Assessment Post Pharmacist Intervention

NCT04361669

Respiratory Disease Cardiovascular Diseases Neurologic Disorder +2 more

WITHDRAWN

Rural Hospital-Level Care at Home for Acutely Ill Adults

NCT05256303

Infections Heart Failure Chronic Obstructive Pulmonary Disease +8 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The Investigators will compare outcomes within and across 2 large hospice agencies using a cluster randomized trial study design.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Randomization to the educational intervention targeting hospice clinicians is at the level of the hospice. Within each of the 2 hospice agencies, The Investigators will randomize 1 office to intervention and 1 to control status. Outcomes assessment is at the level of the patient and family caregiver who will be masked to randomization status.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SPECTORx Educational Intervention

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.

Group Type EXPERIMENTAL

STOPPFrail (Screening Tool of Older Persons Prescriptions)

Intervention Type BEHAVIORAL

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"

Intervention Type BEHAVIORAL

Education resoruce used by clinicians to simplify and align medications with goals of care

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

Intervention Type BEHAVIORAL

Education resource used by clinicians to support Family Care Givers (FCGs)

Attention Control

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.

Group Type ACTIVE_COMPARATOR

NIA Medication Management - Active Comparator

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

Education resource used by clinicians to support Family Care Givers (FCGs)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No