Skip to main content
OpenTrials
Completed

NCT Number: NCT03972163

Standardized Patient-Centered Medication Review in Home Hospice

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Care Dimensions

Danvers, Massachusetts, 01923, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NIA Medication Management - Active Comparator

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.

STOPPFrail (Screening Tool of Older Persons Prescriptions)

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"

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"

Behavioral

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

Primary outcomes

  1. Intervention Training Completion by Hospice Staff

    Time frame: Baseline

    Number of Completed Intervention Trainings

  2. Patient and Family Caregiver Eligibility Screens

    Time frame: 2 weeks prior to enrollment

    Number of Eligible Dyad Participants (i.e. participant = 1 dyad) screened for potential eligibility to inform subsequent eligibility criteria to obtain a sufficient study population.

  3. Patient and Family Caregiver Enrollment

    Time frame: Baseline

    Number of Patients and Family Caregivers who enrolled

  4. Completion of Primary Patient Outcome--Retention

    Time frame: Baseline

    Number of Dyads who completed the Medication Regimen Complexity Score at Baseline

Secondary outcomes

  1. Family Caregiver Medication Administration Hassle Scale

    Time frame: Baseline, 2, 4, 6, 8 12, 16, 20, 24 weeks(or death)

    The 24-item Family Caregiver Medication Administration Hassle Scale has four subscales: Information Seeking/Sharing, Safety Issues, Scheduling Logistics, and Polypharmacy. The theoretical range of the scores across 4 subscales is 0 to 120. Higher scores indicate greater burden. Overall scale reliability is .95.

  2. Medication Regimen Complexity Index

    Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks(or death)

    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. MRCI score of 0 indicates no medication use. There is no established maximum score.

  3. Potential Adverse Event

    Time frame: Week 2, 4, 6, 8, 12, 16, 20, 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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Boston College
  • National Institute on Aging (NIA)
  • University of Utah

Registry information

Official study title

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

Acronym: SPECTORx

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 3, 2019
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.