Standardized Patient-Centered Medication Review in Home Hospice

NCT03972163 | Completed Results DMC

• 2 other identifiers: H000154171R21AG060017
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Intervention Training Completion by Hospice Staff

  Number of Completed Intervention Trainings

  Baseline

• Patient and Family Caregiver Eligibility Screens

  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.

  2 weeks prior to enrollment

• Patient and Family Caregiver Enrollment

  Number of Patients and Family Caregivers who enrolled

  Baseline

• Completion of Primary Patient Outcome--Retention

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

  Baseline

Secondary Outcomes (3)

• Family Caregiver Medication Administration Hassle Scale

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

• Medication Regimen Complexity Index

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

• Potential Adverse Event

  Week 2, 4, 6, 8, 12, 16, 20, 24

Study Arms (2)

SPECTORx Educational Intervention

EXPERIMENTAL

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.

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"

Attention Control

ACTIVE COMPARATOR

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.

Behavioral: NIA Medication Management - Active Comparator

Interventions

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.

Attention Control

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

SPECTORx Educational Intervention

"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

SPECTORx Educational Intervention

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

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

SPECTORx Educational Intervention

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient - Newly admitted home hospice enrollees, aged ≥65 years old with:
• \. advanced life-limiting illness;
• \. an estimated life expectancy of \>1 month;
• \. recent functional status decline (defined as change in Karnofsky Performance Status \[KPS\] to \< 80% in prior 3 months);
• \. polypharmacy (defined as ≥ 5 regularly scheduled medications \[excluding antimicrobials\]);
• \. 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.

You may not qualify if:

• Patient:
• Imminent death;
• pain crisis;
• no family caregiver or health care proxy
• Family Caregiver:
• no telephone access;
• cognitive impairment.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• University of Utah: collaborator
• Boston College: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Care Dimensions

Danvers, Massachusetts, 01923, United States

Location

Related Publications (1)

• Tjia J, Clayton M, Chiriboga G, Staples B, Puerto G, Rappaport L, DeSanto-Madeya S. Stakeholder-engaged process for refining the design of a clinical trial in home hospice. BMC Med Res Methodol. 2021 Apr 30;21(1):92. doi: 10.1186/s12874-021-01275-0.

  PMID: 33941089 DERIVED

MeSH Terms

Conditions

Prescription Drug Overuse

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jennifer Tjia, Principal Investigator
• Organization: UMass Chan Medical School

jennifer.tjia@umassmed.edu

774-455-3538

Study Officials

• Jennifer Tjia, MD, MSCE

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: June 3, 2019
• Study Start: January 15, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)