Standardized Patient-Centered Medication Review in Home Hospice

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03972163

Acronym

SPECTORx

Enrollment

Registered

2019-06-03

Start date

2020-01-15

Completion date

2023-12-31

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

BEHAVIORALNIA 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.

BEHAVIORALSTOPPFrail (Screening Tool of Older Persons Prescriptions)

A screening tool used by clinicians with frail older adults with life-limiting illness to review medications

BEHAVIORALDiscontinuing Medication Appropriately and Understanding the Art of Communication about Deprescribing

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

BEHAVIORALKey Approaches to Support Informal Family Caregivers in Managing Medications

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

65 Years to 110 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Intervention Training Completion by Hospice Staff	Baseline	Number of Completed Intervention Trainings
Patient and Family Caregiver Eligibility Screens	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.
Patient and Family Caregiver Enrollment	Baseline	Number of Patients and Family Caregivers who enrolled
Completion of Primary Patient Outcome--Retention	Baseline	Number of Dyads who completed the Medication Regimen Complexity Score at Baseline

Secondary

Measure	Time frame	Description
Medication Regimen Complexity Index	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.
Potential Adverse Event	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
Family Caregiver Medication Administration Hassle Scale	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.

Countries

United States

Participant flow

Recruitment details

Recruitment occurred at two hospice organizations where each hospice organization randomized 1 office to intervention and 1 office to control

Participants by arm

Arm	Count
Patients: 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. STOPPFrail (Screening Tool of Older Persons Prescriptions): 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: Education resoruce used by clinicians to simplify and align medications with goals of care Key Approaches to Support Informal Family Caregivers in Managing Medications: Education resource used by clinicians to support Family Care Givers (FCGs)	7
Patients: 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. 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.	15
Caregivers 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. STOPPFrail (Screening Tool of Older Persons Prescriptions): 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: Education resoruce used by clinicians to simplify and align medications with goals of care Key Approaches to Support Informal Family Caregivers in Managing Medications: Education resource used by clinicians to support Family Care Givers (FCGs)	7
Caregivers: 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. 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.	15
Total	44

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	0	1

Baseline characteristics

Characteristic	Patients: SPECTORx Educational Intervention	Patients: Attention Control	Caregivers SPECTORx Educational Intervention	Caregivers: Attention Control	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	7 Participants	15 Participants	3 Participants	7 Participants	32 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	3 Participants	8 Participants	11 Participants
Age, Continuous	83.6 years STANDARD_DEVIATION 14.5	79.5 years STANDARD_DEVIATION 10.3	—	—	80.8 years STANDARD_DEVIATION 11.6
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants	14 Participants	6 Participants	14 Participants	41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Race (NIH/OMB) White	6 Participants	13 Participants	5 Participants	13 Participants	37 Participants
Region of Enrollment United States	7 participants	15 participants	7 participants	15 participants	22 participants
Sex: Female, Male Female	4 Participants	11 Participants	4 Participants	13 Participants	32 Participants
Sex: Female, Male Male	3 Participants	4 Participants	2 Participants	2 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	2 / 7	10 / 15	0 / 0	0 / 0
other Total, other adverse events	0 / 7	0 / 15	0 / 0	0 / 0
serious Total, serious adverse events	0 / 7	0 / 15	0 / 0	0 / 0

Outcome results

Primary

Completion of Primary Patient Outcome--Retention

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

Time frame: Baseline

Population: number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed

Arm	Measure	Value (NUMBER)
SPECTORx Educational Intervention	Completion of Primary Patient Outcome--Retention	7 Dyads
Attention Control	Completion of Primary Patient Outcome--Retention	15 Dyads

Primary

Intervention Training Completion by Hospice Staff

Number of Completed Intervention Trainings

Time frame: Baseline

Population: Control group did not offer intervention training.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
SPECTORx Educational Intervention	Intervention Training Completion by Hospice Staff	17 Participants
Attention Control	Intervention Training Completion by Hospice Staff	0 Participants

Primary

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.

Time frame: 2 weeks prior to enrollment

Population: Screened dyads who met eligibility criteria

Arm	Measure	Value (NUMBER)
SPECTORx Educational Intervention	Patient and Family Caregiver Eligibility Screens	77 Dyads
Attention Control	Patient and Family Caregiver Eligibility Screens	184 Dyads

Primary

Patient and Family Caregiver Enrollment

Number of Patients and Family Caregivers who enrolled

Time frame: Baseline

Population: number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed

Arm	Measure	Value (NUMBER)
SPECTORx Educational Intervention	Patient and Family Caregiver Enrollment	7 Dyads
Attention Control	Patient and Family Caregiver Enrollment	15 Dyads

Secondary

Family Caregiver Medication Administration Hassle Scale

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.

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

Population: number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed

Arm	Measure	Group	Value (MEAN)	Dispersion
SPECTORx Educational Intervention	Family Caregiver Medication Administration Hassle Scale	Baseline	13.6 score on a scale	Standard Deviation 21.1
SPECTORx Educational Intervention	Family Caregiver Medication Administration Hassle Scale	2 weeks	19.7 score on a scale	Standard Deviation 30.6
SPECTORx Educational Intervention	Family Caregiver Medication Administration Hassle Scale	4 weeks	16.7 score on a scale	Standard Deviation 19.5
SPECTORx Educational Intervention	Family Caregiver Medication Administration Hassle Scale	6 weeks	22.5 score on a scale	Standard Deviation 13.4
SPECTORx Educational Intervention	Family Caregiver Medication Administration Hassle Scale	8 weeks	21.5 score on a scale	Standard Deviation 23.3
SPECTORx Educational Intervention	Family Caregiver Medication Administration Hassle Scale	12 weeks	10 score on a scale	—
SPECTORx Educational Intervention	Family Caregiver Medication Administration Hassle Scale	16 weeks	7 score on a scale	—
Attention Control	Family Caregiver Medication Administration Hassle Scale	6 weeks	26.8 score on a scale	Standard Deviation 12.2
Attention Control	Family Caregiver Medication Administration Hassle Scale	16 weeks	30 score on a scale	—
Attention Control	Family Caregiver Medication Administration Hassle Scale	8 weeks	26.5 score on a scale	Standard Deviation 9.5
Attention Control	Family Caregiver Medication Administration Hassle Scale	Baseline	31 score on a scale	Standard Deviation 16.7
Attention Control	Family Caregiver Medication Administration Hassle Scale	20 weeks	47 score on a scale	—
Attention Control	Family Caregiver Medication Administration Hassle Scale	2 weeks	37 score on a scale	Standard Deviation 17.5
Attention Control	Family Caregiver Medication Administration Hassle Scale	12 weeks	33.3 score on a scale	Standard Deviation 3.9
Attention Control	Family Caregiver Medication Administration Hassle Scale	4 weeks	36.1 score on a scale	Standard Deviation 17.5
Attention Control	Family Caregiver Medication Administration Hassle Scale	24 weeks (or death)	21 score on a scale	—

Secondary

Medication Regimen Complexity Index

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.

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

Population: number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed

Arm	Measure	Group	Value (MEAN)	Dispersion
SPECTORx Educational Intervention	Medication Regimen Complexity Index	2 weeks	43.5 score on a scale	Standard Deviation 13.1
SPECTORx Educational Intervention	Medication Regimen Complexity Index	12 weeks	43.8 score on a scale	Standard Deviation 21.1
SPECTORx Educational Intervention	Medication Regimen Complexity Index	6 weeks	46.4 score on a scale	Standard Deviation 13.9
SPECTORx Educational Intervention	Medication Regimen Complexity Index	16 weeks	51.1 score on a scale	Standard Deviation 11.3
SPECTORx Educational Intervention	Medication Regimen Complexity Index	baseline	39 score on a scale	Standard Deviation 8.8
SPECTORx Educational Intervention	Medication Regimen Complexity Index	20 weeks	52.3 score on a scale	Standard Deviation 12.3
SPECTORx Educational Intervention	Medication Regimen Complexity Index	8 weeks	44 score on a scale	Standard Deviation 19.4
SPECTORx Educational Intervention	Medication Regimen Complexity Index	24 weeks (or death)	47 score on a scale	Standard Deviation 16.9
SPECTORx Educational Intervention	Medication Regimen Complexity Index	4 weeks	43.3 score on a scale	Standard Deviation 12.9
Attention Control	Medication Regimen Complexity Index	24 weeks (or death)	23.5 score on a scale	Standard Deviation 22.6
Attention Control	Medication Regimen Complexity Index	baseline	23.5 score on a scale	Standard Deviation 8.2
Attention Control	Medication Regimen Complexity Index	2 weeks	31.0 score on a scale	Standard Deviation 10.3
Attention Control	Medication Regimen Complexity Index	4 weeks	32.5 score on a scale	Standard Deviation 11.2
Attention Control	Medication Regimen Complexity Index	6 weeks	33.6 score on a scale	Standard Deviation 12.8
Attention Control	Medication Regimen Complexity Index	8 weeks	31.1 score on a scale	Standard Deviation 12.4
Attention Control	Medication Regimen Complexity Index	12 weeks	26.8 score on a scale	Standard Deviation 12.5
Attention Control	Medication Regimen Complexity Index	16 weeks	29 score on a scale	Standard Deviation 15.2
Attention Control	Medication Regimen Complexity Index	20 weeks	33.4 score on a scale	Standard Deviation 15

Secondary

Potential Adverse Event

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

Time frame: Week 2, 4, 6, 8, 12, 16, 20, 24

Population: Data on Potential Adverse Drug Events for patient participants

Arm	Measure	Group	Value (NUMBER)
SPECTORx Educational Intervention	Potential Adverse Event	Week 2	0 Adverse Events
SPECTORx Educational Intervention	Potential Adverse Event	Week 12	0 Adverse Events
SPECTORx Educational Intervention	Potential Adverse Event	Week 6	0 Adverse Events
SPECTORx Educational Intervention	Potential Adverse Event	Week 16	0 Adverse Events
SPECTORx Educational Intervention	Potential Adverse Event	Week 4	0 Adverse Events
SPECTORx Educational Intervention	Potential Adverse Event	Week 20	0 Adverse Events
SPECTORx Educational Intervention	Potential Adverse Event	week 8	0 Adverse Events
SPECTORx Educational Intervention	Potential Adverse Event	Week 24	0 Adverse Events
SPECTORx Educational Intervention	Potential Adverse Event	Baseline	0 Adverse Events
Attention Control	Potential Adverse Event	Week 24	0 Adverse Events
Attention Control	Potential Adverse Event	Baseline	0 Adverse Events
Attention Control	Potential Adverse Event	Week 2	0 Adverse Events
Attention Control	Potential Adverse Event	Week 4	0 Adverse Events
Attention Control	Potential Adverse Event	Week 6	0 Adverse Events
Attention Control	Potential Adverse Event	week 8	0 Adverse Events
Attention Control	Potential Adverse Event	Week 12	0 Adverse Events
Attention Control	Potential Adverse Event	Week 16	0 Adverse Events
Attention Control	Potential Adverse Event	Week 20	0 Adverse Events

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026

Standardized Patient-Centered Medication Review in Home Hospice

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Completion of Primary Patient Outcome--Retention

Intervention Training Completion by Hospice Staff

Patient and Family Caregiver Eligibility Screens

Patient and Family Caregiver Enrollment

Family Caregiver Medication Administration Hassle Scale

Medication Regimen Complexity Index

Potential Adverse Event