An interventional study of NIA Medication Management - Active Comparator and STOPPFrail (Screening Tool of Older Persons Prescriptions) in Hospices, Poly Pharmacy and Deprescriptions, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Open to participants aged 65 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Supportive care
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.
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.
33 studies on the registry are indexed under Prescription Drug Overuse; 1 is open to participants now.
This study's enrollment of 23 is below the median of 62 across 28 interventional studies indexed under Prescription Drug Overuse.
Browse Prescription Drug Overuse studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
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Patient - Newly admitted home hospice enrollees, aged ≥65 years old with:
Family ("any relative, partner, friend or neighbor who has a significant personal relationship with, and provides a broad range of assistance) Caregiver -
Exclusion Criteria:
Patient:
Family Caregiver:
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"
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
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.
A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
Education resoruce used by clinicians to simplify and align medications with goals of care
Education resource used by clinicians to support Family Care Givers (FCGs)
Intervention Training Completion by Hospice Staff
Number of Completed Intervention Trainings
Time frame: 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.
Time frame: 2 weeks prior to enrollment
Patient and Family Caregiver Enrollment
Number of Patients and Family Caregivers who enrolled
Time frame: Baseline
Completion of Primary Patient Outcome--Retention
Number of Dyads who completed the Medication Regimen Complexity Score at Baseline
Time frame: Baseline
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)
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)
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
Recruitment occurred at two hospice organizations where each hospice organization randomized 1 office to intervention and 1 office to control
| Milestone | SPECTORx Educational Intervention | Attention Control |
|---|---|---|
| Started | 7 | 16 |
| Hospice 1 | 5 | 12 |
| Hospice 2 | 2 | 4 |
| Completed | 7 | 15 |
| Not completed | 0 | 1 |
| Withdrew: Death | 0 | 1 |
Number of Completed Intervention Trainings
| Participants | SPECTORx Educational Intervention | Attention Control |
|---|---|---|
| Intervention Training Completion by Hospice Staff | 17 | 0 |
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.
| Dyads | SPECTORx Educational Intervention | Attention Control |
|---|---|---|
| Patient and Family Caregiver Eligibility Screens | 77 | 184 |
Number of Patients and Family Caregivers who enrolled
| Dyads | SPECTORx Educational Intervention | Attention Control |
|---|---|---|
| Patient and Family Caregiver Enrollment | 7 | 15 |
Number of Dyads who completed the Medication Regimen Complexity Score at Baseline
| Dyads | SPECTORx Educational Intervention | Attention Control |
|---|---|---|
| Completion of Primary Patient Outcome--Retention | 7 | 15 |
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.
| score on a scale | SPECTORx Educational Intervention | Attention Control |
|---|---|---|
| Baseline | 13.6 ± 21.1 | 31 ± 16.7 |
| 2 weeks | 19.7 ± 30.6 | 37 ± 17.5 |
| 4 weeks | 16.7 ± 19.5 | 36.1 ± 17.5 |
| 6 weeks | 22.5 ± 13.4 | 26.8 ± 12.2 |
| 8 weeks | 21.5 ± 23.3 | 26.5 ± 9.5 |
| 12 weeks | 10 | 33.3 ± 3.9 |
| 16 weeks | 7 | 30 |
| 20 weeks | — | 47 |
| 24 weeks (or death) | — | 21 |
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.
| score on a scale | SPECTORx Educational Intervention | Attention Control |
|---|---|---|
| baseline | 39 ± 8.8 | 23.5 ± 8.2 |
| 2 weeks | 43.5 ± 13.1 | 31.0 ± 10.3 |
| 4 weeks | 43.3 ± 12.9 | 32.5 ± 11.2 |
| 6 weeks | 46.4 ± 13.9 | 33.6 ± 12.8 |
| 8 weeks | 44 ± 19.4 | 31.1 ± 12.4 |
| 12 weeks | 43.8 ± 21.1 | 26.8 ± 12.5 |
| 16 weeks | 51.1 ± 11.3 | 29 ± 15.2 |
| 20 weeks | 52.3 ± 12.3 | 33.4 ± 15.0 |
| 24 weeks (or death) | 47 ± 16.9 | 23.5 ± 22.6 |
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
| Adverse Events | SPECTORx Educational Intervention | Attention Control |
|---|---|---|
| Baseline | 0 | 0 |
| Week 2 | 0 | 0 |
| Week 4 | 0 | 0 |
| Week 6 | 0 | 0 |
| week 8 | 0 | 0 |
| Week 12 | 0 | 0 |
| Week 16 | 0 | 0 |
| Week 20 | 0 | 0 |
| Week 24 | 0 | 0 |
Collected over AE were measured up to 24 weeks (or death). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients: SPECTORx Educational Intervention | 2/7 (28.6%) | 0/7 (0%) | 0/7 (0%) |
| Patients: Attention Control | 10/15 (66.7%) | 0/15 (0%) | 0/15 (0%) |
| Family Caregivers: SPECTORx Educational Intervention | — | — | — |
| Family Caregivers: Attention Control | — | — | — |
| Age, Categorical(Participants) | Patients: SPECTORx Educational Intervention | Patients: Attention Control | Caregivers SPECTORx Educational Intervention | Caregivers: Attention Control | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 3 | 8 | 11 |
| >=65 years | 7 | 15 | 3 | 7 | 32 |
| Age, Continuous(years) | Patients: SPECTORx Educational Intervention | Patients: Attention Control | Caregivers SPECTORx Educational Intervention | Caregivers: Attention Control | Total |
|---|---|---|---|---|---|
| Mean | 83.6 ± 14.5 | 79.5 ± 10.3 | — | — | 80.8 ± 11.6 |
| Sex: Female, Male(Participants) | Patients: SPECTORx Educational Intervention | Patients: Attention Control | Caregivers SPECTORx Educational Intervention | Caregivers: Attention Control | Total |
|---|---|---|---|---|---|
| Female | 4 | 11 | 4 | 13 | 32 |
| Male | 3 | 4 | 2 | 2 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Patients: SPECTORx Educational Intervention | Patients: Attention Control | Caregivers SPECTORx Educational Intervention | Caregivers: Attention Control | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 | 2 |
| Not Hispanic or Latino | 7 | 14 | 6 | 14 | 41 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Patients: SPECTORx Educational Intervention | Patients: Attention Control | Caregivers SPECTORx Educational Intervention | Caregivers: Attention Control | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 | 0 | 2 |
| White | 6 | 13 | 5 | 13 | 37 |
| More than one race | 0 | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 | 2 |
| Region of Enrollment(participants) | Patients: SPECTORx Educational Intervention | Patients: Attention Control | Caregivers SPECTORx Educational Intervention | Caregivers: Attention Control | Total |
|---|---|---|---|---|---|
| United States | 7 | 15 | 7 | 15 | 22 |
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University of Massachusetts, Worcester