HospicesSPECTORxNCT03972163
Standardized Patient-Centered Medication Review in Home Hospice
A study testing NIA Medication Management - Active Comparator, STOPPFrail (Screening Tool of Older Persons Prescriptions) and "Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing" in people with Hospices and Poly Pharmacy, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Hospices, Poly Pharmacy, Deprescriptions
- What is being tested?
- NIA Medication Management - Active Comparator, STOPPFrail (Screening Tool of Older Persons Prescriptions) and "Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- Patient:
- Imminent death;
- pain crisis;
- no family caregiver or health care proxy
- Family Caregiver:
- no telephone access;
- cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standardized PatiEnt-CenTered medicatiOn Review (SPECTORx) 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.
Read the 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.
- Conditions
- Hospices, Poly Pharmacy, Deprescriptions, Caregivers, Palliative Care, Prescription Drug Overuse
- Being tested
- NIA Medication Management - Active Comparator, STOPPFrail (Screening Tool of Older Persons Prescriptions), "Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing", "Key Approaches to Support Informal Family Caregivers in Managing Medications"
- Medical subject headings
- Prescription Drug Overuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIA Medication Management - Active ComparatorBehavioural
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)Behavioural
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"Behavioural
Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications"Behavioural
Education resource used by clinicians to support Family Care Givers (FCGs)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: NIA Medication Management - Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Training Completion by Hospice Staff
Number of Completed Intervention Trainings
Measured: 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.
Measured: 2 weeks prior to enrollment
Patient and Family Caregiver Enrollment
Number of Patients and Family Caregivers who enrolled
Measured: Baseline
Completion of Primary Patient Outcome--Retention
Number of Dyads who completed the Medication Regimen Complexity Score at Baseline
Measured: Baseline
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Week 2, 4, 6, 8, 12, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start15 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HospicesStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Investigators will compare outcomes within and across 2 large hospice agencies using a cluster randomized trial study design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Boston College, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jennifer Tjia, University of Massachusetts, Worcester
- Investigators
- Jennifer Tjia, MD, MSCE, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972163
- Sponsor's protocol ID
- H00015417
- Other IDs
- 1R21AG060017
- Acronym
- SPECTORx
- Status last verified
- May 2025
- First submitted
- 13 May 2019
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tjia J, Clayton MF, Puerto G, Duodu V, Troiani F, Tanikella S, DeSanto-Madeya S. Shared Medication PLanning In Home Hospice to Address Medication Regimen Complexity and Family Caregiver Burden: A Brief Report. J Palliat Med. 2024 Dec;27(12):1653-1656. doi: 10.1089/jpm.2024.0229. Epub 2024 Oct 28.
PubMed 39463285Tjia 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.
PubMed 33941089
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized PatiEnt-CenTered medicatiOn Review (SPECTORx) in Home Hospice
- ClinicalTrials.gov ID
- NCT03972163
- Acronym / sponsor ID
- SPECTORx / H00015417
- Conditions
- Hospices, Poly Pharmacy, Deprescriptions, Caregivers, Palliative Care, Prescription Drug Overuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Utah, Boston College, National Institute on Aging (NIA)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The Investigators will compare outcomes within and across 2 large hospice agencies using a cluster randomized trial study design.
| Arm | Type | Receives |
|---|---|---|
| SPECTORx Educational Intervention | Experimental | 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"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. |
| Attention Control | Active comparator | Behavioral: NIA Medication Management - Active ComparatorAs 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. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- Imminent death;
- pain crisis;
- no family caregiver or health care proxy
- no telephone access;
- cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIA Medication Management - Active ComparatorAs 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. | Behavioural | Attention Control |
| STOPPFrail (Screening Tool of Older Persons Prescriptions)A screening tool used by clinicians with frail older adults with life-limiting illness to review medications | Behavioural | SPECTORx Educational Intervention |
| "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 | Behavioural | SPECTORx Educational Intervention |
| "Key Approaches to Support Informal Family Caregivers in Managing Medications"Education resource used by clinicians to support Family Care Givers (FCGs) | Behavioural | SPECTORx Educational Intervention |
Primary outcome
Intervention Training Completion by Hospice Staff
Time frame: Baseline
Number of Completed Intervention Trainings
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.
Patient and Family Caregiver Enrollment
Time frame: Baseline
Number of Patients and Family Caregivers who enrolled
Completion of Primary Patient Outcome--Retention
Time frame: Baseline
Number of Dyads who completed the Medication Regimen Complexity Score at Baseline
3 secondary outcomes
Family Caregiver Medication Administration Hassle Scale
Time frame: Baseline, 2, 4, 6, 8 12, 16, 20, 24 weeks(or death)
Medication Regimen Complexity Index
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks(or death)
Potential Adverse Event
Time frame: Week 2, 4, 6, 8, 12, 16, 20, 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39463285Tjia J, Clayton MF, Puerto G, Duodu V, Troiani F, Tanikella S, DeSanto-Madeya S. Shared Medication PLanning In Home Hospice to Address Medication Regimen Complexity and Family Caregiver Burden: A Brief Report. J Palliat Med. 2024 Dec;27(12):1653-1656. doi: 10.1089/jpm.2024.0229. Epub 2024 Oct 28.
- Derived from this study: PubMed 33941089Tjia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Tjia, MD, MSCE principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIA Medication Management - Active Comparator, STOPPFrail (Screening Tool of Older Persons Prescriptions) and "Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing" in people with Hospices and Poly Pharmacy, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Training Completion by Hospice Staff (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972163, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.