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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG060017 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Utah | OTHER |
| Boston College | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2, 4, 6, 8 12, 16, 20, 24 weeks(or death) |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Tjia, MD, MSCE | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care Dimensions | Danvers | Massachusetts | 01923 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33941089 | Derived | 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. |
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Recruitment occurred at two hospice organizations where each hospice organization randomized 1 office to intervention and 1 office to control
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2020 |
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The Investigators will compare outcomes within and across 2 large hospice agencies using a cluster randomized trial study design.
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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.
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| 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 |
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| "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 |
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| "Key Approaches to Support Informal Family Caregivers in Managing Medications" | Behavioral | Education resource used by clinicians to support Family Care Givers (FCGs) |
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| 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. | 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 | Week 2, 4, 6, 8, 12, 16, 20, 24 |
| FG001 | 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. |
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| Hospice 1 | units for cluster randomzed trial |
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| Hospice 2 | units for cluster randomized trial |
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| COMPLETED | completed is for all dyad participants across both hospices |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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. |
| BG002 | 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) |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
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| Age, Categorical | Demographic data for Caregiver Intervention group missing/not available for select participants | Count of Participants | Participants |
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| Age, Continuous | Demographic data for Caregiver Intervention group missing/not available. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Demographic data for Caregiver Intervention group missing/not available for select participants | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention Training Completion by Hospice Staff | Number of Completed Intervention Trainings | Control group did not offer intervention training. | Posted | Count of Participants | Participants | Baseline |
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| 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. | Screened dyads who met eligibility criteria | Posted | Number | Dyads | 2 weeks prior to enrollment | Dyads | Dyads |
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| Primary | Patient and Family Caregiver Enrollment | Number of Patients and Family Caregivers who enrolled | number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed | Posted | Number | Dyads | Baseline | Dyads | Dyads |
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| Primary | Completion of Primary Patient Outcome--Retention | Number of Dyads who completed the Medication Regimen Complexity Score at Baseline | number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed | Posted | Number | Dyads | Baseline | Dyads | Dyads |
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| 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. | number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, 8 12, 16, 20, 24 weeks(or death) |
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| 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. | number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks(or death) |
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| 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 | Data on Potential Adverse Drug Events for patient participants | Posted | Number | Adverse Events | Week 2, 4, 6, 8, 12, 16, 20, 24 |
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AE were measured up to 24 weeks (or death)
Any event due to the presence or progression of illness that a patient had on study enrollment are not be considered an adverse event (AE), since death more likely related to disease progression than not related to disease progression. Only events more likely not related to known underlying illness are considered an AE.
Family caregivers were not assessed for All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | 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) | 2 | 7 | 0 | 7 | 0 | 7 |
| EG001 | 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 Caregiver (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 Caregiver (FCG) support. | 10 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Family Caregivers: SPECTORx Educational Intervention | Refer to "Patients: SPECTORx Educational Intervention" for description of intervention | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Family Caregivers: Attention Control | Refer to "Patients: Attention Control" for description of control | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
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| Dr. Jennifer Tjia, Principal Investigator | UMass Chan Medical School | 774-455-3538 | jennifer.tjia@umassmed.edu |
| Apr 29, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000067490 | Prescription Drug Overuse |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| OG001 | 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. |
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