Clinical trial NCT03972163: Standardized Patient-Centered Medication Review in Home Hospice
Official title: Standardized PatiEnt-CenTered medicatiOn Review (SPECTORx) in Home Hospice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospices
Poly Pharmacy
Deprescriptions
Caregivers
Palliative Care
Prescription Drug Overuse
Interdisciplinary Communication
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: University of Utah
name: Boston College
name: National Institute on Aging (NIA)
First posted: 2019-06-03
Enrollment: 23
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Investigators will compare outcomes within and across 2 large hospice agencies using a cluster randomized trial study design.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Training Completion by Hospice Staff
timeFrame: Baseline
measure: Patient and Family Caregiver Eligibility Screens
timeFrame: 2 weeks prior to enrollment
measure: Patient and Family Caregiver Enrollment
timeFrame: Baseline
measure: Completion of Primary Patient Outcome--Retention
timeFrame: Baseline
Secondary outcomes:
measure: Family Caregiver Medication Administration Hassle Scale
timeFrame: Baseline, 2, 4, 6, 8 12, 16, 20, 24 weeks(or death)
measure: Medication Regimen Complexity Index
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks(or death)
measure: Potential Adverse Event
timeFrame: Week 2, 4, 6, 8, 12, 16, 20, 24
Other outcomes:
Locations:
city: Danvers
country: United States
facility: Care Dimensions
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Jennifer Tjia, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.