Indiana Palliative Excellence in Alzheimer's Care Efforts

Dementia Clinical Trial

— IN-PEACE  

Official title:

Indiana Palliative Excellence in Alzheimer's Care Efforts- Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773757
• Other study ID #: 1707549593
• Secondary ID: 1R01AG057733-01A
• Status: Completed
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: January 7, 2023

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of this research is to improve the care of community dwelling patients with dementia and their family caregivers through an innovative model of supportive care that combines an existing, evidence-based intervention for dementia care with an innovative intervention for palliative care in dementia. The intervention projects this care into the homes of patients and caregivers, empowering caregivers, and integrating with ongoing care. IN-PEACE will enroll 200 patient-caregiver dyads, randomizing 100 dyads each to the intervention and usual care arms and follow for 24 months with quarterly outcome assessments. The core of the multi-component intervention is regular, proactive telephone contact by a dementia care coordinator (DCC; social worker or RN) to anticipate and identify patients' symptoms and caregivers needs and address by utilizing specific, evidence-based protocols. Protocols cover basic dementia care, caregiver distress, neuropsychiatric symptoms, pain, navigating the hospital, feeding difficulties, and transition to hospice. The intervention also involves advance care planning and support with caregivers tailored to decisions faced in dementia care, highlighting where palliative care options can replace the default that often results in burdensome treatments.

The primary aim of IN-PEACE is to test the effect of the intervention on patients' neuropsychiatric symptoms. Other aims include testing the effect of IN-PEACE on patients' overall symptom outcomes, caregiver mood and distress, and the provision of burdensome treatments to patients (hospitalizations and emergency room visits).

Description:

Dementia is an increasingly prevalent, costly and burdensome condition. The dramatic aging of the US population is creating a dementia "epidemic" that our health care system is poorly prepared to handle. More than 5 million people are affected by Alzheimer's disease (AD) and related dementias in 2016, with that number estimated to nearly triple to 13.8 million by 2050. The direct health care costs alone for dementia care are projected to increase from $236 billion in 2016 to more than $1 trillion in 2050. In addition to cognitive and functional deterioration, patients with dementia experience behavioral and psychological complications such as agitation and depression. Family caregivers of patients with dementia experience higher levels of anxiety, depression, chronic fatigue, and an increased mortality risk.

Dementia and palliative care are national research priorities. Both dementia and palliative care have been identified as priority conditions for research and quality improvement by numerous organizations such as the Institute of Medicine, National Quality Forum, the Centers for Medicare and Medicaid Services, and Agency for Healthcare Research and Quality and National Institute on Aging. In addition, a workgroup developing milestones for care and support under the U.S. National Alzheimer's Plan has explicitly stated that palliative care needs to be incorporated throughout the course of caring for patients and families affected by dementia.

2.0 Rationale and Specific Aims

Aim 1: To test the effect of the IN-PEACE intervention on patients' neuropsychiatric symptoms (e.g., agitation/aggression, anxiety, repetitive behaviors). Mixed effects models will be used to compare repeated Neuropsychiatric Inventory Questionnaire (NPI-Q) scores obtained at 3, 6, 9, 12, 15, 18, 21, and 24 months. Repeatedly measured NPI-Q scores will be the dependent variable in the model.

Aim 2: To test the effect of the IN-PEACE intervention on patients' overall symptom outcomes. Analyses in this aim will use repeatedly measured Symptom Measures in End-of-Life Dementia (SM-EOLD) scores over 24 months of follow-up as the dependent variable in the mixed effects model, similarly to the approach described for Aim 1.

Aim 3: To test the effect of the IN-PEACE intervention on caregivers' distress and mood. Aim 3 analyses will use repeatedly measured caregiver NPI-Q distress scores and caregiver Patient Health Questionnaire (PHQ-9) over 24 months of follow-up as the dependent variables in separate mixed effects models, similar to the approach for Aim 1.

Aim 4: Evaluate the effect of the IN-PEACE intervention on ER/hospital use. ER/hospitalization events will be obtained from accessing electronic medical records maintained by the Indiana Health Information Exchange (IHIE) and the Indiana Network for Patient Care (INPC). Poisson regression models will be used to compare rates of any ER/hospitalization event between the two groups while adjusting for dementia severity and significant baseline variables that differ between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: January 7, 2023
• Est. primary completion date: January 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria: Community-dwelling and living in the Indianapolis metropolitan area; Patient with an established diagnosis of dementia of any etiology; Dementia in the moderate (FAST stage 5) to severe stage (FAST 6-7); and English-speaking Primary caregiver informant enrolled in study.

Exclusion Criteria: Patient with dementia residing in a nursing facility or receiving hospice care; Patient or Caregiver with long-standing history of severe mental illness or Psychiatric disorder preexisting the dementia diagnosis. Initially, non-English speaking patients were excluded. On April 14, 2020, Institutional Review Board (IRB) Amendment eliminated this exclusion so non-English speaking patients could be enrolled as long as their Caregiver was English-speaking and able to complete assessments.

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• IN-PEACE Dementia Care Coordination
Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.

Locations

Country	Name	City	State
United States	Sandra Eskenazi Center for Brain Care Innovation	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA), Regenstrief Institute, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233 — View Citation

Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006. — View Citation

Volicer L, Hurley AC, Blasi ZV. Scales for evaluation of End-of-Life Care in Dementia. Alzheimer Dis Assoc Disord. 2001 Oct-Dec;15(4):194-200. doi: 10.1097/00002093-200110000-00005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity	The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. Each symptom reported as present is scored on a scale of 1-3 with higher scores indicating more severity of the symptom: mild, moderate, or severe. The NPI-Q Patient Symptom and Severity total score is constructed by summing the value of each presenting symptom's severity and ranges from 0-36 with higher scores indicating more severe patient neuropsychiatric symptoms.	0-24 months
Secondary	Symptom Management - End of Life for Dementia (SM-EOLD)	The Symptom Measures in End-of-Life Dementia (SM-EOLD) measures the presence and frequency of 9 symptoms experienced by the person with dementia (PWD) in the previous 90 days per caregiver report: pain, shortness of breath, depression, fear, anxiety, agitation, calm, skin breakdown, and resistance to care. Each symptom is scored on a scale ranging 0 - 5 (daily, several days a week, once a week, 2 or 3 days a month, once a month, never) with higher scores indicating better symptom control. The SM-EOLD total score is constructed by summing the value of each item, and ranges from 0-45 with higher scores indicating better symptom control (comfort).	0-24 months
Secondary	Patient Health Questionnaire (PHQ-8) Caregiver	The Patient Health Questionnaire-8 item measures the frequency of depressive symptoms experienced by the caregiver in the last two weeks per caregiver report. Each symptom is scored on a scale of 0-3 (not at all, several days, more than half the days, nearly every day) with higher scores indicating more frequency of depressive symptoms. The PHQ-8 Caregiver total score is constructed by summing the value of each item and ranges from 0-24 with higher scores indicating more frequent depressive symptoms in the caregiver.	0-24 months
Secondary	Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress	The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. If the symptom was reported as present, then the caregiver rated the level of distress they experienced related to the patient's symptom on a scale of 0-5 with higher scores indicating more distress. The NPI-Q Caregiver Distress total score is constructed by summing the value of each distress item and ranges from 0-60 with higher scores indicating more caregiver distress.	0-24 months
Secondary	Emergency Department Visits and Hospitalizations	Combined measure of counts of emergency department (ED) visits and hospital admissions drawn from hospital reported data in the Indiana Network for Patient Care (INPC) database, managed by the Indiana Health Information Exchange (IHIE). As pre-specified, this data only includes the patient from each dyad and not the caregiver.	0-24 months