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Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE)

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ClinicalTrials.gov Identifier: NCT03773757
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Regenstrief Institute, Inc.
Information provided by (Responsible Party):
Indiana University

Tracking Information
First Submitted Date  ICMJE November 21, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date December 19, 2018
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: 0-24 months ]
To test the effect of the IN-PEACE intervention on patients' neuropsychiatric symptoms (e.g., agitation/aggression, anxiety, repetitive behaviors). Repeatedly measured NPI-Q scores will be the dependent variable in the model. Neuropsychiatric Inventory-Questionnaire is a questionnaire completed by caregivers about patients designed to measure both neuropsychiatric symptoms and caregiver stress. There were 12 symptoms included in NPI-Q. Each domain includes an initial response of "yes" or "no". If "yes", then the caregiver rates the severity of the symptom on a 3-point scale and caregiver distress in a 5-point scale. The NPI-Q provides a total severity score ranged 0-36 with higher scores indicating more severe symptoms.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Symptom Outcomes [ Time Frame: 0-24 months ]
    To test the effect of the IN-PEACE intervention on patients' overall symptom outcomes. Analyses in this aim will use repeatedly measured Symptom Management - End of Life for Dementia (SM-EOLD) scores as the dependent variable in the mixed effects model. Symptom Management in End of Life Dementia (SM-EOLD) is a 9-item scale that measures comfort in patients with advanced dementia. The symptoms assessed are pain, fear, depression, anxiety, dyspnea, agitation, skin breakdown, resistance to care, and calm (reverse scored). For each symptom, the frequency over the preceding 90 days is reported by a caregiver on a scale of 0 to 5 (daily, several days a week, once a week, 2 or 3 days a month, once a month, never). The SM-EOLD score is constructed by summing the value of each item, and ranges from 0-45 with higher scores indicating better symptom control.
  • Caregiver Mood, Distress [ Time Frame: 0-24 months ]
    To test the effect of the IN-PEACE intervention on caregivers' distress and mood. Analyses will use repeatedly measured caregiver Neuropsychiatric Inventory Questionnaire (NPI-Q) distress scores and caregiver Patient Health Questionnaire (PHQ-8) over 24 months of follow-up as the dependent variables in separate mixed effects models. See above for NPI-Q. The NPI-Q distress score is constructed by summing the values of the distress score of each symptom and ranges from 0-60 with higher score indicating more distress. PHQ-8 is a 8-item depression scale with a total score ranging from 0 to 24 with higher score indicating more depressive symptoms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Indiana Palliative Excellence in Alzheimer's Care Efforts
Official Title  ICMJE Indiana Palliative Excellence in Alzheimer's Care Efforts- Randomized Control Trial
Brief 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).

Detailed 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 NIA. 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 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 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Dementia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: IN-PEACE Dementia Care Coordination
    In-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms 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.
    Intervention: Behavioral: IN-PEACE Dementia Care Coordination
  • No Intervention: Usual Care
    The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Exclusion Criteria: Patient with dementia residing in a nursing facility; Non-English speaking; Patient or Caregiver with long-standing history of severe mental illness or Psychiatric disorder preexisting the dementia diagnosis.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Greg A Sachs, MD (317) 278-5570 sachsg@iu.edu
Contact: Laura R Holtz, MS 317-274-9114 holtzl@iupui.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773757
Other Study ID Numbers  ICMJE 1707549593
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Regenstrief Institute, Inc.
Investigators  ICMJE
Principal Investigator: Greg A Sachs, MD Indiana University
PRS Account Indiana University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP