Indiana Palliative Excellence in Alzheimer's Care Efforts

NCT03773757 | Completed Results DMC

• 2 other identifiers: 17075495931R01AG057733-01A1
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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).

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Symptom Management - End of Life for Dementia (SM-EOLD)

  0-24 months

• Patient Health Questionnaire (PHQ-8) Caregiver

  0-24 months

• Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress

  0-24 months

• Emergency Department Visits and Hospitalizations

  0-24 months

Study Arms (2)

IN-PEACE Dementia Care Coordination

EXPERIMENTAL

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.

Behavioral: IN-PEACE Dementia Care Coordination

Usual Care

NO INTERVENTION

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.

Interventions

IN-PEACE Dementia Care Coordination BEHAVIORAL

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.

IN-PEACE Dementia Care Coordination

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• Indiana University: lead
• Regenstrief Institute, Inc.: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Sandra Eskenazi Center for Brain Care Innovation

Indianapolis, Indiana, 46202, United States

Location

Related Publications (5)

• 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.

  PMID: 11001602 RESULT

• 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.

  PMID: 11723370 RESULT

• 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.

  PMID: 15550799 RESULT

• Sachs GA, Johnson NM, Gao S, Torke AM, Hickman SE, Pemberton A, Vrobel A, Pan M, West J, Kroenke K. Palliative Care Program for Community-Dwelling Individuals With Dementia and Caregivers: The IN-PEACE Randomized Clinical Trial. JAMA. 2025 Mar 18;333(11):962-971. doi: 10.1001/jama.2024.25845.

  PMID: 39878993 DERIVED

• Holtz LR, Kroenke K, Gao S, Hickman SE, Torke AM, Johnson NM, Pemberton A, Vrobel A, Pan M, Sachs GA. Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE): Protocol for a randomized controlled trial in persons with advanced dementia. Contemp Clin Trials. 2023 Jul;130:107217. doi: 10.1016/j.cct.2023.107217. Epub 2023 May 4.

  PMID: 37149000 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Study subjects drawn primarily from two health systems in central Indiana and required to have an English-speaking caregiver. No technical difficulties; targeted enrollment completed on time and intervention and data collection very complete despite coronavirus disease 2019 (COVID-19) pandemic and move to fully remote operations. Low levels of symptoms in patients and caregivers in both arms may have limited ability to demonstrate impact of intervention on these measures.

Results Point of Contact

• Title: Dr. Greg Sachs
• Organization: Indiana University

sachsg@iu.edu

317-278-5570

Study Officials

• Greg A Sachs, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division Chief General Internal Medicine and Geriatrics

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 12, 2018
• Study Start: March 14, 2019
• Primary Completion: January 7, 2023
• Study Completion: January 7, 2023
• Last Updated: August 27, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)