Dementia
Conditions
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 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.
Interventions
BEHAVIORALIN-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.
Sponsors
Regenstrief Institute, Inc.
National Institute on Aging (NIA)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity | 0-24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Management - End of Life for Dementia (SM-EOLD) | 0-24 months | 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). |
| Patient Health Questionnaire (PHQ-8) Caregiver | 0-24 months | 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. |
| Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress | 0-24 months | 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. |
| Emergency Department Visits and Hospitalizations | 0-24 months | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment started on 3/14/2019 and ended on 12/21/2020. Recruitment locations included two health systems and personal referrals at a caregiver symposium within a 50-mile radius of Indianapolis. Initially, recruitment included an in-person approach in the medical clinic followed by in-person enrollment in the caregiver's home. After the Institutional Review Board (IRB) approved verbal consent 3/17/2020, all recruitment took place over the phone.
Pre-assignment details
Data values reported in the Participant Flow represent individual participants.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 99 |
| 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.
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. | 99 |
| 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. | 102 |
| 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. | 102 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | IN-PEACE Dementia Care Coordination | Total | Usual Care |
|---|---|---|---|
| Age, Continuous Caregiver Participants | 60.8 years STANDARD_DEVIATION 12.3 | 60.5 years STANDARD_DEVIATION 11.2 | 60.2 years STANDARD_DEVIATION 10.1 |
| Age, Continuous Patient Participants | 83.7 years STANDARD_DEVIATION 7.7 | 83.6 years STANDARD_DEVIATION 7.9 | 83.4 years STANDARD_DEVIATION 8.1 |
| Caregiver Relationship to Patient Daughter/Son/Daughter-in-Law/Son-in-Law | 68 Participants | 135 Participants | 67 Participants |
| Caregiver Relationship to Patient Grandchild | 1 Participants | 3 Participants | 2 Participants |
| Caregiver Relationship to Patient Other relationship | 8 Participants | 19 Participants | 11 Participants |
| Caregiver Relationship to Patient Spouse/Partner | 22 Participants | 44 Participants | 22 Participants |
| Caregiver Strain Index | 6.6 units on a scale STANDARD_DEVIATION 3.8 | 6.7 units on a scale STANDARD_DEVIATION 3.7 | 6.8 units on a scale STANDARD_DEVIATION 3.5 |
| Education Caregiver did not answer | 0 Participants | 1 Participants | 1 Participants |
| Education Caregiver High School or Less | 13 Participants | 31 Participants | 18 Participants |
| Education Caregiver Post graduate | 26 Participants | 55 Participants | 29 Participants |
| Education Caregiver Some college or college degree | 60 Participants | 114 Participants | 54 Participants |
| Education PWD did not answer | 0 Participants | 1 Participants | 1 Participants |
| Education PWD High School or Less | 53 Participants | 106 Participants | 53 Participants |
| Education PWD Post graduate | 16 Participants | 35 Participants | 19 Participants |
| Education PWD Some college or college degree | 30 Participants | 59 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Caregiver Participants Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Caregiver Participants Not Hispanic or Latino | 94 Participants | 188 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Caregiver Participants Unknown or Not Reported | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Patient Participants Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Patient Participants Not Hispanic or Latino | 94 Participants | 189 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Patient Participants Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Functional Assessment Staging Tool for Dementia (FAST) Moderate (FAST=5) | 4 participants | 8 participants | 4 participants |
| Functional Assessment Staging Tool for Dementia (FAST) Severe (FAST=6-7) | 95 participants | 193 participants | 98 participants |
| Income Caregiver : $100,000 and over No | 75 Participants | 148 Participants | 73 Participants |
| Income Caregiver : $100,000 and over Yes | 24 Participants | 53 Participants | 29 Participants |
| Income Caregiver : $25,000 - 49,999 No | 73 Participants | 146 Participants | 73 Participants |
| Income Caregiver : $25,000 - 49,999 Yes | 26 Participants | 55 Participants | 29 Participants |
| Income Caregiver : $50,000 - 99,999 No | 76 Participants | 157 Participants | 81 Participants |
| Income Caregiver : $50,000 - 99,999 Yes | 23 Participants | 44 Participants | 21 Participants |
| Income Caregiver : Do not wish to answer No | 86 Participants | 178 Participants | 92 Participants |
| Income Caregiver : Do not wish to answer Yes | 13 Participants | 23 Participants | 10 Participants |
| Income Caregiver : Under $24,999 No | 86 Participants | 175 Participants | 89 Participants |
| Income Caregiver : Under $24,999 Yes | 13 Participants | 26 Participants | 13 Participants |
| Income PWD : $100,000 and over No | 96 Participants | 193 Participants | 97 Participants |
| Income PWD : $100,000 and over Yes | 3 Participants | 8 Participants | 5 Participants |
| Income PWD : $25,000 - 49,999 No | 87 Participants | 168 Participants | 81 Participants |
| Income PWD : $25,000 - 49,999 Yes | 12 Participants | 33 Participants | 21 Participants |
| Income PWD : $50,000 - 99,999 No | 93 Participants | 188 Participants | 95 Participants |
| Income PWD : $50,000 - 99,999 Yes | 6 Participants | 13 Participants | 7 Participants |
| Income PWD : Caregiver is the spouse No | 79 Participants | 163 Participants | 84 Participants |
| Income PWD : Caregiver is the spouse Yes | 20 Participants | 38 Participants | 18 Participants |
| Income PWD : Do not wish to answer No | 89 Participants | 177 Participants | 88 Participants |
| Income PWD : Do not wish to answer Yes | 10 Participants | 24 Participants | 14 Participants |
| Income PWD : Under $24,999 No | 53 Participants | 118 Participants | 65 Participants |
| Income PWD : Under $24,999 Yes | 46 Participants | 83 Participants | 37 Participants |
| Marital Status Caregiver Divorced/Separated | 13 Participants | 28 Participants | 15 Participants |
| Marital Status Caregiver Married/Living together | 66 Participants | 137 Participants | 71 Participants |
| Marital Status Caregiver Never Married | 19 Participants | 32 Participants | 13 Participants |
| Marital Status Caregiver Widowed | 1 Participants | 4 Participants | 3 Participants |
| Marital Status PWD Divorced/Separated | 25 Participants | 37 Participants | 12 Participants |
| Marital Status PWD Married/Living together | 32 Participants | 62 Participants | 30 Participants |
| Marital Status PWD Never Married | 6 Participants | 14 Participants | 8 Participants |
| Marital Status PWD Widowed | 36 Participants | 88 Participants | 52 Participants |
| Montreal Cognitive Assessment (MoCA) | 10.5 score on a scale STANDARD_DEVIATION 4.2 | 10.9 score on a scale STANDARD_DEVIATION 4.3 | 11.4 score on a scale STANDARD_DEVIATION 4.5 |
| Neuropsychiatric Inventory Questionnaire (NPI-Q: Caregiver Distress) | 10.8 score on a scale STANDARD_DEVIATION 9.2 | 10.6 score on a scale STANDARD_DEVIATION 8.8 | 10.4 score on a scale STANDARD_DEVIATION 8.4 |
| Neuropsychiatric Inventory Questionnaire (NPI-Q: PWD) | 9.9 score on a scale STANDARD_DEVIATION 6.7 | 9.7 score on a scale STANDARD_DEVIATION 6.5 | 9.4 score on a scale STANDARD_DEVIATION 6.4 |
| Patient Health Questionnaire (PHQ-8: Caregiver) | 3.7 score on a scale STANDARD_DEVIATION 4.2 | 3.9 score on a scale STANDARD_DEVIATION 4.1 | 4.1 score on a scale STANDARD_DEVIATION 4 |
| Patient Institution Eskenazi | 56 Participants | 121 Participants | 65 Participants |
| Patient Institution IU Health | 42 Participants | 79 Participants | 37 Participants |
| Patient Institution St. Vincent | 1 Participants | 1 Participants | 0 Participants |
| Patient Medical Conditions (Comorbidities) Angina, heart failure, or other types of heart disease No | 66 Participants | 132 Participants | 66 Participants |
| Patient Medical Conditions (Comorbidities) Angina, heart failure, or other types of heart disease Yes | 33 Participants | 69 Participants | 36 Participants |
| Patient Medical Conditions (Comorbidities) Arthritis or rheumatism (inflammation of the joints) No | 45 Participants | 88 Participants | 43 Participants |
| Patient Medical Conditions (Comorbidities) Arthritis or rheumatism (inflammation of the joints) Yes | 54 Participants | 113 Participants | 59 Participants |
| Patient Medical Conditions (Comorbidities) Asthma, emphysema, or chronic bronchitis No | 81 Participants | 172 Participants | 91 Participants |
| Patient Medical Conditions (Comorbidities) Asthma, emphysema, or chronic bronchitis Yes | 18 Participants | 29 Participants | 11 Participants |
| Patient Medical Conditions (Comorbidities) Cancer No | 89 Participants | 181 Participants | 92 Participants |
| Patient Medical Conditions (Comorbidities) Cancer Yes | 10 Participants | 20 Participants | 10 Participants |
| Patient Medical Conditions (Comorbidities) High blood pressure or hypertension No | 28 Participants | 57 Participants | 29 Participants |
| Patient Medical Conditions (Comorbidities) High blood pressure or hypertension Yes | 71 Participants | 144 Participants | 73 Participants |
| Patient Medical Conditions (Comorbidities) High blood sugar or diabetes No | 74 Participants | 147 Participants | 73 Participants |
| Patient Medical Conditions (Comorbidities) High blood sugar or diabetes Yes | 25 Participants | 54 Participants | 29 Participants |
| Patient Medical Conditions (Comorbidities) Kidney or renal disease No | 83 Participants | 167 Participants | 84 Participants |
| Patient Medical Conditions (Comorbidities) Kidney or renal disease Yes | 16 Participants | 34 Participants | 18 Participants |
| Patient Medical Conditions (Comorbidities) Liver disease No | 97 Participants | 197 Participants | 100 Participants |
| Patient Medical Conditions (Comorbidities) Liver disease Yes | 2 Participants | 4 Participants | 2 Participants |
| Patient Medical Conditions (Comorbidities) Stroke, seizures, Parkinson's disease, or another neurological condition No | 74 Participants | 139 Participants | 65 Participants |
| Patient Medical Conditions (Comorbidities) Stroke, seizures, Parkinson's disease, or another neurological condition Yes | 25 Participants | 62 Participants | 37 Participants |
| Physical Self-Maintenance Scale/Activities of Daily Living (PSMS/ADLs) | 1.1 score on a scale STANDARD_DEVIATION 1.3 | 1.1 score on a scale STANDARD_DEVIATION 1.4 | 1.2 score on a scale STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized African American: Caregiver | 43 Participants | 89 Participants | 46 Participants |
| Race/Ethnicity, Customized African American: PWD | 44 Participants | 87 Participants | 43 Participants |
| Race/Ethnicity, Customized Others: Caregiver | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Others: PWD | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized Refused to Answer: Caregiver | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Refused to Answer: PWD | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized White: Caregiver | 49 Participants | 101 Participants | 52 Participants |
| Race/Ethnicity, Customized White: PWD | 48 Participants | 101 Participants | 53 Participants |
| Region of Enrollment United States | 99 Dyad: Patient and Caregiver | 201 Dyad: Patient and Caregiver | 102 Dyad: Patient and Caregiver |
| Sex: Female, Male Caregiver Participants Female | 82 Participants | 163 Participants | 81 Participants |
| Sex: Female, Male Caregiver Participants Male | 17 Participants | 38 Participants | 21 Participants |
| Sex: Female, Male Patient Participants Female | 67 Participants | 136 Participants | 69 Participants |
| Sex: Female, Male Patient Participants Male | 32 Participants | 65 Participants | 33 Participants |
| Symptom Measures in End-of-Life Dementia (SM-EOLD) | 29.8 score on a scale STANDARD_DEVIATION 9 | 29.3 score on a scale STANDARD_DEVIATION 8.9 | 28.8 score on a scale STANDARD_DEVIATION 8.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 40 / 99 | 43 / 102 |
| other Total, other adverse events | 77 / 99 | 89 / 102 |
| serious Total, serious adverse events | 50 / 99 | 61 / 102 |
Outcome results
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.
Time frame: 0-24 months
Population: This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IN-PEACE Dementia Care Coordination | Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity | 9.149 score on a scale | Standard Deviation 0.747 |
| Usual Care | Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity | 9.39 score on a scale | Standard Deviation 0.756 |
p-value: 0.8719Mixed Models Analysis
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.
Time frame: 0-24 months
Population: As pre-specified, this data only includes the patient from each dyad and not the caregiver.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IN-PEACE Dementia Care Coordination | Emergency Department Visits and Hospitalizations | 50 Participants |
| Usual Care | Emergency Department Visits and Hospitalizations | 80 Participants |
p-value: 0.0007Zero-Inflated Poisson Regression Model
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.
Time frame: 0-24 months
Population: This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IN-PEACE Dementia Care Coordination | Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress | 9.282 score on a scale | Standard Deviation 1.063 |
| Usual Care | Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress | 10.148 score on a scale | Standard Deviation 1.073 |
p-value: 0.6612Mixed Models Analysis
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.
Time frame: 0-24 months
Population: This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IN-PEACE Dementia Care Coordination | Patient Health Questionnaire (PHQ-8) Caregiver | 4.472 score on a scale | Standard Deviation 0.507 |
| Usual Care | Patient Health Questionnaire (PHQ-8) Caregiver | 4.522 score on a scale | Standard Deviation 0.511 |
p-value: 0.3431Mixed Models Analysis
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).
Time frame: 0-24 months
Population: This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IN-PEACE Dementia Care Coordination | Symptom Management - End of Life for Dementia (SM-EOLD) | 28.36 score on a scale | Standard Deviation 0.972 |
| Usual Care | Symptom Management - End of Life for Dementia (SM-EOLD) | 26.133 score on a scale | Standard Deviation 0.984 |
p-value: 0.8389Mixed Models Analysis