Pain Communication Toolkit for Caregivers of Alzheimer's Patients
(PICT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byCatherine A Riffin, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Weill Medical College of Cornell University
Disqualifiers: Paid caregiver, Hospice, Cancer treatment, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This study will evaluate the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention for caregivers of people with Alzheimer's disease and related dementias (ADRD). PICT provides training in observational pain assessment and coaching in effective pain communication techniques. It will recruit participants from programs of all-inclusive care for the elderly (PACE) and partnering health care clinics. The investigators hypothesize that PICT will help caregivers to recognize and communicate about pain in their care recipients.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the Pain Identification and Communication Toolkit (PICT) treatment for caregivers of Alzheimer's patients?
The Pain Identification and Communication Toolkit (PICT) has shown promise in a pilot trial by training caregivers to better recognize and communicate about pain in dementia patients, which is often underdetected and undermanaged. This suggests that PICT could help improve pain management by empowering caregivers with the skills needed to identify and report pain effectively.
12345Is the Pain Communication Toolkit safe for use in humans?
The Pain Identification and Communication Toolkit (PICT) has been evaluated in a pilot trial for caregivers of people with dementia, focusing on training for pain assessment and communication. The study did not report any safety concerns, suggesting it is generally safe for use in humans.
12467How is the Pain Communication Toolkit treatment different from other treatments for Alzheimer's patients?
The Pain Communication Toolkit is unique because it focuses on training caregivers to better observe and communicate about pain in Alzheimer's patients, rather than directly treating the pain itself. This approach empowers caregivers to play a crucial role in pain management by improving their ability to recognize and report pain symptoms, which is often challenging in patients who cannot communicate effectively.
148910Eligibility Criteria
This trial is for caregivers over 21 years old who speak English, are cognitively intact, and provide weekly care to someone with dementia or cognitive impairment and chronic pain enrolled in a PACE program. The person with dementia must not be in hospice or have a terminal illness with less than 6 months life expectancy.Inclusion Criteria
I have been diagnosed with pain.
I visit the person I care for at least once a week.
CAREGIVER PARTICIPANTS: Provides care to a PACE participant
+12 more
Exclusion Criteria
PATIENT PARTICIPANTS: Unresponsive to environment
I visit the person I care for less than once a week.
CAREGIVER PARTICIPANTS: Does not provide care to a person with dementia or cognitive impairment who also has a pain diagnosis
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the Pain Identification and Communication Toolkit (PICT) intervention, consisting of 4 weekly telephone sessions (30-60 minutes each) delivered by a trained interventionist.
4 weeks
4 visits (telephone)
Follow-up
Participants are monitored for changes in pain management and caregiver self-efficacy at 1, 3, and 6 months post-treatment.
6 months
3 visits (assessment at 1, 3, and 6 months)
Participant Groups
The study tests the Pain Identification and Communication Toolkit (PICT), designed to help caregivers of people with Alzheimer's disease recognize and communicate about their care recipient's pain through training and coaching.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pain Identification and Communication ToolkitExperimental Treatment1 Intervention
The Pain Identification and Communication Toolkit (PICT) components include: a) training using an observational assessment tool to detect pain in persons with Alzheimer's disease and related dementias (ADRD), b) coaching and feedback by a trained interventionist in effective strategies for communicating with providers about pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set through routine practice and homework exercises. A trained interventionist will deliver the PICT intervention following a manualized protocol to the caregiver participants. Patient participants will not receive any intervention.
Group II: Attention ControlPlacebo Group1 Intervention
The Attention Control (AC) condition, also known as the Health Promotion Program (HPP), focuses on caregiver health promotion topics, such as nutrition, exercise, and sleep. A trained interventionist will provide education on these topics using scripted material, use active listening and open questioning techniques, and provide the HPP participants with worksheets (e.g., meal plans) to complete between sessions to mirror the homework activities in the PICT condition for the caregiver participants. Patient participants will not receive any intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Weill Cornell MedicineNew York, NY
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
A pain assessment tool for people with advanced Alzheimer's and other progressive dementias. [2019]Appropriate pain management can only be achieved through accurate pain assessment that is individualized, ongoing, and well documented. Assessment tools must focus on the patient as the authority on pain's existence and severity; however, self-reports are not feasible when patients lose their ability to verbally communicate. This article describes a scientifically proven pain assessment tool that can be used for patients with advanced dementia and Alzheimer's Disease.
Pain assessment and cognitive impairment: part 2. [2019]To evaluate the use of a tool for pain assessment in cognitively impaired adults.
Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. [2022]To develop a clinically relevant and easy to use pain assessment tool for individuals with advanced dementia that has adequate psychometric properties.
Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. [2023]Despite its prevalence and impact, pain is underdetected and undermanaged in persons with dementia. Family caregivers are well positioned to detect pain and facilitate its management in their care recipients, but they lack training in symptom recognition and communication. This study reports findings from a pilot trial evaluating the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention that provides training in observational pain assessment and coaching in pain communication techniques.
Development and evaluation of the Pain Assessment in the Communicatively Impaired (PACI) tool: part I. [2018]Pain is a common symptom for long-term care residents, particularly those in need of palliative care. However, pain assessment in residents who have communication limitations is challenging. A study was conducted with the aim of developing a pain assessment tool that could feasibly be used by direct care providers in long-term care with minimal training yet demonstrating strong psychometric properties. The study used both qualitative and quantitative methods to develop and test the Pain Assessment in the Communicatively Impaired (PACI) tool. Part I of this paper reports on the development phase; a forthcoming second part will report on the testing phase. The overall results of this study support the psychometric properties and feasibility of the PACI tool, offering preliminary support for its use in clinical practice.
Using Pictures to Assess Pain Location in Children. [2019]This study uses the Pain Area Locator (PAL) tool, a picture communication aid with body and medical equipment icons, to identify pain location in postoperative pediatric patients and assesses discrepancies between nurses' pain location assessment and pain location identified using the PAL tool.
Algoplus® Scale in Older Patients with Dementia: A Reliable Real-World Pain Assessment Tool. [2019]Pain is still a neglected clinical issue in elderly people with dementia and/or communicative disorders, with an unacceptable higher rate of under diagnosis and under treatment. Cognitive deficit and emotional and psychological disturbances entangle pain symptoms, affecting patient self-report. So far, observational pain tools do not have fully adequate clinimetric properties and quality requirements for easy-to-use daily rating. Older patients with dementia represent a clinical challenge. The assessment of pain is important for improving clinical outcomes, such as functional status, frailty trajectories, comorbidity, and quality of life. The PAINAID scale appears to be the most accurate pain tool in people with dementia along with the Algoplus® scale, a recently developed tool to rapidly assess acute pain in hospitals settings. The present study aimed to assess the clinimetric properties of the Algoplus®, as compared to PAINAID, for detecting acute pain in a real-world cohort of hospitalized older patients with dementia.
Caregiver-provider communication about pain in persons with dementia. [2023]Pain in older persons with dementia is both under-detected and under-managed. Family caregivers can play an important role in addressing these deficiencies by communicating their care recipient's symptoms and behaviors to medical providers, but little is known about how caregivers and providers approach pain-related discussions in the context of dementia. The goal of this study was to explore how ambulatory care providers and family caregivers of persons with dementia view pain communication.
How do patients with Alzheimer's disease imagine their pain? [2021]Pain is underdiagnosed and undertreated in patients with Alzheimer's disease (AD). Pain management is of major importance in this population to limit behavioural and functional consequences. Our study aimed to assess the capacity of AD patients to represent pain using a questionnaire exploring daily painful situations and to determine the most appropriate pain scale assessment.
Pain assessment as intervention: a study of older adults with severe dementia. [2022]The communication impairments that characterize severe dementia make pain assessment challenging. As such, pain problems often go undetected. Our goal was to determine whether systematic pain assessment leads to improved pain management practices and decreases nursing stress in comparison with a control condition.