Pain Communication Toolkit for Caregivers of Alzheimer's Patients

(PICT Trial)

Overseen By Lisa Sacerio

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Paid caregiver, Hospice, Cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a toolkit designed to help caregivers of individuals with Alzheimer's and similar conditions identify and communicate about pain. The Pain Identification and Communication Toolkit includes training on recognizing pain, coaching on effective communication with doctors, and planning for managing pain symptoms. It aims to improve how caregivers handle pain-related issues for those they care for. Caregivers who visit someone with dementia and a pain diagnosis at least once a week, and are not paid for their caregiving, might be suitable for this trial. As an unphased study, this trial offers caregivers the chance to enhance their skills and improve the quality of care they provide.

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 prior data suggests that the Pain Identification and Communication Toolkit is safe for caregivers of Alzheimer's patients?

Research has shown that the Pain Identification and Communication Toolkit (PICT) helps caregivers recognize and discuss pain in individuals with Alzheimer's and similar conditions. PICT is not a medicine or medical procedure; it is a training program with various components. Caregivers learn to identify signs of pain and how to communicate these with doctors. They also receive guidance on responding when they notice pain.

As PICT is a training program rather than a medical treatment, no reports of side effects like those seen in drug trials exist. The program focuses on enhancing caregivers' skills, so the safety concerns typical of drug treatments do not apply. This makes it a low-risk option for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pain Identification and Communication Toolkit (PICT) because it addresses a critical gap in Alzheimer's care: effectively identifying and communicating pain. While standard care often relies on medications or behavioral interventions, PICT empowers caregivers with tools to spot pain in non-verbal patients using an observational assessment tool. It also equips caregivers with strategies to communicate effectively with healthcare providers and includes ongoing coaching to enhance caregiver skills. This approach not only aims to improve patient comfort but also supports caregivers in making informed decisions, potentially transforming pain management for Alzheimer's patients.

What evidence suggests that the Pain Identification and Communication Toolkit is effective for caregivers of Alzheimer's patients?

Research has shown that up to 60% of older adults with Alzheimer's and similar conditions experience significant pain, which often goes unnoticed and untreated. In this trial, caregivers will join one of two groups. One group will use the Pain Identification and Communication Toolkit (PICT), which studies have shown helps caregivers better notice and report pain in these patients. PICT provides training on spotting signs of pain and effectively communicating these signs to healthcare providers. Early trials suggested that caregivers using PICT felt more confident in managing their loved one's pain. This toolkit could improve life for both caregivers and patients by ensuring pain is addressed more quickly and effectively. ^{4 5 6 7 8}

Who Is on the Research Team?

Catherine A Riffin, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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

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 PACE participant

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Pain Identification and Communication Toolkit

Trial Overview 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.

How Is the Trial Designed?

Group I: Pain Identification and Communication Toolkit Experimental Treatment 1 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 Control Placebo Group 1 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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The study evaluated a multi-dimensional tool for assessing pain in cognitively impaired adults, revealing that certain pain indicators were more frequently observed and documented, particularly during morning shifts.

Nurses' compliance in recording pain observations was inconsistent, highlighting the need for better training and support to enhance pain assessment practices, which should combine physiological and behavioral indicators based on clinical judgment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain assessment and cognitive impairment: part 2. Davies, E., Male, M., Reimer, V., et al.[2019]

Accurate pain management in patients with advanced dementia and Alzheimer's Disease requires individualized and ongoing pain assessment, as self-reports may not be possible due to communication difficulties.

The article introduces a scientifically validated pain assessment tool specifically designed for non-verbal patients, emphasizing the importance of recognizing the patient's authority on their pain experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pain assessment tool for people with advanced Alzheimer's and other progressive dementias. Lane, P., Kuntupis, M., MacDonald, S., et al.[2019]

The Pain Assessment in Advanced Dementia (PAINAD) tool was developed and validated for assessing pain in individuals with advanced dementia who cannot communicate their pain, showing good reliability and validity in a study involving 19 residents and expert clinicians.

PAINAD effectively detected changes in pain levels before and after analgesic medication was administered, indicating its potential utility in clinical settings for improving pain management in noncommunicative patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. Warden, V., Hurley, AC., Volicer, L.[2022]

The Pain Identification and Communication Toolkit (PICT) was successfully implemented in a pilot trial with family caregivers of 34 individuals with dementia, showing that 100% of participants completed the intervention and 94% completed follow-up assessments.

Caregivers who used PICT reported increased confidence in recognizing (67%) and communicating about pain symptoms (83%), indicating that the toolkit may effectively enhance caregivers' skills in managing pain in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. Riffin, C., Brody, L., Mukhi, P., et al.[2023]

The Pain Assessment in the Communicatively Impaired (PACI) tool was developed to help assess pain in long-term care residents who have communication limitations, aiming for ease of use by direct care providers with minimal training.

Preliminary results indicate that the PACI tool has strong psychometric properties, suggesting it could be a reliable and feasible option for pain assessment in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of the Pain Assessment in the Communicatively Impaired (PACI) tool: part I. Kaasalainen, S., Stewart, N., Middleton, J., et al.[2018]

Patients with Mild and Moderate Alzheimer's Disease (AD) struggle to differentiate between high and low pain levels, showing significantly lower discrimination scores compared to matched controls, indicating challenges in pain recognition.

Despite these difficulties, AD patients can still assess imagined painful situations, but they tend to overestimate pain levels, suggesting that pain assessment tools need to be tailored to their cognitive and sensory abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do patients with Alzheimer's disease imagine their pain? Borg, C., Sala, E., Chainay, H., et al.[2021]

Systematic pain assessment using the PACSLAC tool significantly improved pain management practices in dementia patients, leading to increased use of analgesic medications compared to a control group.

Nurses who implemented the PACSLAC reported lower levels of distress and burnout, indicating that systematic pain assessment not only benefits patient care but also supports caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain assessment as intervention: a study of older adults with severe dementia. Fuchs-Lacelle, S., Hadjistavropoulos, T., Lix, L.[2022]

The study highlights the significant challenge of accurately assessing pain in elderly patients with dementia, as cognitive deficits can hinder their ability to self-report pain, leading to underdiagnosis and undertreatment.

The Algoplus® scale was evaluated for its effectiveness in detecting acute pain in hospitalized older patients with dementia and was found to be comparable to the PAINAID scale, suggesting it could be a valuable tool for improving pain management in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Algoplus® Scale in Older Patients with Dementia: A Reliable Real-World Pain Assessment Tool. Monacelli, F., Signori, A., Roffredo, L., et al.[2019]

Caregivers play crucial roles in communicating about pain in individuals with dementia, often acting as historians, interpreters, and advocates, but face challenges such as inadequate information and conflicts with healthcare providers.

To improve communication about pain management, strategies like using written records, pain scales, and building rapport between caregivers and providers are recommended, which can enhance the accuracy of information and support better treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver-provider communication about pain in persons with dementia. Riffin, C., Patrick, K., Lin, SL., et al.[2023]

All 41 pediatric patients in the study successfully used the Pain Area Locator (PAL) tool to identify their pain locations after surgery, demonstrating its effectiveness as a communication aid.

The PAL tool revealed that 83% of the children identified pain locations that nurses had not documented, highlighting its potential to improve pain assessment in postoperative pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Pictures to Assess Pain Location in Children. Mesko, PJ., Eliades, AB.[2019]

Citations

1. reporter.nih.gov reporter.nih.gov/search/10EECF0E478CC3D57598B8961CAA4A01A2FFCEB861BF/project-details/11023145

The Pain Identification and Communication Toolkit PROJECT SUMMARY Up to 60% of older persons with Alzheimer's disease and related dementias (ADRD) suffer from bothersome pain and nearly half experience ...

2. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/the-pain-identification-and-communication-toolkit-a-training-program-to-support-family-caregivers-of-persons-with-alzheimer%E2%80%99s-disease-and-related-dementias

The Pain Identification and Communication Toolkit The purpose of this study is to compare the efficacy of the Pain Identification and Communication Toolkit (PICT) with a Health Promotion (HP) program.

3. clinicaltrial.be clinicaltrial.be/en/details/418971?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Evaluating the Efficacy of the Pain Identification and Co... Despite best-practice guidelines calling for routine pain assessment of persons with ADRD, pain is severely under-detected and poorly managed in ...

4. withpower.com withpower.com/trial/phase-dementia-11-2023-53d1e

Pain Communication Toolkit for Caregivers of Alzheimer's ... This study will evaluate the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention for caregivers of people with Alzheimer's ...

5. neurosurgery.weill.cornell.edu neurosurgery.weill.cornell.edu/clinical-trials/pain-identification-and-communication-toolkit-training-program-support-family

The Pain Identification and Communication Toolkit Trial Description: The purpose of this study is to compare the efficacy of the Pain Identification and Communication Toolkit (PICT) with a Health Promotion (HP) ...

6. reporter.nih.gov reporter.nih.gov/search/0Rg-xjhKh0-9YY7FBlu83g/project-details/10570403

The Pain Identification and Communication Toolkit PROJECT SUMMARY Up to 60% of older persons with Alzheimer's disease and related dementias (ADRD) suffer from bothersome pain and nearly half experience pain- ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06168604?term=alzheimer

Evaluating the Efficacy of the Pain Identification and ... A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different ...

8. trialx.com trialx.com/clinical-trials/listings/277531/evaluating-the-efficacy-of-the-pain-identification-and-communication-toolkit/?&geo_lat=40.8882&geo_lng=-74.0503&radius=10&place=Hackensack&user_country=United%20States

Evaluating the Efficacy of the Pain Identification and ... This study will evaluate the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention for caregivers of people with ...