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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 4 6 7}

How 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. ^{1 4 8 9 10}

Research Team

Catherine A Riffin, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility 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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pain assessment tool for people with advanced Alzheimer's and other progressive dementias. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Pain assessment and cognitive impairment: part 2. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of the Pain Assessment in the Communicatively Impaired (PACI) tool: part I. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Using Pictures to Assess Pain Location in Children. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Algoplus® Scale in Older Patients with Dementia: A Reliable Real-World Pain Assessment Tool. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Caregiver-provider communication about pain in persons with dementia. [2023]

9. England pubmed.ncbi.nlm.nih.gov

How do patients with Alzheimer's disease imagine their pain? [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Pain assessment as intervention: a study of older adults with severe dementia. [2022]