Evaluating the Efficacy of the Pain Identification and Communication Toolkit (PICT)

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Alzheimer Disease; Cognitive Impairment; Caregiver Burden; Pain, Chronic; Dementia

Treatments: Behavioral: Pain Identification and Communication Toolkit; Behavioral: Health Promotion Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06168604

22-08025205

R01AG079932 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Up to 60% of older persons with Alzheimer's disease and related dementias (ADRD) suffer from bothersome pain and nearly half experience pain-related activity limitations. Despite best-practice guidelines calling for routine pain assessment of persons with ADRD, pain is severely under-detected and poorly managed in this population. A major barrier to the identification and treatment of pain in persons with ADRD is impaired communication. Informal (family) caregivers are well situated to detect pain and facilitate management in persons with ADRD, given their extensive involvement in care activities. However, caregivers receive virtually no guidance or training in these areas. The Pain Identification and Communication Toolkit (PICT) is a multicomponent intervention for ADRD caregivers that provides training in observational pain assessment and coaching in effective pain communication techniques. PICT consists of 4 weekly telephone sessions (30-60 minutes each) delivered by a trained interventionist. This project aims to (1) determine the efficacy of PICT compared with an Attention Control (AC) condition, (2) identify the patient and caregiver factors that may moderate the effects of PICT on study outcomes, and (3) evaluate the mechanisms (theoretically-derived variables) by which PICT affects study outcomes. Participants will be recruited from programs of all-inclusive care for the elderly (PACE) programs and partnering health care clinics. They will complete assessments at 0 (baseline), 1, 3, and 6 months.

Enrollment: 440 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

CAREGIVER PARTICIPANTS

Inclusion Criteria:

1. Age 21 or older
2. Any gender
3. English speaking
4. Cognitively intact (BOMC ≤10)
5. Provides care to a community-dwelling adult with dementia or cognitive impairment who also has a pain diagnosis
6. Care recipient is not enrolled in hospice
7. Visits the care recipient at least weekly
8. Accessible by telephone

Exclusion Criteria:

1. Paid caregiver
2. Age 20 or younger
3. Non-English speaking
4. Cognitively impaired
5. Does not provide care to a person with dementia or cognitive impairment who also has a pain diagnosis
6. Currently enrolled in hospice
7. The patient to whom the caregiver provides assistance is enrolled in hospice
8. Visits care recipient less than weekly
9. Not accessible by telephone.

PATIENT PARTICIPANTS

Inclusion Criteria:

1. Residing in community settings
2. Record of dementia or cognitive impairment
3. Diagnosis of pain
4. Responsive to environment
5. No terminal illness with life expectancy <6 months
6. Not in active cancer treatment

Exclusion Criteria:

1. Lives in a residential facility (such as a nursing home or assisted living)
2. Enrolled in hospice
3. No dementia or cognitive impairment
4. Unresponsive to environment
5. Has terminal illness with life expectancy <6 months
6. Are in active cancer treatment

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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440 participants in 2 patient groups

Pain Identification and Communication Toolkit

Experimental group

Description:

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.

Treatment:

Behavioral: Pain Identification and Communication Toolkit

Attention Control

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Health Promotion Program