Clinical trial NCT06168604: Evaluating the Efficacy of the Pain Identification and Communication Toolkit
Official title: The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons With ADRD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Cognitive Impairment
Dementia
Alzheimer Disease
Pain, Chronic
Keywords: Family Caregivers
Informal Caregivers
Dementia
Pain
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-12-13
Enrollment: 440
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in caregiver-reported pain communication
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in pain management discussions with health care providers
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in concordance between patient and caregiver pain ratings
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in caregiver's ability to recognize pain
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in caregiver's ability to recognize pain behaviors
timeFrame: Baseline, 1 month, 3 month, 6 month
Secondary outcomes:
measure: Change in patient's behavioral disturbance
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in patient's pain treatments or regimens
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in caregiver burden
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in caregiver distress level
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in caregiver self-efficacy in pain recognition
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in caregiver self-confidence in recognizing pain
timeFrame: Baseline, 1 month, 3 month, 6 month
measure: Change in caregiver self-efficacy in pain-related communication
timeFrame: Baseline, 1 month, 3 month, 6 month
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Catherine A Riffin, PhD
role: PRINCIPAL_INVESTIGATOR
References: