Evaluating the Efficacy of the Pain Identification and Communication Toolkit
Purpose
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.
Conditions
- Caregiver Burden
- Cognitive Impairment
- Dementia
- Alzheimer Disease
- Pain, Chronic
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Single blind allocation. The outcomes assessors will be masked to group allocation. Other research personnel (investigator, project manager, interventionist) may become aware of group allocation. Participants will be asked not to disclose to outcomes assessors the group to which they are assigned.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Pain Identification and Communication Toolkit |
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. |
|
|
Sham Comparator Attention Control |
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. |
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Recruiting Locations
New York 5128581, New York 5128638 10065
More Details
- Status
- Recruiting
- Sponsor
- Weill Medical College of Cornell University
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.