Evaluating the Efficacy of the Pain Identification and Communication Toolkit

Alzheimer Disease Clinical Trial

— PICT  

Official title:

The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons With ADRD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168604
• Other study ID #: 22-08025205
• Secondary ID: R01AG079932
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: February 2028

Study information

• Verified date: January 2024
• Source: Weill Medical College of Cornell University
• Contact: Lauren Mei, BA
• Phone: 516-528-4027
• Email: lam4011[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). The investigators hypothesize that PICT will help caregivers to recognize and communicate about pain in their care recipients.

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. They will complete assessments at 0 (baseline), 1, 3, and 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: February 2028
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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 person with dementia or cognitive impairment who also has a pain diagnosis

6. Provides care to a PACE participant

7. Care recipient is not enrolled in hospice

8. Visits the care recipient at least weekly

9. 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. Does not provide care to a PACE participant

7. Currently enrolled in hospice

8. The patient to whom the caregiver provides assistance is enrolled in hospice

9. Visits care recipient less than weekly

10. Not accessible by telephone. PATIENT PARTICIPANTS

Inclusion Criteria:

1. Currently enrolled at a PACE program

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. Not enrolled at a PACE program

2. No dementia or cognitive impairment

3. Unresponsive to environment

4. Has terminal illness with life expectancy <6 months

5. Is in active cancer treatment

6. Enrolled in hospice

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden
• Chronic Pain
• Cognitive Impairment
• Dementia
• Pain, Chronic

Intervention

Behavioral:
• Pain Identification and Communication Toolkit
The Pain Identification and Communication Toolkit (PICT) is a multicomponent (6 module) intervention for family caregivers of persons with Alzheimer's disease and related dementias (ADRD). PICT consists of 4 weekly telephone sessions (30-60 minutes each) delivered by a trained interventionist
• Health Promotion Program
The attention control (AC) condition is referred to as the Health Promotion Program (HPP). The HPP will consist of 4 weekly telephone sessions (30-60 minutes each) but focus on caregiver health promotion topics, such as nutrition, exercise, and sleep.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in caregiver-reported pain communication	Change in caregiver-reported pain-related communication as measured by ten questions from the Perceived Involvement in Care Scale (PICS). The range of possible scores is 10-50, where higher scores indicate greater caregiver involvement in patient consultation.	Baseline, 1 month, 3 month, 6 month
Primary	Change in pain management discussions with health care providers	Change in pain management discussions as measured by the combined number of phone calls and appointments made to discuss pain management recorded in the patient's medical chart.	Baseline, 1 month, 3 month, 6 month
Primary	Change in concordance between patient and caregiver pain ratings	Change in concordance in patient and caregiver pain ratings as measured by the absolute difference between caregiver and patient pain ratings of the patient's pain on the Iowa Pain Thermometer (IPT). The IPT is scored on a scale of 0-10 where 0 means "no pain" and 10 means "the most intense pain imaginable."	Baseline, 1 month, 3 month, 6 month
Primary	Change in caregiver's ability to recognize pain	Change in caregiver's ability to recognize pain as measured by the absolute difference between the caregiver-reported PAINAD score and correct PAINAD score (i.e. absolute value of the deviance between the scores). The PAINAD is scored on a scale from 0-10 where 0 means "no pain" and 10 means "severe pain." Participants will be shown multiple videos on which to score the PAINAD.	Baseline, 1 month, 3 month, 6 month
Primary	Change in caregiver's ability to recognize pain behaviors	Change in caregiver's ability to recognize pain behaviors as measured by the absolute difference between the number of caregiver-reported behaviors within each of the 5 PAINAD behaviors (i.e., Breathing, Negative Vocalization, Facial Expression, Body Language, Consolability) and correct number of behaviors. Participants will be shown multiple videos on which to score the PAINAD.	Baseline, 1 month, 3 month, 6 month
Secondary	Change in patient's behavioral disturbance	Change in patient's behavioral disturbance as measured by 11 items on the Memory and Behavior Problem Checklist. Questions are asked on a likert scale of 0-never occurs to 4-occurs daily or more often for a total possible score of 44, with higher scores indicating more behavioral disturbance in the patient.	Baseline, 1 month, 3 month, 6 month
Secondary	Change in patient's pain treatments or regimens	Change in number of each type of caregiver-reported patient treatment/regimens.	Baseline, 1 month, 3 month, 6 month
Secondary	Change in caregiver burden	Change in caregiver burden will be assessed by the 7-item version of the Zarit Burden Index (ZBI). Response options for each item range from 0-"never" to 4-"nearly always". The highest possible score is 28 and the lowest possible score is 0; higher scores indicate more caregiver burden.	Baseline, 1 month, 3 month, 6 month
Secondary	Change in caregiver distress level	Change in caregiver distress as measured by 11 items on the Memory and Behavior Problem Checklist. Questions are asked on a likert scale of 0-not at all to 4-extremely for a highest possible score of 44 and a lowest possible score of 0, with higher scores indicating more caregiver distress.	Baseline, 1 month, 3 month, 6 month
Secondary	Change in caregiver self-efficacy in pain recognition	Change in caregiver self-efficacy in pain recognition as measured by 9 items adapted from The Health Education Impact Questionnaire on a scale of 1-"completely disagree" to 5-"completely agree" with a highest total score of 45 and a lowest total score of 9. Higher total scores indicate higher self-efficacy in pain recognition.	Baseline, 1 month, 3 month, 6 month
Secondary	Change in caregiver self-confidence in recognizing pain	Change in self-confidence in recognizing pain as measured by four items adapted from McCabe et al., 2012. Questions are asked on a scale of 1-"not at all confident" to 4-"very confident," with a highest possible score of 16 and a lowest possible score of 4. Higher scores indicate more confidence in ones ability to recognize pain.	Baseline, 1 month, 3 month, 6 month
Secondary	Change in caregiver self-efficacy in pain-related communication	Change in caregiver self-efficacy in pain-related communication as measured by a modified 10-item version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI) Scale. Questions are asked on a scale of 1 - "not at all confident" to 5 - "very confident" with a highest total score of 50 and a lowest total score of 10. Higher scores indicate higher self-efficacy in pain-related communication between a caregiver and a healthcare provider.	Baseline, 1 month, 3 month, 6 month