Developing a Pain Identification and Communication Toolkit (PICT)

• ClinicalTrials.gov Identifier: NCT03853291
• Recruitment Status: Terminated
• First Posted: February 25, 2019
• Results First Posted: June 7, 2022
• Last Update Posted: June 7, 2022
• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA); Cornell University; Rutgers University; University of Iowa
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

Brief Summary:

The proposed research will develop, refine, and pilot test the Pain Identification and Communication Toolkit (PICT), an intervention to help family caregivers of community-dwelling persons with dementia identify pain symptoms and communicate those symptoms to health care providers. Informed by self-efficacy theory, PICT will include: a) training in administering an observational assessment tool to identify pain in persons with dementia, b) coaching in effective communication about the person with dementia's pain symptoms, c) future planning for steps to take when pain is detected, and d) updating caregivers' skills through routine practice with the pain assessment tool. All components will be vetted and iteratively field-tested with a sample of racially and ethnically diverse caregivers of community-dwelling persons with dementia and health care providers. A two-group pilot randomized trial will examine the acceptability, feasibility, and preliminary impact of PICT on caregivers' initiation of pain-related communication with health care providers.

Condition or disease	Intervention/treatment	Phase
Dementia; Chronic Pain	Behavioral: PICT Workbook; Behavioral: Information Pamphlet	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
• Actual Study Start Date: March 8, 2019
• Actual Primary Completion Date: August 11, 2021
• Actual Study Completion Date: August 11, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: PICT Workbook; PICT Workbook components includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's 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.	Behavioral: PICT Workbook; PICT Workbook: The PICT workbook is a 31-page manual, which includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set. Participants in the intervention condition also attended four weekly 30-minute sessions with an interventionist through a combination of online (video observation) and telephone coaching to go over the Workbook.
Active Comparator: Information Pamphlet; Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.	Behavioral: Information Pamphlet; Pamphlet with information about pain and dementia and links to Alzheimer's Association
No Intervention: Family Caregivers - Interview Phase; Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
No Intervention: Healthcare Providers - Interview Phase; Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
No Intervention: Family Caregivers - Field Test Phase; Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
No Intervention: Healthcare Providers - Field Test Phase; Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.

Outcome Measures

Primary Outcome Measures :

1. Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions [ Time Frame: Post-intervention, 3 months ]
2. Feasibility, as Measured by the Number of Participants Recruited [ Time Frame: Baseline ]
3. Acceptability, as Measured by the Number of Participants Who Report That the Intervention Was "Very Effective" or "Moderately Effective" in Helping Them Feel More Confident in Their Ability to Communicate Pain to Healthcare Providers [ Time Frame: Post-intervention, 3 months ]

Secondary Outcome Measures :

1. Caregiver Initiated Pain-related Communication, as Measured by the Number of Caregivers Who Report Making Contact With Any of the Care Recipients' Health Care Providers to Discuss Pain-related Concerns [ Time Frame: Baseline, Post-intervention-3 months ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

For all phases:

Inclusion Criteria:

• Family caregiver
• Age 21 or older
• English speaking
• Cognitively intact
• Provides at least 8 hours of care per week to a person with dementia and pain
• Has provided care for at least 6 months

Exclusion Criteria:

• Paid caregiver
• Age 20 or younger
• Non-English speaking
• Cognitively impaired
• Does not provide at least 8 hours of care per week to a person with dementia who also has a pain diagnosis
• Has not provided care for at least 6 months
• Currently enrolled in hospice
• The patient to whom the caregiver provides assistance is in enrolled in hospice
• Care recipient does not have dementia diagnosis or pain diagnosis

For field test and interview phases:

Healthcare professionals:

• Currently providing clinical services to persons with dementia and/or chronic pain
• Has provided these clinical services for at least 1 year

Contacts and Locations

Locations

United States, New York

Weill Cornell Medicine

New York, New York, United States, 10065

Sponsors and Collaborators

Weill Medical College of Cornell University

National Institute on Aging (NIA)

Cornell University

Rutgers University

University of Iowa

Investigators

• Principal Investigator: Cary Reid, MD/PhD; Weill Medical College of Cornell University
• Principal Investigator: Catherine Riffin, PhD; Weill Medical College of Cornell University
• Principal Investigator: Karl Pillemer, PhD; Cornell University

  Study Documents (Full-Text)

Documents provided by Weill Medical College of Cornell University:

Study Protocol and Statistical Analysis Plan  [PDF] September 17, 2021

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03853291
• Other Study ID Numbers: 1811019718; 3P30AG022845-15S1 ( U.S. NIH Grant/Contract )
• First Posted: February 25, 2019
• Results First Posted: June 7, 2022
• Last Update Posted: June 7, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dementia; Chronic Pain; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pain; Neurologic Manifestations