Developing a Pain Identification and Communication Toolkit

NCT03853291 | Terminated Results

• 2 other identifiers: 18110197183P30AG022845-15S1
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions

  Post-intervention, 3 months

• Feasibility, as Measured by the Number of Participants Recruited

  Baseline

• 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

  Post-intervention, 3 months

Secondary Outcomes (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

  Baseline, Post-intervention-3 months

Study Arms (6)

PICT Workbook

EXPERIMENTAL

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

Information Pamphlet

ACTIVE COMPARATOR

Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.

Behavioral: Information Pamphlet

Family Caregivers - Interview Phase

NO INTERVENTION

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.

Healthcare Providers - Interview Phase

NO INTERVENTION

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.

Family Caregivers - Field Test Phase

NO INTERVENTION

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.

Healthcare Providers - Field Test Phase

NO INTERVENTION

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.

Interventions

PICT Workbook BEHAVIORAL

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.

PICT Workbook

Information Pamphlet BEHAVIORAL

Pamphlet with information about pain and dementia and links to Alzheimer's Association

Information Pamphlet

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator
• Cornell University: collaborator
• Rutgers University: collaborator
• University of Iowa: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (1)

• Riffin C, Brody L, Mukhi P, Herr K, Pillemer K, Rogers M, Henderson CR Jr, Reid MC. Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. Innov Aging. 2023 Jul 13;7(10):igad074. doi: 10.1093/geroni/igad074. eCollection 2023.

  PMID: 38094933 DERIVED

MeSH Terms

Conditions

Dementia; Chronic Pain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is a pilot RCT focused on feasibility and acceptability, and was not fully powered to evaluate the intervention's efficacy.

Results Point of Contact

• Title: Dr. Catherine Riffin, Assistant Professor of Psychology in Medicine
• Organization: Weill Cornell Medicine

acr2213@med.cornell.edu

646.962.7160

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: March 8, 2019
• Primary Completion: August 11, 2021
• Study Completion: August 11, 2021
• Last Updated: June 7, 2022
• Results First Posted: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)