Developing a Pain Identification and Communication Toolkit

NCT ID: NCT03853291

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-08
• Study Completion Date: 2021-08-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PICT Workbook

Intervention Type: 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.

Information Pamphlet

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

Group Type: ACTIVE_COMPARATOR

Information Pamphlet

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Information Pamphlet

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: collaborator

Rutgers University

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cary Reid, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Catherine Riffin, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Karl Pillemer, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38094933 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3P30AG022845-15S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1811019718

Identifier Type: -

Identifier Source: org_study_id