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Developing a Pain Identification and Communication Toolkit (PICT)

Primary Purpose

Dementia, Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PICT Workbook
Information Pamphlet
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dementia

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

No Intervention

No Intervention

No Intervention

No Intervention

Arm Label

PICT Workbook

Information Pamphlet

Family Caregivers - Interview Phase

Healthcare Providers - Interview Phase

Family Caregivers - Field Test Phase

Healthcare Providers - Field Test Phase

Arm Description

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.

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

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2019
Last Updated
June 6, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA), Cornell University, Rutgers University, University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT03853291
Brief Title
Developing a Pain Identification and Communication Toolkit
Acronym
PICT
Official Title
Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
terminated due to Covid and end of funding period for key personnel
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
August 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA), Cornell University, Rutgers University, University of Iowa

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Chronic Pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PICT Workbook
Arm Type
Experimental
Arm Description
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.
Arm Title
Information Pamphlet
Arm Type
Active Comparator
Arm Description
Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.
Arm Title
Family Caregivers - Interview Phase
Arm Type
No Intervention
Arm Description
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.
Arm Title
Healthcare Providers - Interview Phase
Arm Type
No Intervention
Arm Description
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.
Arm Title
Family Caregivers - Field Test Phase
Arm Type
No Intervention
Arm Description
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.
Arm Title
Healthcare Providers - Field Test Phase
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PICT Workbook
Intervention Description
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
Intervention Name(s)
Information Pamphlet
Intervention Description
Pamphlet with information about pain and dementia and links to Alzheimer's Association
Primary Outcome Measure Information:
Title
Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Time Frame
Post-intervention, 3 months
Title
Feasibility, as Measured by the Number of Participants Recruited
Time Frame
Baseline
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cary Reid, MD/PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Riffin, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl Pillemer, PhD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Developing a Pain Identification and Communication Toolkit

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