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Developing a Pain Identification and Communication Toolkit (PICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03853291
Recruitment Status : Terminated (terminated due to Covid and end of funding period for key personnel)
First Posted : February 25, 2019
Results First Posted : June 7, 2022
Last Update Posted : June 7, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Cornell University
Rutgers University
University of Iowa
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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.



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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853291


Locations
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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
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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:
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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    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Chronic Pain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pain
Neurologic Manifestations