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Developing a Pain Identification and Communication Toolkit (PICT)

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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

Tracking Information
First Submitted Date  ICMJE February 22, 2019
First Posted Date  ICMJE February 25, 2019
Results First Submitted Date  ICMJE April 11, 2022
Results First Posted Date  ICMJE June 7, 2022
Last Update Posted Date June 7, 2022
Actual Study Start Date  ICMJE March 8, 2019
Actual Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2022)
  • Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions [ Time Frame: Post-intervention, 3 months ]
  • Feasibility, as Measured by the Number of Participants Recruited [ Time Frame: 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 [ Time Frame: Post-intervention, 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • Feasibility, as measured by the number of sessions completed by participants in the intervention condition [ Time Frame: Post-intervention, 3 months ]
    Feasibility, as measured by the number of sessions completed by participants in the intervention condition
  • Feasibility, as measured by the number of participants recruited [ Time Frame: Post-intervention, 3 months ]
    Feasibility, as measured by the number of participants recruited
  • Acceptability, as measured by the number of participants who report that they are "satisfied" or "very satisfied" with the intervention [ Time Frame: Post-intervention, 3 months ]
    Acceptability, as measured by the number of caregivers who report that they are "satisfied" or "very satisfied" with the intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2022)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
Caregiver initiated pain-related communication, as measured by the number of caregivers who makes contact with health care providers to discuss pain-related concerns [ Time Frame: At 3 months ]
Caregiver initiated pain-related communication, as measured by the number of caregivers who makes contact with health care providers to discuss pain-related concerns
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Developing a Pain Identification and Communication Toolkit
Official Title  ICMJE Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Dementia
  • Chronic Pain
Intervention  ICMJE
  • 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.
  • Behavioral: Information Pamphlet
    Pamphlet with information about pain and dementia and links to Alzheimer's Association
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: PICT Workbook
  • Active Comparator: Information Pamphlet
    Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.
    Intervention: Behavioral: Information Pamphlet
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 6, 2022)
85
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2019)
80
Actual Study Completion Date  ICMJE August 11, 2021
Actual Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03853291
Other Study ID Numbers  ICMJE 1811019718
3P30AG022845-15S1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Weill Medical College of Cornell University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Weill Medical College of Cornell University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Cornell University
  • Rutgers University
  • University of Iowa
Investigators  ICMJE
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
PRS Account Weill Medical College of Cornell University
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP