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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Conditions Dementia
Chronic Pain
Interventions Behavioral: PICT Workbook
Behavioral: Information Pamphlet
Enrollment 85
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PICT Workbook Information Pamphlet Family Caregivers - Interview Phase Healthcare Providers - Interview Phase Family Caregivers - Field Test Phase Healthcare Providers - Field Test Phase
Hide Arm/Group 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.

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

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

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.
Period Title: Overall Study
Started 18 16 18 16 6 11
Completed 16 13 18 16 6 11
Not Completed 2 3 0 0 0 0
Reason Not Completed
Lost to Follow-up             1             2             0             0             0             0
Determined to be ineligible             1             1             0             0             0             0
Arm/Group Title PICT Workbook Information Pamphlet Family Caregivers - Interview Phase Healthcare Providers - Interview Phase Family Caregivers - Field Test Phase Healthcare Providers - Field Test Phase Total
Hide Arm/Group 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.

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

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

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. Total of all reporting groups
Overall Number of Baseline Participants 18 16 18 16 6 11 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 18 participants 0 participants 6 participants 0 participants 58 participants
63.1  (9.72) 61.6  (9.14) 61.5  (11.63) 61.67  (9.35) 62.0  (9.57)
[1]
Measure Analysis Population Description: Age was not collected from healthcare providers
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 18 participants 16 participants 6 participants 11 participants 85 participants
Female
15
  83.3%
16
 100.0%
15
  83.3%
12
  75.0%
6
 100.0%
8
  72.7%
72
  84.7%
Male
3
  16.7%
0
   0.0%
3
  16.7%
4
  25.0%
0
   0.0%
3
  27.3%
13
  15.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 18 participants 16 participants 6 participants 11 participants 85 participants
Hispanic or Latino
2
  11.1%
2
  12.5%
3
  16.7%
1
   6.3%
1
  16.7%
1
   9.1%
10
  11.8%
Not Hispanic or Latino
15
  83.3%
14
  87.5%
15
  83.3%
14
  87.5%
5
  83.3%
10
  90.9%
73
  85.9%
Unknown or Not Reported
1
   5.6%
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
2
   2.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 18 participants 16 participants 6 participants 11 participants 85 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.6%
1
   6.3%
2
  11.1%
5
  31.3%
0
   0.0%
2
  18.2%
11
  12.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.2%
Black or African American
3
  16.7%
2
  12.5%
3
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
8
   9.4%
White
12
  66.7%
11
  68.8%
12
  66.7%
10
  62.5%
6
 100.0%
8
  72.7%
59
  69.4%
More than one race
2
  11.1%
1
   6.3%
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
4
   4.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
1
   9.1%
2
   2.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 18 participants 16 participants 6 participants 11 participants 85 participants
18 16 18 16 6 11 85
1.Primary Outcome
Title Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Hide Description [Not Specified]
Time Frame Post-intervention, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants did not complete the intervention, n=1 lost to follow-up, n=1 determined ineligible post-enrollment. Data were not collected from participants in the interview and field test arms/phases.
Arm/Group Title PICT Workbook
Hide Arm/Group 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.
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
16
 100.0%
2.Primary Outcome
Title Feasibility, as Measured by the Number of Participants Recruited
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected from participants in the interview and field test arms/phases.
Arm/Group Title PICT Workbook Information Pamphlet
Hide Arm/Group 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.

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

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

Overall Number of Participants Analyzed 18 16
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
16
 100.0%
3.Primary Outcome
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
Hide Description [Not Specified]
Time Frame Post-intervention, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
For the intervention condition: 2 participants did not complete the intervention, n=1 lost to follow-up, n=1 determined ineligible post-enrollment. Data from the information pamphlet arm was not collected. Data were not collected from participants in the interview and field test arms/phases.
Arm/Group Title PICT Workbook
Hide Arm/Group 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.
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
13
  81.3%
4.Secondary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline, Post-intervention-3 months
Hide Outcome Measure Data
Hide Analysis Population Description
5 participants overall were not analyzed. For the workbook: n=1 lost to follow-up, n=1 deemed ineligible. For informational pamphlet: n=2 lost to follow-up, n=1 deemed ineligible. Data were not collected from participants in the interview and field test arms/phases.
Arm/Group Title PICT Workbook Informational Pamphlet
Hide Arm/Group 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.

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

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

Overall Number of Participants Analyzed 16 13
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
13
  81.3%
8
  61.5%
3 Month Assessment
12
  75.0%
8
  61.5%
Time Frame Up to 3 months.
Adverse Event Reporting Description Participants were assessed for SAEs and safety alerts. SAEs included caregiver hospitalization, institutionalization, ER visit, and death. Safety alerts included severe medical problem of the caregiver, caregiver or care recipient abuse, caregiver threatens to harm themselves or disruptions in caregiver/patient relationship. Safety alerts were not considered SAEs. All-Cause Mortality, Serious, and Other AE data were not collected for "Interview Phase" and the "Field Test Phase" Arms/Groups.
 
Arm/Group Title PICT Control Group Family Caregivers - Interview Phase Healthcare Providers - Interview Phase Family Caregivers - Field Test Phase Healthcare Providers - Field Test Phase
Hide Arm/Group Description

Pain Identification and Communication Toolkit (PICT) components include: a) training using an observational assessment tool to detect pain in persons with dementia, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about their care recipient'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.

PICT: PICT is a manualized, multicomponent intervention delivered by a trained interventionist. PICT consists of 4 weekly telephone sessions (30-60 mins each) guided by an Instructor Manual and companion Caregiver Workbook

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

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

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.
All-Cause Mortality
PICT Control Group Family Caregivers - Interview Phase Healthcare Providers - Interview Phase Family Caregivers - Field Test Phase Healthcare Providers - Field Test Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%)   0/0   0/0   0/0   0/0 
Hide Serious Adverse Events
PICT Control Group Family Caregivers - Interview Phase Healthcare Providers - Interview Phase Family Caregivers - Field Test Phase Healthcare Providers - Field Test Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%)   0/0   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PICT Control Group Family Caregivers - Interview Phase Healthcare Providers - Interview Phase Family Caregivers - Field Test Phase Healthcare Providers - Field Test Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%)   0/0   0/0   0/0   0/0 
This is a pilot RCT focused on feasibility and acceptability, and was not fully powered to evaluate the intervention's efficacy.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Catherine Riffin, Assistant Professor of Psychology in Medicine
Organization: Weill Cornell Medicine
Phone: 646.962.7160
EMail: acr2213@med.cornell.edu
Layout table for additonal information
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 Submitted: February 22, 2019
First Posted: February 25, 2019
Results First Submitted: April 11, 2022
Results First Posted: June 7, 2022
Last Update Posted: June 7, 2022