PICT: Developing a Pain Identification and Communication Toolkit

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03853291
• Collaborator: National Institute on Aging (NIA) (NIH), Cornell University (Other), Rutgers University (Other), University of Iowa (Other)
• Enrollment: 85
• Location: 1
• Arms: 6
• Actual Duration (Months): 29.1
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Chronic Pain	Behavioral: PICT Workbook; Behavioral: Information Pamphlet	N/A

Study Design

• Study Type: Interventional
• 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: Mar 8, 2019
• Actual Primary Completion Date: Aug 11, 2021
• Actual Study Completion Date: Aug 11, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions [Post-intervention, 3 months]

2. Feasibility, as Measured by the Number of Participants Recruited [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 [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 [Baseline, Post-intervention-3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• 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)

• Study Protocol and Statistical Analysis Plan - Sep 17, 2021

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03853291
• Other Study ID Numbers: 1811019718; 3P30AG022845-15S1
• First Posted: Feb 25, 2019
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia; Chronic Pain

Study Results

Participant Flow

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
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

Baseline Characteristics

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
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 Participants	18	16	18	16	6	11	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.1 (9.72)	61.6 (9.14)	61.5 (11.63)	61.67 (9.35)	62.0 (9.57)
Sex: Female, Male (Count of Participants)
Female	15 83.3%	16 100%	15 83.3%	12 75%	6 100%	8 72.7%	72 84.7%
Male	3 16.7%	0 0%	3 16.7%	4 25%	0 0%	3 27.3%	13 15.3%
Ethnicity (NIH/OMB) (Count of 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%	1 6.3%	0 0%	0 0%	2 2.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	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%	2 18.2%	11 12.9%
Native Hawaiian or Other Pacific Islander	0 0%	1 6.3%	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%	8 9.4%
White	12 66.7%	11 68.8%	12 66.7%	10 62.5%	6 100%	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%	4 4.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	1 6.3%	0 0%	1 9.1%	2 2.4%
Region of Enrollment (participants) [Number]
United States	18 100%	16 100%	18 100%	16 100%	6 100%	11 100%	85 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Time Frame	Post-intervention, 3 months

Outcome Measure Data

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
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.
Measure Participants	16
Count of Participants [Participants]	16 88.9%

2. Primary Outcome

Title	Feasibility, as Measured by the Number of Participants Recruited
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Data were not collected from participants in the interview and field test arms/phases.

Arm/Group Title	PICT Workbook	Information Pamphlet
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
Measure Participants	18	16
Count of Participants [Participants]	18 100%	16 100%

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
Time Frame	Post-intervention, 3 months

Outcome Measure Data

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
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.
Measure Participants	16
Count of Participants [Participants]	13 72.2%

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
Time Frame	Baseline, Post-intervention-3 months

Outcome Measure Data

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
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
Measure Participants	16	13
Baseline	13 72.2%	8 50%
3 Month Assessment	12 66.7%	8 50%

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

This is a pilot RCT focused on feasibility and acceptability, and was not fully powered to evaluate the intervention's efficacy.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.