Trial Outcomes & Findings for Developing a Pain Identification and Communication Toolkit (NCT NCT03853291)

NCT ID: NCT03853291

Last Updated: 2022-06-07

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

85 participants

Primary outcome timeframe

Post-intervention, 3 months

Results posted on

2022-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Information Pamphlet 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	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.	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.	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.	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.
Overall Study STARTED	18	16	18	16	6	11
Overall Study COMPLETED	16	13	18	16	6	11
Overall Study NOT COMPLETED	2	3	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Information Pamphlet 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	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.	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.	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.	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.
Overall Study Lost to Follow-up	1	2	0	0	0	0
Overall Study Determined to be ineligible	1	1	0	0	0	0

Baseline Characteristics

Age was not collected from healthcare providers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PICT Workbook n=18 Participants 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.	Information Pamphlet n=16 Participants 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	Family Caregivers - Interview Phase n=18 Participants 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.	Healthcare Providers - Interview Phase n=16 Participants 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.	Family Caregivers - Field Test Phase n=6 Participants 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.	Healthcare Providers - Field Test Phase n=11 Participants 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 n=85 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 9.72 • n=18 Participants • Age was not collected from healthcare providers	61.6 years STANDARD_DEVIATION 9.14 • n=16 Participants • Age was not collected from healthcare providers	61.5 years STANDARD_DEVIATION 11.63 • n=18 Participants • Age was not collected from healthcare providers	—	61.67 years STANDARD_DEVIATION 9.35 • n=6 Participants • Age was not collected from healthcare providers	—	62.0 years STANDARD_DEVIATION 9.57 • n=58 Participants • Age was not collected from healthcare providers
Sex: Female, Male Female	15 Participants n=18 Participants	16 Participants n=16 Participants	15 Participants n=18 Participants	12 Participants n=16 Participants	6 Participants n=6 Participants	8 Participants n=11 Participants	72 Participants n=85 Participants
Sex: Female, Male Male	3 Participants n=18 Participants	0 Participants n=16 Participants	3 Participants n=18 Participants	4 Participants n=16 Participants	0 Participants n=6 Participants	3 Participants n=11 Participants	13 Participants n=85 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=18 Participants	2 Participants n=16 Participants	3 Participants n=18 Participants	1 Participants n=16 Participants	1 Participants n=6 Participants	1 Participants n=11 Participants	10 Participants n=85 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=18 Participants	14 Participants n=16 Participants	15 Participants n=18 Participants	14 Participants n=16 Participants	5 Participants n=6 Participants	10 Participants n=11 Participants	73 Participants n=85 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=18 Participants	1 Participants n=16 Participants	0 Participants n=6 Participants	0 Participants n=11 Participants	2 Participants n=85 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=6 Participants	0 Participants n=11 Participants	0 Participants n=85 Participants
Race (NIH/OMB) Asian	1 Participants n=18 Participants	1 Participants n=16 Participants	2 Participants n=18 Participants	5 Participants n=16 Participants	0 Participants n=6 Participants	2 Participants n=11 Participants	11 Participants n=85 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	1 Participants n=16 Participants	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=6 Participants	0 Participants n=11 Participants	1 Participants n=85 Participants
Race (NIH/OMB) Black or African American	3 Participants n=18 Participants	2 Participants n=16 Participants	3 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=6 Participants	0 Participants n=11 Participants	8 Participants n=85 Participants
Race (NIH/OMB) White	12 Participants n=18 Participants	11 Participants n=16 Participants	12 Participants n=18 Participants	10 Participants n=16 Participants	6 Participants n=6 Participants	8 Participants n=11 Participants	59 Participants n=85 Participants
Race (NIH/OMB) More than one race	2 Participants n=18 Participants	1 Participants n=16 Participants	1 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=6 Participants	0 Participants n=11 Participants	4 Participants n=85 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=18 Participants	1 Participants n=16 Participants	0 Participants n=6 Participants	1 Participants n=11 Participants	2 Participants n=85 Participants
Region of Enrollment United States	18 participants n=18 Participants	16 participants n=16 Participants	18 participants n=18 Participants	16 participants n=16 Participants	6 participants n=6 Participants	11 participants n=11 Participants	85 participants n=85 Participants

PRIMARY outcome

Timeframe: Post-intervention, 3 months

Population: 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.

Outcome measures

Outcome measures
Measure	PICT Workbook n=16 Participants 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.	Information Pamphlet 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
Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions	16 Participants	—

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	PICT Workbook n=18 Participants 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.	Information Pamphlet n=16 Participants 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
Feasibility, as Measured by the Number of Participants Recruited	18 Participants	16 Participants

PRIMARY outcome

Timeframe: Post-intervention, 3 months

Population: 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.

Outcome measures

Outcome measures
Measure	PICT Workbook n=16 Participants 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.	Information Pamphlet 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
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	13 Participants	—

SECONDARY outcome

Timeframe: Baseline, Post-intervention-3 months

Population: 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.