Chronic Pain, Dementia
Conditions
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.
Interventions
BEHAVIORALPICT 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.
BEHAVIORALInformation Pamphlet
Pamphlet with information about pain and dementia and links to Alzheimer's Association
Sponsors
National Institute on Aging (NIA)
Cornell University
Rutgers University
University of Iowa
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
For all phases: Inclusion Criteria: * Family caregiver * Age 21 or older * English speaking * Cognitively intact * Provides at least 8 hours of care per week to a person with dementia and pain * Has provided care for at least 6 months
Exclusion criteria
* Paid caregiver * Age 20 or younger * Non-English speaking * Cognitively impaired * Does not provide at least 8 hours of care per week to a person with dementia who also has a pain diagnosis * Has not provided care for at least 6 months * Currently enrolled in hospice * The patient to whom the caregiver provides assistance is in enrolled in hospice * Care recipient does not have dementia diagnosis or pain diagnosis For field test and interview phases: Healthcare professionals: * Currently providing clinical services to persons with dementia and/or chronic pain * Has provided these clinical services for at least 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions | Post-intervention, 3 months |
| Feasibility, as Measured by the Number of Participants Recruited | 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 | Post-intervention, 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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 | 16 |
| 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. | 18 |
| 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. | 16 |
| 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. | 6 |
| 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. | 11 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Determined to be ineligible | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Family Caregivers - Interview Phase | Family Caregivers - Field Test Phase | Total | PICT Workbook | Information Pamphlet | Healthcare Providers - Field Test Phase | Healthcare Providers - Interview Phase |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 11.63 | 61.67 years STANDARD_DEVIATION 9.35 | 62.0 years STANDARD_DEVIATION 9.57 | 63.1 years STANDARD_DEVIATION 9.72 | 61.6 years STANDARD_DEVIATION 9.14 | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 10 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 5 Participants | 73 Participants | 15 Participants | 14 Participants | 10 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 11 Participants | 1 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 8 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 6 Participants | 59 Participants | 12 Participants | 11 Participants | 8 Participants | 10 Participants |
| Region of Enrollment United States | 18 participants | 6 participants | 85 participants | 18 participants | 16 participants | 11 participants | 16 participants |
| Sex: Female, Male Female | 15 Participants | 6 Participants | 72 Participants | 15 Participants | 16 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 13 Participants | 3 Participants | 0 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 18 | 0 / 16 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PICT Workbook | 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 |
Primary
Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PICT Workbook | Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions | 16 Participants |
Primary
Feasibility, as Measured by the Number of Participants Recruited
Time frame: Baseline
Population: Data were not collected from participants in the interview and field test arms/phases.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PICT Workbook | Feasibility, as Measured by the Number of Participants Recruited | 18 Participants |
| Information Pamphlet | Feasibility, as Measured by the Number of Participants Recruited | 16 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PICT Workbook | 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 | 13 Participants |
| PICT Workbook | 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 | 3 Month Assessment | 12 Participants |
| Information Pamphlet | 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 | 8 Participants |
| Information Pamphlet | 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 | 3 Month Assessment | 8 Participants |