Developing a Pain Identification and Communication Toolkit (PICT)
6. juni 2022 opdateret af: Weill Medical College of Cornell University
Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
85
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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New York, New York, Forenede Stater, 10065
- Weill Cornell Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
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Aktiv komparator: Information Pamphlet
Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.
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Pamphlet with information about pain and dementia and links to Alzheimer's Association
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Ingen indgriben: 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.
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Ingen indgriben: 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.
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Ingen indgriben: 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.
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Tidsramme: Post-intervention, 3 months
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Post-intervention, 3 months
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Feasibility, as Measured by the Number of Participants Recruited
Tidsramme: Baseline
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Baseline
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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
Tidsramme: Post-intervention, 3 months
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Post-intervention, 3 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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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
Tidsramme: Baseline, Post-intervention-3 months
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Baseline, Post-intervention-3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cary Reid, MD/PhD, Weill Medical College of Cornell University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. marts 2019
Primær færdiggørelse (Faktiske)
11. august 2021
Studieafslutning (Faktiske)
11. august 2021
Datoer for studieregistrering
Først indsendt
22. februar 2019
Først indsendt, der opfyldte QC-kriterier
22. februar 2019
Først opslået (Faktiske)
25. februar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juni 2022
Sidst verificeret
1. juni 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1811019718
- 3P30AG022845-15S1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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