Developing a Pain Identification and Communication Toolkit (PICT)
2022년 6월 6일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
85
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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New York, New York, 미국, 10065
- Weill Cornell Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
21년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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간섭 없음: 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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간섭 없음: 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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간섭 없음: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
기간: 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
기간: 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
기간: Post-intervention, 3 months
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Post-intervention, 3 months
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2차 결과 측정
결과 측정 |
기간 |
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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
기간: Baseline, Post-intervention-3 months
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Baseline, Post-intervention-3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Cary Reid, MD/PhD, Weill Medical College of Cornell University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 3월 8일
기본 완료 (실제)
2021년 8월 11일
연구 완료 (실제)
2021년 8월 11일
연구 등록 날짜
최초 제출
2019년 2월 22일
QC 기준을 충족하는 최초 제출
2019년 2월 22일
처음 게시됨 (실제)
2019년 2월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 6월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 6월 6일
마지막으로 확인됨
2022년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .