- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02708498
Implementation of Knowledge-Based Palliative Care (KUPA)
Implementation of Knowledge-Based Palliative Care for Frail Older Persons in Nursing Homes
The research on ageing during the last couple of decades has increasingly focused on questions regarding the quality of life and life satisfaction of the old people. Yet the research indicates that when it comes to the final stage of life, the end includes unnecessary suffering and the quality of life drops. Palliative care has traditionally been provided successfully to younger persons dying from incurable illnesses while older people dying of multiple morbidities or "old age" has received far less of this type of care. However, sixty percent of all people who died in Sweden in 2010 were at least 80 years old and it is well known that dying among older people often is a prolonged period of suffering. One reason might be that it is more difficult to identify when the final stages of life begins for older persons.
The purpose of this project is to implement and evaluate how a knowledge-based model for palliative care in nursing homes affects the quality of life and the participation in the care process for older persons in nursing homes and their next of kin. A second aim is to explore the staff's implementation process of palliative care and the role of the leadership. The final aim is to investigate which factors (barriers and facilitators) that affect the implementation process of this model.
연구 개요
상세 설명
The project was planned to be conducted using a cross-over design in two counties in south of Sweden based on a feasibility/pilot study that was conducted during fall 2014 co-created palliative care educational intervention through seminars for professionals in nursing homes. Due to a more significant amount of drop-outs compared with expected (and for not receiving the total amount of applied foundation), the plan needed to be revised. The knowledge-based palliative care intervention was conducted as a non-blinded control trial, implemented over a six-month period in 30 nursing homes in two different counties in the south of Sweden (County A and County B). The data collection was made in two sequential periods in each county. First, the intervention was implemented in ten nursing homes in County A (Kronoberg County from April 2015), while ten nursing homes in County B served as a control group. Then, County B implemented the intervention (Skåne county from April 2016), and ten new nursing homes in County A, which had not received the intervention, were chosen as a control group. After the two sequential time periods were data from one intervention and one control group analysed. The selection through voluntary participation resulted in a mixture of both larger and smaller nursing homes in the two counties, as well as both from urban and rural areas.
Every seminar group met once a month and included different professions (unit manager, district nurse, assistant nurse, and other staff i.e. occupational therapist and physiotherapist). There were 5 meetings in each nursing home during a period of 6 months.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kronoberg
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Alvesta, Kronoberg, 스웨덴, 34230
- Bryggaren
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Alvesta, Kronoberg, 스웨덴, 34235
- Högåsen
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Grimslöv, Kronoberg, 스웨덴, 34032
- Asken
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Ingelstad, Kronoberg, 스웨덴, 360 44
- Kvarngården
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Konga, Kronoberg, 스웨덴, 362 40
- Konga Allhus
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Lagan, Kronoberg, 스웨덴, 34014
- Åbrinken
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Ljungby, Kronoberg, 스웨덴, 34135
- Ljungberga
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Ljungby, Kronoberg, 스웨덴, 34138
- Ljungsätra
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Ljungby, Kronoberg, 스웨덴, 34183
- Brunnsgården
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Lönashult, Kronoberg, 스웨덴, 34253
- Torsgården
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Moheda, Kronoberg, 스웨덴, 34260
- Furuliden
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Ryd, Kronoberg, 스웨덴, 360 10
- Solängen
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Tingsryd, Kronoberg, 스웨덴, 362 30
- Örnen
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Urshult, Kronoberg, 스웨덴, 360 13
- Äppelgården
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Vislanda, Kronoberg, 스웨덴, 34250
- Björkliden
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Väckelsång, Kronoberg, 스웨덴, 362 51
- Solhaga
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Växjö, Kronoberg, 스웨덴, 352 41
- Birkagården
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Växjö, Kronoberg, 스웨덴, 352 44
- Hovslund
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Växjö, Kronoberg, 스웨덴, 352 64
- Evelid
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Älmeboda, Kronoberg, 스웨덴, 360 23
- Älmegården
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Skåne
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Höör, Skåne, 스웨덴, 24395
- Skogsgläntan
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Kågeröd, Skåne, 스웨덴, 28677
- Åsgården
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Lund, Skåne, 스웨덴, 224 60
- Mårtenslund
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Lund, Skåne, 스웨덴, 22460
- Brunnslyckan
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Lund, Skåne, 스웨덴, 22466
- Norrdala
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Osby, Skåne, 스웨덴, 283 42
- Rönnebacken
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Svalöv, Skåne, 스웨덴, 26834
- Solgården
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Svedala, Skåne, 스웨덴, 23338
- Holmagården
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Södra Sandby, Skåne, 스웨덴, 24731
- Fästan
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Teckomatorp, Skåne, 스웨덴, 26872
- Ängslyckan
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Older persons living in the participating nursing homes
- Next of kin to older persons living in the participating nursing homes
- Staff working at the participating nursing homes
- Managers working at the participating nursing homes
- The participating nursing homes must be located in either Kronoberg County or Skåne County in Sweden
Exclusion Criteria:
- Not being cognitive able to participate in interviews or answering the questionnaires
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Kronoberg Educational Intervention
The educational intervention is provided to ten nursing homes.
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The seminar groups will be led by two experienced clinical nurses and researchers from the field of palliative care and geriatric care.
The educational material consist of six themes; values in palliative care, symptom relief, dignity and a dignified death, collaborative co-creating care, support to next of kin and dialogue with older persons and next of kin about death and dying.
The content of the different themes will have a common core for each nursing home but will be adjusted based on the expressed needs of each nursing home.
New themes can be created related to the needs of the unique nursing home.
The participants in the seminar groups will reflect together over the content of the developed binder of educational material and will relate it to their own work in order to identify areas suitable for changes and/or development.
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간섭 없음: Skåne Control
The control group consists of an equal number of nursing homes.
This group receives no intervention.
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실험적: Skåne Educational Intervention
The educational intervention is provided to ten nursing homes.
|
The seminar groups will be led by two experienced clinical nurses and researchers from the field of palliative care and geriatric care.
The educational material consist of six themes; values in palliative care, symptom relief, dignity and a dignified death, collaborative co-creating care, support to next of kin and dialogue with older persons and next of kin about death and dying.
The content of the different themes will have a common core for each nursing home but will be adjusted based on the expressed needs of each nursing home.
New themes can be created related to the needs of the unique nursing home.
The participants in the seminar groups will reflect together over the content of the developed binder of educational material and will relate it to their own work in order to identify areas suitable for changes and/or development.
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간섭 없음: Kronoberg Control
The control group consists of an equal number of nursing homes.
This group receives no intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
기간: 9 months
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World Health Organization Quality of Life-BREF (WHOQOL-BREF) measure quality of life for older persons' at the end of life living in nursing homes. Five-point Likert-scale. Higher values mean better outcomes. Total score Min 26. Max 130. The range for the sub scale Overall Quality of Life; Min 1 Max 5 The range for the sub scale General health; Min 1 Max 5 The range for the sub scale Physical Health; Min 7 Max 35 The range for the sub scale Psychological; Min 6 Max 30 The range for the sub scale Social relationships; Min 3 Max 15 The range for the sub scale Environment; Min 8 Max 40 |
9 months
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World Health Organization Quality of Life-OLD (WHOQOL-OLD)
기간: 9 months
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World Health Organization Quality of Life-OLD (WHOQOL-OLD) measure quality of life for older persons living in nursing homes. Five point Likert-scale. Higher value means better outcome. Min 24. Max. 120. The range for the all the sub scales are; Min 1 Max 20 |
9 months
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Person-centred Care Assessment Tool (P-CAT)(Patient Version)
기간: 9 months
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Person-centred Care Assessment Tool (P-CAT) (patient version) measure person-centred care for older persons living in nursing homes. Five point Likert-scale. Higher score means better outcomes. Min 13. Max. 65. The range for the sub scale Extent of personalizing care; Min 8 Max 40 The range for the sub scale Amount of organizational and environmental support; Min 5 Max 25 |
9 months
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Person-Centred Climate Questionnaire (PCQ Patient Version)
기간: 9 months
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Person-Centred Climate Questionnaire (PCQ patient version) measure person-centred care for older persons living in nursing homes. Six point Likert-scale. Higher score means better outcome. Min 17. Max. 102. The range for the sub scale Safety; Min 10 Max 60 The range for the sub scale Everydayness; Min 4 Max 24 The range for the sub scale Hospitality; Min 3 Max 18 |
9 months
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Next-of-Kin Participation in Care (NoK-PiC); Psychometric Evaluation
기간: 9 months
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Next-of-Kin Participation in Care (NoK-PiC) measure participation for next of kin to older persons in nursing homes. The study includes both intervention and control groups. The two scales are 1) Communication and Trust (CaT); and 2) Collaboration in Care (CiC). The scales contains nine items each and items are scored from 0 to 4 (agree not at all (=0); agree to a low degree (=1); agree partly (=2); agree to a high degree (=3); and agree totally (=4). The possible score range from 0 to 36 in each of the two scales, and from 0-72 in the total scale. Higher score means better outcomes. This results are based upon a recently published psychometric evaluation by Westergren et al (2020). |
9 months
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World Health Organization Quality of Life-BREF (WHOQOL-BREF) for Next of Kin
기간: 9 months
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World Health Organization Quality of Life-BREF (WHOQOL-BREF) measure quality of life for next of kin to older persons in nursing homes. Five-point Likert-scale. Higher values mean better outcomes. Min 26. Max 130. he range for the sub scale Overall Quality of Life; Min 1 Max 5 The range for the sub scale General health; Min 1 Max 5 The range for the sub scale Physical Health; Min 7 Max 35 The range for the sub scale Psychological; Min 6 Max 30 The range for the sub scale Social relationships; Min 3 Max 15 The range for the sub scale Environment; Min 8 Max 40 |
9 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Person-centred Care Assessment Tool (P-CAT) (Staff Version)
기간: 6 months
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Person-centred Care Assessment Tool (P-CAT)(staff version) measure person-centred care for staff working in nursing homes. Five-point Likert-scale. Higher values mean better outcomes. Min 13. Max 65. The range for the sub scale Extent of personalizing care; Min 8 Max 40 The range for the sub scale Amount of organizational and environmental support; Min 5 Max 25 |
6 months
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Person-Centred Climate Questionnaire (PCQ-S)
기간: 6 months
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Person-Centred Climate Questionnaire (PCQ-S) measure person-centred care for staff working in nursing homes. Six-point Likert-scale. Higher values mean better outcomes. Min 14. Max 84. The range for the sub scale Safety; Min 5 Max 30 The range for the sub scale Everydayness; Min 5 Max 30 The range for the sub scale Community; Min 4 Max 24 |
6 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Gerd Ahlström, PhD, Department of Health Sciences, Lund University
간행물 및 유용한 링크
일반 간행물
- Persson HA, Ahlstrom G, Ekwall A. Professionals readiness for change to knowledge-based palliative care at nursing homes: a qualitative follow-up study after an educational intervention. BMC Palliat Care. 2022 Jul 20;21(1):132. doi: 10.1186/s12904-022-01018-y.
- Ahlstrom G, Rosen H, Persson EI. Quality of Life among Next of Kin of Frail Older People in Nursing Homes: An Interview Study after an Educational Intervention concerning Palliative Care. Int J Environ Res Public Health. 2022 Feb 24;19(5):2648. doi: 10.3390/ijerph19052648.
- Bokberg C, Sandberg J. Until death do us part Adult children's perspective of their parents' transition from living at home to moving into a nursing home and the time after death. BMC Geriatr. 2021 Nov 27;21(1):666. doi: 10.1186/s12877-021-02633-9.
- Sandgren A, Arnoldsson L, Lagerholm A, Bokberg C. Quality of life among frail older persons (65+ years) in nursing homes: A cross-sectional study. Nurs Open. 2021 May;8(3):1232-1242. doi: 10.1002/nop2.739. Epub 2020 Dec 13.
- Westergren A, Ahlstrom G, Persson M, Behm L. Next of kin participation in the care of older persons in nursing homes: A pre-post non-randomised educational evaluation, using within-group and individual person-level comparisons. PLoS One. 2021 Jan 25;16(1):e0244600. doi: 10.1371/journal.pone.0244600. eCollection 2021.
- Tjernberg J, Bokberg C. Older persons' thoughts about death and dying and their experiences of care in end-of-life: a qualitative study. BMC Nurs. 2020 Dec 16;19(1):123. doi: 10.1186/s12912-020-00514-x.
- Rosen H, Ahlstrom G, Lexen A. Psychometric properties of the WHOQOL-BREF among next of kin to older persons in nursing homes. Health Qual Life Outcomes. 2020 Apr 19;18(1):103. doi: 10.1186/s12955-020-01345-9.
- Westergren A, Behm L, Lindhardt T, Persson M, Ahlstrom G. Measuring next of kin's experience of participation in the care of older people in nursing homes. PLoS One. 2020 Jan 31;15(1):e0228379. doi: 10.1371/journal.pone.0228379. eCollection 2020.
- Rosen H, Behm L, Wallerstedt B, Ahlstrom G. Being the next of kin of an older person living in a nursing home: an interview study about quality of life. BMC Geriatr. 2019 Nov 21;19(1):324. doi: 10.1186/s12877-019-1343-4.
- Bokberg C, Behm L, Ahlstrom G. Next of kin's quality of life before and after implementation of a knowledge-based palliative care intervention in nursing homes. Qual Life Res. 2019 Dec;28(12):3293-3301. doi: 10.1007/s11136-019-02268-9. Epub 2019 Aug 14.
- Bokberg C, Behm L, Wallerstedt B, Ahlstrom G. Evaluation of person-centeredness in nursing homes after a palliative care intervention: pre- and post-test experimental design. BMC Palliat Care. 2019 May 31;18(1):44. doi: 10.1186/s12904-019-0431-8.
- Ahlstrom G, Nilsen P, Benzein E, Behm L, Wallerstedt B, Persson M, Sandgren A. Implementation of knowledge-based palliative care in nursing homes and pre-post post evaluation by cross-over design: a study protocol. BMC Palliat Care. 2018 Mar 22;17(1):52. doi: 10.1186/s12904-018-0308-2.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2014-2759
- 2014-0071 (기타 보조금/기금 번호: The Vardal Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
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