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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02708498
Other study ID # 2014-2759
Secondary ID 2014-0071
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2015
Est. completion date October 15, 2017

Study information

Verified date October 2020
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 1151
Est. completion date October 15, 2017
Est. primary completion date June 20, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational Intervention
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.

Locations

Country Name City State
Sweden Älmegården Älmeboda Kronoberg
Sweden Bryggaren Alvesta Kronoberg
Sweden Högåsen Alvesta Kronoberg
Sweden Asken Grimslöv Kronoberg
Sweden Skogsgläntan Höör Skåne
Sweden Kvarngården Ingelstad Kronoberg
Sweden Åsgården Kågeröd Skåne
Sweden Konga Allhus Konga Kronoberg
Sweden Åbrinken Lagan Kronoberg
Sweden Brunnsgården Ljungby Kronoberg
Sweden Ljungberga Ljungby Kronoberg
Sweden Ljungsätra Ljungby Kronoberg
Sweden Torsgården Lönashult Kronoberg
Sweden Brunnslyckan Lund Skåne
Sweden Mårtenslund Lund Skåne
Sweden Norrdala Lund Skåne
Sweden Furuliden Moheda Kronoberg
Sweden Rönnebacken Osby Skåne
Sweden Solängen Ryd Kronoberg
Sweden Fästan Södra Sandby Skåne
Sweden Solgården Svalöv Skåne
Sweden Holmagården Svedala Skåne
Sweden Ängslyckan Teckomatorp Skåne
Sweden Örnen Tingsryd Kronoberg
Sweden Äppelgården Urshult Kronoberg
Sweden Solhaga Väckelsång Kronoberg
Sweden Birkagården Växjö Kronoberg
Sweden Evelid Växjö Kronoberg
Sweden Hovslund Växjö Kronoberg
Sweden Björkliden Vislanda Kronoberg

Sponsors (3)

Lead Sponsor Collaborator
Lund University Linnaeus University, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary World Health Organization Quality of Life-BREF (WHOQOL-BREF) 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
Primary World Health Organization Quality of Life-OLD (WHOQOL-OLD) 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
Primary Person-centred Care Assessment Tool (P-CAT)(Patient Version) 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
Primary Person-Centred Climate Questionnaire (PCQ Patient Version) 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
Primary Next-of-Kin Participation in Care (NoK-PiC); Psychometric Evaluation 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
Primary World Health Organization Quality of Life-BREF (WHOQOL-BREF) for Next of Kin 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
Secondary Person-centred Care Assessment Tool (P-CAT) (Staff Version) 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
Secondary Person-Centred Climate Questionnaire (PCQ-S) 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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