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Implementation of Knowledge-Based Palliative Care (KUPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02708498
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : September 2, 2020
Last Update Posted : October 28, 2020
Sponsor:
Collaborators:
Linnaeus University
The Swedish Research Council
Information provided by (Responsible Party):
Lund University

Brief 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.


Condition or disease Intervention/treatment Phase
Ageing Behavioral: Educational Intervention Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1151 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The knowledge-based palliative care intervention was conducted as a non-randomized control trial.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementation of Knowledge-Based Palliative Care for Frail Older Persons in Nursing Homes
Actual Study Start Date : April 9, 2015
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : October 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kronoberg Educational Intervention
The educational intervention is provided to ten nursing homes.
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.

No Intervention: Skåne Control
The control group consists of an equal number of nursing homes. This group receives no intervention.
Experimental: Skåne Educational Intervention
The educational intervention is provided to ten nursing homes.
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.

No Intervention: Kronoberg Control
The control group consists of an equal number of nursing homes. This group receives no intervention.



Primary Outcome Measures :
  1. World Health Organization Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: 9 months ]

    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


  2. World Health Organization Quality of Life-OLD (WHOQOL-OLD) [ Time Frame: 9 months ]

    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


  3. Person-centred Care Assessment Tool (P-CAT)(Patient Version) [ Time Frame: 9 months ]

    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


  4. Person-Centred Climate Questionnaire (PCQ Patient Version) [ Time Frame: 9 months ]

    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


  5. Next-of-Kin Participation in Care (NoK-PiC); Psychometric Evaluation [ Time Frame: 9 months ]

    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).


  6. World Health Organization Quality of Life-BREF (WHOQOL-BREF) for Next of Kin [ Time Frame: 9 months ]

    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



Secondary Outcome Measures :
  1. Person-centred Care Assessment Tool (P-CAT) (Staff Version) [ Time Frame: 6 months ]

    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


  2. Person-Centred Climate Questionnaire (PCQ-S) [ Time Frame: 6 months ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708498


Locations
Show Show 30 study locations
Sponsors and Collaborators
Lund University
Linnaeus University
The Swedish Research Council
Investigators
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Principal Investigator: Gerd Ahlström, PhD Department of Health Sciences, Lund University
  Study Documents (Full-Text)

Documents provided by Lund University:
Study Protocol  [PDF] October 6, 2020
Statistical Analysis Plan  [PDF] October 6, 2020

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT02708498    
Other Study ID Numbers: 2014-2759
2014-0071 ( Other Grant/Funding Number: The Vardal Foundation )
First Posted: March 15, 2016    Key Record Dates
Results First Posted: September 2, 2020
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lund University:
Palliative care
Frail elderly
Comorbidity
Staff Development
Nursing Homes