NCT02708498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

September 2, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

February 26, 2016

Results QC Date

March 20, 2019

Last Update Submit

October 6, 2020

Conditions

Keywords

Palliative careFrail elderlyComorbidityStaff DevelopmentNursing Homes

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Person-centred Care Assessment Tool (P-CAT) (Staff Version)

    6 months

  • Person-Centred Climate Questionnaire (PCQ-S)

    6 months

Study Arms (4)

Kronoberg Educational Intervention

EXPERIMENTAL

The educational intervention is provided to ten nursing homes.

Behavioral: Educational Intervention

Skåne Control

NO INTERVENTION

The control group consists of an equal number of nursing homes. This group receives no intervention.

Skåne Educational Intervention

EXPERIMENTAL

The educational intervention is provided to ten nursing homes.

Behavioral: Educational Intervention

Kronoberg Control

NO INTERVENTION

The control group consists of an equal number of nursing homes. This group receives no intervention.

Interventions

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.

Kronoberg Educational InterventionSkåne Educational Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not being cognitive able to participate in interviews or answering the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Bryggaren

Alvesta, Kronoberg County, 34230, Sweden

Location

Högåsen

Alvesta, Kronoberg County, 34235, Sweden

Location

Älmegården

Älmeboda, Kronoberg County, 360 23, Sweden

Location

Asken

Grimslöv, Kronoberg County, 34032, Sweden

Location

Kvarngården

Ingelstad, Kronoberg County, 360 44, Sweden

Location

Konga Allhus

Konga, Kronoberg County, 362 40, Sweden

Location

Åbrinken

Lagan, Kronoberg County, 34014, Sweden

Location

Ljungberga

Ljungby, Kronoberg County, 34135, Sweden

Location

Ljungsätra

Ljungby, Kronoberg County, 34138, Sweden

Location

Brunnsgården

Ljungby, Kronoberg County, 34183, Sweden

Location

Torsgården

Lönashult, Kronoberg County, 34253, Sweden

Location

Furuliden

Moheda, Kronoberg County, 34260, Sweden

Location

Solängen

Ryd, Kronoberg County, 360 10, Sweden

Location

Örnen

Tingsryd, Kronoberg County, 362 30, Sweden

Location

Äppelgården

Urshult, Kronoberg County, 360 13, Sweden

Location

Birkagården

Vaxjo, Kronoberg County, 352 41, Sweden

Location

Hovslund

Vaxjo, Kronoberg County, 352 44, Sweden

Location

Evelid

Vaxjo, Kronoberg County, 352 64, Sweden

Location

Solhaga

Väckelsång, Kronoberg County, 362 51, Sweden

Location

Björkliden

Vislanda, Kronoberg County, 34250, Sweden

Location

Skogsgläntan

Höör, Skåne County, 24395, Sweden

Location

Åsgården

Kågeröd, Skåne County, 28677, Sweden

Location

Mårtenslund

Lund, Skåne County, 224 60, Sweden

Location

Brunnslyckan

Lund, Skåne County, 22460, Sweden

Location

Norrdala

Lund, Skåne County, 22466, Sweden

Location

Rönnebacken

Osby, Skåne County, 283 42, Sweden

Location

Fästan

Södra Sandby, Skåne County, 24731, Sweden

Location

Solgården

Svalöv, Skåne County, 26834, Sweden

Location

Holmagården

Svedala, Skåne County, 23338, Sweden

Location

Ängslyckan

Teckomatorp, Skåne County, 26872, Sweden

Location

Related Publications (12)

  • 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.

Related Links

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Results Point of Contact

Title
Professor Gerd Ahlström
Organization
Department of Health Sciences, Lund University

Study Officials

  • Gerd Ahlström, PhD

    Department of Health Sciences, Lund University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: The knowledge-based palliative care intervention was conducted as a non-randomized control trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 15, 2016

Study Start

April 9, 2015

Primary Completion

June 20, 2017

Study Completion

October 15, 2017

Last Updated

October 28, 2020

Results First Posted

September 2, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations