Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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15 July 2019 |
Main ID: |
ISRCTN69571462 |
Date of registration:
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14/03/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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End-of-life communication in nursing homes – Patient preferences and participation
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Scientific title:
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Implementation of advance care planning in Norwegian nursing homes - a cluster randomized controlled trial |
Date of first enrolment:
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21/04/2015 |
Target sample size:
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317 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN69571462 |
Study type:
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Interventional |
Study design:
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Multi-centre cluster randomised controlled trial (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Norway
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Contacts
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Name:
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Reidar
Pedersen |
Address:
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University of Oslo
Postboks 1130 Blindern
0318
Oslo
Norway |
Telephone:
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+47 22844663 |
Email:
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reidar.pedersen@medisin.uio.no |
Affiliation:
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Name:
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Trygve Johannes Lereim
Sævareid |
Address:
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University of Oslo
Postboks 1130 Blindern
0318
Oslo
Norway |
Telephone:
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+47 22859204 |
Email:
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t.j.l.savareid@medisin.uio.no |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Nursing home resident 2. Aged 70 years and over
Exclusion criteria: 1. Under the age of 70 2. Do not understand or speak Norwegian 3. Severe psychiatric condition
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Care Not Applicable Care
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Intervention(s)
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Eight nursing home wards from eight nursing homes are pair-matchedusing the following data from a national survey/KOSTRA/the nursing home’s annual report: size of the municipality, size of the nursing home and ward (number of beds), number of hours with doctor present per week, and personnel position characteristics (educational backgrounds, percentage of professionals, ratio of part time/full time). One ward from each pair of wards is then randomized to be included in the intervention group and the other to the control group.
Intervention group: : The intervention consists of systematic implementation of Advance care planning (ACP) conversations. A guideline has been developed for these conversations which includes a definition of ACP, outlines aims and purposes of ACP, emphasizes voluntary participation and includes a suggested text on how to invite patients to the conversation, addresses competency to consent, notes the researchers aim of including patients with cognitive impairment in conversations, recommends setting and timing of conversation, recommends who should participate and how to prepare for and lead the conversation, recommends what questions to ask and suggests how the conversations should progress, and finally states recommendations on what to do after the conversation. Patients at the ward, or next of kin when patients could not consent, are invited to an ACP conversation. The ACP conversation lasts no more than an hour. Each patient did not get invitation to more than one conversation during the 12 month intervention period. A project group from each of the nursing home wards in the intervention group are educated in ACP, the guideline and how to conduct ACP conversations prior to the intervention. They also got a recommendation on how to assess competency to consent, and are told the importance of doing so. They are responsible for educating their own staff. However, the research g
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Primary Outcome(s)
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Current primary outcome measures as of 15/02/2018: Number of patients with a documented conversation on end-of-life treatment assessed through electronic health record review at baseline and 12 months.
Previous primary outcome measures: 1. Number of patients with a documented conversation on end-of-life treatment is assessed through electronic health record review at baseline and 12 months 2. Number of patients with a documented wish regarding life-prolonging treatment and hospitalisation assessed through electronic health record review at baseline and 12 months 3. Concordance between patient wishes and treatment given will be measured based on documentation of events assessed through electronic health record review at baseline and 12 months
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Secondary Outcome(s)
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Current secondary outcome measures as of 15/02/2018: Based on information in the patient's EHR the following secondary outcomes will be assessed (at baseline and at the end of the 12 month intervention period): 1. Patient's hopes and worries for the future 2. Patient’s wishes for a proxy, information to oneself and NOK, and patient wishes for participation in decision-making processes 3. Patient’s competence to consent assessed in relation to conversations on future life-prolonging treatment 4. Wishes regarding life-prolonging treatment and hospitalization 5. Patient’s own wishes regarding life-prolonging treatment and hospitalization are known 6. NOK's knowledge of the patients’ wishes regarding life-prolonging treatment and hospitalization 7. NOK's own opinion on life-prolonging treatment and hospitalization 8. Wishes regarding life-prolonging treatment and hospitalization being positive to treatment 9. Life-prolonging treatments and hospitalizations during the past 12 months 10. Life-prolonging treatments and hospitalizations decided not given during the past 12 months 11. Patient's competence to consent assessed during the past 12 months, when life-prolonging treatments and hospitalizations were given or decided not given 12. Concordance between patient wishes and treatment given will be measured based on documentation of events during the past 12 months.
Previous secondary outcome measures: 1. Documentation of: patient's hopes and worries for the future, wishes for information to oneself and next of kin, wishes for participation in end-of-life decision-making 2. Decisions on end-of-life treatment and hospitalisation 3. Concordance between patient's previously expressed wishes and actual treatment given
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Secondary ID(s)
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The Research Council of Norway project number: 222088
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Source(s) of Monetary Support
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The Research Council of Norway
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Ethics review
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Status:
Approval date:
Contact:
1. The Regional Ethics Committee, 15/04/2015, ref: 2014/2210/REK sør-øst
2. Norwegian Social Science Data Services, 03/03/2015, ref: 41114
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/08/2018 |
URL:
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