NCT02091622

Brief Summary

Introduction: Honest prognostication and information for patients are important parts of end-of-life care. This study examined whether an educational intervention could increase the proportion of patients who received information about the transition to end-of-life care (ITEOL). Method: Two municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses. The proportion of patients who received ITEOL was measured with data from the Swedish Register of Palliative Care (SRPC). Patients were only included if they died an expected death and maintained their ability to express their will until days or hours before their death. Four hospitals and four municipalities were assigned controls, matched by hospital size, population, and proportion of patients receiving ITEOL at baseline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,431

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

March 13, 2014

Last Update Submit

March 17, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who received ITEOL

    The proportion of patients who received ITEOL was measured with data from the Swedish Register of Palliative Care (SRPC). Six months after the intervention data were collected from the SRPC for all patients who had died at the included hospitals and municipalities. Data were collected from six months before the intervention to six months after the intervention. The outcome was compared before and after the intervention.

    Six months after intervention

Study Arms (2)

Educative intervention

OTHER

Two municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses.

Other: Educative intervention

No intervention

NO INTERVENTION

No intervention.

Interventions

Two municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses.

Educative intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitals and municipalities: Participation in the Swedish Register of Palliative Care.
  • Patients: Reported from an included hospital or municipality during six months before to six months after intervention.

You may not qualify if:

  • Patients were excluded when death was unexpected, when a forensic post mortem examination was performed, or when the patients had lost their ability to express their will and take part in decisions concerning the content of medical care one week or more before death.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University, Dept of radiation sciences

Umeå, Umeå, SE-901 87, Sweden

Location

Study Officials

  • Bertil Axelsson, MD PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 19, 2014

Study Start

August 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations