Research Into the Quality of the Dying Phase | NCT02822690

Studies
Research Into the Quality of the Dying Phase

NCT02822690

Sponsor

University Medical Center Groningen

Status

Completed

Last Update Posted

Apr 19, 2024Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Cessation of Life

Interventions

Hospice care at UMCG

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Jun 2019Actual

Completion Date

Jun 2019Actual

First Submitted Date

Jun 24, 2016

First Submission Date that Met QC Criteria

Jun 29, 2016

First Posted Date

Jul 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2024

Last Update Posted Date

Apr 19, 2024Actual

Name	Class
Martini Hospital Groningen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to get insight in the quality of life at the end of life and quality of dying for patients died at the hospital in the department Groningen (the Netherlands).

The primary endpoint is the quality of life at the end of life and the secondary endpoint is the quality of dying. Both according a numerical rating scale.

An explorative analysis will be done for differences for the hospitals in Groningen, effect of using the Liverpool care Pathway for the dying, effect of using consultation by the palliative consultation team, effect of using the Hospice@UMCG intervention, correlation with the quality of life at the end of life and quality of dying according to nurses and doctors.

Detailed Description

Three hospitals in the department Groningen (the Netherlands) will participate in this study. When a patient died in one of these hospitals (except the emergency department, child ward and intensive care unit) the bereaved relatives will get an information letter. After about 12 weeks a questionnaire will be sent to the bereaved relative. This questionnaire is developed to evaluate the end of life care at the hospital.

Shortly after the patient died at the hospital, also the nurse and doctor of this patient are requested to fill out a questionnaire.

The questionnaire for the bereaved relatives consists of items, divided in groups: a general part, followed by questions of the last days of life, existing symptoms (physical, psychological, existential and social), the care and treatment and the loss.

The questionnaire for the nurses exists of similar items. Special attention for recognizing the impending dying and problems, care and therapy at the end of life.

In all questionnaires there are also 2 main questions: What is your opinion of the quality of life during the last days of life and What is your opinion of the quality of dying.

In the three hospitals the end of life care is managed at somehow different ways: the use of the Liverpool care Pathway of the dying, the hospice@UMCG intervention and consultation by the palliative team of the hospital.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
University Medical Center Groningen	all patients that died on one of the wards with the exception of children; on several wards the Hospice care will be introduced as an intervention	Other: Hospice care at UMCG
Martini Ziekenhuis	all patients that died on one of the wards with the exception of children
Ommelander ZorgGroep	all patients that died on one of the wards with the exception of children

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hospice care at UMCG	Other	introduction of hospice care facilities on the wards at the UMCG	University Medical Center Groningen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life questionnaire		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients dying in the hospital

Exclusion Criteria:

patients dying at the child ward, emergency dept. and intensive care dept.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all patients dying in the hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
An KL Reyners, MD/PhD	University Medical Center Groningen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen		Groningen		9713 GZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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