Improving Quality of Care for the Dying Patient in Hospice: A Quasi Experimental Trial in Liguria Region

January 11, 2013 updated by: Regional Palliative Care Network
This is a before-after phase II study, according to the Medical Research Council framework, investigating the feasibility of introducing the Liverpool Care Pathway for the dying patient (LCP) in 5 Ligurian hospices.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
282

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16000
        • Hospice Gigi Ghirotti "Albaro"
      • Genova, Italy, 16000
        • Hospice Gigi Ghirotti "Bolzaneto"
      • Imperia, Italy, 18014
        • Hospice ASL1 Liguria
      • Savona, Italy, 171000
        • CENTRO MISERICORDIA" SANTA M.G.ROSSELLO. Ist.Figlie Ns Signora Misericordia
    • Genova
      • Chiavari, Genova, Italy, 16000
        • Hospice ASL 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients deceased in the hospice during the evaluation period
  • Approval of ethics committee

Exclusion Criteria:

  • Prior use of LCP in the hospice
  • Deceased was a relative of a hospice member of staff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: LCP Program
The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice
Other: LCP Program
The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
feasibility of LCP implementation
Time Frame: 6 months after the end of LCP implementation
measured as proportion of hospices that complete the experimental phase of introducing the LCP Program and maintain the program in the 6 months subsequent the process of experimental LCP implementation
6 months after the end of LCP implementation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
quality of information provided to patients and to family
Time Frame: 2-4 months after the patient's death
measured with the scale 1 (Informing and promoting shared decision making) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2-4 months after the patient's death
Level of advanced care planning among patients
Time Frame: 2 - 4 months after the patient's death
measured with the scale 2 (Encouraging advance care planning) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the patient's death
Provision of care focusing on patient's individual needs.
Time Frame: 2 - 4 months after the patient's death
measured with the scale 3 (Focus on individual) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the patient's death
Quality of emotional support to family members before an after the patient's death
Time Frame: 2 - 4 months after the patient's death
measured with the scale 4 (Attending to the emotional and spiritual needs of the family) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the patient's death
Level of care coordination
Time Frame: 2 - 4 months after the patient's death
measured with the scale 5 (Providing coordination of care) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the patient's death
Family support levels
Time Frame: 2 - 4 months after the death of the patient
measured with the scale 6 (Supporting the self-efficacy of the family) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the death of the patient
Appropriateness of therapeutic and diagnostic procedures
Time Frame: the last 3 days of life
measured with a specific tool in which all diagnostic and therapeutic procedures and drugs administered to the patient during the last 3 days of life are reported
the last 3 days of life
Overall quality of care experience for patients and family
Time Frame: 2 - 4 months after the death of the patient
measured with the scale 7 (Overall quality of care provided to patients and family) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the death of the patient
Quality of communication between General Practitioner and hospice
Time Frame: an expected average of 2 months after the patient's death
measured with a telephonic interview
an expected average of 2 months after the patient's death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regional Palliative Care Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Massimo Costantini, IRCCS AOU San Martino- IST

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCP-I LIG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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