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

End-of-Life Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470625
• Other study ID #: LCP-I LIG
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2011
• Last updated: January 11, 2013
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: Regional Palliative Care Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• End-of-Life

Intervention

Other:
• LCP Program
The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice

Locations

Country	Name	City	State
Italy	Hospice ASL 4	Chiavari	Genova
Italy	Hospice Gigi Ghirotti "Albaro"	Genova
Italy	Hospice Gigi Ghirotti "Bolzaneto"	Genova
Italy	Hospice ASL1 Liguria	Imperia
Italy	CENTRO MISERICORDIA" SANTA M.G.ROSSELLO. Ist.Figlie Ns Signora Misericordia	Savona

Sponsors (1)

Lead Sponsor	Collaborator
Regional Palliative Care Network

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility 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	No
Secondary	quality of information provided to patients and to family	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	No
Secondary	Level of advanced care planning among patients	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	No
Secondary	Provision of care focusing on patient's individual needs.	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	No
Secondary	Quality of emotional support to family members before an 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	No
Secondary	Level of care coordination	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	No
Secondary	Family support levels	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	No
Secondary	Appropriateness of therapeutic and diagnostic procedures	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	No
Secondary	Overall quality of care experience for patients and family	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	No
Secondary	Quality of communication between General Practitioner and hospice	measured with a telephonic interview	an expected average of 2 months after the patient's death	No