Dignity Talk: Helping Palliative Care Patients and Families Have Important Conversations

Palliative Care Clinical Trial

— DTalk  

Official title:

Dignity Talk: a Novel Palliative Care Intervention for Patients and Their Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883375
• Other study ID #: H2013:024
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: December 12, 2017
• Start date: March 2013
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2016
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dying patients and their families face many challenges near the end-of-life. Not only do patients often experience physical distress, but they also have feelings of loss of dignity, isolation, and uncertainty. Family members also face many challenges. They bear witness to the suffering of loved ones, and they face uncertainty, loss, and at times a mounting sense of helplessness.

The purpose of this study is to introduce and evaluate a new intervention called Dignity Talk, meant to enhance end-of-life experience for both patients and their families. Dignity Talk is based on a set of questions by which terminally ill patients and their family members can engage in meaningful conversations with each other. It is intended to lessen feelings of loss and helplessness and enhance feelings of connectedness by facilitating conversations that tap into a sense of meaning and purpose, sharing of memories, wishes, hopes, and giving guidance to those who will soon be left behind.

In Phase 1, 20 patients and family members will help finalize the method and Dignity Talk question framework (is it easy to understand, do the investigators have the right questions, and is the wording sensitive). In Phase 2 of the study the investigators will ask 100 patient-family pairs for feedback about Dignity Talk: what influence it had on their palliative care experience, whether it works well, and whether this intervention should become a regular part of palliative care. The investigators will also ask for feedback from health-care providers in both phases. We are requesting approval for an amendment to the healthcare provider feedback focus group questions. Will add those documents when they are approved.

Four to six months after the death of their loved one, the investigators will contact the family member to ask their thoughts about Dignity Talk, how it shaped their experience of their grief and bereavement.

The investigators expect that the study will show that Dignity Talk can be an effective, highly accessible palliative care intervention, which will enhance the end-of-life experience for palliative patients and the families who support them.

Description:

See above summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 31, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For Patient:

Patients being cared for:

• in a palliative care unit or whose care is focused on palliation as determined by clinical staff

• or patients who have have a confirmed diagnosis of amyotropic lateral sclerosis, and have symptoms in a domain that interferes with their social or occupation functioning: a) mobility, b) dysphasia, c) dyspnea, or d) speech or patients who have are have been on dialysis > 3 months and are > 60 years of age - or residents of Personal Care Home all of whom are:

• 18 years of age or older

• able to provide informed oral and written consent

• cognitive capacity (based on clinical consensus)

For Family Member or Close Friend:

• Family member or close friend who the patient identifies they would be comfortable talking with using the Dignity Talk question framework

• Family member who is 18 years of age or older

• Family member who is able to provide oral and written consent

• Family member who has cognitive capacity to participate in meaningful conversation (based on research staff decision)

For Healthcare Provider:

• Employed one of the participating sites

• in a discipline directly involved in clinical care (physician, nursing, social work, spiritual care, allied healthcare, etc.)

Exclusion Criteria:

• not meeting the above inclusion criteria

Related Conditions & MeSH terms

• End of Life Care
• Family
• Palliative Care

Intervention

Behavioral:
• Dignity Talk
Patient and family member participants will be given the Dignity Talk framework questions and asked to use them in conversation with each other. Research nurse will return at day 4-6 to confirm both participants have covered all items they wish to discuss. 4-6 months after the death of patient, family members will be contacted in order to collect data pertaining to their bereavement experiences and distress. Will also be asked to complete evaluative feedback on Dignity Talk.
• The Dignity Talk Communication Topics
There have not been any non-completers - this arm not being used currently

Locations

Country	Name	City	State
Canada	Dr. Bob Kemp Hospice	Hamilton	Ontario
Canada	Victoria Hospice	Victoria	British Columbia
Canada	Concordia Hospital	Winnipeg	Manitoba
Canada	Deer Lodge Centre	Winnipeg	Manitoba
Canada	Grace Hospital	Winnipeg	Manitoba
Canada	Health Sciences Centre	Winnipeg	Manitoba
Canada	Manitoba Renal Program	Winnipeg	Manitoba
Canada	Riverview Health Centre	Winnipeg	Manitoba
Canada	Seven Oaks Hospital	Winnipeg	Manitoba
Canada	St. Boniface Hospital	Winnipeg	Manitoba
Canada	Victoria Hospital	Winnipeg	Manitoba
Canada	Winnipeg Regional Health Authority	Winnipeg	Manitoba
Canada	WRHA Personal Care Homes	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family communication connectedness Index		31 months
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		31 months