Palliative Care Clinical Trial
— DTalkOfficial title:
Dignity Talk: a Novel Palliative Care Intervention for Patients and Their Families
Verified date | November 2016 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Canadian Institutes of Health Research (CIHR) |
Canada,
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 |
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