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

Study Overview
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Brief Summary
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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.

Detailed Description
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See above summary

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

Conditions
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Palliative Care, Family, End of Life Care

Intervention / Treatment
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* Behavioral: Dignity Talk
* Behavioral: The Dignity Talk Communication Topics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dignity Talk dyad completers<br>Those dyads where both patient and family member co-participant complete the protocol using the Dignity Talk Communication Topics | Behavioral: Dignity Talk<br>* 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.<br>|
| Experimental: Dignity Talk non-completers<br>Those dyads where patient and family member co-participant either do not complete the protocol or do not use the Dignity Talk Communication Topics (November 2016 - the investigators have not as yet enrolled any participants who have not completed the study without using the Dignity Talk Topics. However some participants have withdrawn from the study without completing. | Behavioral: The Dignity Talk Communication Topics<br>* There have not been any non-completers - this arm not being used currently<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family communication connectedness Index |  | 31 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 31 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Family, adaptation, psychological