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

Sponsor

University of Manitoba (Other)

Overall Status

Completed

CT.gov ID

NCT01883375

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Locations

Arms

Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Palliative Care Family End of Life Care	Behavioral: Dignity Talk Behavioral: The Dignity Talk Communication Topics	N/A

Detailed Description

See above summary

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Sep 30, 2017

Actual Study Completion Date :

Oct 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dignity Talk dyad completers Those dyads where both patient and family member co-participant complete the protocol using the Dignity Talk Communication Topics	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.
Experimental: Dignity Talk non-completers 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 There have not been any non-completers - this arm not being used currently

Arm

Intervention/Treatment

Experimental: Dignity Talk dyad completers

Those dyads where both patient and family member co-participant complete the protocol using the Dignity Talk Communication Topics

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.

Experimental: Dignity Talk non-completers

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

There have not been any non-completers - this arm not being used currently

Outcome Measures

Primary Outcome Measures

Family communication connectedness Index [31 months]

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [31 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Victoria Hospice	Victoria	British Columbia	Canada
2	St. Boniface Hospital	Winnipeg	Manitoba	Canada	R3E 0V9
3	Riverview Health Centre	Winnipeg	Manitoba	Canada	R3L 2P4
4	Concordia Hospital	Winnipeg	Manitoba	Canada
5	Deer Lodge Centre	Winnipeg	Manitoba	Canada
6	Grace Hospital	Winnipeg	Manitoba	Canada
7	Health Sciences Centre	Winnipeg	Manitoba	Canada
8	Manitoba Renal Program	Winnipeg	Manitoba	Canada
9	Seven Oaks Hospital	Winnipeg	Manitoba	Canada
10	Victoria Hospital	Winnipeg	Manitoba	Canada
11	Winnipeg Regional Health Authority	Winnipeg	Manitoba	Canada
12	WRHA Personal Care Homes	Winnipeg	Manitoba	Canada
13	Dr. Bob Kemp Hospice	Hamilton	Ontario	Canada	L9B 1B1

Sponsors and Collaborators

University of Manitoba
Canadian Institutes of Health Research (CIHR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Manitoba

ClinicalTrials.gov Identifier:

NCT01883375

Other Study ID Numbers:

H2013:024

First Posted:

Jun 21, 2013

Last Update Posted:

Dec 14, 2017

Last Verified:

Nov 1, 2016

Keywords provided by University of Manitoba

Palliative Care

Family

adaptation, psychological

Additional relevant MeSH terms:

Death

Study Results

No Results Posted as of Dec 14, 2017