Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT02261935
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2014-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supporting Family Caregivers of Palliative Patients at Home: the Carer Support Needs Assessment Intervention
Sponsor:
Kelli Stajduhar
Organization:
Study Overview
Official Title:
Clustered, Randomized, Controlled Trial of the Home Care Nurse Carer Support Needs Assessment Practice Tool With Family Caregivers of Palliative Patients at Home
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSNAT
Brief Summary:
In this project the investigators will train home care nurses to use the Carer Support Needs Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then compare the family caregivers' quality of life, burden and other outcomes to a group of family caregivers whose home care nurse is not using the CSNAT (control group). Findings will allow us to determine the effectiveness of using the CSNAT as a tool to identify, monitor and address family caregiver support needs in palliative home care.
Detailed Description:
Caregiving places considerable burdens on family caregivers (FCG). While burden has been studied as a FCG outcome, it is also a predictor of other outcomes, including FCG quality of life (QoL). We have adapted a model of caregiver burden to hypothesize the various mechanisms by which addressing support needs may contribute to FCG QoL. In this model, support needs are closely associated with FCGs' perceived social support and preparedness for caregiving. These variables operate as (partial) mediators of the relationships between primary stressors, including patient functional dependence and symptom distress, and secondary appraisals, such as the perceived burden associated with caregiving, which, in turn influences FCGs QoL. The model further posits that FCGs' primary appraisal of patient caregiving needs (e.g., amount of care provided) is influenced by the functional dependence and symptom distress of the patient, and in turn influences perceived support, preparedness for caregiving, FCG burden, and, ultimately, FCG QoL. These variables are associated with a variety of demographic and health-related characteristics of the caregiver and patient.
Within the context of this conceptual framework outlined above, the CSNAT intervention is viewed as a mediator of the relationships between primary stressors and appraisals and FCG QoL (primary outcome). Also, the CSNAT intervention would lead to enhanced social support, preparedness, and reduced caregiver burden.
A clustered randomized control trial (RCT) design will be used to ascertain the effectiveness of the CSNAT as an intervention to improve the QoL of FCGs of patients receiving palliative care at home. Participating home care nurses will be randomized to one of two comparator groups (usual care and intervention) and the FCGs of their patients will be assigned to the corresponding comparator group. Data will additionally be collected over the same time frame and in the same manner from a non-randomized comparison usual care comparator group from a separate home care site where no nurses will be delivering the intervention, to help interpret the results (e.g., to determine the extent to which contamination may be have occurred). Update - August 31, 2015 - Due to low recruitment the non-randomized, comparison, usual care, comparator group has been discontinued.
Update - December 22, 2016 - Due to home care workloads of participant nurses and home care visit schedules in some participating home care offices, delivery of the intervention will be done by a dedicated study nurse (in some offices only). In these offices, family caregivers will continue to be assigned based on the randomized group assignment of their home care nurse. The dedicated study nurse will meet separately with FCGs who are in the intervention group to deliver the CSNAT intervention. Information arising from the CSNAT about family caregivers' support needs will be communicated by the study nurse to the home care nurse so that the home care nurse can incorporate this into the home care plan for the patient and patient's family. In home care offices that are not part of this change in procedures, the home care nurses in the intervention group will continue to deliver the CSNAT intervention during home care visits as before.
Our specific hypotheses are as follows:
* Hypothesis 1: The use of the CSNAT as a practice support tool intervention will lead to improved FCG QoL during the time prior to the patients' death and in bereavement.
* Hypothesis 2: The use of the CSNAT as a practice support tool intervention will contribute to the following secondary outcomes in FCGs during the time prior to the patient's death: enhanced perceived social support, improved preparedness to provide care and reduced caregiving burden.
* Hypothesis 3: CSNAT use during home care of patient before death will reduce grief symptoms during bereavement, among FCGs.
In addition to the RCT, qualitative and quantitative research will be conducted to understand the process related to implementing the CSNAT intervention in palliative home care and to explain the treatment results. We will specifically address the following questions:
* How are the CSNAT support needs being documented and met by home care nurses?
* How do home care nurses experience the use of the CSNAT in their daily practice?
* How comfortable are FCGs speaking to home care nurses about their own personal needs?
* To what extent are the relationships in the hypothesized conceptual framework supported?
* What is the relative importance of different CSNAT support needs with respect to FCG QoL and health during the illness trajectory, and the presence of post-bereavement grief symptoms?
Within the context of this conceptual framework outlined above, the CSNAT intervention is viewed as a mediator of the relationships between primary stressors and appraisals and FCG QoL (primary outcome). Also, the CSNAT intervention would lead to enhanced social support, preparedness, and reduced caregiver burden.
A clustered randomized control trial (RCT) design will be used to ascertain the effectiveness of the CSNAT as an intervention to improve the QoL of FCGs of patients receiving palliative care at home. Participating home care nurses will be randomized to one of two comparator groups (usual care and intervention) and the FCGs of their patients will be assigned to the corresponding comparator group. Data will additionally be collected over the same time frame and in the same manner from a non-randomized comparison usual care comparator group from a separate home care site where no nurses will be delivering the intervention, to help interpret the results (e.g., to determine the extent to which contamination may be have occurred). Update - August 31, 2015 - Due to low recruitment the non-randomized, comparison, usual care, comparator group has been discontinued.
Update - December 22, 2016 - Due to home care workloads of participant nurses and home care visit schedules in some participating home care offices, delivery of the intervention will be done by a dedicated study nurse (in some offices only). In these offices, family caregivers will continue to be assigned based on the randomized group assignment of their home care nurse. The dedicated study nurse will meet separately with FCGs who are in the intervention group to deliver the CSNAT intervention. Information arising from the CSNAT about family caregivers' support needs will be communicated by the study nurse to the home care nurse so that the home care nurse can incorporate this into the home care plan for the patient and patient's family. In home care offices that are not part of this change in procedures, the home care nurses in the intervention group will continue to deliver the CSNAT intervention during home care visits as before.
Our specific hypotheses are as follows:
* Hypothesis 1: The use of the CSNAT as a practice support tool intervention will lead to improved FCG QoL during the time prior to the patients' death and in bereavement.
* Hypothesis 2: The use of the CSNAT as a practice support tool intervention will contribute to the following secondary outcomes in FCGs during the time prior to the patient's death: enhanced perceived social support, improved preparedness to provide care and reduced caregiving burden.
* Hypothesis 3: CSNAT use during home care of patient before death will reduce grief symptoms during bereavement, among FCGs.
In addition to the RCT, qualitative and quantitative research will be conducted to understand the process related to implementing the CSNAT intervention in palliative home care and to explain the treatment results. We will specifically address the following questions:
* How are the CSNAT support needs being documented and met by home care nurses?
* How do home care nurses experience the use of the CSNAT in their daily practice?
* How comfortable are FCGs speaking to home care nurses about their own personal needs?
* To what extent are the relationships in the hypothesized conceptual framework supported?
* What is the relative importance of different CSNAT support needs with respect to FCG QoL and health during the illness trajectory, and the presence of post-bereavement grief symptoms?
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: