Palliative Care Clinical Trial
Official title:
Feasibility Of An Advanced Care Decision Aid Among Patients And Physicians
The investigators propose an evaluation of an end of life patient decision aid (EOL-PtDA)
developed by the Foundation for Informed Medical Decision Making using the RE-AIM (Reach
Effectiveness, Adoption, Implementation, and Maintenance) framework. To evaluate the Reach
and Effectiveness, the investigators propose a pilot randomized clinical trial of the
EOL-PtDA among patients on the inpatient palliative care service at University Hospital in
Colorado. To evaluate barriers and facilitators of Adoption, Implementation, and Maintenance
of the EOL-PtDA, we propose focus groups of non-palliative care physicians as we perceive
these physicians to be the largest barrier to ultimate adoption of the EOL-PtDA.
Additionally we propose a focus group of the palliative care physicians who participated in
the implementation of this decision guide study to evaluate the feasibility of conducting a
randomized control trial within a pall. care service and to evaluate the acceptability of
this decision aid as it was implemented. The investigators also propose to conduct focus
groups of normal, healthy clinic patients to determine the acceptability among that
population. The End-of-Life decision aid is different from other decision aids. From the
vantage point of decision quality, a major difference is that its primary focus is on
helping patients clarify their values rather than gain knowledge. The results from this
study will provide critical preliminary data to inform a randomized clinical trial and/or
widespread implementation of the EOL-PtDA.
Specific Aims/Research question(s):Aim 1: To determine the Reach and Effectiveness of an
end-of-life patient decision aid by conducting a pilot randomized clinical trial in an
inpatient palliative care service. Aim 2: To determine physicians' attitudes towards the
end-of-life patient decision aid and to gain insights into potential barriers and
facilitators to Adoption, Implementation, and Maintenance by conducting a qualitative study
of non-palliative care, and separately, palliative care physicians. Aim 3: To determine
healthy clinic patients' attitudes towards the end-of-life patient decision aid and to gain
insight into its Reach and Effectiveness.
The aims 2-3 of this study include focus groups for physicians (both palliative care and non-palliative care physicians, aim 2) as well as healthy clinic patients (aim 3). Since these two arms are not randomized, they are not reported here. For additional information on the protocol and findings, please contact the PI, Daniel.Matlock@ucdenver.edu or the study coordinator, Tarah.Keech@ucdenver.edu. ;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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