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NCT01190488 · ClinicalTrials.gov registry record · NA
Feasibility Of An Advanced Care Decision Aid Among Patients And Physicians_Matlock
A NA study of Palliative Care and Decision Making, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT01190488: Completed NA study of Palliative Care and Decision Making, sponsored by University of Colorado, Denver.
NCT01190488 is a NA study of Palliative Care and Decision Making that has completed, run by University of Colorado, Denver. The registered enrollment target is 120 participants, below the 1,410-participant average among 18 other Palliative Care trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190488, a NA study of Palliative Care and Decision Making, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
We will follow enrolled patients for the duration of the study and examine the following metrics: days in the ICU, place of death, resuscitation status, chemotherapy, feeding tube, discharge disposition and re-hospitalization status. Patients in both groups will be asked to complete a brief quantitative survey.
Conditions Studied
Interventions
- BEHAVIORAL Active Comparator
- BEHAVIORAL End-of-Life / Advanced Care Decision Aid
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-11 |
| Phase | NA |
What the finished NCT01190488 record still lists
NCT01190488 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,410-participant average among 18 other Palliative Care trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Palliative Care appearing as the primary indexed condition, and to 2 interventions - of which Active Comparator is the first listed.
NCT01190488 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01190488 about?
NCT01190488 is a clinical study titled "Feasibility Of An Advanced Care Decision Aid Among Patients And Physicians_Matlock". 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 investi...
What is the current status of trial NCT01190488?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2009-11. Estimated completion is 2011-11.
What conditions does trial NCT01190488 study?
This clinical trial studies the following conditions: Palliative Care, Decision Making, Decision Support Systems, Clinical, Hospices, Decision Support Techniques.
What interventions are being tested in trial NCT01190488?
The interventions under investigation include: Active Comparator (BEHAVIORAL), End-of-Life / Advanced Care Decision Aid (BEHAVIORAL).
Who is sponsoring clinical trial NCT01190488?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01190488 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01190488's enrollment target sits among peer trials
120 10th of 18 higher than 9 of 18 other Palliative Care trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Palliative Care trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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