Feasibility Of An Advanced Care Decision Aid Among Patients And Physicians_Matlock

Completed · Not applicable

Conditions studied: Palliative Care, Decision Making, Decision Support Techniques, Decision Support Systems, Clinical, Hospices

In brief

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.

Key facts

Study ID

NCT01190488

Run by

University of Colorado, Denver

People needed

120

Starts

2009-11-01

Expected to finish

2011-11-01

Last updated by the study team

2012-10-15

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For 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.
• Participants/Setting: Inpatient Palliative Care Service - University of Colorado Hospital: Patients may be included in this study if they are hospitalized at University of Colorado Hospital (UCH) and the UCH inpatient palliative care service has been consulted. This service, which consists of 6 physicians and two advanced practice nurses, sees approximately 40 new consults per month. More than 30% of consults originate from the hematology and oncology services, with the bulk of the remaining consults originating from the critical care services, cardiology, internal medicine, pulmonology and oncologic surgery. More than half of consults are for "goal clarification," others are for assistance with symptom control or disposition issues. We have chosen this population for the pilot because they are a high risk population with significant advanced care planning needs and they are captive and easily accessible to both PIs of this study. We will include adult patients and/or decision makers (ages 18 or greater) with end-of-life decisional needs as judged by the practitioners on the palliative care service. In cases where the patient is unable to participate due to an altered mental status, the person identified as the decision maker will be invited to participate in the study. Patients will be considered eligible if the UCH palliative care service has been consulted for "goal clarification" and/or assistance with end-of-life discussions rather than symptom control.

You may not qualify if…

• For Aim 1: We will exclude patients who cannot speak English or who are visually impaired as the decision aid is visual and only available in English. We will also exclude patients and decision makers with cognitive impairment as determined by ability to consent to the study. Ability to consent will be determined by the potential subject's ability, after being informed, to comprehend and explain the purposes, risks and benefits, and components of the study. If through the consent process, we determine that the person designated as the decision maker is unable to consent to the study, we will notify the primary team taking care of this patient. Additionally, we will exclude patients for whom the primary decision maker is unclear.

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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