CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool

Study Overview
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Brief Summary
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The goal is to develop a pragmatic, scalable intervention to overcome problems with surrogate decision making in ICUs. The aim is to conduct a pilot study among surrogates and clinicians of 50 incapacitated patients at high risk of death to assess the feasibility of deploying the web-based tool as well as to examine the tools impact on the patient and family outcome measures summarized in the hypotheses below.

Detailed Description
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Roughly 600,000 Americans annually die in or shortly after an ICU admission, generally after decisions by surrogates to forego life support. Several decades of research indicate: Family members in ICUs often struggle in the role of surrogate and experience high rates of lasting psychological sequelae (e.g. depression, anxiety, PTSD). For example, a systematic review found that one third of surrogates have long term feelings of guilt and doubt about the decisions they made. Patients often receive treatment that is inconsistent with their values and preferences. For example, in the SUPPORT trial, physicians were frequently unaware of patients' wishes regarding end-of-life care, and patients often died receiving more invasive treatment than they preferred. Intensive care near the end of life is a significant contributor to health care costs. For example, medical care in the last year of life accounts for 25% of Medicare costs, and ICU care contributes substantially. Breakdowns in clinician-family communication in ICUs are common and an important target for interventions. Using quantitative analysis of audiorecorded goals of care discussions in ICUs, we found that in more than 50% of conversations clinicians did not inquire about the patient's values and treatment preferences, and in a similar proportion failed to explicitly offer alternatives to indefinite life-prolonging treatment, such as time-limited trials or comfort-focused treatment. We have also documented frequent omissions of important prognostic information during such conversations and other researchers have documented that surrogates often hold unduly optimistic estimates of patients' prognosis. These data highlight the importance of improving the quality of collaborative decision making in ICUs. This proposal is responsive to national research priorities: The proposed research addresses priority areas for national action from the Institute of Medicine and NIH: improving clinician-family communication and end-of-life care for patients with advanced organ system failure. It is responsive to calls by the Institute on Aging to promote patient-centered decision making for elderly patients. A critical barrier to addressing these problems is the absence of a scalable intervention. No empirically validated decision support tools exist for the range of critical illnesses confronted in ICUs. Prior interventions to address these problems (e.g., proactive palliative care consultation or adding a family support counselor to the ICU team) face major barriers to dissemination due to projected palliative care workforce shortages and the high cost of adding more personnel to ICU care teams. A pragmatic, scalable intervention to overcome these problems has been developed. This pilot study among surrogates and clinicians of 50 incapacitated patients will assess the feasibility of deploying the web-based tool as well as to examine the tools impact on measures of communication and decision quality.

Official Title
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CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool

Conditions
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Intervention Compliance, Usability, Acceptability

Intervention / Treatment
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* Other: CSDM Web-Based Tool Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surrogate decision maker for ICU patient that lacks decisional capacity Permission from Patient's ICU Primary Attending Physician Exclusion Criteria: Non-English Speaking Inability to read or write

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSDM Tool<br>Surrogate will complete educational sessions on CSDM tool prior to each family meeting with clinical team. | Other: CSDM Web-Based Tool Intervention<br>* The web and tablet-based tool is designed to help family members become familiar with ICU environment, routines, and clinicians, prepare for family meetings, and learn how to make values-based decisions for their loved one. The tool contains short videos, interactive exercises, and links to other resources. Family members work through the tool shortly after admission to the ICU, before each family meeting, and any other time they wish to during the ICU admission.<br>|
| No Intervention: Control<br>Surrogates will receive augmented usual care. The augmentation is that there will be 2 family meetings scheduled during the first 10 days of enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention compliance | Data tracking analytics will be employed to determine the extent to which the tool is used as per protocol. | Duration of ICU stay, an expected average of 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' ratings of usability of the tool | Usability of the tool will be measured with the System Usability Scale | Duration of hospital stay, an expected average of 4 weeks | 
| Participants' ratings of acceptability of the tool | Acceptability will be measured with the user Acceptability Assessment | Duration of hospital stay, an expected average of 4 weeks | 
| Participants' ratings of perceived usefulness of the tool | Usefulness will be measured with the Usefulness Assessment | Duration of hospital stay, an expected average of 4 weeks | 
| Feasibility of enrolling family members in a critical care setting | Measured by meeting target enrollment | Through study completion, estimate one year past primary start date | 
| Feasibility of retaining family members in a critical care setting in a trial | The number of subjects that complete the long term follow up | Three months post-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision making for incapacitated patients, intensive care, surrogate decision making, patient centered care, Palliative Care, End of Life, Quality of Communication, Anxiety, Depression