Usability Clinical Trial
— CSDM PilotOfficial title:
CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool
NCT number | NCT02955563 |
Other study ID # | PRO16050247 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | May 16, 2019 |
Verified date | June 2019 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | May 16, 2019 |
Est. primary completion date | May 16, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hospital Anxiety and Depression Scale | To assess surrogate emotional state during intervention | Three months post-discharge | |
Other | Impact of Events Scale | To assess risk of post-traumatic stress disorder | Three months post-discharge | |
Other | Inventory of Complicated Grief | To assess complicated grief | Three months post-discharge | |
Other | Quality of Communication Scale | To assess communication between surrogates and clinicians | Three months post-discharge | |
Other | Mortality | Death | Three months post-discharge | |
Other | Functional status | To assess basic activities of daily living | Three months post-discharge | |
Other | Patient-Perceived Centeredness of Care Scale | To assess patient centeredness of care adapted for use by surrogates | Three months post-discharge | |
Other | Hospital costs | To assess costs of hospital | Three months post-discharge | |
Other | 3-month health care utilization | To assess health care utilization over specified period | Three months post-discharge | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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