Critical IllnessINVOLVENCT03099746
Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE)
A study testing INVOLVE and Informational Support in people with Critical Illness, run by Case Western Reserve University at 1 site in United States.
Trial summary
Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life care.This is particularly the case for patients with chronic critical illness, a life-limiting syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- INVOLVE and Informational Support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligibility criteria for CCI patients:
- aged 18 years or older
- required mechanical ventilation and ICU stay for greater than or equal to 3 days
- not expected to be transferred out of the ICU within 48 hours
- lacks cognitive capacity, as determined by a Glasgow Coma Scale eye score of less than 3 or the motor score less than 6 and verifying the status by asking the patients's attending physician or advanced practice nurse whether he or she would obtain consent from the patient or a family member
- has an identified SDM (next-of-kin or legal representative for healthcare decision making).
Show all 11Show fewer
- Eligibility criteria for SDMs:
- aged 18 years or older
- identified by the healthcare team as the patient's next of kin or legal representative for healthcare decision making
- able to speak and understand English
- able to view images on an 10-inch computer screen and hear audio through a standard set of headphones.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill
Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life care.This is particularly the case for patients with chronic critical illness, a life-limiting syndrome. Most (74%-82%) ICU patients who require mechanical ventilation have transient or persistent cognitive impairment that precludes them from making their own healthcare decisions. Among ICU patients, the chronically critically ill (CCI) are at highest risk for cognitive impairment and thus require a surrogate decision maker (SDM), usually a family member. SDMs for the critically ill often describe high states of psychological stress associated with the uncertainty of the patient's condition and their decision making role.
The purpose of this study is to test the effectiveness of two decision support interventions for end-of-life care delivered to SDMs of CCI patients. This will be the first study to test interventions tailored to the unique needs of the SDMs of CCI patients delivered using an interactive avatar based format.
Read the detailed description
The investigators will conduct a three-arm unblinded clinical trial using pre- and post-tests to evaluate the efficacy of two electronic decision-support interventions, Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE) and Informational Support (IS), compared to each other and to usual care (UC) among 270 SDMs of cognitively impaired CCI patients. This design will allow the investigators to prospectively compare the efficacy of the experiential avatar-based decision support tool (INVOLVE) with both an information-only condition and UC. Subjects assigned to an experimental condition (INVOLVE or IS) will receive two doses of the intervention, at enrollment and 1 day later. After the second dose, these subjects will have access to their assigned condition for subsequent self-administered doses, which will be electronically captured until the patient's ICU discharge or death. Data will be collected at (T1) baseline (Day 3 or 4 of the patient's ICU stay), and then on Days 1, 3, 7 and 90 post-baseline
.
The investigators aim to:
- Identify the essential elements of the graphical user interface and educational content needed to revise the INVOLVE prototype for a set of common end-of-life decisions that occur in the ICU.
- Evaluate if there are differences in the decision making readiness and decision making quality between subjects exposed to INVOLVE, IS, or UC on Days 1, 3, and 7 days post-baseline while accounting for covariates (prior SDM experience, SDM knowledge of the patient's preferences, and SDM's religious beliefs).
- Determine if there are differences in the post-decision outcomes of SDMs and their CCI patient by study condition while accounting for covariates at 90 days post-baseline.
- Conditions
- Critical Illness
- Being tested
- INVOLVE, Informational Support, Usual Care
- Keywords
- chronically critically ill, surrogate decision maker
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVOLVEBehavioural
Interactive content and decision coaching with tailored framing of messages to subject's informational processing style and stage of change to promote participatory decision making behavior. Consideration of options, consequences, values, and preferences to formulate an informed decision.
Informational SupportBehavioural
Passive, non-tailored informational support. Screen-based education (videos) with information content on advance care decisions that occur in the intensive care unit.
Usual CareBehavioural
Routine decision support practices by the healthcare team. Family meetings, bedside updates, and access to printed or electronic decision aids.
| Study group | Role | What they receive |
|---|---|---|
| INVOLVE | Experimental | The first study condition, called "Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE)" will consist of exposures to an avatar-based decision support technology that will be administered via tablet computer and allow SDMs opportunities to practice their communication and decision making skills through interactions with avatars that portray a decision coach and various healthcare providers. Receives: Behavioral: INVOLVE |
| Informational Support | Experimental | The second condition, called Informational Support (IS), will also be administered via tablet computers and expose SDMs to educational resources of INVOLVE without the experiential components. Receives: Behavioral: Informational Support |
| Usual Care | Experimental | The third condition, usual care (UC), will expose SDMs to the routine communication and decisional support practices provided by the healthcare team. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeated Measures
ANOVA Model (F-Statistic)
Measured: From (T1) baseline through (T5) 90 days post-baseline
Secondary outcomes (7)
Change in Preparation for Decision Making Scale
Measure of Decision Making Preparedness
Measured: (T1) baseline through (T4) 7 days post-baseline
Change in Family Decision Making Self-Efficacy Scale
Measure of Decision Making Self-Efficacy
Measured: (T1) baseline through (T4) 7 days post-baseline
Change in Single item measure of Role Stress
Measure of Decisional Role Stress
Measured: (T1) baseline through (T4) 7 days post-baseline
Change in Decision Conflict Scale
Measure of Decision Conflict
Measured: (T1) baseline through (T4) 7 days post-baseline
Change in Modified Control Preferences Scale
Measure of Behavioral Activation
Measured: (T1) baseline through (T4) 7 days post-baseline
Change in Decision Regret Scale
Measure of Decision Regret
Measured: (T1) baseline and (T5) 90 days post-baseline
Change in Hospital Anxiety and Depression Scale
Measure of Anxiety and Depressive Symptoms
Measured: (T1) baseline and (T5) 90 days post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startSep 2015
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Ronald Hickman, Case Western Reserve University
- Investigators
- Ronald L. Hickman, PhD, RN, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099746
- Sponsor's protocol ID
- 08-16-25
- Other IDs
- 5R01NR015750-02
- Acronym
- INVOLVE
- Status last verified
- Dec 2021
- First submitted
- 22 Feb 2017
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pignatiello GA, Tuschman PJ, Griggs S, Schiltz NK, Hoffer A, Hickman RL Jr. Rethinking Regret: Reappraisal Tendencies Buffer Regret for ICU Surrogates Following Patient Death. West J Nurs Res. 2025 Sep;47(9):799-809. doi: 10.1177/01939459251344205. Epub 2025 Jun 16.
PubMed 40521758Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
PubMed 35802350
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill
- ClinicalTrials.gov ID
- NCT03099746
- Acronym / sponsor ID
- INVOLVE / 08-16-25
- Conditions
- Critical Illness
- Keywords
- chronically critically ill, surrogate decision maker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life care.This is particularly the case for patients with chronic critical illness, a life-limiting syndrome. Most (74%-82%) ICU patients who require mechanical ventilation have transient or persistent cognitive impairment that precludes them from making their own healthcare decisions. Among ICU patients, the chronically critically ill (CCI) are at highest risk for cognitive impairment and thus require a surrogate decision maker (SDM), usually a family member. SDMs for the critically ill often describe high states of psychological stress associated with the uncertainty of the patient's condition and their decision making role.
The purpose of this study is to test the effectiveness of two decision support interventions for end-of-life care delivered to SDMs of CCI patients. This will be the first study to test interventions tailored to the unique needs of the SDMs of CCI patients delivered using an interactive avatar based format.
Detailed description
The investigators will conduct a three-arm unblinded clinical trial using pre- and post-tests to evaluate the efficacy of two electronic decision-support interventions, Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE) and Informational Support (IS), compared to each other and to usual care (UC) among 270 SDMs of cognitively impaired CCI patients. This design will allow the investigators to prospectively compare the efficacy of the experiential avatar-based decision support tool (INVOLVE) with both an information-only condition and UC. Subjects assigned to an experimental condition (INVOLVE or IS) will receive two doses of the intervention, at enrollment and 1 day later. After the second dose, these subjects will have access to their assigned condition for subsequent self-administered doses, which will be electronically captured until the patient's ICU discharge or death. Data will be collected at (T1) baseline (Day 3 or 4 of the patient's ICU stay), and then on Days 1, 3, 7 and 90 post-baseline
.
The investigators aim to:
- Identify the essential elements of the graphical user interface and educational content needed to revise the INVOLVE prototype for a set of common end-of-life decisions that occur in the ICU.
- Evaluate if there are differences in the decision making readiness and decision making quality between subjects exposed to INVOLVE, IS, or UC on Days 1, 3, and 7 days post-baseline while accounting for covariates (prior SDM experience, SDM knowledge of the patient's preferences, and SDM's religious beliefs).
- Determine if there are differences in the post-decision outcomes of SDMs and their CCI patient by study condition while accounting for covariates at 90 days post-baseline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INVOLVE | Experimental | Behavioral: INVOLVEThe first study condition, called "Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE)" will consist of exposures to an avatar-based decision support technology that will be administered via tablet computer and allow SDMs opportunities to practice their communication and decision making skills through interactions with avatars that portray a decision coach and various healthcare providers. |
| Informational Support | Experimental | Behavioral: Informational SupportThe second condition, called Informational Support (IS), will also be administered via tablet computers and expose SDMs to educational resources of INVOLVE without the experiential components. |
| Usual Care | Experimental | Behavioral: Usual CareThe third condition, usual care (UC), will expose SDMs to the routine communication and decisional support practices provided by the healthcare team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- aged 18 years or older
- required mechanical ventilation and ICU stay for greater than or equal to 3 days
- not expected to be transferred out of the ICU within 48 hours
- lacks cognitive capacity, as determined by a Glasgow Coma Scale eye score of less than 3 or the motor score less than 6 and verifying the status by asking the patients's attending physician or advanced practice nurse whether he or she would obtain consent from the patient or a family member
- has an identified SDM (next-of-kin or legal representative for healthcare decision making).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INVOLVEInteractive content and decision coaching with tailored framing of messages to subject's informational processing style and stage of change to promote participatory decision making behavior. Consideration of options, consequences, values, and preferences to formulate an informed decision. | Behavioural | INVOLVE |
| Informational SupportPassive, non-tailored informational support. Screen-based education (videos) with information content on advance care decisions that occur in the intensive care unit. | Behavioural | Informational Support |
| Usual CareRoutine decision support practices by the healthcare team. Family meetings, bedside updates, and access to printed or electronic decision aids. | Behavioural | Usual Care |
Primary outcome
Repeated Measures
Time frame: From (T1) baseline through (T5) 90 days post-baseline
ANOVA Model (F-Statistic)
7 secondary outcomes
Change in Preparation for Decision Making Scale
Time frame: (T1) baseline through (T4) 7 days post-baseline
Change in Family Decision Making Self-Efficacy Scale
Time frame: (T1) baseline through (T4) 7 days post-baseline
Change in Single item measure of Role Stress
Time frame: (T1) baseline through (T4) 7 days post-baseline
Change in Decision Conflict Scale
Time frame: (T1) baseline through (T4) 7 days post-baseline
Change in Modified Control Preferences Scale
Time frame: (T1) baseline through (T4) 7 days post-baseline
Change in Decision Regret Scale
Time frame: (T1) baseline and (T5) 90 days post-baseline
Change in Hospital Anxiety and Depression Scale
Time frame: (T1) baseline and (T5) 90 days post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Derived from this study: PubMed 40521758Pignatiello GA, Tuschman PJ, Griggs S, Schiltz NK, Hoffer A, Hickman RL Jr. Rethinking Regret: Reappraisal Tendencies Buffer Regret for ICU Surrogates Following Patient Death. West J Nurs Res. 2025 Sep;47(9):799-809. doi: 10.1177/01939459251344205. Epub 2025 Jun 16.
- Derived from this study: PubMed 35802350Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald L. Hickman, PhD, RN principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVOLVE and Informational Support in people with Critical Illness, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeated Measures (time frame: From (T1) baseline through (T5) 90 days post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03099746, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.