Critical IllnessPONDER-ICUNCT03139838
Prognosticating Outcomes and Nudging Decisions With Electronic Records in the ICU Trial
A study testing EHR-Based Intervention A and EHR-Based Intervention B in people with Critical Illness, run by University of Pennsylvania at 10 sites in United States.
Trial summary
This is a pragmatic, stepped-wedge, cluster randomized trial testing the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- EHR-Based Intervention A and EHR-Based Intervention B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Feb 2018to 30 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old; AND
- Admitted to 1 of the 17 participating ICUs; AND
- Receipt of continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
- ≥ 1 life-limiting illness present on admission (ICD-9/10 code or discrete medical history data from EHR in prior 12 months):
- Chronic obstructive pulmonary disease
- Cirrhosis
Show all 14Show fewer
- Congestive heart failure
- Dementia (all types)
- End-stage renal disease
- Hematologic malignancy
- Metastatic malignancy
- Motor neuron disease
- Pulmonary fibrosis
- Solid organ malignancy
Who cannot join
- 1) Patients younger than 18 years old are excluded.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Carolinas HealthCare System Stanly
Albemarle, North Carolina, 28001
Carolinas HealthCare System, NorthEast
Charlotte, North Carolina, 28025
Carolinas Medical Center
Charlotte, North Carolina, 28203
Atrium Health CMC-Mercy
Charlotte, North Carolina, 28207
Atrium Health Pineville
Charlotte, North Carolina, 28210
Atrium Health University City
Charlotte, North Carolina, 28262
Atrium Health Lincoln
Lincolnton, North Carolina, 28092
Atrium Health Union
Monroe, North Carolina, 28112
Carolinas HealthCare System Blue Ridge-Morganton
Morganton, North Carolina, 28655
Atrium Health Cleveland
Shelby, North Carolina, 28150
About this study
Official title: Behavioral Economic Approaches to Improve Palliative Care for Critically Ill Patients
This is a pragmatic, stepped-wedge, cluster randomized trial testing the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that outcomes can be improved without raising costs by requiring intensive care unit clinicians to (i) document a prognostic estimate and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care. To test this hypothesis the investigators will conduct a 33-month trial at 17 intensive care units in 10 hospitals using the same Cerner EHR within Atrium Health System.
Read the detailed description
The PONDER-ICU trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The interventions are designed to increase intensive care unit (ICU) physicians' and advanced practitioners' (physician assistants and nurse practitioners) engagement of critically ill patients and caregivers in discussions about alternative treatment options, including care focused on comfort. To achieve this goal, the investigators will conduct a 33-month pragmatic, stepped-wedge cluster randomized clinical trial at 17 ICUs within 10 Atrium Health System hospitals. The investigators hypothesize that outcomes can be improved without raising costs by requiring ICU clinicians to (i) document a prognostic estimate (Intervention A) and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care (Intervention B). Approximately 4,750 adult patients (1) with chronic life-limiting illness and receiving continuous mechanical ventilation for ≥48 hours will be enrolled. Participating hospitals will be randomized into 5 clusters of 2 hospitals each. Each hospital will first contribute a minimum of 5 months of data collection during usual care in a control phase. Then, using the step-wedge design, all hospitals will implement the two EHR-based interventions. The order in which the interventions will be adopted and the timing of adoption at each hospital will both be determined by random assignment. After 12 months of utilizing Intervention A or Intervention B, each hospital will adopt and implement the second intervention in combination with the other. By the end of the trial, all hospitals will have utilized the combined interventions for at least 4 months. The primary outcome is a composite measure of hospital length of stay and mortality. Secondary outcomes include an array of clinical outcomes, as well as palliative care-related process measures.
- Conditions
- Critical Illness
- Being tested
- EHR-Based Intervention A, EHR-Based Intervention B
- Keywords
- Palliative Care, Pragmatic Clinical Trial, Electronic Health Records, Economics, Behavioral
- Medical subject headings
- Critical Illness, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR-Based Intervention ABehavioural
Also called Prognostication
Intervention A will be a prompt for clinicians to document an estimated prognosis for patients at 6 months, and an assessment of predicted functional outcome if expected to survive.
EHR-Based Intervention BBehavioural
Also called Accountable Justification
Intervention B will entail a prompt for clinicians to provide a reason for not offering patients and their families the alternative of care focused entirely on comfort despite recommendations from critical care professional societies to do so for patients at high risk for death or severely impaired functional recovery.
| Study group | Role | What they receive |
|---|---|---|
| EHR-Based Intervention A | Active comparator | Intervention A (Prognostication) will be an EHR-based screen prompt triggered for eligible patients. The intervention will consist of no more than two questions that can be completed in two minutes or less. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner. Receives: Behavioral: EHR-Based Intervention A |
| EHR-Based Intervention B | Active comparator | Intervention B (Accountable Justification) will be an EHR-based screen prompt triggered for eligible patients. The intervention will consist of no more than two questions that can be completed in two minutes or less. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner. Receives: Behavioral: EHR-Based Intervention B |
| Combined EHR-Based Intervention (A+B) | Active comparator | Intervention A and B prompts will be combined and triggered for eligible patients simultaneously. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner. Receives: Behavioral: EHR-Based Intervention A; Behavioral: EHR-Based Intervention B |
| Pre-Intervention (Control) | No intervention | There is no trial-driven approach to care. All hospitals contribute a minimum of 5 months of outcomes data prior to adopting the intervention. Pre-specified outcomes data will be electronically extracted for patients meeting eligibility criteria but there will be no attempt to influence delivery of usual care within the hospital. The length of the control phase will differ at each hospital, dependent on the sequence in which hospitals are assigned to switch to the intervention phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Measure: Length of Stay and In-Hospital Mortality
The primary outcome is a composite measure of hospital length-of-stay and mortality that ranks deaths along the length-of-stay distribution
Measured: Duration of hospital stay, an expected average of 16 days
Secondary outcomes (20)
Change in code status
Change in documented code status during hospital admission
Measured: Duration of hospital stay, an expected average of 16 days
Initiation of additional forms of life-support
Initiation of additional form of life-support (e.g. surgical feeding tube, dialysis) during hospital admission
Measured: Duration of hospital stay, an expected average of 16 days
Palliative care consult
Receipt of palliative care consult during hospital admission
Measured: Duration of hospital stay, an expected average of 16 days
Time to palliative care consult
The number of hours from ICU admission to inpatient palliative care consult
Measured: Duration of hospital stay, an expected average of 16 days
Palliative withdrawal of mechanical ventilation
Palliative withdrawal of mechanical ventilation during hospital admission
Measured: Duration of hospital stay, an expected average of 16 days
Receipt of cardiopulmonary resuscitation (CPR)
CPR prior to death or discharge
Measured: Duration of hospital stay, an expected average of 16 days
ICU mortality
ICU mortality
Measured: Duration of hospital stay, an expected average of 16 days
ICU length of stay
ICU length of stay (hours)
Measured: Duration of hospital stay, an expected average of 16 days
ICU readmission
Readmission to an ICU within the same hospitalization
Measured: Duration of hospital stay, an expected average of 16 days
Duration of mechanical ventilation
Hours of mechanical ventilation during hospital admission
Measured: Duration of hospital stay, an expected average of 16 days
Time to withdrawal of life-support
The number of hours from trial enrollment to time that comfort-care order is placed
Measured: Duration of hospital stay, an expected average of 16 days
Hospital discharge disposition
Hospital discharge disposition to home, hospice, long-term acute care, nursing facility, or rehabilitation
Measured: Duration of hospital stay, an expected average of 16 days
Quality of Dying & Death (1-item)
Nurse-reported postmortem rating of a patient's dying experience
Measured: 48-72 hours following an in-hospital death
30-day hospital readmission
30-day hospital readmission
Measured: 30 days
90-day hospital readmission
30-day hospital readmission
Measured: 30 days
180-day hospital readmission
30-day hospital readmission
Measured: 30 days
30-day mortality
Mortality rate at 30 days
Measured: 30 days
90-day mortality
Mortality rate at 90 days
Measured: 90 days
180-day mortality
Mortality rate at 180 days
Measured: 180 days
Hospital free days
Hospital free days within 180 days
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Feb 2018
- Primary completion24 Apr 2021
- Study completion30 Jun 2022
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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Donaghue Medical Research Foundation
- Responsible party
- Sponsor
- Investigators
- Scott D Halpern, PhD, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139838
- Sponsor's protocol ID
- UPenn IRB #826933
- Other IDs
- 52635
- Acronym
- PONDER-ICU
- Status last verified
- Aug 2022
- First submitted
- 25 Apr 2017
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Courtright KR, Singh J, Dress EM, Bayes B, Harhay MO, Chowdhury M, Lu Y, Lee KM, Small DS, Whitman C, Tian J, Madden V, Hetherington T, Placket L, Sullivan DM, Burke HL, Green MB, Halpern SD. Nudging Clinicians to Promote Serious Illness Communication for Critically Ill Patients: A Pragmatic Cluster Randomized Trial. JAMA Intern Med. 2025 May 1;185(5):510-520. doi: 10.1001/jamainternmed.2025.0090.
PubMed 40094649Courtright KR, Dress EM, Singh J, Bayes BA, Chowdhury M, Small DS, Hetherington T, Plickert L, Detsky ME, Doctor JN, Harhay MO, Burke HL, Green MB, Huynh T, Sullivan DM, Halpern SD; PONDER-ICU Investigative Team. Prognosticating Outcomes and Nudging Decisions with Electronic Records in the Intensive Care Unit Trial Protocol. Ann Am Thorac Soc. 2021 Feb;18(2):336-346. doi: 10.1513/AnnalsATS.202002-088SD.
PubMed 32936675
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economic Approaches to Improve Palliative Care for Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03139838
- Acronym / sponsor ID
- PONDER-ICU / UPenn IRB #826933
- Conditions
- Critical Illness
- Keywords
- Palliative Care, Pragmatic Clinical Trial, Electronic Health Records, Economics, Behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Donaghue Medical Research Foundation
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 May 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.
This is a pragmatic, stepped-wedge, cluster randomized trial testing the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that outcomes can be improved without raising costs by requiring intensive care unit clinicians to (i) document a prognostic estimate and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care. To test this hypothesis the investigators will conduct a 33-month trial at 17 intensive care units in 10 hospitals using the same Cerner EHR within Atrium Health System.
Detailed description
The PONDER-ICU trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The interventions are designed to increase intensive care unit (ICU) physicians' and advanced practitioners' (physician assistants and nurse practitioners) engagement of critically ill patients and caregivers in discussions about alternative treatment options, including care focused on comfort. To achieve this goal, the investigators will conduct a 33-month pragmatic, stepped-wedge cluster randomized clinical trial at 17 ICUs within 10 Atrium Health System hospitals. The investigators hypothesize that outcomes can be improved without raising costs by requiring ICU clinicians to (i) document a prognostic estimate (Intervention A) and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care (Intervention B). Approximately 4,750 adult patients (1) with chronic life-limiting illness and receiving continuous mechanical ventilation for ≥48 hours will be enrolled. Participating hospitals will be randomized into 5 clusters of 2 hospitals each. Each hospital will first contribute a minimum of 5 months of data collection during usual care in a control phase. Then, using the step-wedge design, all hospitals will implement the two EHR-based interventions. The order in which the interventions will be adopted and the timing of adoption at each hospital will both be determined by random assignment. After 12 months of utilizing Intervention A or Intervention B, each hospital will adopt and implement the second intervention in combination with the other. By the end of the trial, all hospitals will have utilized the combined interventions for at least 4 months. The primary outcome is a composite measure of hospital length of stay and mortality. Secondary outcomes include an array of clinical outcomes, as well as palliative care-related process measures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EHR-Based Intervention A | Active comparator | Behavioral: EHR-Based Intervention AIntervention A (Prognostication) will be an EHR-based screen prompt triggered for eligible patients. The intervention will consist of no more than two questions that can be completed in two minutes or less. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner. |
| EHR-Based Intervention B | Active comparator | Behavioral: EHR-Based Intervention BIntervention B (Accountable Justification) will be an EHR-based screen prompt triggered for eligible patients. The intervention will consist of no more than two questions that can be completed in two minutes or less. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner. |
| Combined EHR-Based Intervention (A+B) | Active comparator | Behavioral: EHR-Based Intervention A, Behavioral: EHR-Based Intervention BIntervention A and B prompts will be combined and triggered for eligible patients simultaneously. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner. |
| Pre-Intervention (Control) | No intervention | –There is no trial-driven approach to care. All hospitals contribute a minimum of 5 months of outcomes data prior to adopting the intervention. Pre-specified outcomes data will be electronically extracted for patients meeting eligibility criteria but there will be no attempt to influence delivery of usual care within the hospital. The length of the control phase will differ at each hospital, dependent on the sequence in which hospitals are assigned to switch to the intervention phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥18 years old; AND
- Admitted to 1 of the 17 participating ICUs; AND
- Receipt of continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
- ≥ 1 life-limiting illness present on admission (ICD-9/10 code or discrete medical history data from EHR in prior 12 months):
Key exclusion criteria (1 listed)
- 1) Patients younger than 18 years old are excluded.
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 |
|---|---|---|
| EHR-Based Intervention AAlso: PrognosticationIntervention A will be a prompt for clinicians to document an estimated prognosis for patients at 6 months, and an assessment of predicted functional outcome if expected to survive. | Behavioural | Combined EHR-Based Intervention (A+B), EHR-Based Intervention A |
| EHR-Based Intervention BAlso: Accountable JustificationIntervention B will entail a prompt for clinicians to provide a reason for not offering patients and their families the alternative of care focused entirely on comfort despite recommendations from critical care professional societies to do so for patients at high risk for death or severely impaired functional recovery. | Behavioural | Combined EHR-Based Intervention (A+B), EHR-Based Intervention B |
Primary outcome
Composite Measure: Length of Stay and In-Hospital Mortality
Time frame: Duration of hospital stay, an expected average of 16 days
The primary outcome is a composite measure of hospital length-of-stay and mortality that ranks deaths along the length-of-stay distribution
20 secondary outcomes
Change in code status
Time frame: Duration of hospital stay, an expected average of 16 days
Initiation of additional forms of life-support
Time frame: Duration of hospital stay, an expected average of 16 days
Palliative care consult
Time frame: Duration of hospital stay, an expected average of 16 days
Time to palliative care consult
Time frame: Duration of hospital stay, an expected average of 16 days
Palliative withdrawal of mechanical ventilation
Time frame: Duration of hospital stay, an expected average of 16 days
Receipt of cardiopulmonary resuscitation (CPR)
Time frame: Duration of hospital stay, an expected average of 16 days
ICU mortality
Time frame: Duration of hospital stay, an expected average of 16 days
ICU length of stay
Time frame: Duration of hospital stay, an expected average of 16 days
ICU readmission
Time frame: Duration of hospital stay, an expected average of 16 days
Duration of mechanical ventilation
Time frame: Duration of hospital stay, an expected average of 16 days
Time to withdrawal of life-support
Time frame: Duration of hospital stay, an expected average of 16 days
Hospital discharge disposition
Time frame: Duration of hospital stay, an expected average of 16 days
Quality of Dying & Death (1-item)
Time frame: 48-72 hours following an in-hospital death
30-day hospital readmission
Time frame: 30 days
90-day hospital readmission
Time frame: 30 days
180-day hospital readmission
Time frame: 30 days
30-day mortality
Time frame: 30 days
90-day mortality
Time frame: 90 days
180-day mortality
Time frame: 180 days
Hospital free days
Time frame: 180 days
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 8 Aug 2022.
- Derived from this study: PubMed 40094649Courtright KR, Singh J, Dress EM, Bayes B, Harhay MO, Chowdhury M, Lu Y, Lee KM, Small DS, Whitman C, Tian J, Madden V, Hetherington T, Placket L, Sullivan DM, Burke HL, Green MB, Halpern SD. Nudging Clinicians to Promote Serious Illness Communication for Critically Ill Patients: A Pragmatic Cluster Randomized Trial. JAMA Intern Med. 2025 May 1;185(5):510-520. doi: 10.1001/jamainternmed.2025.0090.
- Derived from this study: PubMed 32936675Courtright KR, Dress EM, Singh J, Bayes BA, Chowdhury M, Small DS, Hetherington T, Plickert L, Detsky ME, Doctor JN, Harhay MO, Burke HL, Green MB, Huynh T, Sullivan DM, Halpern SD; PONDER-ICU Investigative Team. Prognosticating Outcomes and Nudging Decisions with Electronic Records in the Intensive Care Unit Trial Protocol. Ann Am Thorac Soc. 2021 Feb;18(2):336-346. doi: 10.1513/AnnalsATS.202002-088SD.
- 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.
Scott D Halpern, PhD, MD principal investigator
University of Pennsylvania
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR-Based Intervention A and EHR-Based Intervention B in people with Critical Illness, run by University of Pennsylvania at 10 sites 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 14 inclusion and 1 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 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Composite Measure: Length of Stay and In-Hospital Mortality (time frame: Duration of hospital stay, an expected average of 16 days). 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 NCT03139838, 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 8 Aug 2022.