What is the trial’s primary aim?
-To determine if compared to usual care, the PCplanner intervention reduces unmet needs for patients and families–things that are appropriate to discuss in any interaction.
What is the PCplanner intervention?
– PCplanner is a novel app platform that acts as a care delivery model for providing need-targeted care by ICU teams…and if necessary, the palliative care team.
– PCplanner measures unmet basic needs across 8 domains as self-reported by patients / family members, and then displays them simply for ICU teams to use in family meetings. It also provides tips for discussing needs to ICU teams and a question coaching feature for family members.
-The PCplanner app DOES NOT MENTION prognosis, diagnosis, end-of-life, DNAR status, or withdrawal of care. This is not an end-of-life study, it is a communication study that focuses on building relationships by addressing basic needs.
What is the target population eligible for this randomized trial?
-ICU patients 50 years or older (and their family member)…
-who meet a high risk ‘trigger‘ condition (see below for the list) after 24 hours in the ICU and…
-have a high level of unmet needs (see screenshot of app below for the list).
What is the general outline of the trial?
If a patient / family have elevated unmet needs and consent, they are randomized to either PCplanner intervention or Usual Care control. Patients / family members fill out needs surveys on Day 1, Day 4, and Day 8 of the hospitalization.
What do ICU physicians need to do in the trial?
Control group patient
Nothing
PCplanner intervention group patient
1. Approve study team to approach
Each day at noon, ICU physicians will get a text if there are new ‘trigger positive’ patients. The physician then clicks on the link in the text to approve the study team to approach the family for the study (or not) in the PCplanner app.
2. Review needs and discuss with the patient / family.
If the family consents, the ICU physician will get a link to the app texted to them when the family enters their needs. Then you simply review their needs in the PCplanner app and discuss the top unmet needs with the family / patient in the next 2 days in person, by phone, formally, or informally. This repeats once more on study Day 4 so you can see if you were able to address the needs.
In the example below, S1 is Survey 1, S2 is Survey 2, and CH is change between the two time points. The top unmet needs at the 2nd survey (S2) are Family Stress, Social Support, and Listen & Answer Questions. If you scroll below the needs scores in the PCplanner app, you can click on the need category and get tips. 
What do the trigger icons mean?
Do I get any advice on discussing needs?
Yes! Just click on the need title in your app and there are hints to help (see screenshot above).
What is the involvement of palliative care consultants?
Palliative care gets involved ONLY if after Study Day 4 the patient’s / family’s needs are either extremely high or have increased (see Figure below). The palliative care team will talk to you first and try to meet the family with you. Palliative care will not consult on the control group.
Who can I contact if I have questions?
-All general questions: Allie Frear
-CCU: Jason Katz
-CTICU: Raquel Bartz
-DRH: Mashael Al-Hegelan
-MICU: Christopher Cox & Dan Gilstrap
-Neuro ICU: Colleen Naglee
-SICU: Krista Haines & Raquel Bartz
-Palliative care: Andy Mumm
What is the oversight and funding of this trial?
This trial is approved by the Duke IRB (Pro00101745), registered at ClinicalTrials.gov, and funded by National Institute for Aging grant R01AG058915.
Thanks so much for supporting critical care research in the Duke Health System. There are many residents, fellows, nurses, and junior faculty involved in this project. Your patience is deeply appreciated because it is helping to build their careers! Also, this trial supports the salary of our research coordinators. Thanks also for supporting them!
