. Author manuscript; available in PMC: 2022 Aug 1.

Published in final edited form as: Contemp Clin Trials. 2021 Jun 3;107:106465. doi: 10.1016/j.cct.2021.106465

Table 2:

Main study measures and data collection protocol

MAIN OUTCOME MEASURES	CONCEPT	DATA COLLECTION: SOURCE & TIME
Aim 1: Outcomes
Primary Outcome: HADS depression score	Depressive and anxiety symptoms	Patients and/or Families: Enrollment (if able),1, 3, 6, months post-randomization for all; 1 month after death for family members
SUPPORT question¹⁰⁹	Goal-concordant care
Impact of event scale (IES)^88,105,106	Post-traumatic stress symptoms
QUAL-E and QUAL-E (Fam)^114–116	Quality of life
Aim 1: Potential Mediators of the Intervention
Perceived Competence Scale (PCS)^117,118	Efficacy/capability/expectations for health behavior	Patients and/or Families: Enrollment (if able),1, 3, 6 months post-randomization
Aim 2: Outcomes
Hospitalizations, ICU admits,, palliative care consultations	Healthcare utilization; use of palliative care	Medical record: After-death or 6 months
Hospital and ICU costs	Inpatient costs of care from index hospitalization (direct and indirect)	Medical record/financial databases(US only)
Aim 3: Implementation Factors and Outcomes
Domains: intervention, settings, individual, process	Key factors identified from CFIR¹²⁵	Patients/families/clinicians: Qualitative interviews
Outcomes: acceptability, fidelity, penetration	Key outcomes identified by Proctor¹²⁶	Patients/families/clinicians: Qualitative interviews