Table 2.

Examples of Pragmatic ACP studies and Specific Design Considerations

Title	Setting and unit of randomization	Participant Identification/Eligibility	Participant Recruitment/Enrollment	Intervention Structure/Implementation	Outcome Selection/Ascertainment
PROVEN JAMA-Internal Medicine 2020	• 360 Nursing homes • Randomized at nursing home level (241 in control, 119 in intervention arm)	• Who: All Participants in nursing home • Source: Electronic health records (EHR) • Exclusion: No exclusion based on cognitive status or prior code status	• Facility: Administrators notified they were assigned to ACP program, with option to opt out • Participants: All eligible Participants in the nursing home enrolled • Consent: Waiver of individual consent	• Target: Participants or their care partners, decided by clinical staff • Administered by: Nursing home staff • Intervention: Informational ACP video • Additional Infrastructure: Report added to EMR to record when video offered	• Source: Participants only. Medicare Claims and EHR • Primary Outcome: Hospital transfers • Secondary Outcomes: Burdensome treatments (eg. tube feeding, ICU admission), hospice enrollment
Hickman Clinical Trials 2022	• 137 Nursing Homes • Randomized at the nursing home level (68 intervention, 69 control)	• Who: All participants in nursing home • Source: Minimum Data Set • Exclusion: Hospice enrollment	• Facility: ACP Specialist to be identified within the nursing home • Participants: All eligible Participants in the nursing home enrolled • Consent: Waiver of individual consent	• Target: Participants or their care partners, decided by clinical staff • Administered by: Nursing home staff • Intervention: ACP Specialists to engage residents in ACP • Additional Infrastructure: Training and salary support for ACP specialist Program	• Source: Participants only. Medicare Claims and EHR • Primary Outcome: Hospital transfers • Secondary Outcomes: ACP Preference Documentation (Orders), hospice enrollment, location of death
Gabbard JAMA-Internal Medicine 2021	8 primary care practice in an accountable care organization • Randomized at the Participant level	• Who: 65 or older, with multimorbidity, cognitive or physical impairment (by ICD codes), or frailty (electronic FI) • Source: EHR • Exclusion: Moderate to severe cognitive impairment, moderate to severe hearing loss	• Facility: Primary Care clinics • Participants: Participants with care partner involvement invited, but not required • Consent: Verbal consent from participants only (not controls). Consent not obtained from care partner	• Target: Participants with option of their care partners • Administered by: Nurse navigators • Intervention: Called participants inviting to ACP visit. If participants agreed, scheduled dyad for ACP visit with PCP • Additional Infrastructure: EHR ACP interface to standardize ACP, integrated into clinical workflow	• Source: Participants only. Medicare claims and EHR • Primary Outcome: New documentation of ACP discussion in EHR identified through manual review • Secondary outcomes: Completion of ACP legal forms, ACP billing codes
Bluestone project	160 Assisted living facilities • Randomized at ALF level to two arms: control (usual care) vs information	• Who: Residents with dementia, full code or missing code status, being cared for by a Bluestone provider • Source: EHR • Exclusion: No Exclusion based on cognitive status	• Facility: Assisted Living Facilities (with affiliated Primary Care Provider group) • Participants: All eligible participants enrolled, with provider discretion for participant participation • Consent: Waiver of informed consent	• Target: PLWD or care partner • Administered by: Clinical/Primary Care Group staff • Intervention: ACP information sent Participants/care partners plus physician ACP training • Additional Infrastructure: Advance directive fields built into EHR	• Source: Participants only. Medicare claims and EHR • Primary outcome: proportion of residents with DNR order at end of 4-month follow up • Secondary Outcome: Proportion of residents with DNH order at end of 4-month follow up, Billing codes for ACP conversations

Note: Abbreviations: ACP – Advance Care Planning, DNI – Do Not Intubate, DNR – Do Not Resuscitate, EHR – Electronic Health Record