Testing an Educational Program to Improve Goals of Care Conversations Between Patients and Their Care Teams

Official title

A Randomized Controlled Trial of an Intervention Called "Algorithm-Enabled Patients Activated in Cancer Care Through Teams" (A-PACT) to Improve Goals of Care Communication for People With Cancer

Overview

This clinical trial evaluates an educational program called Algorithm-Enabled Patients Activated in Cancer Care Through Teams (A-PACT) for reducing unplanned hospital visits and improving goals of care conversations with providers among patients with solid cancers. A-PACT is an educational program where lay health workers (educators) help patients talk with their health care team about issues that matter most to them (goals of care). During A-PACT sessions, patients receive assistance in formulating health care and end of life care preferences, assistance in completing advance directives, guidance on how to engage in these conversations with family members, friends, and clinical teams, and encouragement to discuss these topics with their clinical team. A-PACT may reduce unplanned hospital visits and improve goals of care communication with providers among patients with solid cancers.

Detailed description

PRIMARY OBJECTIVE:

I. To compare the proportion of participants who have any hospitalizations within 12 months after randomization between those receiving A-PACT (intervention arm) and those receiving usual care alone (control arm).

SECONDARY OBJECTIVES:

I. To compare the proportion of participants who report anxiety at 3 months compared to baseline between participants receiving A-PACT and participants receiving usual care.

II. To compare the proportion of participants who report depression at 3 months compared to baseline between participants receiving A-PACT and participants receiving usual care.

III. To assess the proportion of participants who receive intensive end-of-life care between participants receiving A-PACT and those receiving usual care alone.

IMPLEMENTATION OBJECTIVES:

I. To quantitatively and qualitatively assess how patient, clinician, and organizational factors shape effectiveness and implementation of A-PACT.

II. To measure feasibility of machine learning (ML) algorithm, adoption of intervention (patient enrollment), and fidelity (% of patients completing A-PACT).

EXPLORATORY OBJECTIVES:

I. To assess the following in participants on the intervention arm versus the usual practice arm:

Ia. The proportion of participants who have any hospitalization or emergency department visits within 12 months from randomization between those receiving A-PACT and those receiving usual care; Ib. The mean number of hospitalizations within 12 months from randomization between participants receiving A-PACT and participants receiving usual care alone; Ic. The mean number of hospitalizations or emergency department visits within 12 months of randomization between participants receiving A-PACT and participants receiving usual care alone; Id. Anxiety at 6 months from baseline; Ie. Depression at 6 months from baseline; If. Heard and Understood measures at 6 months from baseline; Ig. Prognostic awareness and treatment preferences at 6 months from baseline; Ih. Presence of goals of care documentation in the electronic health record at 12 months; Ii. Presence of advance directive documentation in the electronic health record at 12 months; Ij. Presence of physician orders for life sustaining treatment documentation in the electronic health record at 12 months; Ik. The potential differential impact of sociodemographic factors on all outcomes.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: Patients attend an initial A-PACT education session over 30-45 minutes by phone and receive follow-up A-PACT phone calls over 15 minutes each twice monthly, or less frequently per patient preference, for up to 6 months, in addition to usual care.

GROUP 2: Patients receive usual care for 6 months.

After completion of study intervention, patients are followed up at months 9 and 12.

Interventions

• Other Best Practice
  Receive usual care
• Other Educational Intervention
  Receive A-PACT education
• Other Electronic Health Record Review
  Ancillary studies
• Other Interview
  Ancillary studies
• Other Questionnaire Administration
  Ancillary studies
• Behavioral Telephone-Based Intervention
  Receive A-PACT phone calls

Primary outcome measures

• Proportion of patients with any hospitalization [Time frame: Within 12 months of enrollment]

Secondary outcome measures (6)

• Proportion of patients with 0 versus >= 1 of the combined endpoint of hospitalizations or emergency room (ER) visits [Time frame: Up to 12 months]
• Number of hospitalizations as a continuous outcome [Time frame: Up to 12 months]
• Number of hospitalizations or ER visits [Time frame: Up to 12 months]
• Intensive end-of-life care [Time frame: Up to 12 months]
• Anxiety [Time frame: At 3 months after enrollment]
• Depression [Time frame: At 3 months after enrollment]

Eligibility criteria

Inclusion criteria

• Participants must have a diagnosis of a solid tumor malignancy of any stage
• Participants must be identified as high risk, defined as having 6 month mortality estimate from machine learning (ML) algorithm >= 20%
• Participants must not be receiving or have pre-existing plans to enter hospice care at the time of study registration
• Participant must be actively receiving or planning to receive systemic anti-cancer therapy (defined as any oral, injection, or intravenous therapy against cancer) within 3 months after registration

• NOTE: This includes chemotherapy (conventional or cytotoxic chemotherapy), hormone therapy, targeted therapy, and immunotherapy
• NOTE: Participants are allowed to be co-enrolled on other clinical trials including trials using investigational agents
• Participants must be >= 18 years of age at the time of study enrollment
• Participants who can complete Patient Reported Outcome (PRO) questionnaires in English or Spanish must be willing to 1) complete PROs at all scheduled assessments; and 2) complete the pre-registration (baseline) PRO forms within 14 days prior to registration
• Participants must be able to provide a valid telephone number for the purpose of being contacted by the lay health worker
• NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

• Patient and clinician participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. This protocol does not permit use of Legally Authorized Representative NOTE: For this study, in the OPEN registration, clinician participants will be listed as their own treating investigator. However, clinician participants must not consent themselves or sign their own eligibility criteria forms

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• CARTI Cancer Center — Little Rock

Identifiers

NCT: NCT07278739 · S2424CD · NCI-2025-08258 · S2424CD · SWOG-S2424CD · S2424CD · R37CA296075 · UG1CA189974

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗