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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
1,020
Receive usual care
Receive A-PACT education
Ancillary studies
Ancillary studies
Ancillary studies
Receive A-PACT phone calls
Proportion of patients with any hospitalization
The primary analysis will be conducted using multivariable logistic regression, adjusting for stratification factors as covariates.
Time frame: Within 12 months of enrollment
Proportion of patients with 0 versus >= 1 of the combined endpoint of hospitalizations or emergency room (ER) visits
Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables.
Time frame: Up to 12 months
Number of hospitalizations as a continuous outcome
Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables.
Time frame: Up to 12 months
Number of hospitalizations or ER visits
Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables.
Time frame: Up to 12 months
Intensive end-of-life care
Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables.
Time frame: Up to 12 months
Anxiety
Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables. Baseline score will also be included as a model covariate.
Time frame: At 3 months after enrollment
Depression
Logistic, linear, and negative binomial regression models will be used, as appropriate for the given endpoint. Each regression analysis will include covariate adjustment for the stratification variables. Baseline score will also be included as a model covariate.
Time frame: At 3 months after enrollment
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