Testing an Educational Program to Improve Goals of Care Conversations Between Patients and Their Care Teams
Purpose
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.
Condition
- Malignant Solid Neoplasm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- Single (Care Provider)
- Masking Description
- Randomization assignment is not revealed to clinicians and general staff.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1 (Usual care + A-PACT) |
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. |
|
|
Active Comparator Group 2 (Usual care) |
Patients receive usual care for 6 months. |
|
Recruiting Locations
Little Rock, Arkansas 72205
More Details
- Status
- Recruiting
- Sponsor
- SWOG Cancer Research Network
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.