Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial

University of Pittsburgh672 enrolled

Overview

The overall goal of this study is to identify the most effective and efficient advance care planning (ACP) strategy for patients with advanced cancer. The specific aims are to: Aim 1. Compare the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes. Aim 2. Assess implementation costs and the effects of in-person, facilitated ACP and web-based ACP on healthcare utilization at end of life. Aim 3. Identify contexts and mechanisms that influence the effectiveness of in-person, facilitated ACP versus web-based ACP.

Study investigators will conduct a single-blind, patient-level randomized trial to compare the effectiveness of two different patient-facing advance care planning (ACP) interventions. Investigators will enroll 400 patients with advanced cancer and their family caregivers to receive either (1) in-person discussions with trained facilitators or (2) web-based ACP using interactive videos. Because these approaches have never been compared directly, it is unclear whether one form of advance care planning is more potent, and if so, for whom and under what circumstances. Aim 1 compares the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes (ACP engagement, ACP discussions, advance directive completion, goal attainment, and caregiver psychological symptoms). Aim 2 assesses implementation costs of each intervention and effects on healthcare utilization at end of life. Aim 3 identifies contexts and mechanisms influencing the effectiveness of each approach. Primary patient outcomes will be assessed at 12 weeks. Participants will be followed until 12 weeks after the patient's death or completion of the 48-month data collection period, whichever occurs first. In-depth interviews with patients, caregivers, and clinicians will begin in Year 2 of the grant and continue until thematic saturation is reached.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Interventions

Facilitated advance care planning (in-person or telephonic)BEHAVIORAL

The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences.

Web-based advance care planningBEHAVIORAL

Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Patient Inclusion Criteria: 1. 18 years of age or older 2. Solid tumor 3. The oncologist "would not be surprised" if the patient died within the next year 4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2 5. Planning to receive ongoing care at a participating oncology clinic 6. Willing to participate in either a web-based or facilitated program Patient Exclusion Criteria: 1. Does not speak English 2. Inability to consent, using a validated teach-back method 3. Hematologic malignancy 4. No phone for additional study contacts and follow-up interviews 5. Unable to participate in advance care planning, as assessed by clinician 6. Unable to complete the baseline interview Patients will be able to identify and enroll a caregiver, designated by the patient as the primary family member or friend involved in their care and best able to participate in the study. Caregiver Inclusion criteria: 1. 18 years of age or older 2. Family member or friend of an eligible patient 3. Primary person involved in patient's care and best able to participate in the study, as assessed by patient Caregiver Exclusion criteria: 1. Does not speak English 2. No phone for additional study contacts and follow-up interviews 3. Unable to complete the baseline interview

Outcomes

Primary Outcomes

Advance Care Planning Engagement

15-item Advance Care Planning (ACP) engagement survey assesses ACP processes related to choosing a medical decision maker, discussing and documenting preference for care at end of life, flexibility for surrogate decision making, and asking questions of medical providers. A single summary score will be reported (range 0-5 with higher scores indicating higher engagement).

Time frame: 12 weeks

Secondary Outcomes

Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers

"Has \[participant\] talked with \[participant's\] family or friends about the kind of medical care \[participant\] would want if \[participant\] were very sick or near the end of life?"

Time frame: 12 weeks

Number of Participants Who Have Had Advance Care Planning Discussions With Physicians

"Has \[participant\] talked with \[participant's\] doctor about the kind of medical care \[participant\] would want if \[participant\] were very sick or near the end of life?"

Time frame: 12 weeks

Number of Participants Who Have Completed an Advance Directive

"Has \[participant\] completed a living will or advance directive?"

Time frame: 12 weeks

Documented Care Goals

Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).

Time frame: 12 weeks

Caregiver Depression Symptoms

Depression subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver depression symptoms at 12 weeks and bereavement. The HADS depression subscale scores range from 0 to 21, with higher scores indicating more distress.

Time frame: 12 weeks

Caregiver Anxiety Symptoms

Anxiety subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver anxiety symptoms at 12 weeks and bereavement. The anxiety subscale scores range from 0 to 21, with higher scores indicating more distress.

Time frame: 12 weeks

Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed

Bereaved caregivers will be asked "In \[participant's\] opinion, to what extent were \[the patient's\] wishes followed in the medical care received in the last month of life?" Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that "followed patients' wishes a great deal."