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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive usual care

  • Educational Intervention

    Other intervention

    Receive A-PACT education

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Interview

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Telephone-Based Intervention

    Behavioral

    Receive A-PACT phone calls

Treatment groups

1,020 Participants
are divided into 2 treatment groups
Group A: Group 1 (Usual care + A-PACT)Experimental treatment 6 interventions
Group B: Group 2 (Usual care)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

Goals of care communication

Abstracted from the electronic health record. Will assess differential impact by income and race and ethnicity.

Time frame
Up to 12 months
2

Emergency room visits

Will assess differential impact by income and race and ethnicity.

Time frame
Up to 12 months
3

Patient-reported anxiety

Measured using Patient Reported Outcomes Measurement Information System (PROMIS) version 1.0 Short Form Anxiety. Will assess differential impact by income and race and ethnicity.

Time frame
At baseline, 3 months, and 6 months
4

Patient-reported depression

Measured using PROMIS version 1.0 Short Form Depression. Will assess differential impact by income and race and ethnicity.

Time frame
At baseline, 3 months, and 6 months

Sponsors and contacts

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SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator