Bilingual Electronic Symptom Management Program Across Multi-site, Comprehensive Cancer Center (NU IMPACT)

Northwestern University

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Patient Self-management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03988543

1UM1CA233035-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Cancer, and cancer treatment, cause many symptoms that can negatively affect quality of life. Despite the development of improved symptom management interventions and several evidence- and consensus-based guidelines, their timely delivery remains uneven in the health care system. Our research center, Northwestern University IMPACT (NU IMPACT), builds upon an electronic health record (EHR)-integrated cancer symptom monitoring and management system, currently deployed by our health care system. We are testing the effectiveness of a system-wide symptom management intervention and the EHR-integrated enhanced care approach, which offers a more personalized symptom monitoring and management experience based on a person's unique needs and language (i.e., English or Spanish).

Full description

Using a clinic-level randomized roll-out implementation trial design, we will test the effectiveness of an enhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. The existing EHR-integrated symptom monitoring system will constitute usual care (UC), and added patient engagement and activation features will comprise the EC condition.

Project aims target both patient- and system-level outcomes. Aim 1: Implement a fully-integrated oncology symptom assessment and management program across six clinical units that are part of the NMHC healthcare delivery system; Aim 2: Evaluate the impact of the program by conducting a hybrid Type I effectiveness-implementation trial to evaluate the enhanced care program (EC: symptom monitoring & self-management intervention), relative to usual care (UC) on patient- and system-level outcomes; Aim 3: Identify facilitators and barriers to implementation and disseminate to other health systems. We will enroll an estimated 12,671 participants. To address possible contamination effects within each clinical unit, and allow for unit-level data collection for pre- and post-implementation comparison within and across clinical units, 50% will be enrolled and followed prior to program implementation. The other half will be enrolled post-implementation and will be randomly assigned at a 1:1 ratio (stratified by sex and cancer phase; curative intent, non-curative intent & survivorship) to UC versus EC. Fatigue, pain, anxiety, and depression will be assessed using Patient Reported Outcome Measurement Information System (PROMIS®) computerized adaptive tests (CATs). In addition, we will assess patient clinical outcomes, including healthcare utilization, and cancer treatment delivery outcomes.

Enrollment: 4,104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Curative Intent Group:

• ≥ 18 years of age;
• medical chart confirmed diagnosis of a solid or hematological malignancy;
• willingness to be randomized (post-implementation only);
• have initiated primary treatment with curative intent within the past 3 months (i.e., as patients receive surgery, standard- or high-dose chemotherapy, biological therapy, and/or radiotherapy);
• provider confirmed planned treatment and follow-up within the Northwestern Medicine HealthCare (NMHC) hospital and clinics;
• able to read English or Spanish; and
• no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures.

Non-Curative/Palliative Intent Group:

• ≥ 18 years of age;
• medical chart confirmed diagnosis of advanced or metastatic solid or hematological malignancy;
• willingness to be randomized (post-implementation only);
• undergoing cancer treatment with non-curative/palliative intent (e.g., patients with advanced or metastatic disease who receive chemotherapy, biological therapy, and/or radiotherapy to control or slow advance of their disease);
• provider confirmed planned treatment and follow-up within the NMHC hospital and clinics;
• able to read English or Spanish; and
• no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures.

Cancer Survivorship Group:

• ≥ 18 years of age;
• medical chart confirmed diagnosis of solid or hematological malignancy within the past 2 years;
• willingness to be randomized (post-implementation only);
• completed active cancer treatment with curative intent, including those who may be receiving maintenance or prophylactic cancer treatment;
• provider confirmed planned follow-up (with or without treatment) within the NMHC e hospital and clinics;
• able to read English or Spanish; and
• no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures.

Exclusion criteria

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,104 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Patients will receive current standard care of EHR-integrated symptom monitoring.

Enhanced Care

Experimental group

Description:

Patient will receive current standard care of EHR-integrated symptom monitoring, plus patient self-management intervention.

Treatment:

Behavioral: Patient Self-management