Evaluation of a Symptom and Needs Assessment for Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT04014751|
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : October 1, 2020
|Condition or disease||Intervention/treatment|
|Cancer||Other: Symptom Monitoring Intervention|
Cancer patients' under-identified symptoms and concerns can result in treatment interference, poor care satisfaction, compromised health-related quality of life, and taxed healthcare systems. Cancer care organizations have emphasized the need for symptom assessment and management within quality cancer care delivery. We have leveraged health information technology to pilot and implement the Lurie Screening Initiative in the Robert H. Lurie Comprehensive Cancer Center (RHLCCC) within the Central region of Northwestern Medicine (NM). Following two pilot implementation projects, the screening initiative program is live in RHLCCC clinics. It allows patients to complete Patient Reported Outcomes Measurement Information System computer adaptive tests (PROMIS CATs) assessing depression, anxiety, fatigue, pain, and physical function, along with checklists of supportive care needs, within the electronic health record (EHR). Patients can do so at home via MyChart (a patient portal of their EHR) or in clinic via an EHR hyperlink. Assessment results immediately populate the EHR; severe symptoms and endorsed supportive care needs trigger notifications to clinicians (social workers, dieticians, oncologists & oncology nurses) who can then make referrals and care decisions in real time.
This study will expand and evaluate implementation of the screening initiative via these aims:
Aim 1. Evaluate the impact of system-wide implementation of the program on patient and system outcomes over 12 months via (a) a quality improvement study (estimated n=4,000 cases) to compare the impact of the program (versus usual care) on EHR-documented health care usage and patient satisfaction using a stepped wedge design in which clusters of study sites will gradually be assigned to cross from serving as a control to implementing the program and (b) a human subjects substudy (n=1,000) with patients who will complete the symptom monitoring and other patient-reported outcomes (PRO) measures of health care usage and satisfaction at baseline, 6 & 12 months. We will examine differences in PROs between participants whose screening responses trigger clinical alerts and those who do not. We will also explore longitudinal trajectories of PRO scores
Aim 3. Identify implementation facilitators and barriers to system-wide expansion of the program. We will conduct qualitative research to gather feedback from patients participating in the program expansion (n=50). This will include multiple assessments throughout implementation.
|Study Type :||Observational|
|Estimated Enrollment :||1050 participants|
|Official Title:||Expansion, Implementation & Evaluation of Electronic Health Record (EHR)-Integrated Patient-Reported Symptom Screening in a Multi-Site Cancer Center|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||July 15, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Symptom Monitoring Cohort
This cohort will include up to1,050 cancer patients being seen at regional Northwestern Medicine (NM) cancer centers for their cancer care. Patients who have recently completed an on-line, EHR-integrated patient-reported symptom and needs assessment as part of their regular care will be invited to complete a survey at baseline, 6- and 12-months targeting the assessment of their symptoms, healthcare experiences and utilization. Patients may also be invited to participate in a one-time interview or focus group designed to help study investigators better understand the value of the symptom and needs assessment from the patient perspective.
Other: Symptom Monitoring Intervention
This study involves a cancer care delivery process improvement component where all cohort participants, at specified timepoints, are assessed for psychological distress, pain, fatigue, physical function, practical and supportive needs, and dietary and nutritional needs. Patients with severe elevations in psychological distress, physical symptoms or those who endorse supportive care and/or dietary needs are triaged in real time to appropriate providers within the health system (i.e., social work, nursing pool, nutrition services) to address elevated scores and/or stated needs. As such, within the context of this process improvement care delivery project, real time referrals function as interventional processes within the health system to route patients to relevant points of care based on their needs.
- Effects of the symptom monitoring system on patient-reported quality of life related to cancer and cancer treatment [ Time Frame: Change from baseline quality of life at 12-months ]Quality of life will be assessed using a brief, validated 7-item patient-reported questionnaire (Functional Assessment of Cancer Therapy-General 7-item or FACT-G7) that asks about symptoms of fatigue, pain, and nausea, sleep quality and contentment with life.
- Effects of the symptom monitoring system on severity of patient-reported symptoms related to cancer and cancer treatment [ Time Frame: Change from baseline symptom severity at 12-months ]Symptom severity will be assessed via a Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive test (CAT) that will ask about depression, anxiety, pain, fatigue, and physical functioning. CAT items are dynamically selected for administration from an item bank based upon the respondent's previous answers. Patient usually completes 4-12 items with a high level of measurement.
- Effects of the symptom monitoring system on patient-reported adverse events related to cancer and cancer treatment [ Time Frame: Change from baseline adverse events at 12-months ]Adverse events will be assessed using the Patient-Reported Outcomes- Common Terminology Criteria for Adverse Events (PRO-CTCAE™) assessment. The PRO-CTCAE questionnaire will ask questions about nausea, constipation, insomnia, vomiting, and diarrhea.
- Impact of the symptom monitoring system on health care services used by patients [ Time Frame: Change from baseline use of healthcare services at 12 months ]Utilization of services related to physical and mental health will be measured using a patient-reported questionnaire to assess healthcare services used by participants, such as number of emergency room visits, oncology urgent care visits, general urgent care visits, doctor visits, referrals for services within and outside the health system, and overnight stays in the hospital.
- Impact of the symptom monitoring system on patient experiences with their cancer care team [ Time Frame: Change from baseline patient experiences with their cancer care team at 12 months ]Patient experiences with their cancer care team will be measured using components of a standardized measure (Consumer Assessment of Healthcare Providers and Systems or CAHPS) designed to assess patient experiences with their healthcare provider and system.
- Patient experiences (barriers and facilitators) using the symptom and needs assessment [ Time Frame: Patient experiences will be assessed at one time point between baseline and 12 months ]Patient experiences with the symptom and needs assessment will be evaluated using qualitative methods (semi-structured interview or focus group)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014751
|Contact: Madison Lyleroehr, MAfirstname.lastname@example.org|
|Contact: Kimberly Webster, MAemail@example.com|
|Principal Investigator:||Sofia Garcia, PHD||Northwestern University Feinberg School of Medicine|