Clinical trial NCT04014751: Evaluation of a Symptom and Needs Assessment for Patients With Cancer
Official title: Expansion, Implementation & Evaluation of Electronic Health Record (EHR)-Integrated Patient-Reported Symptom Screening in a Multi-Site Cancer Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Symptom-monitoring
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2019-07-10
Enrollment: 1166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients at Northwestern Medicine (NM) who have a confirmed diagnosis of a solid or hematological malignancy and have had oncology services at NM within the past 12-months.

Brief summary: This is a quality improvement study that aims to improve on the timely identification and management of symptoms and supportive care needs in patients with cancer. The study will be evaluating the relative success of an existing on-line patient-reported symptom and needs assessment, and then the implementation and use of an updated version of the symptom and needs assessment with Northwestern Medicine (NM) cancer patients. It also aims to evaluate the impact of the symptom and needs assessment system on healthcare delivery and quality of care. Participants who complete the symptom and needs assessment as part of their usual care are invited to participate in the study by agreeing to complete an on-line survey (at 3 different time points) that asks about quality of life, adverse symptoms related to cancer and cancer treatment, patient experiences with their cancer care team, and the healthcare services they have received. Patients may also be invited to participate in a one-time interview or focus group about patient experiences with the symptom and needs assessment.

Detailed description: 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.

Eligibility criteria: 1. Must have medical chart confirmed diagnosis of a solid or hematological malignancy
2. Must have had oncology services at a Northwestern Medicine location within the past 12 months
3. Must have completed the current symptom monitoring assessment offered by Northwestern Medicine
4. Must be willing to complete electronic patient-reported measures (i.e. patient reported health care utilization and satisfaction surveys) at baseline, 6-month, and 12-month follow-up time points, and
5. Must consent to give authorized study staff access to details of their cancer diagnosis and treatment as documented in their electronic health record
6. If participating in a semi-structured interview or focus group, must consent to have their comments audio-recorded

Exclusion Criteria:

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Primary outcomes:
measure: Effects of the symptom monitoring system on patient-reported quality of life related to cancer and cancer treatment
timeFrame: Change from baseline quality of life at 12-months
measure: Effects of the symptom monitoring system on severity of patient-reported symptoms related to cancer and cancer treatment
timeFrame: Change from baseline symptom severity at 12-months
measure: Effects of the symptom monitoring system on patient-reported adverse events related to cancer and cancer treatment
timeFrame: Change from baseline adverse events at 12-months
measure: Impact of the symptom monitoring system on health care services used by patients
timeFrame: Change from baseline use of healthcare services at 12 months
Secondary outcomes:
measure: Impact of the symptom monitoring system on patient experiences with their cancer care team
timeFrame: Change from baseline patient experiences with their cancer care team at 12 months
measure: Patient experiences (barriers and facilitators) using the symptom and needs assessment
timeFrame: Patient experiences will be assessed at one time point between baseline and 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Sofia Garcia, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia SF, Smith JD, Kallen M, Webster KA, Lyleroehr M, Kircher S, Bass M, Cella D, Penedo FJ. Protocol for a type 2 hybrid effectiveness-implementation study expanding, implementing and evaluating electronic health record-integrated patient-reported symptom monitoring in a multisite cancer centre. BMJ Open. 2022 May 3;12(5):e059563. doi: 10.1136/bmjopen-2021-059563.