| 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 |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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.
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Exclusion Criteria:
-
| Contact: Madison Lyleroehr, MA | 312-503-3486 | madison@northwestern.edu | |
| Contact: Kimberly Webster, MA | 312-503-3421 | k-webster@northwestern.edu |
| United States, Illinois | |
| Northwestern Medicine | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Sofia Garcia, PhD 312-503-3449 sofia-garcia@northwestern.edu | |
| Contact: Madison Lyleroehr, MA 312-503-3486 madison@northwestern.edu | |
| Principal Investigator: | Sofia Garcia, PHD | Northwestern University Feinberg School of Medicine |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 4, 2019 | ||||||||
| First Posted Date | July 10, 2019 | ||||||||
| Last Update Posted Date | October 1, 2020 | ||||||||
| Actual Study Start Date | July 15, 2019 | ||||||||
| Estimated Primary Completion Date | July 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition | Cancer | ||||||||
| Intervention | 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.
|
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| Study Groups/Cohorts | 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.
Intervention: Other: Symptom Monitoring Intervention
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1050 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | August 31, 2021 | ||||||||
| Estimated Primary Completion Date | July 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Exclusion Criteria: - |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04014751 | ||||||||
| Other Study ID Numbers | 1R18HS026170-01( U.S. AHRQ Grant/Contract ) | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Sofia Garcia, Northwestern University | ||||||||
| Study Sponsor | Northwestern University | ||||||||
| Collaborators | Agency for Healthcare Research and Quality (AHRQ) | ||||||||
| Investigators |
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| PRS Account | Northwestern University | ||||||||
| Verification Date | September 2020 | ||||||||