Multiple Myeloma Clinical Trial
Official title:
Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans: Pilot Testing the Impact of Continuing Education and Care Planning on Symptom Management
The overarching objective of this study is to evaluate the symptom assessment and management behaviors used by multiple myeloma (MM) providers for alignment with evidence-based practices, and to explore changes in these symptom care behaviors from baseline to following use of the Carevive Care Planning System (CPS). The overarching goal of the larger program of research is to evaluate the impact of the platform on symptom assessment and management strategies with individuals receiving treatment for multiple myeloma. The current study is focused on determining feasibility of research methods and effect size finding so as to gather the requisite data needed to design fully powered hypothesis testing studies.
Treatment of multiple myeloma (MM) is currently undergoing rapid transformation. With so many
new agents and regimens to choose from, significant practice gaps have emerged in the
treatment and management of newly diagnosed MM patients. Innovative strategies are needed to
(1) enhance the personalized treatment of MM and (2) proactively identify, assess, and manage
disease- and treatment-related symptoms so that new therapies are optimally translated to
practice. This study will explore the symptom assessment and management practices of
providers caring for individuals receiving active therapy for multiple myeloma, and will also
employ a two-part intervention (with both patients and providers) to evaluate the impact of a
novel existing technology, the Carevive Care Planning System (CPS), on supportive care and
symptom management for multiple myeloma patients. The primary objective of this study is to
evaluate provider adherence to evidence-based practices for symptom assessment and management
(i.e., "symptom care behaviors") of physicians and nurses (providers) caring for individuals
receiving active treatment for multiple myeloma (MM). Carevive. The Carevive intervention
will include personalized supportive care and symptom management plans for patients
auto-generated by the Carevive CPS based on each individual's data. The Care plans were
created based on nationally recognized National Comprehensive Cancer Network (NCCN)
supportive care guidelines and validated by a Multiple Myeloma (MM) nurse and physician
experts. Investigators will use a study-specific scorecard of evidence-based symptom
assessment and management metrics to evaluate adherence of provider (n=8-20) symptom
assessment and management behaviors, measured at the individual patient (n=120) level, to
evidence-based practices for symptom care. Changes in adherence to evidence-based practices
will be explored using an across subject comparison to retrospective data abstracted from a
matched sample of historical controls. Use of a care planning technology to provide tailored
education and individualized information may provide an easy, accessible and effective way to
improve supportive care and symptom management for individuals receiving active treatment for
multiple myeloma.
Multiple myeloma (MM) is a neoplastic plasma-cell disorder characterized by clonal
proliferation of malignant plasma cells in the bone marrow microenvironment, monoclonal
protein in the blood or urine, and associated organ dysfunction. In 2014, approximately
24,050 new cases of MM will be diagnosed and 11,090 deaths are expected to occur. The
treatment of MM is currently undergoing a rapid evolution. The FDA has approved several new
agents over the past several years. Dozens of regimens are now available, with best practices
and consensus guidelines continually evolving as new data are published. Indeed, major
updates to the International Myeloma Working Group (IMWG) and the 2014 National Comprehensive
Cancer Network (NCCN) guidelines highlight the recent revolution in MM care.
With so many agents and regimens to choose from, it is more crucial now than ever for
providers to understand how to individualize treatment and symptom management based on
patient- and disease-related factors. However, significant practice gaps exist among
providers treating patients newly diagnosed with MM. Transplant eligibility, cytogenetics,
comorbidities, renal function, and other factors are often not adequately considered when
designing personalized induction, consolidation, and maintenance treatment plans. In
addition, institutional MM pathways often do not include symptom management. Adverse events
are common in patients with MM, and can be dose limiting, forcing patients to change
therapies and jeopardize treatment outcomes.
A between subject design using matched historical controls from each institution will be used
to evaluate adherence of provider (n=8-20) symptom assessment and management behaviors,
measured at the individual multiple myeloma (MM) patient (n=120) level, to evidence-based
practices for symptom care, and to explore correlates of adherence to these evidence-based
symptom care behaviors. Retrospective reviews of enrolled patient participant charts will be
conducted to evaluate achievement of adherence to evidence-based practices at the individual
patient level, following engagement with the two part study intervention, plus a novel
individualized care planning technology (Carevive CPS). Retrospective chart reviews will be
completed on de-identified, matched historical controls (matching on demographics, diagnosis
and treatment variables) at each institution (e.g Cleveland Clinic) to assess the impact of
the project intervention on the outcome metrics. Data will be entered into the score card
appendix B. The use of matched historical controls for comparative analyses addresses the
threat of diffusion of intervention; i.e., that participation in this project will have an
impact on provider's clinical behaviors in caring for all patients and thus would potentially
effect baseline data collection on patients enrolled later on in the study. Providers will be
caring for individuals receiving active treatment for multiple myeloma (MM).
The Carevive CPS intervention will focus on the use of the Carevive CPS at the point of care
to enable providers to deliver evidence-based and personalized supportive care and symptom
management plans to their MM patients receiving active treatment. The Carevive CPS collects
electronic patient reported outcomes (ePROs) and clinical data, reported and entered by
clinical staff and/or extracted from the electronic medical record (EMR), and uses these to
auto-generate the personalized care plans. Care plan content is driven by practice guidelines
and other peer-reviewed evidence, and includes patient education, resources, and referrals
developed by expert cancer clinicians and researchers. Changes in symptom assessment and
management behaviors will be assessed by matching against a scorecard of evidence-based
symptom assessment and management metrics. A scorecard metric is being developed by an
interdisciplinary team and will be informed by similar approaches used within the Oncology
Nursing Society's (ONS) Quality Initiative. Recommendations for symptom assessment and
management as well as other evidence based recommendations will be operationalized as
metrics.
The intervention is centered on use of the Carevive CPS at the point of care, in conjunction
with two consecutive clinical visits, baseline and the second, similar questionnaire will be
completed at a clinic visit that occurs at least 4 weeks later. Eligible patients and
potentially eligible visits will be identified via weekly chart review of upcoming clinic
schedules and of corresponding individual patient medical records. In the exam room, prior to
their potential baseline study visit, the patient will be approached and informed of the
study (for follow-up visits, patients will be approached and reminded of the study). Once a
patient has consented, research staff will open the electronic questionnaire via the Carevive
CPS application on one of the study designated tablet computers or secure Cleveland Clinic
desktop device according to patient preference . Research staff will then either a) register
the patient using their year of birth and a unique Study ID numbers assigned by the Cleveland
Clinic or b) open the patients' already existing file (follow-up). The research staff will
then select and open the appropriate questionnaire (baseline or interim) and allow the
patient to complete. The patient will report their symptoms, history, and current concerns.
Once the patient has completed the questionnaire, the survey window will automatically close.
Data will be stored centrally and managed by a third party (PRS) in a HIPAA compliant manner.
The study research coordinator will then enter limited clinical data into the Diagnosis and
Treatment Summary section of the Carevive CPS and click submit. Once submitted, the total
composite of ePRO and research staff entered data will run through the guideline-driven and
proprietary Carevive CPS algorithms to auto-generate a draft supportive care plan. The draft
care plan contains, based on individual patient data, personalized supportive care and
symptom management data to be reviewed by the provider during visit. The patient will proceed
to the intervention visit where the provider will review, edit if needed, finalize and
deliver the electronic care plan (and/or a print copy) to each patient. The patient will also
be provided with his or her own copy of the care plan (electronically via email, thumb drive
and/or paper) to take home.
Research staff will track patient enrollment and monitor return visits for all participants
that fall within the follow-up visit window which begins at least 4 weeks later (+/- 1 week)
and continues until the second survey is completed. At this follow up visit, the study
patients will take their second electronic survey in the Carevive CPS, and receive their
second provider-approved care plan. Patients will also be offered the opportunity to complete
a brief questionnaire on their satisfaction with, and utilization of, the care plan since
their first intervention visit. The questionnaire will ask about specific recommendations
made within the care plan and if the patient recalls receiving it and what action, if any,
they have taken. Patients will be offered the opportunity to complete this survey on the
study provided tablet or secure Cleveland Clinic desktop device at the time of their second
visit or to have a link to the survey emailed to them to be completed at their leisure. This
survey will be completed independently of the Carevive CPS through the on-line survey hosting
site Surveymonkey.com and will be optional for patients.
Study-specific data collection will occur at multiple time points. Chart reviews of enrolled
patient participants will the period of time from baseline intervention (baseline visit) to
12-weeks post the second intervention (encompassing the follow-up visit). Retrospective chart
abstractions for the matched controls examine a 12-week time period matched as close as
possible to the intervention time period of their respective enrolled patients. Retrospective
chart reviews can occur at any time. Chart reviews must reflect the time period of enrolled
patients. Patient satisfaction and utilization questionnaire will be completed at or
following the follow-up visits. Data sources include the patient questionnaire, previously
collected data collected as part of the study intervention and stored within the Carevive CPS
platform database (for enrolled patients) limited diagnosis and treatment data on controls
(for matching purposes), as well as chart review score card data. A brief worksheet
collecting care plan delivery variables (e.g., who delivered the care plan to the patient,
how much time was spent reviewing the care plan, etc.) will also be completed by the research
staff following each clinic visit at which a care plan is delivered.
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