Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans

NCT03046329 | Completed

• 1 other identifier: G401
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

patient care planning

Outcome Measures

Primary Outcomes (2)

• Level of provider adherence to evidence-based practices for symptom assessment/management according to chart abstractions

  Charts will be abstracted and data will be entered into scorecards to determine whether participating providers adhered to evidence-based practices for symptom assessment and management for study participants.

  Year 1

• Degree of changes in symptom care behaviors following engagement with the supportive care intervention according to chart abstractions

  Charts will be abstracted and data will be entered into scorecards to explore changes in symptom care behaviors following engagement with a supportive care intervention (the Carevive CPS), and compare to adherence rates for historical controls from the pre-intervention period.

  Year 1

Secondary Outcomes (2)

• Time spent delivering care plans at both baseline and follow-up using self-report by clinicians

  Year 1

• Level of patient satisfaction and utilization of care plans using the SUS survey

  Year 1

Interventions

Carevive CPS BEHAVIORAL

This 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older
• Diagnosed with MM and currently receiving treatment
• Receiving active treatment for at least 4 weeks prior to study enrollment

You may not qualify if:

• Any participant who cannot understand written or spoken English
• Any participant who is not competent to provide informed consent
• Any participant who cannot be present for the related study visits and/or complete the post-test assessment.

Sponsors & Collaborators

• Carevive Systems, Inc.: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 8, 2017
• Study Start: June 1, 2015
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share