Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology

NCT ID: NCT02123797

Last Updated: 2020-07-02

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

781 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-09

Study Completion Date

2020-02-29

Brief Summary

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Lung cancer kills 160,000 patients annually; this represents 28% of all US cancer deaths. The overall year survival rate has only improved from 12% to 17% in 33 years. This failure reflects the innate lethality of lung cancer, but also reflects defects in patient care delivery. Care for the lung cancer patient starts with an abnormal radiologic scan, proceeds through a diagnostic biopsy, tests to determine the extent of spread of the disease (stage), selection of appropriate treatment, and finally ends with patient outcomes. At each step are multiple options and independent specialists, each one engaged by a process of sequential referrals in the serial care model. This process is often not user-friendly, is riddled with inefficiency, delays, and outcome variances.

The coordinated multidisciplinary model, in which patients and their doctors collaborate to provide evidence-based care, is believed by experts to be superior, but has few examples of successful implementation. The implementation gap exists because of the paucity of good quality data, and lack of implementation know-how.

Embedded in the highest US lung cancer mortality zone, the greater Memphis area has a racially, culturally, economically and geographically diverse population. The investigators research group has shown how poor quality care impairs patient survival in this region and in the greater US. The investigators have linked patient survival to compliance with multidisciplinary care plans. In this project, the investigators propose to rigorously test the impact of the multidisciplinary care model on patient outcomes in a community-based, private practice environment, similar to where 70% of lung cancer care is delivered in the US.

The objective of this study is to provide high-level evidence of the impact of multidisciplinary care on lung cancer patient outcomes. Multidisciplinary care is defined as a model of care in which patients, their care-givers and key specialists concurrently and directly evaluate the same patients in the presence of the patients and their informal caregivers, in order to develop evidence-based consensus care plans

Detailed Description

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Within the Baptist Memorial Health Care system, the Multidisciplinary Thoracic Oncology Program has two components: Primarily, the program is centered in a multidisciplinary clinic, wherein patients and their informal caregivers are seen by multiple specialists at a single appointment time; secondarily, the program includes a multidisciplinary conference, wherein all of the specialists potentially involved in lung cancer care discuss patients referred for presentation and make consensus recommendations for care. This study focuses primarily on the experience and outcomes of care delivered to patients evaluated in the multidisciplinary clinic. However, data from the conference will also be included in some aspects of the study. The goal is to improve the access and quality of thoracic oncologic care delivery within the Baptist Healthcare System The investigators specific aim is to perform a prospective, matched cohort comparative effectiveness study of patients receiving serial vs. multidisciplinary care, with key patient-centered endpoints (survival, stakeholder satisfaction with the care experience, timeliness and stage-appropriateness of care, quality of staging). Serial care is defined as the current system of linear, sequential, referral-based care delivery.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Multidisciplinary Clinic Patients

: 150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients

No interventions assigned to this group

Serial Care Patients

150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients = 450 patients Since Baptist Health Care System manages \>800 new cases each year, 300 of which are expected to be seen in multidisciplinary clinic, in practice, we conservatively expect to be able to recruit 150 cases from multidisciplinary clinic and 300 matched serial care controls (1:2 match) in 18 months.

No interventions assigned to this group

Multidisciplinary Caregivers

Consenting caregivers of consented multidisciplinary clinic patients (patients seen by multiple specialists at a single appointment time).

No interventions assigned to this group

Serial Care Caregivers

Consenting caregivers of consented serial care patients (patients who receive the current system of linear, sequential, referral-based care delivery).

No interventions assigned to this group

Clinical Providers

Clinical providers who referred at least 5 patients to the multidisciplinary program and consented to the study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- All patients who undergo care for lung cancer or an undiagnosed lung mass within the Baptist Memorial Health Care Corporation's hospitals from January 1, 2009 until the end of the defined study period will be eligible for inclusion in the data collection for this study. In addition, caregivers of patients within the same institution and within the study window, clinical care providers (doctors and nurses) who have taken care of patients within the eligible institutions during the study window.

Exclusion Criteria

* Patients who do not have a radiology-identified lung lesion or lung cancer are excluded from this study.
* Patients not receiving care within the Baptist Memorial Healthcare Corporation are excluded from this study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Baptist Memorial Health Care Corporation

OTHER

Sponsor Role lead

Responsible Party

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Raymond Osarogiagbon, MD

Director, Thoracic Oncology Research Group, Mutidisciplinary Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond Osarogiagbon

Role: PRINCIPAL_INVESTIGATOR

Baptist Memorial Health Care Corporation

Locations

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Baptist Memorial Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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Shao H, Faris NR, Ward KD, Chen W, McHugh L, Smeltzer M, Ray MA, Osarogiagbon RU. Lung Cancer Patients' and Caregivers' Satisfaction With Multidisciplinary Versus Serial Care in a Community Healthcare Setting: A Prospective Comparative-Effectiveness Cohort Study. Clin Lung Cancer. 2023 Nov;24(7):e267-e274. doi: 10.1016/j.cllc.2023.06.006. Epub 2023 Jun 20.

Reference Type DERIVED
PMID: 37451932 (View on PubMed)

Smeltzer MP, Ray MA, Faris NR, Meadows-Taylor MB, Rugless F, Berryman C, Jackson B, Fehnel C, Pacheco A, McHugh L, Robbins ET, Ward KD, Klesges LM, Osarogiagbon RU. Prospective Comparative Effectiveness Trial of Multidisciplinary Lung Cancer Care Within a Community-Based Health Care System. JCO Oncol Pract. 2023 Jan;19(1):e15-e24. doi: 10.1200/OP.21.00815. Epub 2022 May 24.

Reference Type DERIVED
PMID: 35609221 (View on PubMed)

Smeltzer MP, Rugless FE, Jackson BM, Berryman CL, Faris NR, Ray MA, Meadows M, Patel AA, Roark KS, Kedia SK, DeBon MM, Crossley FJ, Oliver G, McHugh LM, Hastings W, Osborne O, Osborne J, Ill T, Ill M, Jones W, Lee HK, Signore RS, Fox RC, Li J, Robbins ET, Ward KD, Klesges LM, Osarogiagbon RU. Pragmatic trial of a multidisciplinary lung cancer care model in a community healthcare setting: study design, implementation evaluation, and baseline clinical results. Transl Lung Cancer Res. 2018 Feb;7(1):88-102. doi: 10.21037/tlcr.2018.01.02.

Reference Type DERIVED
PMID: 29535915 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Patient ICF

View Document

Document Type: Informed Consent Form: Care Giver ICF

View Document

Document Type: Informed Consent Form: Provider ICF

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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The Milestone Project

Identifier Type: -

Identifier Source: org_study_id

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