NCT02123797

Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology

Completed Results posted Last updated 2 July 2020

What this trial tests

trial in Lung Cancer in 781 participants. Completed in 29 February 2020.

Timeline

9 October 2014

Primary endpoint
31 October 2017

29 February 2020

Quick facts

Lead sponsor	Baptist Memorial Health Care Corporation
Status	Completed
Study type	OBSERVATIONAL
Enrollment	781
Start date	9 October 2014
Primary completion	31 October 2017
Estimated completion	29 February 2020
Sites	1 location across United States

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Baptist Memorial Health Care Corporation

Who can join

Eligibility, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC) Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

Group	Value	95% CI
Multidisciplinary Clinic Patients	108
Serial Care Patients	168
Multidisciplinary Clinic Patients	70
Serial Care Patients	180

Thoroughness of Invasive Mediastinal Staging, MD vs SC Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence of mediastinal nodal metastasis. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

Group	Value	95% CI
Multidisciplinary Clinic Patients	91
Serial Care Patients	126
Multidisciplinary Clinic Patients	87
Serial Care Patients	222

Thoroughness of Bi-Modal Staging Practice, MD vs SC Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

Group	Value	95% CI
Multidisciplinary Clinic Patients	161
Serial Care Patients	267
Multidisciplinary Clinic Patients	17
Serial Care Patients	81

Thoroughness of Tri-Modal Staging Practice, MD vs SC Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

Group	Value	95% CI
Multidisciplinary Clinic Patients	99
Serial Care Patients	132
Multidisciplinary Clinic Patients	79
Serial Care Patients	216

Thoroughness of Invasive Staging, MD vs SC (Conference) vs SC (no Conference) Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conferenc

Group	Value	95% CI
Multidisciplinary Clinic Patients	108
Serial Care Patients Presented in Conference	46
Serial Care Patients Not Presented in Conference	122
Multidisciplinary Clinic Patients	70
Serial Care Patients Presented in Conference	30
Serial Care Patients Not Presented in Conference	150

Thoroughness of Invasive Mediastinal Staging, MD vs SC (no Conference) vs SC (Conference) Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence mediastinal nodal metastasis. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.

Group	Value	95% CI
Multidisciplinary Clinic Patients	91
Serial Care Patients Presented in Conference	40
Serial Care Patients Not Presented in Conference	86
Multidisciplinary Clinic Patients	87
Serial Care Patients Presented in Conference	36
Serial Care Patients Not Presented in Conference	186

Thoroughness of Bi-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference) Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.

Group	Value	95% CI
Multidisciplinary Clinic Patients	161
Serial Care Patients Presented in Conference	62
Serial Care Patients Not Presented in Conference	205
Multidisciplinary Clinic Patients	17
Serial Care Patients Presented in Conference	14
Serial Care Patients Not Presented in Conference	67

Thoroughness of Tri-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference) Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the mul

Group	Value	95% CI
Multidisciplinary Clinic Patients	99
Serial Care Patients Presented in Conference	39
Serial Care Patients Not Presented in Conference	93
Multidisciplinary Clinic Patients	79
Serial Care Patients Presented in Conference	37
Serial Care Patients Not Presented in Conference	179

Stage-Appropriateness Treatment Selection, MD vs SC Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy).

Group	Value	95% CI
Multidisciplinary Clinic Patients	140
Serial Care Patients	232
Multidisciplinary Clinic Patients	33
Serial Care Patients	106

Stage-Appropriateness Treatment Selection, MD vs SC (Conference) vs SC (no Conference) Primary · From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months

Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy). This measure compares 3 groups, instead of 2, because some patients in the serial care g

Group	Value	95% CI
Multidisciplinary Clinic Patients	140
Serial Care Patients Presented in Conference	58
Serial Care Patients Not Presented in Conference	174
Multidisciplinary Clinic Patients	33
Serial Care Patients Presented in Conference	15
Serial Care Patients Not Presented in Conference	91

Timeliness of Communication, MD vs SC(Conference) Primary · Within 48 hours of a documented care recommendation made through the multidisciplinary thoracic oncology program

Number of patients for whom formal, verified communication of care management decisions was made to all team members (providers inside and outside the multidisciplinary program, patients and their care-givers) within 48 hours of a care recommendation being made. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.

Group	Value	95% CI
Multidisciplinary Clinic Patients	168
Serial Care Patients Presented in Conference	74
Overall Conference	242
Multidisciplinary Clinic Patients	10
Serial Care Patients Presented in Conference	2
Overall Conference	12

Concordance Rate for Initial Conference Recommendations, MD vs SC (Conference) Primary · From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months

Number of patients for whom all recommendations made at the initial multidisciplinary conference were completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.

Group	Value	95% CI
Multidisciplinary Clinic Patients	140
Serial Care Conference Patients	45
Multidisciplinary Clinic Patients	37
Serial Care Conference Patients	30

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pragmatic trial of a multidisciplinary lung cancer care model in a community healthcare setting: study design, implementation evaluation, and baseline clinical results.
   Smeltzer MP, Rugless FE, Jackson BM, Berryman CL, et al · · 2018 · cited 20× · PMID 29535915 · DOI 10.21037/tlcr.2018.01.02
2. Prospective Comparative Effectiveness Trial of Multidisciplinary Lung Cancer Care Within a Community-Based Health Care System.
   Smeltzer MP, Ray MA, Faris NR, Meadows-Taylor MB, et al · · 2023 · cited 9× · PMID 35609221 · DOI 10.1200/op.21.00815
3. Lung Cancer Patients' and Caregivers' Satisfaction With Multidisciplinary Versus Serial Care in a Community Healthcare Setting: A Prospective Comparative-Effectiveness Cohort Study.
   Shao H, Faris NR, Ward KD, Chen W, et al · · 2023 · cited 1× · PMID 37451932 · DOI 10.1016/j.cllc.2023.06.006
4. Raymond U. Osarogiagbon: lung cancer is a global challenge that needs our close cooperation!
   Li B. · · 2018 · PMID 30705865 · DOI 10.21037/tlcr.2018.09.12