Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology

June 15, 2020 updated by: Raymond Osarogiagbon, MD, Baptist Memorial Health Care Corporation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
781

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lung Cancer Patients coming through the Baptist health care system

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Multidisciplinary Clinic Patients
: 150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients
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.
Multidisciplinary Caregivers
Consenting caregivers of consented multidisciplinary clinic patients (patients seen by multiple specialists at a single appointment time).
Serial Care Caregivers
Consenting caregivers of consented serial care patients (patients who receive the current system of linear, sequential, referral-based care delivery).
Clinical Providers
Clinical providers who referred at least 5 patients to the multidisciplinary program and consented to the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC)
Time Frame: 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.
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
Thoroughness of Invasive Mediastinal Staging, MD vs SC
Time Frame: 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.
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
Thoroughness of Bi-Modal Staging Practice, MD vs SC
Time Frame: 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.
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
Thoroughness of Tri-Modal Staging Practice, MD vs SC
Time Frame: 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.
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
Thoroughness of Invasive Staging, MD vs SC (Conference) vs SC (no Conference)
Time Frame: 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 conference model, separate from the multidisciplinary clinic model.
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
Thoroughness of Invasive Mediastinal Staging, MD vs SC (no Conference) vs SC (Conference)
Time Frame: 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.
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
Thoroughness of Bi-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)
Time Frame: 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.
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
Thoroughness of Tri-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)
Time Frame: 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 multidisciplinary clinic model.
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
Stage-Appropriateness Treatment Selection, MD vs SC
Time Frame: 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).
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
Stage-Appropriateness Treatment Selection, MD vs SC (Conference) vs SC (no Conference)
Time Frame: 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 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.
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
Timeliness of Communication, MD vs SC(Conference)
Time Frame: 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.
Within 48 hours of a documented care recommendation made through the multidisciplinary thoracic oncology program
Concordance Rate for Initial Conference Recommendations, MD vs SC (Conference)
Time Frame: 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.
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
Concordance Rate for Initial Conference Recommendation(s) With Prior Condition Met, MD vs SC (Conference)
Time Frame: 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 initial conference recommendations were completed, excluding conditional recommendations for which the prior condition was not met. 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.

E.g., if a recommendation was to have a PET/CT and then a staging biopsy if the PET showed suspicious metastatic disease, the staging biopsy recommendation was excluded from the concordance measure if the PET/CT did not happen or was negative.
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
Concordance Rate for Any Conference Recommendation, MD vs SC (Conference)
Time Frame: 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 any initial conference recommendation was 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.
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
Overall Concordance Rate Using a Hierarchy of Initial Conference Recommendations, MD vs SC (Conference)
Time Frame: 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 the overall initial conference recommendation was 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.

The hierarchy to rank recommendations, from highest priority to lowest, was (1) treatment, (2) staging, (3) diagnosis, (4) surveillance.

If a patient had a treatment recommendation and it happened, he/she was concordant. If treatment was recommended and it did not happen, he/she was discordant. If no treatment recommendation was made, then concordance was measured by whether or not the staging recommendation was met. If no staging recommendation was made, then the diagnostic recommendation was given priority for a concordance measurement. If no diagnostic recommendation, then a surveillance recommendation was used to measure overall concordance.
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
Concordance Rate for Treatment Recommendations With Prior Recommendations Completed, MD vs SC (Conference)
Time Frame: 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 the treatment recommendation made at the initial conference presentation was completed, excluding any patient for whom prior recommendations (staging, diagnosis, surveillance) were not also completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
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
Baseline Patient Survey Response Rate, MD vs SC
Time Frame: Baseline
Number of patients who completed a baseline patient survey
Baseline
3-month Patient Survey Response Rate, MD vs SC
Time Frame: Within 30 days of 3 months after baseline survey administration
Number of patients who completed a 3-month survey
Within 30 days of 3 months after baseline survey administration
6-Month Patient Survey Response Rate, MD vs SC
Time Frame: Within 30 days of 6 months after baseline survey administration
Number of patients who completed a 6-month survey
Within 30 days of 6 months after baseline survey administration
Patient Survey Scores at Baseline, MD vs SC
Time Frame: Baseline

Scores from patient surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken.

Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range: 0-4 (higher is better) Financial burden of care - assessment of financial burden of care; range: 3-6 (sum of 3 items, higher is worse) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 1-5 (sum of 2 items, higher is better) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) (descriptions continued in 3 month survey description)
Baseline
Patient Survey Scores at 3 Months, MD vs SC
Time Frame: Within 30 days of 3 months after baseline survey administration

Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken.

(continued from baseline) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-21 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 0-18 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Physical/Social/Functional well-being - health-related quality of life relating to physical/social/functional well-being; range 0-28 (each a sum of 7 items, higher is better) (description continues in 6 month survey description)
Within 30 days of 3 months after baseline survey administration
Patient Survey Scores at 6 Months, MD vs SC
Time Frame: Within 30 days of 6 months after baseline survey administration

Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken.

(cont) Emotional well-being - health-related quality of life related to emotional well-being; range 0-30 (sum of 6 items, higher is better) Lung cancer specific QOL - health-related quality of life related to lung cancer diagnosis; range: 0-36 (sum of 9 items, higher is better) Total Summary Score FACTL - full survey, functional assessment of cancer therapy - lung; range: 0-136 (sum of 36 items, higher is better) Generic Score FACTG - full survey, functional assessment of cancer therapy - general; range: 0-108 (sum of 27 items, higher is better) Trial Outcome Index - health related quality of life - trial outcome index; range: 0-84 (sum of 23 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items each, higher is worse)
Within 30 days of 6 months after baseline survey administration
Baseline Caregiver Survey Response Rate, MD vs SC
Time Frame: Baseline
Number of caregivers who completed a baseline patient survey
Baseline
3-month Caregiver Survey Response Rate, MD vs SC
Time Frame: Within 30 days of 3 months after baseline survey administration
Number of caregivers who completed a 3-month survey
Within 30 days of 3 months after baseline survey administration
6-Month Caregiver Survey Response Rate, MD vs SC
Time Frame: Within 30 days of 6 months after baseline survey administration
Number of caregivers who completed a 6-month survey
Within 30 days of 6 months after baseline survey administration
Caregiver Survey Scores at Baseline, MD vs SC
Time Frame: Baseline

Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken.

Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range:0-4 (higher is better) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 0-2 (higher is better) Satisfaction patient can complete treatment plan; range: 0-2 (higher is better) (continued in 3 month survey description)
Baseline
Caregiver Survey Scores at 3 Months, MD vs SC
Time Frame: Within 30 days of 3 months after baseline survey administration

Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken.

(cont) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-28 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 6-24 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items, higher is worse) (continued in 6 month survey description)
Within 30 days of 3 months after baseline survey administration
Caregiver Survey Scores at 6 Months, MD vs SC
Time Frame: Within 30 days of 6 months after baseline survey administration

Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken.

(cont) Physical Functioning QOL - 10 items; Physical Health Problems QOL - 4 items; Pain QOL - 2 items; General health perceptions - 5 items; Energy/fatigue QOL - 4 items; Social Functioning QOL - 2 items; Emotional health problems QOL - 3 items; Emotional well-being QOL - 5 items.

All health related quality of life measures are from the SF-36 survey tool, and use a range of 0-100 mean score (higher is better).
Within 30 days of 6 months after baseline survey administration
Timeliness of Care, MD vs SC
Time Frame: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below
Aggregate time in days from enrollment to a specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below
Timeliness of Care, MD vs SC (Conference) vs SC (no Conference)
Time Frame: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below

Aggregate time in days from enrollment to specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment.

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.
From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below
Clinical Provider Survey Responses - Ease of Referring Patients to the Conference
Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - How Quickly my Patients Get Scheduled to be Discussed at the Conference
Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - The Helpfulness of the Staff in Scheduling Patients
Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - The Quality of Treatment Recommendations That I Received for my Patient
Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - How Quickly I Receive Feedback on my Patient
Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - The Consistency With Which my Patients Are Sent Back for Further Treatment
Time Frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Patient Overall Survival
Time Frame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.
As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Patient Overall Survival With SC Further Broken Down
Time Frame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years

Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.

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.
As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Patient Disease/Progression Free Survival
Time Frame: measured from the time from cancer diagnosis to disease progression, death, or data censoring, up to 6 years
Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.
measured from the time from cancer diagnosis to disease progression, death, or data censoring, up to 6 years
Patient Disease/Progression Free Survival With SC Further Broken Down
Time Frame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years

Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.

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.
As measured from the time from cancer diagnosis to death or data censor, up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baptist Memorial Health Care Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raymond Osarogiagbon, Baptist Memorial Health Care Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • The Milestone Project

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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