Clinical trial NCT02123797: Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology
Official title: Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Baptist Memorial Health Care Corporation
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-04-28
Enrollment: 781
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung Cancer Patients coming through the Baptist health care system

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC)
timeFrame: 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
measure: Thoroughness of Invasive Mediastinal Staging, MD vs SC
timeFrame: 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
measure: Thoroughness of Bi-Modal Staging Practice, MD vs SC
timeFrame: 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
measure: Thoroughness of Tri-Modal Staging Practice, MD vs SC
timeFrame: 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
measure: Thoroughness of Invasive Staging, MD vs SC (Conference) vs SC (no Conference)
timeFrame: 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
measure: Thoroughness of Invasive Mediastinal Staging, MD vs SC (no Conference) vs SC (Conference)
timeFrame: 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
measure: Thoroughness of Bi-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)
timeFrame: 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
measure: Thoroughness of Tri-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)
timeFrame: 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
measure: Stage-Appropriateness Treatment Selection, MD vs SC
timeFrame: 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
measure: Stage-Appropriateness Treatment Selection, MD vs SC (Conference) vs SC (no Conference)
timeFrame: 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
measure: Timeliness of Communication, MD vs SC(Conference)
timeFrame: Within 48 hours of a documented care recommendation made through the multidisciplinary thoracic oncology program
measure: Concordance Rate for Initial Conference Recommendations, MD vs SC (Conference)
timeFrame: 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
measure: Concordance Rate for Initial Conference Recommendation(s) With Prior Condition Met, MD vs SC (Conference)
timeFrame: 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
measure: Concordance Rate for Any Conference Recommendation, MD vs SC (Conference)
timeFrame: 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
measure: Overall Concordance Rate Using a Hierarchy of Initial Conference Recommendations, MD vs SC (Conference)
timeFrame: 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
measure: Concordance Rate for Treatment Recommendations With Prior Recommendations Completed, MD vs SC (Conference)
timeFrame: 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
measure: Baseline Patient Survey Response Rate, MD vs SC
timeFrame: Baseline
measure: 3-month Patient Survey Response Rate, MD vs SC
timeFrame: Within 30 days of 3 months after baseline survey administration
measure: 6-Month Patient Survey Response Rate, MD vs SC
timeFrame: Within 30 days of 6 months after baseline survey administration
measure: Patient Survey Scores at Baseline, MD vs SC
timeFrame: Baseline
measure: Patient Survey Scores at 3 Months, MD vs SC
timeFrame: Within 30 days of 3 months after baseline survey administration
measure: Patient Survey Scores at 6 Months, MD vs SC
timeFrame: Within 30 days of 6 months after baseline survey administration
measure: Baseline Caregiver Survey Response Rate, MD vs SC
timeFrame: Baseline
measure: 3-month Caregiver Survey Response Rate, MD vs SC
timeFrame: Within 30 days of 3 months after baseline survey administration
measure: 6-Month Caregiver Survey Response Rate, MD vs SC
timeFrame: Within 30 days of 6 months after baseline survey administration
measure: Caregiver Survey Scores at Baseline, MD vs SC
timeFrame: Baseline
measure: Caregiver Survey Scores at 3 Months, MD vs SC
timeFrame: Within 30 days of 3 months after baseline survey administration
measure: Caregiver Survey Scores at 6 Months, MD vs SC
timeFrame: Within 30 days of 6 months after baseline survey administration
measure: Timeliness of Care, MD vs SC
timeFrame: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below
measure: Timeliness of Care, MD vs SC (Conference) vs SC (no Conference)
timeFrame: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below
measure: Clinical Provider Survey Responses - Ease of Referring Patients to the Conference
timeFrame: 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
measure: Clinical Provider Survey Responses - How Quickly my Patients Get Scheduled to be Discussed at the Conference
timeFrame: 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
measure: Clinical Provider Survey Responses - The Helpfulness of the Staff in Scheduling Patients
timeFrame: 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
measure: Clinical Provider Survey Responses - The Quality of Treatment Recommendations That I Received for my Patient
timeFrame: 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
measure: Clinical Provider Survey Responses - How Quickly I Receive Feedback on my Patient
timeFrame: 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
measure: Clinical Provider Survey Responses - The Consistency With Which my Patients Are Sent Back for Further Treatment
timeFrame: 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
measure: Patient Overall Survival
timeFrame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
measure: Patient Overall Survival With SC Further Broken Down
timeFrame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
measure: Patient Disease/Progression Free Survival
timeFrame: measured from the time from cancer diagnosis to disease progression, death, or data censoring, up to 6 years
measure: Patient Disease/Progression Free Survival With SC Further Broken Down
timeFrame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
Study officials:
affiliation: Baptist Memorial Health Care Corporation
name: Raymond Osarogiagbon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.