Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology

Completed

Conditions: Lung Cancer

Registration Number: NCT02123797

Lead Sponsor: Baptist Memorial Health Care Corporation

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 781

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thoroughness of Invasive Mediastinal Staging, MD vs SC	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.
Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC)	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.
Thoroughness of Bi-Modal Staging Practice, MD vs SC	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.
Thoroughness of Tri-Modal Staging Practice, MD vs SC	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.
Thoroughness of Invasive Staging, MD vs SC (Conference) vs SC (no Conference)	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.
Thoroughness of Invasive Mediastinal Staging, MD vs SC (no Conference) vs SC (Conference)	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.
Thoroughness of Bi-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)	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.
Thoroughness of Tri-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)	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.
Stage-Appropriateness Treatment Selection, MD vs SC	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).
Stage-Appropriateness Treatment Selection, MD vs SC (Conference) vs SC (no Conference)	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.
Timeliness of Communication, MD vs SC(Conference)	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.
Concordance Rate for Initial Conference Recommendations, MD vs SC (Conference)	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.
Concordance Rate for Initial Conference Recommendation(s) With Prior Condition Met, MD vs SC (Conference)	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.
Concordance Rate for Any Conference Recommendation, MD vs SC (Conference)	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.
Overall Concordance Rate Using a Hierarchy of Initial Conference Recommendations, MD vs SC (Conference)	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.
Concordance Rate for Treatment Recommendations With Prior Recommendations Completed, MD vs SC (Conference)	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.
Baseline Patient Survey Response Rate, MD vs SC	Baseline	Number of patients who completed a baseline patient survey
3-month Patient Survey Response Rate, MD vs SC	Within 30 days of 3 months after baseline survey administration	Number of patients who completed a 3-month survey
Patient Survey Scores at Baseline, MD vs SC	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)
Patient Survey Scores at 3 Months, MD vs SC	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)
Patient Survey Scores at 6 Months, MD vs SC	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)
Baseline Caregiver Survey Response Rate, MD vs SC	Baseline	Number of caregivers who completed a baseline patient survey
3-month Caregiver Survey Response Rate, MD vs SC	Within 30 days of 3 months after baseline survey administration	Number of caregivers who completed a 3-month survey
6-Month Caregiver Survey Response Rate, MD vs SC	Within 30 days of 6 months after baseline survey administration	Number of caregivers who completed a 6-month survey
Caregiver Survey Scores at Baseline, MD vs SC	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)
Caregiver Survey Scores at 3 Months, MD vs SC	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)
Caregiver Survey Scores at 6 Months, MD vs SC	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).
Timeliness of Care, MD vs SC	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.
Timeliness of Care, MD vs SC (Conference) vs SC (no Conference)	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.
Clinical Provider Survey Responses - Ease of Referring Patients to the Conference	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.
Clinical Provider Survey Responses - How Quickly my Patients Get Scheduled to be Discussed at the Conference	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.
Clinical Provider Survey Responses - The Helpfulness of the Staff in Scheduling Patients	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.
Clinical Provider Survey Responses - The Quality of Treatment Recommendations That I Received for my Patient	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.
Clinical Provider Survey Responses - How Quickly I Receive Feedback on my Patient	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.
Clinical Provider Survey Responses - The Consistency With Which my Patients Are Sent Back for Further Treatment	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.
Patient Overall Survival	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.
Patient Overall Survival With SC Further Broken Down	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.
Patient Disease/Progression Free Survival	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.
Patient Disease/Progression Free Survival With SC Further Broken Down	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.
6-Month Patient Survey Response Rate, MD vs SC	Within 30 days of 6 months after baseline survey administration	Number of patients who completed a 6-month survey