Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial
Abstract Background As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially...
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| Format: | Article |
| Language: | English |
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BMC
2021-11-01
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| Series: | BMC Family Practice |
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| Online Access: | https://doi.org/10.1186/s12875-021-01569-8 |
| _version_ | 1828471397190467584 |
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| author | Leah L. Zullig Mohammad Shahsahebi Benjamin Neely Terry Hyslop Renee A. V. Avecilla Brittany M. Griffin Kacey Clayton-Stiglbauer Theresa Coles Lynda Owen Bryce B. Reeve Kevin Shah Rebecca A. Shelby Linda Sutton Michaela A. Dinan S. Yousuf Zafar Nishant P. Shah Susan Dent Kevin C. Oeffinger |
| author_facet | Leah L. Zullig Mohammad Shahsahebi Benjamin Neely Terry Hyslop Renee A. V. Avecilla Brittany M. Griffin Kacey Clayton-Stiglbauer Theresa Coles Lynda Owen Bryce B. Reeve Kevin Shah Rebecca A. Shelby Linda Sutton Michaela A. Dinan S. Yousuf Zafar Nishant P. Shah Susan Dent Kevin C. Oeffinger |
| author_sort | Leah L. Zullig |
| collection | DOAJ |
| description | Abstract Background As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. Methods/Design The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers. Discussion As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale. Trial registration This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020. |
| first_indexed | 2024-12-11T05:10:30Z |
| format | Article |
| id | doaj.art-0926ca688a2f483487aa85f2281b1b8b |
| institution | Directory Open Access Journal |
| issn | 1471-2296 |
| language | English |
| last_indexed | 2024-12-11T05:10:30Z |
| publishDate | 2021-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Family Practice |
| spelling | doaj.art-0926ca688a2f483487aa85f2281b1b8b2022-12-22T01:19:56ZengBMCBMC Family Practice1471-22962021-11-0122111010.1186/s12875-021-01569-8Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trialLeah L. Zullig0Mohammad Shahsahebi1Benjamin Neely2Terry Hyslop3Renee A. V. Avecilla4Brittany M. Griffin5Kacey Clayton-Stiglbauer6Theresa Coles7Lynda Owen8Bryce B. Reeve9Kevin Shah10Rebecca A. Shelby11Linda Sutton12Michaela A. Dinan13S. Yousuf Zafar14Nishant P. Shah15Susan Dent16Kevin C. Oeffinger17Department of Population Health Sciences, Duke University School Of MedicineDuke University Family Medicine and Community HealthDuke Cancer Institute, Duke UniversityDepartment of Biostatistics, Duke UniversityCenter for Onco-Primary Care, Duke Cancer InstituteCenter for Onco-Primary Care, Duke Cancer InstituteCenter for Onco-Primary Care, Duke Cancer InstituteDepartment of Population Health Sciences, Duke University School Of MedicineDuke Cancer NetworkDepartment of Population Health Sciences, Duke University School Of MedicineDuke Institute for Health Innovation, Duke University Health SystemDuke Psychiatry and Behavioral Sciences, Duke University School of MedicineDuke Cancer NetworkDepartment of Chronic Disease Epidemiology, Yale School of Public HealthDuke University School of MedicineDuke Heart Center, Duke University School of MedicineDuke Cancer Institute, Duke UniversityDuke Cancer Institute, Duke University School of MedicineAbstract Background As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. Methods/Design The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers. Discussion As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale. Trial registration This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.https://doi.org/10.1186/s12875-021-01569-8Cancer survivorshiponco-primary careprimary careoncologyhealth services research |
| spellingShingle | Leah L. Zullig Mohammad Shahsahebi Benjamin Neely Terry Hyslop Renee A. V. Avecilla Brittany M. Griffin Kacey Clayton-Stiglbauer Theresa Coles Lynda Owen Bryce B. Reeve Kevin Shah Rebecca A. Shelby Linda Sutton Michaela A. Dinan S. Yousuf Zafar Nishant P. Shah Susan Dent Kevin C. Oeffinger Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial BMC Family Practice Cancer survivorship onco-primary care primary care oncology health services research |
| title | Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial |
| title_full | Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial |
| title_fullStr | Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial |
| title_full_unstemmed | Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial |
| title_short | Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial |
| title_sort | low touch team based care for co morbidity management in cancer patients the one team randomized controlled trial |
| topic | Cancer survivorship onco-primary care primary care oncology health services research |
| url | https://doi.org/10.1186/s12875-021-01569-8 |
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