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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oai:doaj.org-article:0926ca688a2f483487aa85f2281b1b8b2021-11-21T12:32:31ZLow-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial10.1186/s12875-021-01569-81471-2296https://doaj.org/article/0926ca688a2f483487aa85f2281b1b8b2021-11-01T00:00:00Zhttps://doi.org/10.1186/s12875-021-01569-8https://doaj.org/toc/1471-2296Abstract 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.Leah L. ZulligMohammad ShahsahebiBenjamin NeelyTerry HyslopRenee A. V. AvecillaBrittany M. GriffinKacey Clayton-StiglbauerTheresa ColesLynda OwenBryce B. ReeveKevin ShahRebecca A. ShelbyLinda SuttonMichaela A. DinanS. Yousuf ZafarNishant P. ShahSusan DentKevin C. OeffingerBMCarticleCancer survivorshiponco-primary careprimary careoncologyhealth services researchMedicine (General)R5-920ENBMC Family Practice, Vol 22, Iss 1, Pp 1-10 (2021) |
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Cancer survivorship onco-primary care primary care oncology health services research Medicine (General) R5-920 |
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Cancer survivorship onco-primary care primary care oncology health services research Medicine (General) R5-920 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 |
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. |
format |
article |
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 |
title |
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_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_sort |
low-touch, team-based care for co-morbidity management in cancer patients: the one team randomized controlled trial |
publisher |
BMC |
publishDate |
2021 |
url |
https://doaj.org/article/0926ca688a2f483487aa85f2281b1b8b |
work_keys_str_mv |
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