Journal article
The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators
BMC primary care, Vol.25(1), 373
10/18/2024
DOI: 10.1186/s12875-024-02610-2
PMCID: PMC11490179
PMID: 39425032
Abstract
Lung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching and navigation intervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm.BACKGROUNDLung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching and navigation intervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm.Patients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching and navigation session about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3 months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18 months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods.METHODSPatients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching and navigation session about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3 months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18 months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods.We will assess whether a decision coaching and patient navigation intervention can feasibly and effectively support high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations.DISCUSSIONWe will assess whether a decision coaching and patient navigation intervention can feasibly and effectively support high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations.This study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022.TRIAL REGISTRATIONThis study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022.Version 1, April 10, 2024.PROTOCOL VERSIONVersion 1, April 10, 2024.
Details
- Title: Subtitle
- The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators
- Creators
- Naomi Q P Tan - Rutgers, The State University of New JerseyLisa M Lowenstein - The University of Texas MD Anderson Cancer CenterElisa E Douglas - The University of Texas MD Anderson Cancer CenterJeanne SilvaJoshua M BershadJinghua An - Rutgers, The State University of New JerseySanjay S Shete - The University of Texas MD Anderson Cancer CenterMichael B Steinberg - Rutgers, The State University of New JerseyJeanne M Ferrante - Rutgers, The State University of New JerseyElizabeth C Clark - Rutgers, The State University of New JerseyAna Natale-PereiraNovneet N Sahu - Rutgers, The State University of New JerseyShirin E Hastings - Rutgers, The State University of New JerseyRichard M Hoffman - University of IowaRobert J Volk - The University of Texas MD Anderson Cancer CenterAnita Y Kinney - Rutgers, The State University of New Jersey
- Resource Type
- Journal article
- Publication Details
- BMC primary care, Vol.25(1), 373
- Publisher
- BMC
- DOI
- 10.1186/s12875-024-02610-2
- PMID
- 39425032
- PMCID
- PMC11490179
- ISSN
- 2731-4553
- eISSN
- 2731-4553
- Grant note
The authors thank Kristen Muldowney (Vice-President, Primary Care and Behavioral Health Sciences, RWJBarnabas Health Medical Group), Katrina Schirmacher (Executive Director, University Hospital), the program managers (Julie Chapman-Greene and Arreum Kim), study coordinators (Sarah Foran, Rebecca Ayala, and Shanzeh Nasir), TELESCOPE Community Advisory Board members (Jimmie Staton (Chair), Walee Jackson, Frances Munet-Vilaro, Elizabeth Talmot, Don Viapree, Donita Devance, Ashita N. Patel), and the navigation team (Avni Patel, Dexter Singh, Amanda Gaughran, Christine Lawther, Shannon Muhammad, Masiel Guzman, Shabika Cooke, Sunita Wagle, Stephanie Elson, Shivon Sessoms, Forzana Mohamed, Erika Brown) for their contributions to this study.
- Language
- English
- Date published
- 10/18/2024
- Academic Unit
- General Internal Medicine; Internal Medicine
- Record Identifier
- 9984736599402771
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