Onco-primary Care Networking to Support TEAM-based Care
NCT ID: NCT04258813
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
313 participants
INTERVENTIONAL
2021-06-14
2026-06-30
Brief Summary
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A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.
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Detailed Description
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Key aspects of the intervention are to: reframe the message to patients, PCPs, oncologists, and the respective health care teams in these two settings to emphasize the importance of optimizing the management of comorbidities during and after cancer therapy; promote a change in the workflow in both PCP and oncology practices; enhance PCP-oncologist relationships, and utilize EHR technology. There are two phases of the intervention, both having patient- and PCP-level components. During the first phase of the intervention, occurring with the first randomization, the investigators will test the effectiveness of a self-guided, informational strategy (iGuide). For PCP clinics that do not achieve the HEDIS targets, a booster phase with tailored (patient-level) and targeted (PCP-level) strategies will be tested with a second randomization (iGuide2).
The intervention has been designed to leverage communication tools with in our electronic health record (EHR), Epic . For patients who agree to receive study communications through Epic's patient portal, MyChart, we created an automated messaging system using a dynamic, rules-based protocol which determines the proper language to send each subject based on their study arm and time since enrollment. We developed a similar rules-based automated messaging system for provider communications. This method sends letters to a provider's Epic inbox, called InBasket, for Duke providers and PCPs in the community who have limited access to the Duke EMR through a portal called MedLink. Epic will send letters to PCPs outside of Duke who do not have MedLink access by fax. These outside providers will also be given the opportunity to enroll in MedLink if they are interested.
All participants in the study will be given a survivorship care plan based on the American Society of Clinical Oncology (ASCO) template. Because the investigators will be recruiting participants at our cancer centers and community practices, there will be an inevitable contamination across cancer specialists. Thus, the investigators did not include an oncology-level intervention. However, cancer specialists are integral to the patient- and PCP-level interventions. At the end of the study, patients and PCPs will be mailed a newsletter with a summary of the study findings. Lastly, it is inevitable that some patients will change their PCP during the study. When notified of the change, the research team will send the new PCP the intervention materials.
Supplement:
A retrospective data analysis of Duke cancer registry data integrated with EHR data elements linked by the medical record number will done. The study cohort will consist of older adults ≥65 years who have ≥1 cardiovascular comorbidity (hypertension, type 2 diabetes, dyslipidemia) and underwent cancer surgery for solid tumors at DUHS from January 1st, 2017 to December 31st 2019. Cancers of interest are breast, prostate, colorectal, endometrial, gastric, esophageal, liver, pancreatic, renal cell, bladder, ovarian, head/neck, and non-small cell lung cancer. Cancer diagnoses will be grouped according to the International Classification of Diseases for Oncology, 3rd revision (ICD-O-3). Key variables to be abstracted include demographic, clinical (comorbidities \& pertinent history, medications, cancer treatment, labs), geriatric-specific (frailty, function, cognition, operative, post-operative, and PCP follow-up data.
The qualitative component will involve semi-structured interviews with PCPs of older adults with solid tumors who underwent cancer surgery within a 12-month period in the DUHS. Participating PCPs will complete an audio-recorded semi-structured interview that will last approximately 30 minutes. Qualitative interview: We will design a semi-structured interview guide assessing perspectives on (1) frequency, modes, and perceived quality of communication with surgical providers during transitions in care from surgery (2) perceived barriers to effective care coordination with surgical providers (3) how communication and care coordination can be improved. Open-ended prompts may include "Please describe your experience with care coordination with surgical providers of older adults undergoing cancer surgery?" "What challenges have you faced when communicating with surgical providers of your older adult patients?"; "What are your thoughts on ways to improve communication and care coordination after an older adult with solid tumor undergoes surgery?", "Please give examples of particularly good or poor care coordination with surgical providers?" The interview guide will be designed with assistance from the experienced research staff in the Duke Behavioral Health and Survey Research Core.
Power re-estimation:
Our original power calculations were completed using methods described in Eldridge et al (ref). At the time of project development, the number of practices (40 per arm) and number of patients per practice (10) were unknown, but we estimated the 10 when computing planned sample size for the study. Following enrollment patterns over time, it has been determined that the average number of patients per practice is much smaller, 1.81, presently. If we had this information at time of study planning, based on the design effect and our original effect size, we see that with smaller sample size than originally planned/proposed, we still retain high power, primarily due to the reduction in the design effect (DE). Using the revised calculations, we estimate a power of 0.85-0.9 for 250 projected randomized participants and a power of 0.9 for 275 projected randomized participants.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
DOUBLE
Study Groups
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Control
40 PCP clinics; 400 patients
Control
Participants randomized to the control group (n=400) will receive current guideline-concordant cancer care. The investigators will also provide information for healthy living during and after cancer and for preparing for transition from cancer therapy to follow-up care. Monthly, patient education material on healthy living will be sent to the participants via the patient portal or by mail, based on participant preference. At the completion of therapy, they will be provided the NCI Facing Forward:Life After Cancer booklet. Note, this approach is not fully equivalent to an attention control as there will be touch points in the iGuide and iGuide2 interventions that the investigators cannot match for the control group. Also, the research team will not engage the PCPs in clinics randomized to the control group.
iGuide Intervention
40 PCP clinics; 400 patients
iGuide Intervention (Self-guided)
The iGuide Intervention consists of two patient-level and four PCP-level components. These components include: (1) the patient-level brief video vignettes with a written summary; and (2) patient-facing webinars. The investigators will not use any institutional branding in the videos, printed materials, or recorded webinars so that these deliverables can be used in other settings.
iGuide 2 Intervention (Tailored/Targeted)
The iGuide2 patient-level intervention will use a stage-based, tailored approach to four monthly 5-minute video vignettes that incorporates a pre-video worksheet. The investigators will send the worksheets and video vignettes in the method preferred by the patient.
The targeted iGuide 2 PCP-level intervention will include a cancer specialist-facing dashboard that includes the specialists's patients who are enrolled in the study and are in the intervention arm. The HEDIS quality measures for our three CVD comorbidities will be used. The dashboard will be populated with data available in Epic for the specific patient. If some information is missing (i.e., there is no lipid profile in the laboratory tab), the dashboard will query the PCP via an e-consult, asking to supply the information. Bimonthly, starting with the second randomization, an asynchronous specialist-to-PCP e-consult will be sent to PCPs whose patient(s) do not meet all three of the HEDIS quality metrics.
Interventions
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iGuide Intervention (Self-guided)
The iGuide Intervention consists of two patient-level and four PCP-level components. These components include: (1) the patient-level brief video vignettes with a written summary; and (2) patient-facing webinars. The investigators will not use any institutional branding in the videos, printed materials, or recorded webinars so that these deliverables can be used in other settings.
iGuide 2 Intervention (Tailored/Targeted)
The iGuide2 patient-level intervention will use a stage-based, tailored approach to four monthly 5-minute video vignettes that incorporates a pre-video worksheet. The investigators will send the worksheets and video vignettes in the method preferred by the patient.
The targeted iGuide 2 PCP-level intervention will include a cancer specialist-facing dashboard that includes the specialists's patients who are enrolled in the study and are in the intervention arm. The HEDIS quality measures for our three CVD comorbidities will be used. The dashboard will be populated with data available in Epic for the specific patient. If some information is missing (i.e., there is no lipid profile in the laboratory tab), the dashboard will query the PCP via an e-consult, asking to supply the information. Bimonthly, starting with the second randomization, an asynchronous specialist-to-PCP e-consult will be sent to PCPs whose patient(s) do not meet all three of the HEDIS quality metrics.
Control
Participants randomized to the control group (n=400) will receive current guideline-concordant cancer care. The investigators will also provide information for healthy living during and after cancer and for preparing for transition from cancer therapy to follow-up care. Monthly, patient education material on healthy living will be sent to the participants via the patient portal or by mail, based on participant preference. At the completion of therapy, they will be provided the NCI Facing Forward:Life After Cancer booklet. Note, this approach is not fully equivalent to an attention control as there will be touch points in the iGuide and iGuide2 interventions that the investigators cannot match for the control group. Also, the research team will not engage the PCPs in clinics randomized to the control group.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with -
* Stage I-III breast \[female\], colorectal, endometrial (carcinomas), head/neck \[H/N\] and non-small cell lung cancer \[NSCLC\]
* Stage I-IV prostate cancer
* Organ transplant recipients are not excluded as long as kidney function is within eligible range
* Chronic Lymphocytic Leukemia or small lymphocytic lymphoma on first or second line treatment
* Treated with curative intent (not applicable for patients diagnosed with CLL/SLL)
* 18-79 years old
* Has at least one of three CVD comorbidities (hypertension, diabetes, or hypercholesterolemia) - based upon whether the patient is currently on a medication for the comorbidity at time of recruitment
* Had a visit with their PCP in the previous 12 months
Patients will be approached for study participation within 120 days of starting their cancer treatment at Duke (except for men with prostate cancer on androgen deprivation therapy \[ADT\] and those previously on active surveillance). Those coming off active surveillance to receive treatment will be approached within the next 120 days. Men with prostate cancer that are on ADT can be approached for consent at any time while on treatment.
Supplement:
A sample size of 2800-3000 patients will be pulled from the Duke Cancer Registry. The retrospective cohort will consist of older adults ≥65 years who have ≥1 CVD comorbidity (hypertension, type 2 diabetes, dyslipidemia) and underwent cancer surgery for solid tumors (breast, prostate, colorectal, endometrial, gastric, esophageal, liver, pancreatic, renal cell, bladder, ovarian, head/neck, and non-small cell lung cancer) at DUHS from January 1st, 2017 to December 31st 2019.
The qualitative component of the supplement (Appendix IV: Aim 3) will involve 12-20 PCPs who arepart of the Duke Primary Care Research Consortium. Eligible PCP participants will be English-speaking providers who have provided care to ≥1 older adult patient who has undergone cancer surgery within a 12-month period at DUHS.
Exclusion Criteria
* Myocardial infarction in the previous 24 months
* Stage III-IV heart failure (EF \<30%)
* Stage IV-V chronic kidney disease (eGFR \<30)
* Neuroendocrine tumors
* Uterine sarcomas
* Bilateral axillary dissections - due to the inability to collect an upper extremity BP
Patients who are coming to Duke for surgery only and not planning to return are ineligible. Patients who cannot read, are blind or do not understand/speak English will not be enrolled.
Participants who progress to metastatic disease during the course of the 18-month study period will be allowed to continue to participate unless they voluntarily withdraw from the study.
Additional health information may be assessed on a case by case basis by the PI to determine if the individual is an appropriate candidate for the intervention.
18 Years
79 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Zullig LL, Shahsahebi M, Neely B, Hyslop T, Avecilla RAV, Griffin BM, Clayton-Stiglbauer K, Coles T, Owen L, Reeve BB, Shah K, Shelby RA, Sutton L, Dinan MA, Zafar SY, Shah NP, Dent S, Oeffinger KC. Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial. BMC Fam Pract. 2021 Nov 18;22(1):234. doi: 10.1186/s12875-021-01569-8.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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PRO00104179
Identifier Type: -
Identifier Source: org_study_id
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