Onco-primary Care Networking to Support TEAM-based Care

Not Applicable

Recruiting

• Conditions: Hypertension; Cancer of Pancreas; Cancer of Head and Neck; Diabetes; Cancer, Renal Cell; Blood Pressure; Cancer; Cancer Colorectal; Non Small Cell Lung Cancer; Hypercholesterolemia
• Interventions: Behavioral: iGuide Intervention (Self-guided); Behavioral: Control; Behavioral: iGuide 2 Intervention (Tailored/Targeted)

• Registration Number: NCT04258813
• Lead Sponsor: Duke University

Brief Summary

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with \>1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be \~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers.

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.

Detailed Description

This is an 18-month cluster randomized controlled trial using a SMART design with two randomizations (the second using an embedded dynamic treatment regimen), with a target enrollment of 800 patients with one of six solid tumors (stage I-III breast, prostate, colorectal, endometrial, and head/neck cancer; stage I-II non-small cell lung cancer) who are being treated with curative intent. To engage the PCP early in the process, the investigators will enroll patients at one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). The investigators estimate that 80 unique community-based PCP clinics across North Carolina will be involved in the study. The investigators will determine the effectiveness of the multi-level intervention compared with usual care on (1) Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of the 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).

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.

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2021-06-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

A total of 800 individuals who fall under the following criteria will be enrolled:

• 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.

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Exclusion Criteria

Individuals with a history of the following conditions will be ineligible:

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
iGuide Intervention	iGuide Intervention (Self-guided)	40 PCP clinics; 400 patients
Control	Control	40 PCP clinics; 400 patients
iGuide Intervention	iGuide 2 Intervention (Tailored/Targeted)	40 PCP clinics; 400 patients

Primary Outcome Measures

Name	Time	Method
HEDIS quality measure of management hypertension	18 months	BP\<140/90 mmHg. Rather than use vital sign BP readings, which tend to have much variation, the research staff will measure the BP at the above time periods. The investigators will assess BP consistent with the TRUE Consortium standards.
HEDIS quality measure of management of diabetes	18 months	A1c\<8.0%. To evaluate diabetes management, the research team will measure fasting laboratory A1c at the time of each study assessment.
HEDIS quality measure of management of statin use	18 months	Statin use if patient is diabetic or has a 10-year ASCVD risk \>10%. To evaluate statin use, the research team will measure fasting laboratory lipid profile at the time of each study assessment.
Patient-Centered Communication in Cancer Care	18 months	Patient-reported Patient-Centered Communication in Cancer Care (PCC-Ca-36). The PCC-Ca-36 is a 36-item survey that measures one overall communication score, and six sub-domains that are consistent with our conceptual models:exchanging information, making decisions,fostering healing relationships, enabling patient self-management, managing uncertainty, and responding to emotions.
Medication adherence	18 months	Medication adherence will be measured as proportion of days covered, and the research team will obtain pharmacy refill data from the EHR. For participants followed by a Duke PCP, all refills (including refill date, amount, number of refills) are captured in Epic. For PCPs outside of Duke, the research team will use the Epic link with Surescripts which captures e-prescribed medications. Using this data, the investigators will calculate the PDC for an index medication from each medication class for the three CVD comorbidities, depending upon the number of CVD comorbidities a participant has. PDC is a measure of how many days a patient is in possession of their medication, calculated as the total number of days in a followup period divided by the total number of days that a medication was available (ratio of the number of days the patient is covered by a medication during a refill period).
Diversity supplement primary outcome: 90-day postoperative cardiovascular complications	90 days	any occurrence of myocardial infarction, stroke, venous thromboembolism (deep venous thrombosis, pulmonary embolism), new-onset atrial fibrillation, heart failure or cardiopulmonary arrest within 90 days of surgery tracked with ICD codes.

Secondary Outcome Measures

Name	Time	Method
Medication adherence defined through patient self-report	18 months	The investigators will use a self-report adherence measure created and validated by Voils et al which assesses extent of non-adherence as well as reasons for non-adherence. Participants will first respond to adherence items for each CVD comorbidity (n = 3 items each). Participants who are identified as non-adherent will be asked a series of medication-specific reasons for nonadherence (up to 18 items).
Clinical laboratory values	18 months	Comparison of LDL-cholesterol levels
Patient activation	18 months	Patient activation will be assessed using the Patient Activation Measure (PAM), which is a 13-item measure that assesses a patient's knowledge, skills, and confidence that are central to managing health and health care. The PAM categorizes patients into four levels of activation: disengaged and overwhelmed (level 1), becoming aware but still struggling level 2), taking action (level 3), and maintaining behaviors and pushing further (level 4).
Financial burden	18 months	Patients' experience with cost of care (financial burden and objective cost) will be assessed through two self-reported measures of financial burden and actual expenditures. To assess financial burden, or financial toxicity, the research team will collect the Functional Assessment of Chronic Illness Therapy COmprehensive Score for financial Toxicity (COST). The FACIT-COST is an 11-item measure. The research team will also objectively ask patients about the amount of out-of-pocket expenditures for care over the last month via survey questions (e.g., insurance premiums, copayments, prescription medications, etc).
Patient-reported care coordination	18 months	Patient-reported care coordination will be collected using a 36-item measure developed by Haggerty et al. The measure contains 9 subscales that address team relational continuity, problems with coordination, gaps in information transfer, and patient's partnership in care.
Provider-reported care coordination	18 months	Provider-reported care coordination will be measured using companion clinician-reported measures, the Coordination of Specialty Care - Specialist Survey (n=13 items) and the Coordination of Specialty Care - Primary Care Survey (n=24 items). Both measures were developed by Vimalananda and colleagues, and include companion domains that facilitate descriptive comparisons across measures.The specialist version includes four domains (i.e., Relationships, Roles and Responsibilities,Communication, Data Transfer). The Roles and Responsibilities domain is broken into three domains in the primary care version (i.e., Role Clarity, Communication, Role Agreement, Making Referrals), resulting in a total of 6 factors.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States