Onco-primary Care Networking to Support TEAM-based Care

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    800
  • sponsor
    Duke University
Updated on 15 June 2021
diabetes
cardiovascular disease
cancer
hypertension
chronic disease
type 2 diabetes mellitus
lung cancer
treatment regimen
primary cancer
hypercholesterolemia
cancer care
lung carcinoma

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.

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 the time of their first or second visit 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 utilize the electronic health record (EHR). At the cancer centers, the research team will use the Epic patient portal, MyChart. For PCPs who do not use Epic, the research team will use an Epic tool, MedLink, which allows them to view a patient's medical records in our system including visit summaries, progress notes and results. They can use the Epic inbasket and receive/send messages related to their patient's care at the Duke Cancer Institute (DCI), receive alerts, make referrals, and track the progress of requests. The PCPs participation is voluntary and their completion of study activities will serve as their implied consent to participate.

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.

Details
Condition Malignant neoplasm of prostate, Non-Small Cell Lung Cancer, Hypercholesterolemia, NIDDM, Diabetes Mellitus, Colorectal Cancer, Endometrial Carcinoma, Cancer, Vascular Diseases, Breast Cancer, Hypertension, Blood Pressure, Blood pressure, Hyperlipidemia, head and neck cancer, Elevated Blood Pressure, High Cholesterol, Diabetes, prostate carcinoma, type 2 diabetes mellitus, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, nsclc, cancer of the head and neck, high blood pressure, arterial hypertension, diabetes mellitus (dm), prostate cancers, elevated cholesterol, hypercholesteremia, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2, CVD - Cardiovascular Disease, CVD - Cardiovascular Disease
Treatment Control, iGuide Intervention (Self-guided), iGuide 2 Intervention (Tailored/Targeted)
Clinical Study IdentifierNCT04258813
SponsorDuke University
Last Modified on15 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

A total of 800 individuals who fall under the following criteria will be
enrolled
Diagnosed with any of the following selected solid tumors -
Stage I-III breast [female], colorectal, endometrial, head/neck [H/N], and prostate cancer
Stage I-II non-small cell lung cancer [NSCLC]
Treated with curative intent
-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

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
Stage III-IV chronic kidney disease
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