Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cancer Colorectal
  • Blood Pressure
  • Cancer
  • Non -Small Cell Lung Cancer
  • Hypertension
  • Cancer of Head and Neck
  • Cancer Of Prostate
  • Cancer Breast
  • Cancer, Endometrial
  • CVD - Cardiovascular Disease
  • Diabetes
  • Diabetes Mellitus
  • Hypercholesterolemia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Investigators will use a SMART design with 2 randomizations - at the time of enrollment and after the 12-month measurement. At enrollment, participants will be cluster randomized to the self-guided multi-level iGuide intervention or control arm. An adaptive intervention will be used for the second randomization. PCP clinics in the intervention arm in which 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 12-month measurement will be considered 'non-responders' and randomized to a tailored/targeted intervention (iGuide2) or a control (iGuide).Masking: Double (Investigator, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 79 years
Gender
Both males and females

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 c...

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.

Tracking Information

NCT #
NCT04258813
Collaborators
Not Provided
Investigators
Not Provided