This clinical trial evaluates a self-guided multi-level intervention (iGuide and iGuide 2) for the improvement of chronic disease management and patient-provider communication among cancer patients and survivors. While there has been a rapid increase in the number of cancer survivors, there has been a lack of progress in improving health care delivery to this population. This clinical trial evaluates the iGuide and iGuide 2 interventions for their ability to optimize disease management and communication among cancer patients and survivors.
Additional locations may be listed on ClinicalTrials.gov for NCT04258813.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the effectiveness of the self-guided multi-level iGuide intervention and the tailored/targeted iGuide2 compared with usual care on (1) Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of the three cardiovascular disease (CVD) comorbidities based upon laboratory and clinical measurement; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care).
II. To determine the effectiveness of the iGuide and iGuide2 on supporting patient-centered outcomes (patient activation, care coordination, barriers to medication adherence, and financial toxicity), health care use (outpatient/emergency department visits, hospital days, measures of provider activation, and costs of care (medical visits, laboratory, out-of-pocket costs, lost productivity).
III. To identify moderating and mediating factors and specific components in each level of the intervention associated with the outcomes.
IV. To qualitatively evaluate the intervention components using patient, primary care provider (PCP), and oncology interviews.
V. 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. (Supplement)
VI. Develop a risk index for cardiovascular complications =< 90 days of surgery among older adult patients with a solid tumor. (Supplement)
VII. Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery. (Supplement)
OUTLINE: Clinics are randomized to 1 of 2 arms.
ARM I: Patients and providers undergo the self-guided iGuide intervention for 12 months. As part of the iGuide intervention, patients view video vignettes monthly, attend a 50-minute webinar, and receive educational materials. As part of the iGuide intervention, providers receive informational updates on the importance of CVD risk factor management, and may attend educational sessions over 45 minutes monthly.
ARM II: Patients receive standard cancer care.
After 12 months, clinics in Arm I meeting HEDIS measures for 90% of patients are assigned to Arm III, and clinics in Arm I not meeting HEDIS measures for 90% of patients are randomized to 1 of 2 arms.
ARM III: Patients and providers undergo the self-guided iGuide intervention as in Arm I for 6 months.
ARM IV: Patients and providers undergo the tailored iGuide 2 intervention for 6 months. As part of the iGuide 2 intervention, patients receive 4 monthly 5-minute video vignettes and worksheets. As part of the iGuide 2 intervention, providers receive electronic consults.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorKevin Charles Oeffinger
