Care Coordination in Oncology, Quality Among Patients With Lung Cancer and Their Caregivers

NCT ID: NCT03694054

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2019-03-31

Brief Summary

The Oncology Care Coordination study is designed to evaluate use of a care coordination tool for lung cancer patients and their caregiver on quality of care and performance outcomes. Eligible patients need to be receiving treatment at Geisinger. Participation in the study involves completion of surveys, permission to review information from the patient's electronic health record, and for some enrollment in the care coordination tool called Harmonized Care. Geisinger oncology care providers who have patients enrolled the study will be invited for interviews.

Detailed Description

The case-matched controlled design, exploratory evaluation study will look at how exposure to a care coordination tool impacts quality and performance indicators associated with oncology care from the perspective of patients, caregivers, and providers.

Geisinger research staff will recruit lung cancer patients and their caregivers across three Geisinger locations: Geisinger Medical Center (GMC), Geisinger Wyoming Valley Medical Center (GWV) and Geisinger Community Medical Center (GCMC). GMC will serve as the intervention site and GWV and GCMC as control sites.

Eligible participants will be identified by the study staff through the electronic health record as well as through clinical staff and approached in the oncology clinic as part of a schedule office visit and/or treatment. For the purpose of study awareness, informational flyers will be available to patients in the exam rooms, waiting rooms, and through Oncology Care's Multi-Disciplinary clinic. Participants will asked to identify a caregiver who will participate in the study as well, however this is not required.

Case dyads enrolled at the intervention site (GMC) will be asked to complete a survey when they join the study and at the end of the study. Participants will also be asked to enroll in the care coordination tool, a health information solution that integrates the patient, caregiver, and clinical data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to give permission to the study team to access their health information via the e electronic health record. Participants will be in the research study for about 8-10 weeks.

Control dyads enrolled at the control site (GWV and GCMC) will be asked to complete a survey eight weeks after consenting to participate. Patients will be asked to give permission to the study team to access their health information via the electronic health record. Participants will be in the research study for about 8-10 weeks.

The study will also enroll oncology care providers within the Medical Oncology or Radiation Oncology departments at GMC and who have patients enrolled in the study. Providers will be asked to participate in a 30-minute interview to get their feedback and insights on the care coordination tool.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Care coordination patients, caregivers

Patients and caregivers enroll in using care coordination tool during oncology care and treatment.

Group Type: EXPERIMENTAL

Care coordination tool

Intervention Type: OTHER

Participants will be asked to enroll in the care coordination tool, a health information technology solution that integrates cross-sector data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to provide consent to allow the study team to access additional health information via the electronic health record.

Standard of care patients, caregivers

Patients and caregivers receive oncology care and treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Oncology Care Providers

Oncology care providers with patients enrolled in care coordination tool.

Group Type: EXPERIMENTAL

Care coordination tool

Intervention Type: OTHER

Participants will be asked to enroll in the care coordination tool, a health information technology solution that integrates cross-sector data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to provide consent to allow the study team to access additional health information via the electronic health record.

Interventions

Care coordination tool

Participants will be asked to enroll in the care coordination tool, a health information technology solution that integrates cross-sector data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to provide consent to allow the study team to access additional health information via the electronic health record.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients:

• Patients who are 18 years of age or older and diagnosed with lung cancer who 1) are scheduled to start Oncology Care (chemo and/or radiation-therapies) OR 2) on active Oncology Care and recently started within 3 weeks (<27 days for experimental arm; <56 days control arm)
• Receive care at GMC, GWV, or GCMC
• English-speaking
• Established/intends to establish a MyGeisinger Account (cases only)

Caregivers:

• Recognized/intends to be recognized as proxy for patient's MyGeisinger Account (cases only)
• English-speaking

Providers:

• Any health care provider within Medical Oncology or Radiation Oncology at GMC, where care coordination tool is standard of care, who has a patient enrolled.

Exclusion Criteria

Patients:

• Patients who are not diagnosed with lung cancer.
• Patients who are diagnosed with lung cancer and are on active Oncology Care exceeding 3 weeks (>27 days experimental arm; >56 days control arm).

Providers:

• Any healthcare provider not within the Medical Oncology or Radiation Oncology departments.
• Any healthcare provider within Medical Oncology or Radiation Oncology who does not have a patient enrolled (Case Dyad).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Bailey-Davis, DEd, RD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Health System

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-0172

Identifier Type: -

Identifier Source: org_study_id