NCT03694054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

September 11, 2018

Last Update Submit

April 5, 2019

Conditions

Keywords

Care CoordinationOncology CareLung Cancer

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    To evaluate the difference in patient satisfaction associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient analyses will also be performed to detect role-level differences in perceptions of satisfaction associated with FCA exposure.To evaluate the association of the change in patient satisfaction associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in satisfaction perceptions based on role.

    8 weeks

Secondary Outcomes (6)

  • Caregiver Satisfaction

    8 weeks

  • Patient Quality of Life

    8 weeks

  • Caregiver Quality of Life

    8 weeks

  • Family Centered Care

    8 weeks

  • Patient Experience

    8 weeks

  • +1 more secondary outcomes

Study Arms (3)

Care coordination patients, caregivers

EXPERIMENTAL

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

Other: Care coordination tool

Standard of care patients, caregivers

NO INTERVENTION

Patients and caregivers receive oncology care and treatment.

Oncology Care Providers

EXPERIMENTAL

Oncology care providers with patients enrolled in care coordination tool.

Other: Care coordination tool

Interventions

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.

Care coordination patients, caregiversOncology Care Providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lisa Bailey-Davis, DEd, RD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2018

First Posted

October 3, 2018

Study Start

June 4, 2018

Primary Completion

February 28, 2019

Study Completion

March 31, 2019

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations