Survivorship Care Plans in a Community Oncology Practice

Breast Cancer Clinical Trial

Official title:

Feasibility of Delivering Electronic Health Record (EHR)-Based Survivorship Care Plans and Planning to Cancer Survivors in a Community Oncology Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028584
• Other study ID #: UW16029
• Secondary ID: P30CA0145202016-
• Status: Completed
• Start date: September 11, 2017
• Est. completion date: March 23, 2018

Study information

• Verified date: October 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a two part observational study evaluating the feasibility of implementing an EHR-based model within a community oncology practice.

Description:

Part 1: The research team will use a sociotechnical work systems model, developed by researchers at the University of Wisconsin (UW) Systems Engineering Initiative for Patience Safety (SEIPS), to guide analysis of the work system barriers and facilitators to implementing an EHR-based care planning model in community oncology practice, collected from direct observations.

Part 2: The research team will measure reach/maintenance (percentage of survivors with EHR-based survivorship care plans (SCPs) over a 9-month time period) and impact (pre/post survey of patient satisfaction and perceived care coordination).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 23, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinicians: Provide cancer care to BrCa, CRCa or PrCa

• Clinicians: Are a physician, advanced practice practitioner, nurse, or equivalent

• Patients: Have a diagnosis of breast, colorectal, or prostate cancer for which and EHR-based SCP will be provided

• Patients: Have been treated with curative intent (e.g. surgery, chemotherapy and/or radiation therapy) for a Stage 1-3 cancer diagnosis

• Patients: Have received some part of active cancer treatment

• Patients: Have complete active treatment (defined as surgery, chemotherapy, and/or radiation therapy). HER2-based and endocrine therapies may be ongoing and do NOT need to have been completed

Exclusion Criteria:

• Unable to complete or unwilling to answer questions in English

• Patients: Received all active cancer treatment elsewhere (e.g. "observation - only" patients)

• Patients: Have metastatic cancer

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Prostate Cancer

Intervention

Behavioral:
• Survey
Subjects (cancer patients and clinicians) will complete up to 2 surveys.

Locations

Country	Name	City	State
United States	UW Cancer Center at ProHealth Care	Waukesha	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EHR-based SCPs and care planning	Asses whether barriers to EHR-based SCPs and care planning have been mitigated, based on clinician survey.	Up to 2 years
Secondary	Feasibility of providing EHR-based care planning, measured by SCP provision rates	Measured by SCP provision rates (percentage of survivors with EHR-based SCPs)	Up to 2 years
Secondary	Feasibility of providing EHR-based care planning, measured by the EHR	Measured by survivor access to SCPs, per the EHR	Up to 2 years
Secondary	Self-reported change in satisfaction, using survey	The impact of providing EHR-based care planning measured in change of satisfaction with perceived care coordination (assessed prior to and at 4 weeks after SCP provision)	Up to 2 years
Secondary	Impact of providing EHR-based care planning	Measured by reported SCP usability, usefulness, and content (assessed prior to and at 4 weeks after SCP provision)	Up to 2 years

External Links

•   UW Cancer Center at ProHealth Care
•   UW Carbone Cancer Center Home Page