Clinical trial NCT03028584: Survivorship Care Plans in a Community Oncology Practice
Official title: Feasibility of Delivering Electronic Health Record (EHR)-Based Survivorship Care Plans and Planning to Cancer Survivors in a Community Oncology Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Prostate Cancer
Colorectal Cancer
Keywords: BrCa
PrCa
CRCa
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinicians who provide care for breast, colon, or prostate patients.

Cancer patients/survivors of breast cancer (BrCa), prostate (PrCa), or colorectal (CRCa) cancer.

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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: EHR-based SCPs and care planning
timeFrame: Up to 2 years
Secondary outcomes:
measure: Feasibility of providing EHR-based care planning, measured by SCP provision rates
timeFrame: Up to 2 years
measure: Feasibility of providing EHR-based care planning, measured by the EHR
timeFrame: Up to 2 years
measure: Self-reported change in satisfaction, using survey
timeFrame: Up to 2 years
measure: Impact of providing EHR-based care planning
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Waukesha
country: United States
facility: UW Cancer Center at ProHealth Care
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Amyé Tevaarwerk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Mary Sesto, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: