Survivorship Care Plans in a Community Oncology Practice

November 14, 2019 updated by: University of Wisconsin, Madison

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

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

Study Overview

Status

Completed

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • UW Cancer Center at ProHealth Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clinicians

Observe up to N=10 clinicians. Observations will include:

  1. Oncology history and care plan development by clinicians including use of EHR technology to develop care plans and methods used to secure necessary information for care plan creation
  2. Provision and coordination of survivorship care occurring during care team meetings, discussions among clinicians, and survivor visits with clinicians, especially visits in which a care plan is provided to a survivor
  3. Clinician seeking survivorship related information or resources through use of technology or discussion with other clinicians
  4. Survivorship work or tasks performed by the clinician including adding, modifying or extracting information from the EHR and adding or modifying information in the care plan
Subjects (cancer patients and clinicians) will complete up to 2 surveys.
Clinicians and Patients

Surveys of N=30 breast cancer, colon cancer, and prostate cancer patients. Subjects will complete 1st survey electronically in-clinic. Subjects will either be e-mailed or mailed a survey at 4 weeks.

Survey of clinicians will be sent via e-mail.

Subjects (cancer patients and clinicians) will complete up to 2 surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EHR-based SCPs and care planning
Time Frame: Up to 2 years
Asses whether barriers to EHR-based SCPs and care planning have been mitigated, based on clinician survey.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of providing EHR-based care planning, measured by SCP provision rates
Time Frame: Up to 2 years
Measured by SCP provision rates (percentage of survivors with EHR-based SCPs)
Up to 2 years
Feasibility of providing EHR-based care planning, measured by the EHR
Time Frame: Up to 2 years
Measured by survivor access to SCPs, per the EHR
Up to 2 years
Self-reported change in satisfaction, using survey
Time Frame: Up to 2 years
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
Impact of providing EHR-based care planning
Time Frame: Up to 2 years
Measured by reported SCP usability, usefulness, and content (assessed prior to and at 4 weeks after SCP provision)
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amyé Tevaarwerk, MD, University of Wisconsin, Madison
  • Principal Investigator: Mary Sesto, PT, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

March 23, 2018

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UW16029
  • P30CA014520 (U.S. NIH Grant/Contract)
  • A534260 (Other Identifier: UW Madison)
  • SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
  • 2016-0760 (Other Identifier: Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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