An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital

Terminated

• Conditions: Prostatic Neoplasms
• Interventions: Other: Registry

• Registration Number: NCT03553732
• Lead Sponsor: University of California, San Francisco

Brief Summary

To implement and evaluate a health information technology platform designed to support the management of patients on active surveillance for prostate cancer in an urban, publicly-funded outpatient setting.

Detailed Description

We aim to implement and evaluate a health information technology (HIT) registry at an urban, public delivery system. We will use systems engineering methodologies to design, develop, and implement the platform. The platform will be implemented in the Urology clinic that cares for patients with prostate cancer. We are conducting a prospective non-randomized pilot study that will follow men who choose active surveillance as a management strategy for prostate cancer. We aim to assess the impact of the HIT registry on patient monitoring and adherence.

The HIT platform seeks to improve the monitoring and alerting functionality of existing systems. Specifically, it replaces paper-based or ineffective computer-based systems previously used by the clinic to monitor its active surveillance patients. It will be implemented clinic-wide for all patients being monitored by an active surveillance protocol. The platform is approved for clinical use and research by the San Francisco Health Network and the University of California, San Francisco.

Research involves materials that are collected for nonresearch purposes, as well as low-risk research employing survey, interview, focus group, program evaluation, and human factors methodologies. We will solicit structured feedback from registry users designed to continuously evaluate and improve performance in a clinical area to reduce patient safety gaps. Patient medical records will be reviewed, but patients monitored on the registry will not be contacted by researchers.

Procedures are in place to monitor the registry. First, quality assurance is performed by the research team, information technology analysts in the San Francisco Health Network, as well as by the third-party software provider. This includes checking that data in the platform matches source data, such as data entered in the electronic health record. In addition, users are audited on a weekly basis. A data dictionary defining variables used in the platform exists and is updated as needed. The HIT platform users include clinicians who are responsible for monitoring patients on active surveillance for prostate cancer. Patients who are enrolled in the active surveillance program will be added to the registry by a clinician. The research team will support the clinicians in data analysis, although this will be performed with population-level, de-identified data. However, if unmediated adverse events are identified by the research team, the research team will alert the clinicians appropriately. The research team will also develop training materials and conduct training sessions to ensure that all clinicians responsible for monitoring patients on active surveillance are provided with up-to-date resources and accessible support. The HIT platform is designed to supplement, but not replace, the existing electronic health record. Data on the registry will be validated with source data and users will still engage with the source data and electronic health record as appropriate clinically and operationally.

Study Timeline

• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Study Start: 2018-07-01
• Primary Completion: 2019-09-29
• Study Completion: 2019-09-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Patients who elect to be managed by Active Surveillance for prostate cancer by the Urology Clinic

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active Surveillance Patients	Registry	Patients who elect to be monitored by an Active Surveillance protocol for prostate cancer

Primary Outcome Measures

Name	Time	Method
Acceptability and feasibility of intervention - Semi-structured interviews	1 year	Acceptability and feasibility of the intervention among clinicians will be measured using the Technology Acceptance Model (Venkatesh et al). Semi-structured interviews will be conducted to assess usefulness and ease of use.
Delayed follow-up - Number of days monitoring is delayed past recommended follow-up interval,	2 years	measured from date monitoring (e.g. prostate-specific antigen test or biopsy) is scheduled to date monitoring occurs.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients that move from active surveillance to active treatment at a cancer stage that is more advanced than the stage recorded upon entry into program.	2 years
Proportion of patients that adhere to recommended monitoring	2 years	Adherence to monitoring (e.g. prostate-specific antigen test every 3 months) will be assessed. Monitoring will be considered adherent if it occurs within 30 days of the recommendation.
Proportion of patients lost to follow-up	2 years	The proportion of patients who are lost to follow-up, defined as three subsequent unsuccessful outreach attempts

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital and Trauma Center; 🇺🇸 San Francisco, California, United States