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

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ClinicalTrials.gov Identifier: NCT03553732
Recruitment Status : Active, not recruiting
First Posted : June 12, 2018
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Urmimala Sarkar, 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.

Condition or disease Intervention/treatment
Prostatic Neoplasms Other: Registry

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: An Electronic Registry to Improve Adherence to Active Surveillance Monitoring Among Men With Prostate Cancer at a Safety-net Hospital: A Study Protocol
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Active Surveillance Patients
Patients who elect to be monitored by an Active Surveillance protocol for prostate cancer
Other: Registry
Patients who are diagnosed with prostate cancer and elect to be monitored by an Active Surveillance protocol by the Urology Clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing but suboptimal systems for tracking patients. All Active Surveillance patients monitored by the clinic will be included.




Primary Outcome Measures :
  1. Delayed follow-up - Number of days monitoring is delayed past recommended follow-up interval, [ Time Frame: 2 years ]
    measured from date monitoring (e.g. prostate-specific antigen test or biopsy) is scheduled to date monitoring occurs.

  2. Acceptability and feasibility of intervention - Semi-structured interviews [ Time Frame: 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.


Secondary Outcome Measures :
  1. Proportion of patients lost to follow-up [ Time Frame: 2 years ]
    The proportion of patients who are lost to follow-up, defined as three subsequent unsuccessful outreach attempts

  2. Proportion of patients that adhere to recommended monitoring [ Time Frame: 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.

  3. 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. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Active Surveillance for prostate cancer is recommended as an initial management strategy for men with low- to intermediate-risk prostate cancer. Eligibility criteria at our institution include diagnostic prostate-specific antigen <= 10 ng/ml, clinical stage T1 or T2, Gleason scores <= 3+4, <=33% positive cores, and <= 50% tumor in any single core. Men who do not meet these eligibility criteria by elect to be managed by Active Surveillance may also be included.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553732


Locations
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United States, California
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Urmimala Sarkar, MD, MPH University of California, San Francisco

Additional Information:

Publications:
Venkatesh, Viswanath; Morris, Michael G.; Davis, Gordon B.; and Davis, Fred D.. 2003.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Urmimala Sarkar, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03553732     History of Changes
Other Study ID Numbers: P30HS023558-2
P30HS023558 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Urmimala Sarkar, University of California, San Francisco:
active surveillance
health information technology
patient safety
adherence
ambulatory
outpatient
human factors
systems engineering
vulnerable populations
chronic disease
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases