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

NCT03553732 | Terminated

• 2 other identifiers: P30HS023558-2P30HS023558
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

active surveillance; health information technology; patient safety; adherence; ambulatory; outpatient; human factors; systems engineering; vulnerable populations; chronic disease

Outcome Measures

Primary Outcomes (2)

• Delayed follow-up - Number of days monitoring is delayed past recommended follow-up interval,

  measured from date monitoring (e.g. prostate-specific antigen test or biopsy) is scheduled to date monitoring occurs.

  2 years

• Acceptability and feasibility of intervention - Semi-structured interviews

  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.

  1 year

Secondary Outcomes (3)

• Proportion of patients lost to follow-up

  2 years

• Proportion of patients that adhere to recommended monitoring

  2 years

• 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

Study Arms (1)

Active Surveillance Patients

Patients who elect to be monitored by an Active Surveillance protocol for prostate cancer

Other: Registry

Interventions

Registry OTHER

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.

Active Surveillance Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of California, San Francisco: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

Related Publications (2)

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

  BACKGROUND

• Cedars B, Lisker S, Borno HT, Kamal P, Breyer B, Sarkar U. An electronic registry to improve adherence to active surveillance monitoring among men with prostate cancer at a safety-net hospital: protocol for a pilot study. Pilot Feasibility Stud. 2019 Aug 14;5:101. doi: 10.1186/s40814-019-0482-x. eCollection 2019.

  PMID: 31428442 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Chronic Disease

Interventions

Registries

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Urmimala Sarkar, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 12, 2018
• Study Start: July 1, 2018
• Primary Completion: September 29, 2019
• Study Completion: September 29, 2019
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)