Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.

Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit

Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager.

Care manager outreach

Bechara N Choucair, MD

The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population.

Patients ages 50 to 80 who are identified through the electronic health record as not being up to date on colorectal cancer screening are eligible for the study and will be randomly assigned to the intervention or usual care group. Individuals in the intervention group will be mailed a letter informing them that they are due for colorectal cancer screening, educational material regarding colorectal cancer screening, a fecal occult blood testing (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients assigned to the intervention versus usual care groups who complete a guideline recommended form of colorectal cancer screening within 4 months of the initiation of outreach will be compared.

Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population

A Randomized Controlled Trial of a Direct-to-Patient Outreach Program to Improve Rates of Colorectal Cancer Screening in a Low Income and Racially Diverse Population

Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)

Northwestern University

Adjunct Associate Professor in Family and Community Medicine

Usual Care

Care Manager Outreach

Total

Age Continuous

Sex: Female, Male

Dr. Muriel Jean-Jacques, Assistant professor

Completion of a Colorectal Cancer Screening

Overall Study

Symptoms and General Pathology

Rare Diseases

Chronic Disease

Head and Neck Neoplasms

Chronic Graft Versus Host Disease

Head and neck cancer patients monitored on registry

Patients who are diagnosed with head and neck cancer and monitored by the Otolaryngology - Head and Neck Surgery 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 paper-based systems for tracking patients. All head and neck cancer patients monitored by the clinic will be included.

Registry

Urmimala Sarkar, MD, MPH

To implement and evaluate a health information technology platform designed to support the management of patients with head and neck cancer in an urban, publicly-funded outpatient setting. This is an observational study; researchers will not assign specific interventions to study participants.

The investigators aim to implement and evaluate a health information technology (HIT) registry at an urban, public delivery system. The investigators will not assign specific interventions to the study participants, but rather observationally assess the effect of the HIT registry, designed to support routine medical care, on participants.

The investigators will use systems engineering methodologies to design, develop, and implement the platform. The platform will be implemented in the Otolaryngology - Head and Neck Surgery clinic that cares for patients with head and neck cancers. The study will assess patient outcomes and evaluate the time it takes for patients to progress through key treatment and post-treatment milestones before and after the HIT tool is implemented. The investigators will use models controlling for secular trend to estimate the effect of the tool on improving timely and successful completion of guideline-based care processes.

The HIT platform seeks to improve the monitoring and alerting functionality of existing systems. Specifically, it replaces paper-based systems previously used by the clinic to monitor its head and neck cancer patients. It will be implemented clinic-wide for all patients being treated for head and neck cancers. The investigators are not assigning a specific intervention to patients, but rather supporting the clinic and health system in the development of a population management platform that improves routine care processes. The platform is approved for clinical use and research by the San Francisco Health Network and the University of California, San Francisco.

The HIT platform users are clinicians who are responsible for monitoring patients with head and neck cancer and agree to partner with the investigators to improve monitoring processes. The clinicians involved may be asked to voluntarily participate in surveys, interviews, focus groups, and program evaluations. 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, and software engineers. This includes checking that data in the platform matches source data, such as data entered in the electronic health record. In addition, the platform users are audited on a weekly basis. A data dictionary defining variables used in the platform exists and is updated as needed. Patients will be added to the registry by a clinician if they are diagnosed with head and neck cancer. 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 immediately. 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.

Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers

Time from diagnosis to initiation of treatment

Proportion of patients that complete tumor board treatment recommendations

Time from diagnosis to presentation at tumor board

Time from diagnosis to first visit in oncology clinics

Proportion of patients who complete post-treatment radiation

Proportion of patients who are lost to follow-up

Agency for Healthcare Research and Quality (AHRQ)

University of California, San Francisco

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

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.

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.

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.

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

An Electronic Registry to Improve Adherence to Active Surveillance Monitoring Among Men With Prostate Cancer at a Safety-net Hospital: A Study Protocol

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

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.

The proportion of patients who are lost to follow-up, defined as three subsequent unsuccessful outreach attempts

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population	NCT01385579	Malignant Neopl...	Care manager ou...	50 Years - 80 Years	Northwestern University
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital	NCT03553732	Prostatic Neopl...	Registry	18 Years -	University of California, San Francisco

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