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Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care

18 Years
65 Years
Not Enrolling
Colon Cancer, Lung Cancer, Prostate Cancer

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Trial Information

Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care

The goal of this proposal is to demonstrate and test methods by which large health care
systems can efficiently identify cancer patients who are more likely to experience
diagnostic delays and pre-emptively rectify these delays. This study will build upon tools
developed in our recent work (Aim1, prior IRB Protocol Number: H-23801) and test their
effectiveness to identify patients at risk of experiencing delays in cancer diagnosis
followed by an intervention that the investigators hypothesize will reduce these delays.

This is Aim 2 (for which the investigators are seeking approval) is the final Aim of this
proposal. Aim 1 was approved under Protocol Number: H-23801.

In Aim 2 the investigators will determine the effectiveness of an IT-based intervention
(consisting of data mining using triggers tested in Aim 1 followed by targeted electronic
communication and surveillance techniques) to facilitate cancer diagnosis as compared with
usual care (no use of trigger or electronic communication and surveillance). Hypothesis 1:
The mean time from first appearance of a diagnostic clue to follow-up action (e.g.
colonoscopy performance after a positive FOBT) will be significantly less in the
intervention arm than in usual care. Hypothesis 2: The proportion of patients receiving
timely follow-up care will be significantly more in the intervention arm than in usual care.
To improve the generalizability of our findings to multiple ambulatory care environments,
the investigators will conduct our research in two settings: an urban Veterans Affairs
facility in Houston, Texas and a large primary care network in central Texas. These settings
include internal medicine and family medicine, academic and nonacademic practices, and
significant racial, gender, ethnic, age, urban/rural, and socioeconomic diversity. Our study
addresses coordination and timeliness of care, both of which are priorities to achieve high
quality care.

Inclusion Criteria:

All primary care providers at both study sites who agree to be in the study. Intervention
will be performed on those whose patients are electronically identified to have suspected
cancer defined as presence of any predefined clue for cancer that is not followed-up in a
timely manner. Three cancers are included; colorectal, lung and prostate and their clues
include • chest x-imaging suspicious for malignancy • suspected or confirmed iron
deficiency anemia • positive FOBT • hematochezia • abnormal PSA Patients will be selected
from the data warehouse .

Exclusion Criteria:

Primary care providers who do not wish to be in the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Outcome Measure:

Time lag from diagnostic clue indicating the potential for cancer to follow-up action by provider

Outcome Description:

The median time from first appearance of a diagnostic clue for cancer (e.g. positive FOBT) to follow-up action taken by a treating provider(e.g. colonoscopy performance) in both intervention and control groups.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Hardeep Singh, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

February 2011

Completion Date:

August 2012

Related Keywords:

  • Colon Cancer
  • Lung Cancer
  • Prostate Cancer
  • Diagnostic delay
  • Prevention
  • Diagnostic errors
  • Colonic Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms



Scott and White Memorial HospitalTemple, Texas  76508
Michael E. DeBakey VA Medical CenterHouston, Texas  77030