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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346839
• Other study ID #: H-24978
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: January 12, 2016
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Diagnostic delays in ambulatory care are often due to breakdowns of related care processes. Electronic systems can improve follow-up and reduce delays by detecting missed appointments or incomplete procedures so that patients are called back to conduct timely investigations when appropriate. To achieve high standards of patient safety in cancer diagnosis, the investigators not only need to use information technology appropriately but also improve the processes, policies, and procedures of monitoring, communication, and coordination of care.

Given the importance of cancer-related diagnostic delays in ambulatory care, the investigators need effective methods to detect them, understand their causes, and intervene to reduce them. Manual techniques to detect these delays, such as spontaneous reporting and random chart reviews, have limited effectiveness. Our proposed study focuses on testing methods to proactively identify delays using certain "triggers" as they occur and intervene in a timely manner.

Description:

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 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 percentage 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.

Hypothesis 3: Overall, the trigger will achieve a positive predictive value (PPV) of at least 50% in identifying delays in care. PPV is defined as the number of charts correctly identified with a delay in diagnostic evaluation, divided by the total number of charts identified by the trigger, and was deemed to be the approximately level necessary to avoid substantial contribution to provider alert fatigue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1256
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colon Cancer
• Lung Cancer
• Prostate Cancer

Intervention

Behavioral:
• Contact Intervention
The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	Scott and White Memorial Hospital	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Scott and White Hospital & Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer	Differences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.	15 months	Yes
Secondary	Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer	The percentage of patients receiving timely follow-up care, as defined by action taken by provider within appropriate pre-defined time intervals for each diagnostic clue, in both intervention and control groups.	15 months	Yes
Secondary	Percentage of Cases With no Documented Justification for no Follow-up	This is a descriptive sub-analysis looking only at cases with no follow-up at the end of the follow-up period. Specifically, out of the cases that never got follow-up, this represents the percent of that subsample that had no justification in the medical record for the lack of follow-up. This is based on manual chart reviews.	15 months	Yes
Secondary	Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation	Subsequent diagnosis of nonmalignant neoplasia, cancer, or death, and treatments required as a result of new cancer diagnoses after a pre-specified interval.	15 months	Yes
Secondary	Trigger Positive Predictive Value	Positive Predictive Values of each of the triggers in identifying patients with a true delay in diagnostic evaluation. Calculated as: percentage of patients identified as trigger positive that actually had a delay.	15 months	Yes