Trial Outcomes & Findings for Measuring and Improving the Safety of Test Result Follow-Up (NCT NCT04166240)

NCT ID: NCT04166240

Last Updated: 2024-08-06

Results Overview

Percentage of missed test results determined by electronic indicators. The percentage of test results with timely follow up was calculated for each participating site, out of all abnormal tests at that site. Reporting measure type: Percentage of tests with timely follow-up across all sites.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: 32 months
• Results posted on: 2024-08-06

Participant Flow

Records from VA's Data warehouse (Fecal Occult Blood Test, Hep C Virus, Mammogram, alpha feto protein, dual energy x-ray absorptiometry, human papillomavirus, Chest X-ray, and Chest CT) Medical records suspicious for breast, lung, bladder, hepatocellular, and colorectal cancer. All data collected at the site level; number enrolled reflects number of sites enrolled Michael E. DeBakey VA Medical Center, Houston, Texas White River Junction VA Medical Center, White River Junction, Vermont

Exclusion criteria: Medical records that don't contain any tests, procedures, or appointments that need to be followed up on.

Unit of analysis: Sites

Participant milestones

Measure	Sequence 1 7 months of pre intervention, 6 months of action phase, 13 months of continuous improvement	Sequence 2 14 months of pre intervention, 6 months of action phase, 6 months of continuous improvement	Sequence 3 20 months of pre intervention, 6 months of action phase
Pre Intervention for All Sites STARTED	0 4	0 4	0 4
Pre Intervention for All Sites COMPLETED	0 4	0 4	0 3
Pre Intervention for All Sites NOT COMPLETED	0 0	0 0	0 1
Action Phase for Sequence 1 STARTED	0 4	0 4	0 3
Action Phase for Sequence 1 COMPLETED	0 4	0 4	0 3
Action Phase for Sequence 1 NOT COMPLETED	0 0	0 0	0 0
Action Phase for Sequence 2 STARTED	0 4	0 4	0 3
Action Phase for Sequence 2 COMPLETED	0 4	0 4	0 3
Action Phase for Sequence 2 NOT COMPLETED	0 0	0 0	0 0
Action Phase for Sequence 3 STARTED	0 4	0 4	0 3
Action Phase for Sequence 3 COMPLETED	0 4	0 4	0 3
Action Phase for Sequence 3 NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participant level data were not collected; only data at the site level were collected

Baseline characteristics by cohort

Measure	Sequence 1 n=4 Sites 7 months of pre intervention, 6 months of action phase, 13 months of continuous improvement	Sequence 2 n=4 Sites 14 months of pre intervention, 6 months of action phase, 6 months of continuous improvement	Sequence 3 n=3 Sites 20 months of pre intervention, 6 months of action phase	Total n=11 Sites Total of all reporting groups
Age, Customized Not Reported	0 Sites n=4 Sites • Participant level data were not collected; only data at the site level were collected	0 Sites n=4 Sites • Participant level data were not collected; only data at the site level were collected	0 Sites n=3 Sites • Participant level data were not collected; only data at the site level were collected	0 Sites n=11 Sites • Participant level data were not collected; only data at the site level were collected
Sex/Gender, Customized Not Reported	0 Sites n=4 Sites	0 Sites n=4 Sites	0 Sites n=3 Sites	0 Sites n=11 Sites
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States : Northeast	2 participants n=4 Sites • Participant level data were not collected; only data at the site level were collected	0 participants n=4 Sites • Participant level data were not collected; only data at the site level were collected	2 participants n=3 Sites • Participant level data were not collected; only data at the site level were collected	4 participants n=11 Sites • Participant level data were not collected; only data at the site level were collected
Region of Enrollment United States : West	1 participants n=4 Sites • Participant level data were not collected; only data at the site level were collected	1 participants n=4 Sites • Participant level data were not collected; only data at the site level were collected	0 participants n=3 Sites • Participant level data were not collected; only data at the site level were collected	2 participants n=11 Sites • Participant level data were not collected; only data at the site level were collected
Region of Enrollment United States : Midwest	0 participants n=4 Sites • Participant level data were not collected; only data at the site level were collected	2 participants n=4 Sites • Participant level data were not collected; only data at the site level were collected	0 participants n=3 Sites • Participant level data were not collected; only data at the site level were collected	2 participants n=11 Sites • Participant level data were not collected; only data at the site level were collected
Region of Enrollment United States : South	1 participants n=4 Sites • Participant level data were not collected; only data at the site level were collected	1 participants n=4 Sites • Participant level data were not collected; only data at the site level were collected	1 participants n=3 Sites • Participant level data were not collected; only data at the site level were collected	3 participants n=11 Sites • Participant level data were not collected; only data at the site level were collected
Percentage of abnormal test results with timely follow-up action Baseline percentage for lung follow up	65.1 percentage n=4 Sites • Participant level data were not collected; only data at the site level were collected	73.3 percentage n=4 Sites • Participant level data were not collected; only data at the site level were collected	77.4 percentage n=3 Sites • Participant level data were not collected; only data at the site level were collected	72.1 percentage n=11 Sites • Participant level data were not collected; only data at the site level were collected
Percentage of abnormal test results with timely follow-up action Baseline percentage for Fecal Occult Blood Test follow up	77.1 percentage n=4 Sites • Participant level data were not collected; only data at the site level were collected	72.1 percentage n=4 Sites • Participant level data were not collected; only data at the site level were collected	80.4 percentage n=3 Sites • Participant level data were not collected; only data at the site level were collected	75.9 percentage n=11 Sites • Participant level data were not collected; only data at the site level were collected

PRIMARY outcome

Timeframe: 32 months

Percentage of missed test results determined by electronic indicators. The percentage of test results with timely follow up was calculated for each participating site, out of all abnormal tests at that site.

Reporting measure type: Percentage of tests with timely follow-up across all sites.

Outcome measures

Measure	Sequence 1 n=4 Participants 7 months of pre intervention, 6 months of action phase, 13 months of continuous improvement	Sequence 2 n=4 Participants 14 months of pre intervention, 6 months of action phase, 6 months of continuous improvement	Sequence 3 n=3 Participants 20 months of pre intervention, 6 months of action phase
Trigger Outcome percent abnormal chest imaging tests with follow up	67.0 percentage of abnormal tests w/ followup	65.9 percentage of abnormal tests w/ followup	78.6 percentage of abnormal tests w/ followup
Trigger Outcome percent abnormal Fecal Occult Blood tests with follow up	78.1 percentage of abnormal tests w/ followup	67.7 percentage of abnormal tests w/ followup	78.2 percentage of abnormal tests w/ followup

PRIMARY outcome

Timeframe: 32 months

Population: Data could not be reported because EPRP measures are aggregated quarterly. Our previous understanding was that these data was granular enough for the needed breakdown of data by month. On final analysis, however, the action phases did not align with EPRP quarters, so EPRP rates could not be assigned correctly to action phase vs other phases.

Percentage of patients notified of actionable test results within seven days via EPRP

Outcome measures

Outcome data not reported

Adverse Events

Sequence 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sequence 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sequence 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hardeep Singh

VAORD

Phone: 713 7948515

Email: hardeep.singh@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place