Making Data Count Intervention Evaluation

Not Applicable

Completed

• Conditions: Statistical Process Control Charts

• Registration Number: NCT04977414
• Lead Sponsor: University of Warwick

Brief Summary

Hospitals collect copious amounts of data to share with their board for quality assurance and improvement purposes. The way these data are presented can influence board members' decisions. For example, time-series charts highlight the highest and lowest data but do not clarify whether those data lie outside expected or 'common cause' variation. Statistical process control charts make this clarification and, in so doing, guide quality assurance and improvements in a more targeted fashion.

A previous study showed that data suitable for presentation as a control chart are seldom presented in that format. A training intervention called 'Making Data Count' was created to improve the uptake of statistical process control charts by hospitals in England. The current study will use a randomized design to evaluate whether the intervention increases control charts in hospitals that were not early adopters of the training intervention.

This study is a parallel cluster randomized trial (with baseline-line measurements) across 20 National Health Service (NHS) hospitals in England. The hospitals will be randomly split into two groups. One group will be scheduled to experience the training intervention, and the other group will be placed on a waiting list to experience the training later. The primary analysis will compare the difference in the use of control charts between waitlist and intervention hospitals (adjusting for pre-intervention use) reported with 95% confidence intervals. A qualitative thematic analysis of feedback forms will be conducted.

The present research will evaluate the impact of the training intervention on the use of control charts. The results will apply to institutions that are not early adopters of this training intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-27
• Study Start: 2021-10-01
• Primary Completion: 2023-01-31
• Study Completion: 2023-06-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• NHS Hospital
• Placed on a red-list for predominantly using R-A-G or two-point data presentations in their board papers.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the proportion of SPC charts out of all quality and safety charts from baseline to five months post intervention	One month pre-intervention and then five months post-intervention.	Change in the proportion of SPC charts (the numerator) out of all charts indicated in each board paper (the denominator)

Secondary Outcome Measures

Name	Time	Method
SPC elements	One month pre-intervention and then five months post-intervention.	counts of whether the charts include recalculated control lines, highlight special cause variation, use R-A-G colouring, and whether the accesses are labeled.
Chart types	One month pre-intervention and then five months post-intervention.	counts of whether the charts are time series charts, between subjects charts, time and between charts, or other (e.g., pie)
SPC supporting text	One month pre-intervention and then five months post-intervention.	counts of whether the charts include recalculated control lines, highlight special counts of whether SPC charts are explained in supporting text, regarding where control lines are set, reasons for variations, and suggestions for improvements.

Trial Locations

Locations (1)

University of Warwick; 🇬🇧 Coventry, United Kingdom