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Completed

NCT Number: NCT04977414

Making Data Count Intervention Evaluation

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.

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Key information

Conditions

Statistical Process Control Charts

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Warwick

Coventry, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Making Data Count Training intervention

Behavioral

The Making Data Count training intervention was designed by NHS-Improvement to improve knowledge about SPC charts and to increase their uptake. Training sessions are tailored for two sets of attendees: board members and data analysts. Board member and analyst training sessions are delivered as close as possible in time, typically within the same month. Training sessions for board members are usually delivered over about one-and-a-half hours and focus more heavily on the benefits of control charts compared to other charts. Training sessions for analysts are usually delivered over three hours and focus more heavily on the structure and interpretation of the individual and moving range charts (X-mR charts).

Primary outcomes

  1. Change in the proportion of SPC charts out of all quality and safety charts from baseline to five months post intervention

    Time frame: 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 outcomes

  1. Chart types

    Time frame: 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)

  2. SPC elements

    Time frame: 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.

  3. SPC supporting text

    Time frame: 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.

Other outcomes

  1. Feedback forms

    Time frame: immediately post intervention

    optional forms participants fill out after training to improve future sessions. Intervention group only.

Sponsors and collaborators

Lead sponsor

University of Warwick

Other

Collaborators

  • University of Birmingham

Registry information

Official study title

A Randomized Controlled Evaluation a Training Intervention to Increase the Use of Statistical Process Control Charts for National Health Service Hospitals in England

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2021
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.