Statistical Process Control ChartsNCT04977414
Making Data Count Intervention Evaluation
A study testing Making Data Count Training intervention in people with Statistical Process Control Charts, run by University of Warwick at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Statistical Process Control Charts
- What is being tested?
- Making Data Count Training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- NHS Hospital
- Placed on a red-list for predominantly using R-A-G or two-point data presentations in their board papers.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Evaluation a Training Intervention to Increase the Use of Statistical Process Control Charts for National Health Service Hospitals in England
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.
Read more
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.
- Conditions
- Statistical Process Control Charts
- Being tested
- Making Data Count Training intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making Data Count Training interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control group | No intervention | Hospitals assigned to this group will be placed in on a waitlist to receive the training intervention at a later date |
| "Making data count" intervention group | Experimental | 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). Receives: Behavioral: Making Data Count Training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of SPC charts out of all quality and safety charts from baseline to five months post intervention
Change in the proportion of SPC charts (the numerator) out of all charts indicated in each board paper (the denominator)
Measured: One month pre-intervention and then five months post-intervention.
Secondary outcomes (3)
Chart types
counts of whether the charts are time series charts, between subjects charts, time and between charts, or other (e.g., pie)
Measured: One month pre-intervention and then five months post-intervention.
SPC elements
counts of whether the charts include recalculated control lines, highlight special cause variation, use R-A-G colouring, and whether the accesses are labeled.
Measured: One month pre-intervention and then five months post-intervention.
SPC supporting text
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.
Measured: One month pre-intervention and then five months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Oct 2021
- Primary completion31 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Statistical Process Control ChartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Kelly Ann Schmidtke, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977414
- Sponsor's protocol ID
- BSREC 100/20-21
- Status last verified
- Dec 2023
- First submitted
- 14 Jul 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmidtke KA, Kudrna L, Quinn L, Bird P, Hemming K, Venable Z, Lilford R. Cluster randomised evaluation of a training intervention to increase the use of statistical process control charts for hospitals in England: making data count. BMJ Qual Saf. 2025 Aug 18;34(9):621-630. doi: 10.1136/bmjqs-2024-017094.
PubMed 39237263
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Evaluation a Training Intervention to Increase the Use of Statistical Process Control Charts for National Health Service Hospitals in England
- ClinicalTrials.gov ID
- NCT04977414
- Acronym / sponsor ID
- BSREC 100/20-21
- Conditions
- Statistical Process Control Charts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist control group | No intervention | –Hospitals assigned to this group will be placed in on a waitlist to receive the training intervention at a later date |
| "Making data count" intervention group | Experimental | Behavioral: Making Data Count Training interventionThe 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- NHS Hospital
- Placed on a red-list for predominantly using R-A-G or two-point data presentations in their board papers.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Making Data Count Training interventionThe 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). | Behavioural | "Making data count" intervention group |
Primary outcome
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)
3 secondary outcomes
Chart types
Time frame: One month pre-intervention and then five months post-intervention.
SPC elements
Time frame: One month pre-intervention and then five months post-intervention.
SPC supporting text
Time frame: One month pre-intervention and then five months post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 39237263Schmidtke KA, Kudrna L, Quinn L, Bird P, Hemming K, Venable Z, Lilford R. Cluster randomised evaluation of a training intervention to increase the use of statistical process control charts for hospitals in England: making data count. BMJ Qual Saf. 2025 Aug 18;34(9):621-630. doi: 10.1136/bmjqs-2024-017094.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Making Data Count Training intervention in people with Statistical Process Control Charts, run by University of Warwick at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04977414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.