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Atrial Fibrillation New OnsetPhase 4PROSPECTORNCT05149820

Point of Care RandOmisation Systems for Performing Embedded Comparative Effectiveness Trials Of Routine Treatments

A Phase 4 study testing Electronic Point of Care Randomisation tool and Magnesium in people with Atrial Fibrillation New Onset and Magnesium Deficiency, run by University College, London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Every day, doctors and nurses make hundreds of decisions about treatments - like when to start or stop them, or how frequently to give them. Ideally, decisions are based on gold standard evidence from Randomised Controlled Trials (RCTs). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Electronic Point of Care Randomisation tool and Magnesium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited Kingdom
Study dates
22 Mar 2022to Aug 2023
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients:
  • Age 18 years or over.
  • Undergoing elective surgery of complexity sufficient to warrant postoperative critical care admission (major/complex major surgery)
  • Must be able to give written informed consent to participate
  • Clinicians:
  • 1. Must be regularly involved in the care of postoperative patients in critical care.

Who cannot join

  • Active treatment for bronchospasm preceding deployment of the electronic prompt, defined as patient receiving bronchodilator therapy or Magnesium infusion.
  • Any documented allergy or intolerance to any preparation of supplemental Magnesium.
  • Serum Magnesium result > 1.5 or < 0.5 mmol/L on blood tests obtained during critical care admission .
  • Pregnancy
  • Atrial Fibrillation on initial arrival to critical care.

Trial locations and contacts

1 site in 1 country.

Matthew G Wilson contact

02034567890

matthew.wilson8@nhs.net

Steve K Harris contact

02034567890

S.harris8@nhs.net

United Kingdom1 site, 1 recruiting
  • University College London Hospitals NHS Trust

    London

    Matthew Wilson, MBBS, matthew.wilson8@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Single-Centre Feasibility Study of PROSPECTOR - Point of Care RandOmisation Systems for Performing Embedded Comparative Effectiveness Trials Of Routine Treatments in Critical Care

Every day, doctors and nurses make hundreds of decisions about treatments - like when to start or stop them, or how frequently to give them. Ideally, decisions are based on gold standard evidence from Randomised Controlled Trials (RCTs). Unfortunately, for many treatments little or no evidence exists and clinicians must use knowledge and experience to decide what is best.

As clinicians are all different, this leads to random variation in how treatments are given to patients. For example, magnesium is routinely given in intensive care to prevent abnormal heart rhythms. There is little evidence supporting this, and clinicians vary in how they administer magnesium. Traditional RCTs might be used to examine whether more magnesium is better than less magnesium, but this method is inefficient and expensive for investigating multiple comparative treatment questions.

Read more

Clinical trials are becoming more efficient by using existing hospital computer systems to run them. However, research teams continue to perform tasks like randomisation manually. For questions like magnesium supplementation, which occur daily, this is labour intensive and infeasible.

Hospital computer systems also possess mechanisms for prompting and alerting clinicians for particular decisions, reminding them of best practices, warning them of potential problems. These systems may be modified to allow clinicians to randomise patients, under specific conditions.

The investigators propose to assess whether modified computer prompts can be used to highlight the magnesium supplementation decision to clinicians. These would prompt the clinician to evaluate the uncertainty around giving or withholding magnesium in that instance. If in agreement that the optimal decision is unclear, clinicians can choose to randomise the patient within a predetermined trial structure. If the clinician knows better, they may override the prompt and continue with their preference. In both cases, the system learns from the decision and the patient receives optimal care determined by their clinician.

Read the detailed description

Trial Design:

A single-centre, mixed methods, feasibility study, embedded within the Electronic Health Record System (EHRS). The study will be conducted on critical care units within University College London Hospitals NHS Trust and will involve patients undergoing elective major surgery which necessitates postoperative admission to critical care. The study will be pragmatic in nature, with minimal disruption to usual care pathways.

The study will consist of three phases:

  1. Feasibility Phase - Simulation guided semi-structured interviews with clinicians.
  2. Intervention Phase - Deployment of electronic prompts to evaluate candidate clinical question.
  3. Follow Up Phase - Patient and clinician semi-structured interviews.

Research Hypothesis:

Electronically delivered prompts provide a feasible method of delivering point-of-care randomisation for the evaluation of routine treatments not amenable to investigation using standard clinical trial designs.

Clinical Example Hypothesis:

Liberal magnesium supplementation (serum concentration < 1.0 mmol/L) is superior to a restrictive supplementation strategy (serum concentration < 0.75 mmol/L) for the prevention of Atrial Fibrillation in a general critical care population.

Summary of Interventions:

This study will compare Nudge and Preference electronic Point-Of-Care Randomisation (ePOCR) prompts against their ability to generate compliance with randomised allocations to liberal or restrictive magnesium supplementation strategy.

Following postoperative admission to the critical care unit, participants will undergo randomisation between Nudge or Preference prompts and Liberal or Restrictive magnesium supplementation strategies. After the two randomisations steps are complete, both ePOCR designs follow the same pathway for activation and deployment to the bedside nurse.

Once the EHRS detects a new serum magnesium result has been received, the system will screen the participant against exclusion criteria 1-5. Each new result triggers the same screening process. If the participant is eligible to proceed, the prompt will activate and display to the bedside nurse under two conditions:

  1. Accessing of the blood test results in the EHRS.
  2. Accessing the supplemental magnesium prescription within the EHRS. Once the prompt has displayed and been acknowledged by the bedside nurse, further activation will be suppressed until a new serum magnesium result becomes available. This process will be tested in silico prior to deployment to the live EHRS and the results of testing made available as part of the study materials.

Where additional supplementation is indicated by the prompt, the nurse retains control over the dose and frequency of administration, as directed by the standardised prescription. All other aspects of postoperative care remain as standard and directed by the clinical team.

Being tested
Electronic Point of Care Randomisation tool, Magnesium
Keywords
Electronic Health Record Trials, Point of Care Randomisation, Comparative Effectiveness Research, Learning Health Systems, Feasibility Studies
Medical subject headings
Magnesium Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic Point of Care Randomisation toolOther

    Also called Nudge Prompt Design and Preference Prompt Design

    Two designs of electronic point of care randomisation tool will be evaluated.

  • MagnesiumDrug

    Also called Liberal and Restrictive Magnesium Supplementation Strategies

    Liberal Strategy: magnesium supplementation at serum level < 0.75 mmol/L Restrictive Strategy: magnesium supplementation at serum level < 1.0 mmol/L

Study groups in NCT05149820
Study groupRoleWhat they receive
Nudge Prompt, Liberal Magnesium StrategyActive comparatorThis group will be randomised to receive the Nudge design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a liberal magnesium supplementation strategy.
Receives: Other: Electronic Point of Care Randomisation tool; Drug: Magnesium
Nudge Prompt, Restrictive Magnesium StrategyActive comparatorThis group will be randomised to receive the Nudge design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a restrictive magnesium supplementation strategy.
Receives: Other: Electronic Point of Care Randomisation tool; Drug: Magnesium
Preference Prompt, Liberal Magnesium StrategyActive comparatorThis group will be randomised to receive the Preference design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a liberal magnesium supplementation strategy.
Receives: Other: Electronic Point of Care Randomisation tool; Drug: Magnesium
Preference Prompt, Restrictive Magnesium StrategyActive comparatorThis group will be randomised to receive the Preference design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a restrictive magnesium supplementation strategy.
Receives: Other: Electronic Point of Care Randomisation tool; Drug: Magnesium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of Electronic Point of Care Randomisation Prompts

    The proportion of each design which result in compliance with the randomised allocation by the clinician. We define compliance with the prompt as 1) the appropriate administration of supplemental magnesium, following receiving the electronic prompt, where the measured serum magnesium is less than the randomised threshold OR; 2) the appropriate withholding of supplemental magnesium following prompt deployment, where the measured serum magnesium is greater than the randomised threshold.

    Measured: Duration of individual participant admission to critical care, or five postoperative days, whichever is sooner

Secondary outcomes (3)
  1. Acceptability to critical care clinicians of using the Electronic Point of Care Randomisation prompts assessed by semi-structured interviews

    The acceptability of using electronic point of care randomisation prompts, for the investigation of routine comparative effectiveness research questions like the study example will be assessed using a program of semi-structured interviews. These interviews will be delivered to critical care clinicians who may interact with the prompts. Interview data will be evaluated using a thematic analysis approach to derive an assessment of overall acceptability.

    Measured: Throughout study duration, maximum 6 months from study start date

  2. Clinician preferences for type of Electronic Point of Care Randomisation Prompt design assessed by semi-structured interviews

    Critical care clinicians will be invited to express a preference for the design of electronic randomisation prompt having been introduced to both designs. This will be evaluated using a programme of semi-structured interviews which will include simulations of both prompt designs to aid recall. Preference will be asked directly and response displayed as proportion of clinicians preferring each design (Nudge or Preference).

    Measured: Throughout study duration, maximum 6 months from study start date

  3. Acceptability to patients of using either a Pre-Emptive or Opt-Out model to obtain informed consent for the conduct of Comparative Effectiveness Research, assessed by semi-structured interview.

    Patients will be invited to undertake a semi-structured interview designed to ascertain their thoughts and opinions on each type of consent model. In addition, the interview will invite patients to consider different hypothetical research questions and how acceptable they feel each method of obtaining consent is for each. Interviews will be evaluated using a thematic analysis approach and examples supporting patient viewpoints presented in the results.

    Measured: Throughout study duration, maximum 6 months from study start date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2021
  2. Study start22 Mar 2022
  3. Primary completionFeb 2023 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two stage randomisation process with participants first randomised to receive either Nudge or Preference electronic point of care randomisation prompt design, and then randomised to receive Liberal or Restrictive magnesium supplementation strategy.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05149820
Sponsor's protocol ID
142382
Other IDs
279737
Acronym
PROSPECTOR
Status last verified
Oct 2022
First submitted
8 Nov 2021
Last updated
1 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wilson MG, Asselbergs FW, Saleem N, Jeilani L, Brealey D, Sydes MR, Harris S. Digital integration of research conduct into clinical care: results of the PROSPECTOR randomised feasibility study. BMJ Evid Based Med. 2025 Sep 22;30(5):323-332. doi: 10.1136/bmjebm-2024-113081.

    PubMed 40348398
  • Wilson MG, Asselbergs FW, Miguel R, Brealey D, Harris SK. Embedded point of care randomisation for evaluating comparative effectiveness questions: PROSPECTOR-critical care feasibility study protocol. BMJ Open. 2022 Sep 19;12(9):e059995. doi: 10.1136/bmjopen-2021-059995.

    PubMed 36123103

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Electronic Point of Care Randomisation tool and Magnesium in people with Atrial Fibrillation New Onset and Magnesium Deficiency, run by University College, London 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Matthew G Wilson (02034567890, matthew.wilson8@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of Electronic Point of Care Randomisation Prompts (time frame: Duration of individual participant admission to critical care, or five postoperative days, whichever is sooner). 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 NCT05149820, which also lists 2 linked publications.

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 1 Nov 2022.

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