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

NCT05149820 | Unknown Phase 4

• 2 other identifiers: 142382279737
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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. 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.

Conditions

Atrial Fibrillation New Onset; Magnesium Deficiency

Keywords

Electronic Health Record Trials; Point of Care Randomisation; Comparative Effectiveness Research; Learning Health Systems; Feasibility Studies

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Acceptability to critical care clinicians of using the Electronic Point of Care Randomisation prompts assessed by semi-structured interviews

  Throughout study duration, maximum 6 months from study start date

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

  Throughout study duration, maximum 6 months from study start date

• 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.

  Throughout study duration, maximum 6 months from study start date

Study Arms (4)

Nudge Prompt, Liberal Magnesium Strategy

ACTIVE COMPARATOR

This 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.

Other: Electronic Point of Care Randomisation tool; Drug: Magnesium

Nudge Prompt, Restrictive Magnesium Strategy

ACTIVE COMPARATOR

This 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.

Other: Electronic Point of Care Randomisation tool; Drug: Magnesium

Preference Prompt, Liberal Magnesium Strategy

ACTIVE COMPARATOR

This 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.

Other: Electronic Point of Care Randomisation tool; Drug: Magnesium

Preference Prompt, Restrictive Magnesium Strategy

ACTIVE COMPARATOR

This 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.

Other: Electronic Point of Care Randomisation tool; Drug: Magnesium

Interventions

Electronic Point of Care Randomisation tool OTHER

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

Also known as: Nudge Prompt Design and Preference Prompt Design

Nudge Prompt, Liberal Magnesium Strategy; Nudge Prompt, Restrictive Magnesium Strategy; Preference Prompt, Liberal Magnesium Strategy; Preference Prompt, Restrictive Magnesium Strategy

Magnesium DRUG

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

Also known as: Liberal and Restrictive Magnesium Supplementation Strategies

Nudge Prompt, Liberal Magnesium Strategy; Nudge Prompt, Restrictive Magnesium Strategy; Preference Prompt, Liberal Magnesium Strategy; Preference Prompt, Restrictive Magnesium Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. Must be regularly involved in the care of postoperative patients in critical care.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator

Study Sites (1)

University College London Hospitals NHS Trust

London, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 40348398 DERIVED

• 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.

  PMID: 36123103 DERIVED

MeSH Terms

Conditions

Magnesium Deficiency

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Steve K Harris

  University College London Hospitals

  STUDY DIRECTOR

• Matthew G Wilson

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew G Wilson

CONTACT

02034567890; matthew.wilson8@nhs.net

Steve K Harris

CONTACT

02034567890; S.harris8@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 8, 2021
• Study Start: March 22, 2022
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)