Electronic Clinical Decision Support for Diabetes and Dysglycaemia in Secondary Mental Healthcare

NCT04792268 | Completed

• 1 other identifier: 285509
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

People with serious mental illness (SMI) such as schizophrenia, schizoaffective disorder and bipolar affective disorder have a significantly reduced life expectancy, caused in part by increased incidences of mortality from physical health conditions such as cardiovascular disease (CVD) and diabetes. Electronic clinical decision support systems (eCDSS) offer clinicians patient-specific advice and recommendations based on clinical guidelines, theoretically overcoming obstacles in the use of existing paper-based guidelines. Adoption of eCDSS to address CVD risk in people with SMI presents a unique opportunity for research, but requires evidence of acceptability and feasibility before scaling up of research. The key objective of this study is to establish the feasibility and acceptability of an eCDSS (CogStack @ Maudsley) compromising a real-time electronic health record powered alerting and clinical decision support system for diabetes management in secondary inpatient mental healthcare settings. End-users of the eCDSS will be clinicians only. Firstly we will conduct initial surveys and interviews with clinicians on inpatient wards to scope experiences of managing diabetes in secondary mental healthcare settings and attitudes towards use of digital technologies to aid in clinical decision making. A feasibility study will then be run to evaluate the acceptability and feasibility of implementing eCDSS on inpatient wards. This will involve a cluster RCT on inpatient general adult psychiatry wards, where 4 months of eCDSS use by clinicians on intervention wards will be compared to 4 months of treatment as usual on control wards. All clinicians on recruited wards will be eligible to participate. At the end of the study, participating clinicians on intervention wards will be invited to take part in a survey and interview which will explore their experiences and attitudes towards using the eCDSS, and an implementation science framework will be applied to inform future implementation of eCDSS. Group level pseudonymised outcome data will be gathered through a separate study.

Conditions

Severe Mental Disorder; Diabetes Mellitus; Dysglycemia; Staff Attitude

Outcome Measures

Primary Outcomes (3)

• Extent to which eCDSS is perceived by clinician users to be acceptable

  This outcome measure will explore clinician perceptions on how acceptable the eCDSS is in improving evidence-based dysglycaemia management, and where applicable, diabetes care. Data will be gathered through qualitative analysis of individual semi-structured interviews with clinician users.

  4 months

• Extent to which eCDSS is perceived by clinician users to be acceptable

  This outcome measure will explore clinician perceptions on how acceptable the eCDSS is in improving evidence-based dysglycaemia management, and where applicable, diabetes care. Data will be gathered through qualitative analysis of survey questionnaires of clinician users

  4 months

• Number of wards and clinician end-users recruited to the study

  Ability to recruit wards and clinicians to the study. Retention and participation of clinicians on recruited wards through to end of study. Availability of data to fulfil outcome measures.

  4 months

Secondary Outcomes (6)

• Rate of HbA1c testing

  12 months

• Rate of documentation of dysglycaemia/diabetes in clinical notes

  4 months

• Rate of documentation of discussion with patient regarding exercise, diet and smoking cessation

  4 months

• Rates of documentation of diabetes related screening interventions

  4 months

• Rate of delivery of evidence-based pharmacological interventions for diabetes or pre-diabetes where clinically indicated

  4 months

Other Outcomes (1)

• Assessment of the implementation of the eCDSS on inpatient ward settings

  4 months

Study Arms (2)

Electronic clinical decision support

EXPERIMENTAL

Electronic clinical decision support (eCDSS) will be available to clinicians on wards recruited to this arm. An eCDSS is a health information technology system designed to assist clinicians and other health care professionals in clinical decision-making. Automated electronic decision support will be provided as a combination of visual prompts on the individual patient's dashboard, accessed by clinicians when they view a patient record on the electronic health record supplemented by an email sent to the NHS Trust email account addresses of the participating ward clinician(s). Alerts will include locally approved guideline-based recommendations for clinician-led monitoring and management of dysglycaemia and known diabetes, tailored to the individual patient based upon reported HbA1c values.

Other: Access to eCDSS on wards

Treatment as usual

NO INTERVENTION

Clinicians will not have access to eCDSS on wards recruited to this arm and will deliver care as usual.

Interventions

Access to eCDSS on wards OTHER

Electronic clinical decision support (eCDSS) will be available to clinicians on wards recruited to this arm. An eCDSS is a health information technology system designed to assist clinicians and other health care professionals in clinical decision-making. The key digital tool to be used for eCDSS in this study is CogStack. This eCDSS has been developed to alert clinicians automatically regarding patients admitted under their care, triggered by the presence of new, old or absent HbA1c pathology reports on the electronic health record (EHR).

Electronic clinical decision support

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General adult psychiatry inpatient wards at South London and Maudsley NHS Foundation Trust. Wards will be entered into the study if their respective management are agreeable to participate.
• All clinical staff on recruited wards will be eligible to participate and will be invited to take part in a preliminary survey and individual interview with the research team at the start of the study.
• Staff on intervention wards will also be asked to complete a survey and individual interview at the end of the study.

You may not qualify if:

• Staff on recruited wards who are not of a clinical or healthcare professional background.
• Staff who lack capacity to provide informed consent to participate.

Sponsors & Collaborators

• King's College London: lead
• National Institute for Health Research, United Kingdom: collaborator
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

South London and Maudsley NHS Foundation Trust

London, United Kingdom

Location

Related Publications (12)

• Gardner-Sood P, Lally J, Smith S, Atakan Z, Ismail K, Greenwood KE, Keen A, O'Brien C, Onagbesan O, Fung C, Papanastasiou E, Eberhard J, Patel A, Ohlsen R, Stahl D, David A, Hopkins D, Murray RM, Gaughran F; IMPaCT team. Cardiovascular risk factors and metabolic syndrome in people with established psychotic illnesses: baseline data from the IMPaCT randomized controlled trial. Psychol Med. 2015;45(12):2619-29. doi: 10.1017/S0033291715000562. Epub 2015 May 12.

  PMID: 25961431 BACKGROUND

• Gaughran F, Stahl D, Stringer D, Hopkins D, Atakan Z, Greenwood K, Patel A, Smith S, Gardner-Sood P, Lally J, Heslin M, Stubbs B, Bonaccorso S, Kolliakou A, Howes O, Taylor D, Forti MD, David AS, Murray RM, Ismail K; IMPACT team. Effect of lifestyle, medication and ethnicity on cardiometabolic risk in the year following the first episode of psychosis: prospective cohort study. Br J Psychiatry. 2019 Dec;215(6):712-719. doi: 10.1192/bjp.2019.159.

  PMID: 31347480 BACKGROUND

• Hayes JF, Marston L, Walters K, King MB, Osborn DPJ. Mortality gap for people with bipolar disorder and schizophrenia: UK-based cohort study 2000-2014. Br J Psychiatry. 2017 Sep;211(3):175-181. doi: 10.1192/bjp.bp.117.202606. Epub 2017 Jul 6.

  PMID: 28684403 BACKGROUND

• Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients' care. Lancet. 2003 Oct 11;362(9391):1225-30. doi: 10.1016/S0140-6736(03)14546-1.

  PMID: 14568747 BACKGROUND

• Kawamoto K, Houlihan CA, Balas EA, Lobach DF. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ. 2005 Apr 2;330(7494):765. doi: 10.1136/bmj.38398.500764.8F. Epub 2005 Mar 14.

  PMID: 15767266 BACKGROUND

• Vancampfort D, Stubbs B, Mitchell AJ, De Hert M, Wampers M, Ward PB, Rosenbaum S, Correll CU. Risk of metabolic syndrome and its components in people with schizophrenia and related psychotic disorders, bipolar disorder and major depressive disorder: a systematic review and meta-analysis. World Psychiatry. 2015 Oct;14(3):339-47. doi: 10.1002/wps.20252.

  PMID: 26407790 BACKGROUND

• Jackson R, Kartoglu I, Stringer C, Gorrell G, Roberts A, Song X, Wu H, Agrawal A, Lui K, Groza T, Lewsley D, Northwood D, Folarin A, Stewart R, Dobson R. CogStack - experiences of deploying integrated information retrieval and extraction services in a large National Health Service Foundation Trust hospital. BMC Med Inform Decis Mak. 2018 Jun 25;18(1):47. doi: 10.1186/s12911-018-0623-9.

  PMID: 29941004 BACKGROUND

• Hex N, Bartlett C, Wright D, Taylor M, Varley D. Estimating the current and future costs of Type 1 and Type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs. Diabet Med. 2012 Jul;29(7):855-62. doi: 10.1111/j.1464-5491.2012.03698.x.

  PMID: 22537247 BACKGROUND

• Fernandes AC, Cloete D, Broadbent MT, Hayes RD, Chang CK, Jackson RG, Roberts A, Tsang J, Soncul M, Liebscher J, Stewart R, Callard F. Development and evaluation of a de-identification procedure for a case register sourced from mental health electronic records. BMC Med Inform Decis Mak. 2013 Jul 11;13:71. doi: 10.1186/1472-6947-13-71.

  PMID: 23842533 BACKGROUND

• Perera G, Broadbent M, Callard F, Chang CK, Downs J, Dutta R, Fernandes A, Hayes RD, Henderson M, Jackson R, Jewell A, Kadra G, Little R, Pritchard M, Shetty H, Tulloch A, Stewart R. Cohort profile of the South London and Maudsley NHS Foundation Trust Biomedical Research Centre (SLaM BRC) Case Register: current status and recent enhancement of an Electronic Mental Health Record-derived data resource. BMJ Open. 2016 Mar 1;6(3):e008721. doi: 10.1136/bmjopen-2015-008721.

  PMID: 26932138 BACKGROUND

• Stewart R, Soremekun M, Perera G, Broadbent M, Callard F, Denis M, Hotopf M, Thornicroft G, Lovestone S. The South London and Maudsley NHS Foundation Trust Biomedical Research Centre (SLAM BRC) case register: development and descriptive data. BMC Psychiatry. 2009 Aug 12;9:51. doi: 10.1186/1471-244X-9-51.

  PMID: 19674459 BACKGROUND

• Patel D, Msosa YJ, Wang T, Williams J, Mustafa OG, Gee S, Arroyo B, Larkin D, Tiedt T, Roberts A, Dobson RJB, Gaughran F. Implementation of an Electronic Clinical Decision Support System for the Early Recognition and Management of Dysglycemia in an Inpatient Mental Health Setting Using CogStack: Protocol for a Pilot Hybrid Type 3 Effectiveness-Implementation Randomized Controlled Cluster Trial. JMIR Res Protoc. 2024 Apr 5;13:e49548. doi: 10.2196/49548.

  PMID: 38578666 DERIVED

MeSH Terms

Conditions

Mental Disorders; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a feasibility study of a two-arm randomized controlled cluster trial conducted in general adult psychiatry inpatient ward settings. Wards will be the unit of recruitment and assigned to either the intervention or control group in a 1:1 ratio, to receive either the eCDSS platform or to follow usual care process.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: March 10, 2021
• Study Start: May 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

GB (1)