Diabetes Mellitus Clinical Trial
Official title:
Implementation of an Electronic Clinical Decision Support System (eCDSS) for the Early Recognition and Management of Diabetes and Dysglycaemia in Secondary Mental Healthcare : Feasibility Study
NCT number | NCT04792268 |
Other study ID # | 285509 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | December 1, 2023 |
Verified date | March 2024 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | December 1, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Staff on recruited wards who are not of a clinical or healthcare professional background. - Staff who lack capacity to provide informed consent to participate. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | South London and Maudsley NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | National Institute for Health Research, United Kingdom, South London and Maudsley NHS Foundation Trust |
United Kingdom,
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. — View Citation
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. Erratum In: Psychol Med. 2015;45(12):2631. Eberherd, J [corrected to Eberhard, J]. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of the implementation of the eCDSS on inpatient ward settings | Process evaluation to be conducted to evaluate the overall implementation of the system.
Data will be gathered from qualitative analysis of individual semi-structured interviews with clinician users. |
4 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Rate of HbA1c testing | Rates of HbA1c testing - Inpatient for initial test, inpatient and community for follow-up tests. | 12 months | |
Secondary | Rate of documentation of dysglycaemia/diabetes in clinical notes | Documentation of diabetes or pre-diabetes diagnosis in case notes during inpatient stay (where indicated) | 4 months | |
Secondary | Rate of documentation of discussion with patient regarding exercise, diet and smoking cessation | Documentation of advice by clinician given to patient regarding lifestyle changes- exercise, diet and smoking cessation in patients with dysglycaemia | 4 months | |
Secondary | Rates of documentation of diabetes related screening interventions | Documentation of completed foot check for patients with dysglycaemia | 4 months | |
Secondary | Rate of delivery of evidence-based pharmacological interventions for diabetes or pre-diabetes where clinically indicated | Documentation of diabetes-related medication changes post-alerting where clinically indicated:
Initiation of diabetes medication Intensification of medication (dose change or introduction of new agent in accordance with algorithm) Documentation of antipsychotic medication changes to reduce risk of dysglycaemia in patients at risk of Hyperosmolar Hyperglycaemic State. |
4 months | |
Secondary | Rates of communication with GP/CMHT regarding diabetes or dysglycaemia follow up | Documentation to relevant community team(s) and GP regarding follow up plans for diabetes care post-discharge where indicated. | 4 months |
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