Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:31 AM
Study NCT ID:
NCT07398235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Qualitative Study Examining Clinical Decision Support System Adoption Among Hospital Clinicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-01-06', 'size': 285150, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-04T13:52', 'hasProtocol': True}, {'date': '2026-01-06', 'size': 113731, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-04T13:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Saturation of Themes Related to Barriers to CDSS Adoption', 'timeFrame': 'The study ran between 10th January 2026 until 31 January 2026. The study was considered complete once all planned participant interviews have been conducted or recruitment has formally ceased following achievement of data saturation.', 'description': 'The primary outcome examines the barriers to clinical decision support system adoption, such as hardware issues, governance concerns, user-interface problems, and trusted information. These themes will be examined during interviews with open-ended questions to allow user experiences to be recorded.\n\nThis study will use purposive sampling with maximum variation to ensure representation across key categories of Emergency Department clinicians who use clinical decision support systems (CDSS). Participants will be selected to capture a range of roles and experiences, including Advanced Clinical Practitioners (ACPs), Physician Associates (PAs), Clinical Support Workers (CSWs), nurses, and doctors at different levels (Foundation Year 1-2, Senior House Officers, Registrars, and Consultants). Recruitment will continue until data saturation of themes related to CDSS adoption is achieved within and across these categories, anticipated at approximately one to two participants per role group.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Decision Support System (CDSS)']}, 'referencesModule': {'references': [{'pmid': '34911719', 'type': 'BACKGROUND', 'citation': 'Mebrahtu TF, Skyrme S, Randell R, Keenan AM, Bloor K, Yang H, Andre D, Ledward A, King H, Thompson C. Effects of computerised clinical decision support systems (CDSS) on nursing and allied health professional performance and patient outcomes: a systematic review of experimental and observational studies. BMJ Open. 2021 Dec 15;11(12):e053886. doi: 10.1136/bmjopen-2021-053886.'}, {'pmid': '36690490', 'type': 'BACKGROUND', 'citation': 'Meunier PY, Raynaud C, Guimaraes E, Gueyffier F, Letrilliart L. Barriers and Facilitators to the Use of Clinical Decision Support Systems in Primary Care: A Mixed-Methods Systematic Review. Ann Fam Med. 2023 Jan-Feb;21(1):57-69. doi: 10.1370/afm.2908.'}, {'pmid': '35902894', 'type': 'BACKGROUND', 'citation': "Chen W, O'Bryan CM, Gorham G, Howard K, Balasubramanya B, Coffey P, Abeyaratne A, Cass A. Barriers and enablers to implementing and using clinical decision support systems for chronic diseases: a qualitative systematic review and meta-aggregation. Implement Sci Commun. 2022 Jul 28;3(1):81. doi: 10.1186/s43058-022-00326-x."}, {'pmid': '28915822', 'type': 'BACKGROUND', 'citation': 'Liberati EG, Ruggiero F, Galuppo L, Gorli M, Gonzalez-Lorenzo M, Maraldi M, Ruggieri P, Polo Friz H, Scaratti G, Kwag KH, Vespignani R, Moja L. What hinders the uptake of computerized decision support systems in hospitals? A qualitative study and framework for implementation. Implement Sci. 2017 Sep 15;12(1):113. doi: 10.1186/s13012-017-0644-2.'}, {'pmid': '32047862', 'type': 'BACKGROUND', 'citation': 'Sutton RT, Pincock D, Baumgart DC, Sadowski DC, Fedorak RN, Kroeker KI. An overview of clinical decision support systems: benefits, risks, and strategies for success. NPJ Digit Med. 2020 Feb 6;3:17. doi: 10.1038/s41746-020-0221-y. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-future', 'label': '10 Year Health Plan for England (Department of Health and Social Care)'}, {'url': 'https://www.gov.uk/government/publications/independent-investigation-of-the-nhs-in-england', 'label': 'Independent Investigation of the NHS in England (Department of Health and Social Care)'}, {'url': 'https://www.england.nhs.uk/long-read/supporting-clinical-decisions-with-health-information-technology', 'label': 'Supporting clinical decisions with health information technology: An implementation guide for clinical decision support systems (NHS England)'}, {'url': 'https://www.thrivebydesign.org.uk/our-learning/nasss-cat-toolkit', 'label': 'NASSS-CAT Toolkit (Thrive by Design)'}]}, 'descriptionModule': {'briefSummary': 'A Qualitative Study to Explore the Barriers to Adoption of Clinical Decision Support Systems', 'detailedDescription': 'Qualitative study looking at clinical decision support system adoption among clinicians in a district general hospital. This will involve semi-structured interviews of various clinical staff in the emergency department, looking at work-habits regarding clinical decision support tool use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital clinicians employed by Medway NHS Foundation Trust', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Employed by Medway NHS Foundation Trust at the time of recruitment\n* Working clinically within the Emergency Department\n* Clinical grade of FY1, FY2, SHO/CTF, SAS/Registrar, Consultant, Nurse, Advanced Clinical practitioner, Physician Assistant, or Clinical Support Worker\n* Involved in the assessment and management of adult emergency department patients\n* Have routine access to the Trust electronic patient record system (Sunrise EPR) during clinical duties\n* Able to provide informed consent to participate\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Bank, agency, or locum staff who are not permanently or regularly employed by the department.\n* Staff currently on leave, secondment, or not actively practising in the ED during the data collection period.\n* Clinicians currently involved in the design, management, or evaluation of the CDSS system under study.'}, 'identificationModule': {'nctId': 'NCT07398235', 'acronym': 'CDSS-ADOPT', 'briefTitle': 'A Qualitative Study Examining Clinical Decision Support System Adoption Among Hospital Clinicians', 'organization': {'class': 'OTHER', 'fullName': 'Medway NHS Foundation Trust'}, 'officialTitle': 'A Qualitative Study to Explore the Barriers to Adoption of Clinical Decision Support Systems', 'orgStudyIdInfo': {'id': '1366'}, 'secondaryIdInfos': [{'id': 'IRAS ID: 365984', 'type': 'OTHER', 'domain': 'NHS Health Research Authority'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'FY1/2', 'description': 'Foundation Year 1 \\& 2 Doctors', 'interventionNames': ['Other: Semi-structured interview']}, {'label': 'SHO', 'description': 'Senior House Officer level doctor above FY2 but below Registrar', 'interventionNames': ['Other: Semi-structured interview']}, {'label': 'Registrar', 'description': 'Registrar level doctor', 'interventionNames': ['Other: Semi-structured interview']}, {'label': 'Consultant', 'description': 'Consultant level doctor', 'interventionNames': ['Other: Semi-structured interview']}, {'label': 'Physician Assistant', 'description': 'Physician Assistant clinician', 'interventionNames': ['Other: Semi-structured interview']}, {'label': 'ANP', 'description': 'Advanced Nurse Practitioner', 'interventionNames': ['Other: Semi-structured interview']}, {'label': 'CSW', 'description': 'Clinical Support Worker', 'interventionNames': ['Other: Semi-structured interview']}], 'interventions': [{'name': 'Semi-structured interview', 'type': 'OTHER', 'description': 'A 20-30 minute semi-structured interview using the pre-defined topic sheet', 'armGroupLabels': ['ANP', 'CSW', 'Consultant', 'FY1/2', 'Physician Assistant', 'Registrar', 'SHO']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ME7 5NY', 'city': 'Gillingham', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Medway NHS Foundation Trust', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medway NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Investigator', 'investigatorFullName': 'Saad Muhammad', 'investigatorAffiliation': 'Medway NHS Foundation Trust'}}}}