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Prospective Risk Assessment in a Mental Heath Trust A Study About Ways to Improve the Quality of Care in Mental Health Services This research is a CLAHRC fellows project and the fellow is Dr Jenny Spencer. The Project PI is Dr Terry Dickerson, Assistant Director of the University of Cambridge Engineering Design Centre. The project Sponsor is Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) through the NIHR CLAHRC for Cambridgeshire and Peterborough. Initial Goals Aim To test whether two closely related methods for identifying risk prospectively (both frequently used in industry) can be efficaciously adapted to a mental health environment. Goal 1. To verify and validate the use of these tools in a mental health setting. 2. Ideally, to improve patient safety and the quality of clinical care in mental health settings. Outcome measures Primary – Comparison of managerial Prospective Hazards Analysis and clinical staff Quality Assurance Data Collection results. Secondary – Change in Patient Safety Culture using MAPSAF. Change in the number and severity of reported near misses and SUIs. Timescale Managerial PHA sessions to be held in January, April and July 2012; Clinical staff data collection to begin in February and continue through May 2012. Final data analysis to be performed July – August 2012 Aim of the Study Prospective Hazards Analysis Quality Assurance Data Collection Compare and contrast Hazards List Number Most likely worst case Brief Descriptio Consequen Probabili Summary n ce ty Hazard 001 Patients might.. Hazard 002 Staff might.. .. .. Feel suicidal .. assess a skin condition .. .. Death Likely Severity Severe Current Layer of protectio nl CPN, 6 years Teams affected Environme Change Implemen nts required ted AO, Crisis Communit y First aid Certain Minor Jr Dr (SHO) Old Age, Adult Inpatient .. .. .. .. .. .. • Classify problems using WHO patient safety classification system • Add or change categories as needed Hazards List Number Most likely worst case Brief Descriptio Consequen Probabili Summary n ce ty Hazard 001 Patients might.. Hazard 002 Staff might.. .. .. Feel suicidal .. assess a skin condition .. .. Current Layer of protectio nl Teams affected Environme Change Implemen nts required ted Death Likely Severe CPN, 6 years AO, Crisis Communit y First aid Certain Minor Jr Dr (SHO) Old Age, Adult Inpatient .. .. .. .. .. .. Severity Health Services Research: Evidence Based Practice Assess the Clinical Safety and Effectiveness of the Quality Assurance methods under study using Adequate and Appropriate Research techniques (Quantitative, Qualitative and/or Mixed Methodologies) Main Study Flowchart (Engineering Diagram) 2011 Oct Nov Dec Sep Project Setup • Project Protocol • QA Tool Design • CPFT Permissions • Peer Reviews • Ethical Review 2012 Jan Feb Mar Apr May Jun Jul Aug PHA Arm • Consists of a management workshop • Takes place early in this period Blinding (as far as practicable) Routine Quality Indicators QA Arm - Control = MaPSaF Timings are indicative • Cambridgeshire North •No Intervention • Out-of-Hours Service • CRHT Service PHA Eval. QAArm Arm - Control QA - Intervention Cambridgeshire South •• Cambridgeshire North ••No QAIntervention Intervention Out-of-Hours Service ••Out-of-Hours Service • CRHT Service • CR&HT Service QA Intervention Evaluation • Objective 2 Blinding (as far as practicable) • Objective 1 Setup | Collection and Monitoring Project Reporting • Formal • Objectives 1, 2 and 3 Gantt Chart 1 (September 2011) AUG Deliverables Owner Planning phase Duration 3w Task I SDO application Jenny, Rv by Terry 2w Task II IRAS application Jenny, Rv by Terry 2w Task III Brief protocol Jenny, Rv by Terry 1w Task IV Approval of brief protocol by CLAHRC lead Jenny Belinda Lennox/ Prof Jones Task VI Detailed protocol Jenny, Rv by Terry 1w Task VI Information sheet for participants Jenny, Rv by Terry 1w Task VII Consent form for participants Jenny, Rv by Terry Team phase 1w 7w Task I Review of Ethics submission by R&D Jenny Steve Kelleher Rachel Kyd 1 w Task II Approval of Ethics submission by faculty Jenny, many others 4w Task III Ethics submission Jenny, Terry 1w Task IV Introductory presentation for various committees Jenny 4w Task V Approval of brief protocol by faculty (sought at Jenny end of meeting) 4w Prototype phase 5w Task I Introductory presentation for out of area trainees Jenny 1w Task II Pilot tool with out of area trainees Jenny, out of area EoE volunteers 3w Task III Peer review of detailed protocol, information sheet and consent forms by out of area reviewers Jenny, 2 out of area reviewers 4w Task I MAPSAF 1a Cecily Morrison 1w Task II MAPSAF 2a Cecily Morrison 1w Task III MAPSAF 3a Cecily Morrison 1w Task IV Prospective Hazards Analysis James Ward/ Terry Dickerson 1w Task V Application of Inclusive design toolkit James Ward/ Terry Dickerson 1w Task VI Data collection tool design workshop forum for Jenny OOH team (Junior doctors) ? Martin Stefan 1w Task VII Data collection tool design workshop forum for Jenny CRHTT ? Martin Stefan Task VIII Data collection and ongoing training for OOH team (Junior doctors) Task IX Data collection and ongoing training for CRHTT ? Martin Stefan 8-12 w Task X Weekly data analysis 16-20 w Task XI Management workshop review of collected data Jenny, ? Others 1w Task XII MAPSAF 1b Cecily Morrison 1w Task XIII MAPSAF 2b Cecily Morrison 1w Task XIV MAPSAF 3b Cecily Morrison Implementation phase 16-20 w Jenny Jenny Closure phase 1w 16-20 w 1w 5w Task I Comparative Risk Culture Analysis Cecily Morrison 5w Task II Completion of collected data analysis (mixed qualitative and quantitative design) Jenny 4w Task III Comparative Economic Analysis James Ward/ Terry Dickerson 5w Annotations W1 SEP W2 W3 W4 W1 OCT W2 W3 W4 W1 NOV W2 W3 W4 W5 W1 DEC W2 W3 W4 W1 JAN W2 W3 W4 W1 FEB W2 W3 W4 W5 W1 MAR W2 W3 W4 W1 APR W2 W3 W4 W1 MAY W2 W3 W4 W1 JUN W2 W3 W4 W1 JUL W2 W3 W4 W1 AUG W2 W3 W4 W1 W2 W3 W4 W5 Gantt Chart 2 (May 2012) AUG Deliverables Owner Duration W1 Task I SDO application Jenny, Rv by Terry 2w Task II IRAS application Jenny, Rv by Terry 2w Task III Brief protocol Jenny, Rv by Terry Task IV Approval of brief protocol by CLAHRC lead Belinda Lennox/Prof Jones Task VI First draft detailed protocol Jenny and Terry 29 w Task VI Information sheet for participants Jenny, Rv by Terry 2w Task VII Consent form for participants Jenny, Rv by Terry Planning phase 32 w Prototype phase 1w 1w 5w Task I Introductory presentation for out of area trainees Jenny 1w Task IIa Pilot tool with out of area trainees Jenny, out of area EoE volunteers 3w Task IIb Second pilot tool with out of area trainees Jenny, out of area EoE volunteers 1w Task III Create electronic form Terry 1w Task IV Pilot electronic form Jenny, out of area EoE volunteers 1w Task I Review of Protocol by R&D Jenny Steve Kelleher Rachel Kyd 3 w Task II Approval of Brief Protocol by Trust Jenny, many others 4w Task III Ethics submission Jenny, Terry 1w Team phase 7w Await results of ethics submission Task IV Introductory presentation for various committees Jenny 4w Task V Approval of brief protocol by meeting members Jenny 4w Task VIa Internal peer review of detailed protocol by EDC Pat Langdon 6w Task VIb External peer review of detailed protocol by statistician CLAHRC statistician 2w Task VIIa External peer review of detailed protocol, information sheet and consent 2 out of area reviewers forms by out of area reviewers Task VIII Approval of protocol by CLAHRC lead* Belinda says if Terry approves the Belinda Lennox/Prof Jones protocol it is all right by her Task IX Internal review of detailed protocol by trust Chess Denman, Martin Stefan, whomever else Chess specifies Implementation phase 1w 3w 16-20 w Task I MAPSAF 1a ? 1w Task II MAPSAF 2a ? 1w Task III MAPSAF 3a ? 1w Task IV Prospective Hazards Analysis - General James Ward/ Terry Dickerson 1w Task V Prospective Hazards Analysis - Detailed James Ward/ Terry Dickerson 1w Task VI Data collection tool design workshop forum for OOH team (Junior doctors) Jenny/ Reba Jacob 1w Task VII Data collection tool design workshop forum for CRHTT Jenny/ Reba Jacob 1w Task VIII Data collection and ongoing training for CRHTT and OOH teams Jenny/Reba Jacob 16-20 w Task IX Data collection and ongoing training for CRHTT ? Martin Stefan 8-12 w Task X Weekly data analysis Jenny Task XI Management workshop review of collected data Jenny, ? Others Task XII MAPSAF 1b ? 1w Task XIII MAPSAF 2b ? 1w Task XIV MAPSAF 3b ? 16-20 w 1w Closure phase 1w 5w Task I Comparative Risk Culture Analysis Task II QADC analysis Jenny TaskIII QADC preliminary report 1 Jenny ? 5w 1w Task IV QADC preliminary report 2 Jenny 1.w Task V QADC Write up Jenny / Martin 4w Task VII PHA analysis Task VIII PHA QADC Comparison Terry Task IX PHA QADC Comparison Write up Terry Task X Comparative Economic Analysis James Ward/ Terry Dickerson 8w 5w SEP OCT NOV W2 W3 W4 W1 W2 W3 W4 W1 W2 W3 W4 W5 W1 DEC JAN FEB W2 W3 W4 W1 W2 W3 W4 W1 W2 W3 W4 W5 W1 MAR W2 W3 W4 W1 APR MAY W2 W3 W4 W1 W2 W3 W4 W1 JUN JUL AUG W2 W3 W4 W1 W2 W3 W4 W1 W2 W3 W4 W1 SEP OCT NOV W2 W3 W4 W5 W1 W2 W3 W4 W1 W2 W3 W4 W5 W1 DEC W2 W3 W4 W1 W2 W3 W4 W5 Gantt Chart 3 (Current) 2011 2012 AUG Deliverables Owner Duration W1 Planning phase 32 w Task I SDO application Jenny, Rv by Terry 2w Task II IRAS application Jenny, Rv by Terry 2w Task III Brief protocol Jenny, Rv by Terry Task IV Approval of brief protocol by CLAHRC lead Belinda Lennox/Prof Jones Task VI First draft detailed protocol Jenny and Terry 29 w Task VI Information sheet for participants Jenny, Rv by Terry 2w Task VII Consent form for participants Jenny, Rv by Terry Prototype phase 1w 1w 5w Task I Introductory presentation for out of area trainees Jenny 1w Task IIa Pilot tool with out of area trainees Jenny, out of area EoE volunteers 3w Task IIb Second pilot tool with out of area trainees Jenny, out of area EoE volunteers 1w Task III Create electronic form Terry 1w Task IV Pilot electronic form Jenny, out of area EoE volunteers Team phase 1w 7w Task I Review of Protocol by R&D Jenny Steve Kelleher Rachel Kyd 3 w Task II Approval of Brief Protocol by Trust Jenny, many others 4w Task III Ethics submission Jenny, Terry 1w Task IV Introductory presentation for various committees Jenny 4w Task V Approval of brief protocol by meeting members Jenny 4w Task VIa Internal peer review of detailed protocol by EDC Pat Langdon 6w Task VIb External peer review of detailed protocol by statistician CLAHRC statistician 2w Task VIIa External peer review of detailed protocol, information sheet and consent forms by out of area reviewers 2 out of area reviewers 1w Task VIII Approval of protocol by CLAHRC lead* Belinda says if Terry approves the protocol it is all right by her Belinda Lennox/Prof Jones Task IX Internal review of protocol by trust Chess Denman, Martin Stefan, whomever else Chess specifies Await results of ethics submission Implementation phase 3w 16-20 w Task I MAPSAF 1a ? 1w Task II MAPSAF 2a ? 1w Task III MAPSAF 3a ? 1w Task IV Prospective Hazards Analysis - General James Ward/ Terry Dickerson 1w Task V Prospective Hazards Analysis - Detailed James Ward/ Terry Dickerson 1w Task VI Data collection tool design workshop forum for OOH team (Junior doctors) Jenny/ Reba Jacob 1w Task VII Data collection tool design workshop forum for CRHTT Jenny/ Reba Jacob 1w Task VIII Data collection and ongoing training for CRHTT and OOH teams Jenny/Reba Jacob 16-20 w Task IX Data collection and ongoing training for CRHTT ? Martin Stefan 8-12 w Task X Weekly data analysis Jenny 16-20 w Task XI Management workshop review of collected data Jenny, ? Others 1w Task XII MAPSAF 1b ? 1w Task XIII MAPSAF 2b ? 1w Task XIV MAPSAF 3b ? Closure phase 1w 5w Task I Comparative Risk Culture Analysis Task II QADC analysis Jenny TaskIII QADC preliminary report 1 Jenny ? 5w 1w Task IV QADC preliminary report 2 Jenny 1.w Task V QADC Write up Jenny / Martin 4w Task VII PHA analysis Task VIII PHA QADC Comparison Terry Task IX PHA QADC Comparison Write up Terry Task X Comparative Economic Analysis James Ward/ Terry Dickerson 8w 5w SEP W2 W3 W4 W1 OCT W2 W3 W4 W1 NOV W2 W3 W4 W5 W1 DEC W2 W3 W4 W1 JAN W2 W3 W4 W1 2013 FEB W2 W3 W4 W5 W1 MAR W2 W3 W4 W1 APR W2 W3 W4 W1 MAY W2 W3 W4 W1 JUN W2 W3 W4 W1 JUL W2 W3 W4 W1 AUG W2 W3 W4 W1 SEP W2 W3 W4 W5 W1 OCT W2 W3 W4 W1 NOV W2 W3 W4 W5 W1 JA W2 W3 W4 W5 W1 Fe W2 W3 W4 W1 MA W2 W3 W4 W1 AP W2 W3 W4 "5 W1 MAY W2 W3 W4 W5 W1 JUN W2 W3 W4 W5 W1 W2 W3 W4 Main Study Flowchart (Engineering Diagram) 2011 Oct Nov Sep Dec 2012 Jan Feb Mar Apr May Jun Jul Project Setup PHA Arm • Project Protocol • QA Tool Design • CPFT Permissions • Peer Reviews • Ethical Review • Consists of a management workshop • Takes place early in this period Aug Blinding (as far as practicable) Routine Quality Indicators We have additionally written a Literature Review And thoroughly researched our evaluation methodologies = MaPSaF Timings are indicative QAArm Arm - Control QA - Intervention Cambridgeshire South ••Cambridgeshire North ••No QAIntervention Intervention Out-of-Hours Service • •Out-of-Hours Service • CRHT Service • CR&HT Service QA Arm - Control • Cambridgeshire North •No Intervention • Out-of-Hours Service • CRHT Service QA Intervention Evaluation • Objective 2 Blinding (as far as practicable) PHA Eval. • Objective 1 Setup | Collection and Monitoring Project Reporting • Formal • Objectives 1, 2 and 3 Barriers to Project Completion Is Your Project Research? • Service Improvement Project (SIP) vs Health Services Research (HSR) • Ethics approval, Sponsorship, Peer review, Indemnity/Insurance, Grant Contracts, Feasibility, Commercial charges, Service Support Costs, Identification of PI, Letters of access/Honorary Research contracts Limit Growth - Project size and goals Collaborator buy - in Ethical approval - Appropriate venue • University Ethics Boards vs LREC Service Provider Buy-in as a moving target • Changes initiated by people other than you Hard-to-Measure Work Learning the ropes • Reviewing current literature • Studying new methodologies • Appreciating the process steps necessary for study approval Spreading the word: Creating a positive feel for the project • Project documents (including PHA) to: • Medical director • Head of Service Improvement • Clinical Directors • Risk Assessment department • Clinical staff who are likely participants • Discussions at RCPsych Faculty Conferences • Literature Review article submission to a peer reviewed journal Suggestions for Future Projects • Limit project scope (and supervisor enthusiasm) • CLAHRC Resources webpage is very useful: • Research Governance Pathway Guidance http://www.clahrccp.nihr.ac.uk/resources/research-governance • Don’t forget to budget time for • Peer Review, Letters of access/Honorary contracts for all involved, Indemnity/Insurance, Sponsorship • As well as Ethical Approval • Make sure you really enjoy your topic, because you will be dedicating a lot of time to it Thank you for listening. “Design for Patient Safety” Department of Health 2003