PROTOCOL PROMDEP RANDOMISED CONTROLLED TRIAL PATIENT-REPORTED OUTCOME MEASURES FOR MONITORING PRIMARY CARE PATIENTS WITH DEPRESSION: PROMDEP RANDOMISED CONTROLLED TRIAL PROTOCOL Chief Investigator: Prof Tony Kendrick MD FRCGP FRCPsych (Hon) Professor of Primary Care Primary Care & Population Sciences University of Southampton Aldermoor Health Centre Southampton SO16 5ST Tel: 02380 591790 Email: [email protected] Sponsor: University of Southampton ERGO Ref: 42615 IRAS Ref: 250225 Funder: National Institute for Health Research Health Technology Assessment programme Ref: HTA 17/42/02. Funding acknowledgement: The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. ISRCTN no: 17299295 Dates: 01/11/2018 – 31/10/2021 NHS Research Ethics Committee ref: 18/WS/0144 approved by West of Scotland REC 5, 21st September 2018 PROMDEP RCT. Protocol version 1.1 Dated 12th September 2018 IRAS ref: 250225 Page 1 of 27 PROTOCOL PROMDEP RANDOMISED CONTROLLED TRIAL Protocol Version Protocol date Signature of CI 1.1 12.09.2018 1.1 21.09.2018 PROMDEP RCT. Protocol version 1.1 Dated 12th September 2018 IRAS ref: 250225 Page 2 of 27 PROTOCOL PROMDEP RANDOMISED CONTROLLED TRIAL Contents MAIN STUDY CONTACTS ................................................................................................................................................... 5 SPONSOR ........................................................................................................................................................................... 5 CO-APPLICANTS ................................................................................................................................................................. 5 Patient colleagues ......................................................................................................................................................... 6 Research team, University of Southampton ................................................................................................................. 6 Research team, University of Liverpool ........................................................................................................................ 6 Research team, University College London .................................................................................................................. 6 FUNDER ............................................................................................................................................................................. 6 PROTOCOL INFORMATION ................................................................................................................................................ 6 LAY SUMMARY .................................................................................................................................................................. 7 ABSTRACT .......................................................................................................................................................................... 8 BACKGROUND ................................................................................................................................................................... 9 AIM .................................................................................................................................................................................. 11 OBJECTIVES ..................................................................................................................................................................... 11 METHODS ........................................................................................................................................................................ 12 Intervention ................................................................................................................................................................ 12 Patient feedback on the meaning of their PHQ-9 score ......................................................................................... 12 GP/NP training and guidance in use of PHQ-9 ........................................................................................................ 13 Setting ......................................................................................................................................................................... 14 Design .......................................................................................................................................................................... 14 Randomisation ........................................................................................................................................................ 14 Blinding ................................................................................................................................................................... 15 Consent ................................................................................................................................................................... 15 Target population ....................................................................................................................................................... 15 Inclusion criteria ...................................................................................................................................................... 15 Exclusion criteria ..................................................................................................................................................... 15 Patient recruitment and consent ................................................................................................................................ 15 Method 1 ................................................................................................................................................................. 15 Method 2 ................................................................................................................................................................. 15 Telephone screening prior to recruitment ............................................................................................................. 16 Baseline visit ............................................................................................................................................................ 16 PROMDEP RCT. Protocol version 1.1 Dated 12th September 2018 IRAS ref: 250225 Page 3 of 27 PROTOCOL PROMDEP RANDOMISED CONTROLLED TRIAL Procedures in intervention and control arms ......................................................................................................... 16 Assessment measures at baseline and follow-up ....................................................................................................... 17 Assessing suicidal ideation ...................................................................................................................................... 18 Sample size .................................................................................................................................................................. 19 Data analysis ............................................................................................................................................................... 19 Primary and secondary outcomes .......................................................................................................................... 19 Quantitative process analysis ................................................................................................................................. 20 Qualitative process analysis .................................................................................................................................... 20 Health economic evaluation ................................................................................................................................... 20 ETHICAL CONSIDERATIONS ............................................................................................................................................. 21 PATIENT AND PUBLIC INVOLVEMENT ............................................................................................................................. 21 PROJECT MANAGEMENT................................................................................................................................................. 22 Trial Steering Committee and Independent Data Monitoring Committee ................................................................. 22 Study group meetings ................................................................................................................................................. 22 SAFETY OF PARTICIPANTS IN THE TRIAL ......................................................................................................................... 22 WITHDRAWAL FROM THE STUDY ................................................................................................................................... 23 CONFIDENTIALITY............................................................................................................................................................ 23 INDEMNITY .....................................................................................................................................................................