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Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial

Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial
Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial

BACKGROUND: Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not yet been researched in the United Kingdom for primary care, which is where most people with depression are treated in the United Kingdom.

METHODS: This is a parallel-group cluster randomised trial with 1:1 allocation to intervention and control. Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria. Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded. The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later. General practitioners are trained in interpreting scores and asked to take them into account in their treatment decisions. Patients are given written feedback on scores and suggested treatments. The primary outcome measure is Depression on the Beck Depression Inventory BDI-II at 12 weeks. Secondary outcomes include BDI-II at 26 weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26 weeks, service use over 26 weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale). The sample includes 676 total participants from 113 practices across three centres. Randomisation is achieved by computerised sequence generation. Blinding is impossible given the nature of the intervention (self-report outcome measures prevent rating bias). Differences at 12 and 26 weeks between intervention and controls in depression, social functioning and quality of life are analysed using linear mixed models, adjusted for socio-demographics, baseline depression, anxiety, and clustering, while including practice as a random effect. Patient satisfaction, quality of life (QALYs) and costs over 26 weeks will be compared between arms. Qualitative process analysis includes interviews with 15-20 GP/NPs and 15-20 patients per arm to reflect trial results and implementation issues, using Normalization Process Theory as a theoretical framework.

DISCUSSION: If PROMs are helpful in improving patient outcomes for depression even to a small extent, then they are likely to be good value for money, given their low cost. The benefits could be considerable, given that depression is common, disabling, and costly.

TRIAL REGISTRATION: ISRCTN no: 17299295. Registered 1st October 2018.

Depression, Monitoring, PHQ-9, Patient-reported outcome measures, Primary care
1745-6215
1-13
Kendrick, Tony
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Moore, Michael
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Leydon, Geraldine
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Stuart, Beth
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Geraghty, Adam W.A.
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Yao, Guiqing
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Lewis, Glyn
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Griffiths, Gareth
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May, Carl
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Dewar-Haggart, Rachel
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Williams, Samantha
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Zhu, Shihua
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Dowrick, Christopher
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Kendrick, Tony
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Moore, Michael
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Leydon, Geraldine
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Stuart, Beth
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Geraghty, Adam W.A.
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Yao, Guiqing
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Lewis, Glyn
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Griffiths, Gareth
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May, Carl
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Dewar-Haggart, Rachel
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Williams, Samantha
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Zhu, Shihua
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Dowrick, Christopher
1869ad5e-1959-446c-b2a8-3fcdf3e79667

Kendrick, Tony, Moore, Michael, Leydon, Geraldine, Stuart, Beth, Geraghty, Adam W.A., Yao, Guiqing, Lewis, Glyn, Griffiths, Gareth, May, Carl, Dewar-Haggart, Rachel, Williams, Samantha, Zhu, Shihua and Dowrick, Christopher (2020) Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial. Trials, 21 (1), 1-13, [441]. (doi:10.1186/s13063-020-04344-9).

Record type: Article

Abstract

BACKGROUND: Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not yet been researched in the United Kingdom for primary care, which is where most people with depression are treated in the United Kingdom.

METHODS: This is a parallel-group cluster randomised trial with 1:1 allocation to intervention and control. Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria. Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded. The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later. General practitioners are trained in interpreting scores and asked to take them into account in their treatment decisions. Patients are given written feedback on scores and suggested treatments. The primary outcome measure is Depression on the Beck Depression Inventory BDI-II at 12 weeks. Secondary outcomes include BDI-II at 26 weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26 weeks, service use over 26 weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale). The sample includes 676 total participants from 113 practices across three centres. Randomisation is achieved by computerised sequence generation. Blinding is impossible given the nature of the intervention (self-report outcome measures prevent rating bias). Differences at 12 and 26 weeks between intervention and controls in depression, social functioning and quality of life are analysed using linear mixed models, adjusted for socio-demographics, baseline depression, anxiety, and clustering, while including practice as a random effect. Patient satisfaction, quality of life (QALYs) and costs over 26 weeks will be compared between arms. Qualitative process analysis includes interviews with 15-20 GP/NPs and 15-20 patients per arm to reflect trial results and implementation issues, using Normalization Process Theory as a theoretical framework.

DISCUSSION: If PROMs are helpful in improving patient outcomes for depression even to a small extent, then they are likely to be good value for money, given their low cost. The benefits could be considerable, given that depression is common, disabling, and costly.

TRIAL REGISTRATION: ISRCTN no: 17299295. Registered 1st October 2018.

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Accepted/In Press date: 24 April 2020
e-pub ahead of print date: 29 May 2020
Published date: 29 May 2020
Additional Information: Funding Information: This study was funded by the National Institute for Health Research (NIHR). The views expressed are the authors' and not necessarily those of the NIHR or the Department of Health and Social Care. 1. Publisher Copyright: © 2020 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
Keywords: Depression, Monitoring, PHQ-9, Patient-reported outcome measures, Primary care

Identifiers

Local EPrints ID: 441926
URI: http://eprints.soton.ac.uk/id/eprint/441926
ISSN: 1745-6215
PURE UUID: 75bb3858-ca68-412d-add2-401d0d20820d
ORCID for Tony Kendrick: ORCID iD orcid.org/0000-0003-1618-9381
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509
ORCID for Geraldine Leydon: ORCID iD orcid.org/0000-0001-5986-3300
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for Adam W.A. Geraghty: ORCID iD orcid.org/0000-0001-7984-8351
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021
ORCID for Carl May: ORCID iD orcid.org/0000-0002-0451-2690
ORCID for Rachel Dewar-Haggart: ORCID iD orcid.org/0000-0002-3757-1152
ORCID for Samantha Williams: ORCID iD orcid.org/0000-0001-9505-6485

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Date deposited: 02 Jul 2020 16:34
Last modified: 10 Jan 2022 03:03

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Contributors

Author: Tony Kendrick ORCID iD
Author: Michael Moore ORCID iD
Author: Beth Stuart ORCID iD
Author: Guiqing Yao
Author: Glyn Lewis
Author: Carl May ORCID iD
Author: Rachel Dewar-Haggart ORCID iD
Author: Shihua Zhu
Author: Christopher Dowrick

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