A nurse-led, preventive, psychological intervention to reduce PTSD symptom severity in critically ill patients: the POPPI feasibility study and cluster RCT

Paul R Mouncey, Dorothy M Wade, Alvin Richards-Belle, Zia Sadique, Jerome Wulff, Richard Grieve, Lydia Emerson, Chris R Brewin, Sheila Harvey, David Howell, Nicholas Hudson, Imran Khan, Monty Mythen, Deborah Smyth, John Weinman, John J Welch, David Harrison, Kathryn M Rowan

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Abstract

Background High numbers of patients experience severe acute stress in critical care units. Acute stress has been linked to post-critical care psychological morbidity, including post-traumatic stress disorder (PTSD). Previously, a preventive, complex psychological intervention [Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI)] was developed by this research team, to be led by nurses, to reduce the development of PTSD symptom severity at 6 months. Objectives The objectives were to (1) standardise and refine the POPPI intervention, and, if feasible, (2) evaluate it in a cluster randomised clinical trial (RCT). Design Two designs were used – (1) two feasibility studies to test the delivery and acceptability (to patients and staff) of the intervention, education package and support tools, and to test the trial procedures (i.e. recruitment and retention), and (2) a multicentre, parallel-group, cluster RCT with a baseline period and staggered roll-out of the intervention. Setting This study was set in NHS adult, general critical care units. Participants The participants were adult patients who were > 48 hours in a critical care unit, receiving level 3 care and able to consent. Interventions The intervention comprised three elements – (1) creating a therapeutic environment in critical care, (2) three stress support sessions for patients identified as acutely stressed and (3) a relaxation and recovery programme for patients identified as acutely stressed. Main outcome measures Primary outcome – patient-reported symptom severity using the PTSD Symptom Scale – Self Report (PSS-SR) questionnaire (to measure clinical effectiveness) and incremental costs, quality-adjusted life-years (QALYs) and net monetary benefit at 6 months (to measure cost-effectiveness). Secondary outcomes – days alive and free from sedation to day 30; duration of critical care unit stay; PSS-SR score of > 18 points; depression, anxiety and health-related quality of life at 6 months; and lifetime cost-effectiveness. Results (1) A total of 127 participants were recruited to the intervention feasibility study from two sites and 86 were recruited to the RCT procedures feasibility study from another two sites. The education package, support tools and intervention were refined. (2) A total of 24 sites were randomised to the intervention or control arms. A total of 1458 participants were recruited. Twelve sites delivered the intervention during the intervention period: > 80% of patients received two or more stress support sessions and all 12 sites achieved the target of > 80% of clinical staff completing the POPPI online training. There was, however, variation in delivery across sites. There was little difference between baseline and intervention periods in the development of PTSD symptom severity (measured by mean PSS-SR score) at 6 months for surviving patients in either the intervention or the control group: treatment effect estimate −0.03, 95% confidence interval (CI) −2.58 to 2.52; p = 0.98. On average, the intervention decreased costs and slightly improved QALYs, leading to a positive incremental net benefit at 6 months (£835, 95% CI −£4322 to £5992), but with considerable statistical uncertainty surrounding these results. There were no significant differences between the groups in any of the secondary outcomes or in the prespecified subgroup analyses. Limitations There was a risk of bias because different consent processes were used and as a result of the lack of blinding, which was mitigated as far as possible within the study design. The intervention started later than anticipated. Patients were not routinely monitored for delirium. Conclusions Among level 3 patients who stayed > 48 hours in critical care, the delivery of a preventive, complex psychological intervention, led by nurses, did not reduce the development of PTSD symptom severity at 6 months, when compared with usual care.
Original languageEnglish
Number of pages206
JournalHealth Services and Delivery Research
Volume7
Issue number30
DOIs
Publication statusPublished - 01 Aug 2019

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Feasibility Studies
Post-Traumatic Stress Disorders
Critical Illness
Randomized Controlled Trials
Nurses
Critical Care
Psychology
Self Report
Quality-Adjusted Life Years
Cost-Benefit Analysis
Confidence Intervals
Education
Costs and Cost Analysis
Delirium
Uncertainty
Anxiety
Quality of Life
Depression
Morbidity
Control Groups

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Mouncey, Paul R ; Wade, Dorothy M ; Richards-Belle, Alvin ; Sadique, Zia ; Wulff, Jerome ; Grieve, Richard ; Emerson, Lydia ; Brewin, Chris R ; Harvey, Sheila ; Howell, David ; Hudson, Nicholas ; Khan, Imran ; Mythen, Monty ; Smyth, Deborah ; Weinman, John ; Welch, John J ; Harrison, David ; Rowan, Kathryn M. / A nurse-led, preventive, psychological intervention to reduce PTSD symptom severity in critically ill patients: the POPPI feasibility study and cluster RCT. In: Health Services and Delivery Research. 2019 ; Vol. 7, No. 30.
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title = "A nurse-led, preventive, psychological intervention to reduce PTSD symptom severity in critically ill patients: the POPPI feasibility study and cluster RCT",
abstract = "Background High numbers of patients experience severe acute stress in critical care units. Acute stress has been linked to post-critical care psychological morbidity, including post-traumatic stress disorder (PTSD). Previously, a preventive, complex psychological intervention [Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI)] was developed by this research team, to be led by nurses, to reduce the development of PTSD symptom severity at 6 months. Objectives The objectives were to (1) standardise and refine the POPPI intervention, and, if feasible, (2) evaluate it in a cluster randomised clinical trial (RCT). Design Two designs were used – (1) two feasibility studies to test the delivery and acceptability (to patients and staff) of the intervention, education package and support tools, and to test the trial procedures (i.e. recruitment and retention), and (2) a multicentre, parallel-group, cluster RCT with a baseline period and staggered roll-out of the intervention. Setting This study was set in NHS adult, general critical care units. Participants The participants were adult patients who were > 48 hours in a critical care unit, receiving level 3 care and able to consent. Interventions The intervention comprised three elements – (1) creating a therapeutic environment in critical care, (2) three stress support sessions for patients identified as acutely stressed and (3) a relaxation and recovery programme for patients identified as acutely stressed. Main outcome measures Primary outcome – patient-reported symptom severity using the PTSD Symptom Scale – Self Report (PSS-SR) questionnaire (to measure clinical effectiveness) and incremental costs, quality-adjusted life-years (QALYs) and net monetary benefit at 6 months (to measure cost-effectiveness). Secondary outcomes – days alive and free from sedation to day 30; duration of critical care unit stay; PSS-SR score of > 18 points; depression, anxiety and health-related quality of life at 6 months; and lifetime cost-effectiveness. Results (1) A total of 127 participants were recruited to the intervention feasibility study from two sites and 86 were recruited to the RCT procedures feasibility study from another two sites. The education package, support tools and intervention were refined. (2) A total of 24 sites were randomised to the intervention or control arms. A total of 1458 participants were recruited. Twelve sites delivered the intervention during the intervention period: > 80{\%} of patients received two or more stress support sessions and all 12 sites achieved the target of > 80{\%} of clinical staff completing the POPPI online training. There was, however, variation in delivery across sites. There was little difference between baseline and intervention periods in the development of PTSD symptom severity (measured by mean PSS-SR score) at 6 months for surviving patients in either the intervention or the control group: treatment effect estimate −0.03, 95{\%} confidence interval (CI) −2.58 to 2.52; p = 0.98. On average, the intervention decreased costs and slightly improved QALYs, leading to a positive incremental net benefit at 6 months (£835, 95{\%} CI −£4322 to £5992), but with considerable statistical uncertainty surrounding these results. There were no significant differences between the groups in any of the secondary outcomes or in the prespecified subgroup analyses. Limitations There was a risk of bias because different consent processes were used and as a result of the lack of blinding, which was mitigated as far as possible within the study design. The intervention started later than anticipated. Patients were not routinely monitored for delirium. Conclusions Among level 3 patients who stayed > 48 hours in critical care, the delivery of a preventive, complex psychological intervention, led by nurses, did not reduce the development of PTSD symptom severity at 6 months, when compared with usual care.",
author = "Mouncey, {Paul R} and Wade, {Dorothy M} and Alvin Richards-Belle and Zia Sadique and Jerome Wulff and Richard Grieve and Lydia Emerson and Brewin, {Chris R} and Sheila Harvey and David Howell and Nicholas Hudson and Imran Khan and Monty Mythen and Deborah Smyth and John Weinman and Welch, {John J} and David Harrison and Rowan, {Kathryn M}",
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Mouncey, PR, Wade, DM, Richards-Belle, A, Sadique, Z, Wulff, J, Grieve, R, Emerson, L, Brewin, CR, Harvey, S, Howell, D, Hudson, N, Khan, I, Mythen, M, Smyth, D, Weinman, J, Welch, JJ, Harrison, D & Rowan, KM 2019, 'A nurse-led, preventive, psychological intervention to reduce PTSD symptom severity in critically ill patients: the POPPI feasibility study and cluster RCT', Health Services and Delivery Research, vol. 7, no. 30. https://doi.org/10.3310/hsdr07300

A nurse-led, preventive, psychological intervention to reduce PTSD symptom severity in critically ill patients: the POPPI feasibility study and cluster RCT. / Mouncey, Paul R; Wade, Dorothy M; Richards-Belle, Alvin; Sadique, Zia; Wulff, Jerome; Grieve, Richard; Emerson, Lydia; Brewin, Chris R; Harvey, Sheila; Howell, David; Hudson, Nicholas; Khan, Imran ; Mythen, Monty; Smyth, Deborah; Weinman, John; Welch, John J; Harrison, David; Rowan, Kathryn M.

In: Health Services and Delivery Research, Vol. 7, No. 30, 01.08.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A nurse-led, preventive, psychological intervention to reduce PTSD symptom severity in critically ill patients: the POPPI feasibility study and cluster RCT

AU - Mouncey, Paul R

AU - Wade, Dorothy M

AU - Richards-Belle, Alvin

AU - Sadique, Zia

AU - Wulff, Jerome

AU - Grieve, Richard

AU - Emerson, Lydia

AU - Brewin, Chris R

AU - Harvey, Sheila

AU - Howell, David

AU - Hudson, Nicholas

AU - Khan, Imran

AU - Mythen, Monty

AU - Smyth, Deborah

AU - Weinman, John

AU - Welch, John J

AU - Harrison, David

AU - Rowan, Kathryn M

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Background High numbers of patients experience severe acute stress in critical care units. Acute stress has been linked to post-critical care psychological morbidity, including post-traumatic stress disorder (PTSD). Previously, a preventive, complex psychological intervention [Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI)] was developed by this research team, to be led by nurses, to reduce the development of PTSD symptom severity at 6 months. Objectives The objectives were to (1) standardise and refine the POPPI intervention, and, if feasible, (2) evaluate it in a cluster randomised clinical trial (RCT). Design Two designs were used – (1) two feasibility studies to test the delivery and acceptability (to patients and staff) of the intervention, education package and support tools, and to test the trial procedures (i.e. recruitment and retention), and (2) a multicentre, parallel-group, cluster RCT with a baseline period and staggered roll-out of the intervention. Setting This study was set in NHS adult, general critical care units. Participants The participants were adult patients who were > 48 hours in a critical care unit, receiving level 3 care and able to consent. Interventions The intervention comprised three elements – (1) creating a therapeutic environment in critical care, (2) three stress support sessions for patients identified as acutely stressed and (3) a relaxation and recovery programme for patients identified as acutely stressed. Main outcome measures Primary outcome – patient-reported symptom severity using the PTSD Symptom Scale – Self Report (PSS-SR) questionnaire (to measure clinical effectiveness) and incremental costs, quality-adjusted life-years (QALYs) and net monetary benefit at 6 months (to measure cost-effectiveness). Secondary outcomes – days alive and free from sedation to day 30; duration of critical care unit stay; PSS-SR score of > 18 points; depression, anxiety and health-related quality of life at 6 months; and lifetime cost-effectiveness. Results (1) A total of 127 participants were recruited to the intervention feasibility study from two sites and 86 were recruited to the RCT procedures feasibility study from another two sites. The education package, support tools and intervention were refined. (2) A total of 24 sites were randomised to the intervention or control arms. A total of 1458 participants were recruited. Twelve sites delivered the intervention during the intervention period: > 80% of patients received two or more stress support sessions and all 12 sites achieved the target of > 80% of clinical staff completing the POPPI online training. There was, however, variation in delivery across sites. There was little difference between baseline and intervention periods in the development of PTSD symptom severity (measured by mean PSS-SR score) at 6 months for surviving patients in either the intervention or the control group: treatment effect estimate −0.03, 95% confidence interval (CI) −2.58 to 2.52; p = 0.98. On average, the intervention decreased costs and slightly improved QALYs, leading to a positive incremental net benefit at 6 months (£835, 95% CI −£4322 to £5992), but with considerable statistical uncertainty surrounding these results. There were no significant differences between the groups in any of the secondary outcomes or in the prespecified subgroup analyses. Limitations There was a risk of bias because different consent processes were used and as a result of the lack of blinding, which was mitigated as far as possible within the study design. The intervention started later than anticipated. Patients were not routinely monitored for delirium. Conclusions Among level 3 patients who stayed > 48 hours in critical care, the delivery of a preventive, complex psychological intervention, led by nurses, did not reduce the development of PTSD symptom severity at 6 months, when compared with usual care.

AB - Background High numbers of patients experience severe acute stress in critical care units. Acute stress has been linked to post-critical care psychological morbidity, including post-traumatic stress disorder (PTSD). Previously, a preventive, complex psychological intervention [Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI)] was developed by this research team, to be led by nurses, to reduce the development of PTSD symptom severity at 6 months. Objectives The objectives were to (1) standardise and refine the POPPI intervention, and, if feasible, (2) evaluate it in a cluster randomised clinical trial (RCT). Design Two designs were used – (1) two feasibility studies to test the delivery and acceptability (to patients and staff) of the intervention, education package and support tools, and to test the trial procedures (i.e. recruitment and retention), and (2) a multicentre, parallel-group, cluster RCT with a baseline period and staggered roll-out of the intervention. Setting This study was set in NHS adult, general critical care units. Participants The participants were adult patients who were > 48 hours in a critical care unit, receiving level 3 care and able to consent. Interventions The intervention comprised three elements – (1) creating a therapeutic environment in critical care, (2) three stress support sessions for patients identified as acutely stressed and (3) a relaxation and recovery programme for patients identified as acutely stressed. Main outcome measures Primary outcome – patient-reported symptom severity using the PTSD Symptom Scale – Self Report (PSS-SR) questionnaire (to measure clinical effectiveness) and incremental costs, quality-adjusted life-years (QALYs) and net monetary benefit at 6 months (to measure cost-effectiveness). Secondary outcomes – days alive and free from sedation to day 30; duration of critical care unit stay; PSS-SR score of > 18 points; depression, anxiety and health-related quality of life at 6 months; and lifetime cost-effectiveness. Results (1) A total of 127 participants were recruited to the intervention feasibility study from two sites and 86 were recruited to the RCT procedures feasibility study from another two sites. The education package, support tools and intervention were refined. (2) A total of 24 sites were randomised to the intervention or control arms. A total of 1458 participants were recruited. Twelve sites delivered the intervention during the intervention period: > 80% of patients received two or more stress support sessions and all 12 sites achieved the target of > 80% of clinical staff completing the POPPI online training. There was, however, variation in delivery across sites. There was little difference between baseline and intervention periods in the development of PTSD symptom severity (measured by mean PSS-SR score) at 6 months for surviving patients in either the intervention or the control group: treatment effect estimate −0.03, 95% confidence interval (CI) −2.58 to 2.52; p = 0.98. On average, the intervention decreased costs and slightly improved QALYs, leading to a positive incremental net benefit at 6 months (£835, 95% CI −£4322 to £5992), but with considerable statistical uncertainty surrounding these results. There were no significant differences between the groups in any of the secondary outcomes or in the prespecified subgroup analyses. Limitations There was a risk of bias because different consent processes were used and as a result of the lack of blinding, which was mitigated as far as possible within the study design. The intervention started later than anticipated. Patients were not routinely monitored for delirium. Conclusions Among level 3 patients who stayed > 48 hours in critical care, the delivery of a preventive, complex psychological intervention, led by nurses, did not reduce the development of PTSD symptom severity at 6 months, when compared with usual care.

U2 - 10.3310/hsdr07300

DO - 10.3310/hsdr07300

M3 - Article

VL - 7

JO - Health Services and Delivery Research

JF - Health Services and Delivery Research

SN - 2050-4357

IS - 30

ER -