Effect of a Nurse-Led Preventive Psychological Intervention on Symptoms of Posttraumatic Stress Disorder Among Critically Ill Patients

Wade, Dorothy; Mouncey, Paul; Richards-Belle, Alvin; Wulff, Jerome; Harrison, David A; Sadique, Zia; Grieve, Richard; Emerson, Lydia M; Mason, Alexina J.; Aaronovitch, David; Als, Nicole; Brewin, Chris R.; Harvey, Sheila; Howell, David C.; Hudson, N.; Mythen, Monty; Smyth, Deborah; Weinman, John; Welch, John J.; Whitman, Chris; Rowan, Kathy

doi:10.1001/jama.2019.0073

Cited by 82 publications

(104 citation statements)

References 38 publications

(58 reference statements)

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Section: Subgroup Analyses Of the Primary Outcomementioning

confidence: 99%

“…Reproduced with permission from JAMA 2019;321(7):665-75. 71 Cost-effectiveness acceptability curve, reporting the probability that the intervention is cost-effective (at lifetime) at alternative willingness-to-pay thresholds for a QALY gain. Reproduced with permission from JAMA 2019;321 (7):665-75.…”

Section: Long-term Costsmentioning

confidence: 99%

“…Numbers 3, 2, 1 and 0 represent scores for the implementation of each of the intervention components. Reproduced with permission from JAMA 2019;321(7):665-75 71. Copyright © 2019 American Medical Association.…”

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confidence: 99%

“…Monthly POPPI online training uptake at each intervention group site (n = 12) from the transition month until the end of intervention period. Reproduced with permission from JAMA 2019;321(7):665-75 71. Copyright © 2019 American Medical Association.…”

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confidence: 99%

“…Uncertainty in the mean costs (GBP) and QALY differences and their distribution for the POPPI intervention versus usual care. Reproduced with permission from JAMA 2019;321(7):665-75 71. Copyright © 2019 American Medical Association.…”

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confidence: 99%

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

Mouncey

Wade

Richards-Belle

et al. 2019

Health Serv Deliv Res

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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. Future work Prior to development and evaluation of subsequent psychological interventions, there is much to learn from post hoc analyses of the cluster RCT rich quantitative and qualitative data. Trial registration This trial is registered as ISRCTN61088114 and ISRCTN53448131. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 23, No. 30. See the NIHR Journals Library website for further project information.

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Section: Subgroup Analyses Of the Primary Outcomementioning

confidence: 99%

Section: Long-term Costsmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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confidence: 99%

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

Mouncey

Wade

Richards-Belle

et al. 2019

Health Serv Deliv Res

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Addressing the Psychological Symptoms of Critical Illness

Kross

Pollak

Curtis

2019

JAMA

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Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors

Cox,

Gallis,

Olsen

et al. 2024

JAMA Intern Med

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ImportanceAlthough psychological distress is common among survivors of critical illness, there are few tailored therapies.ObjectiveTo determine the optimal method for delivering a mindfulness intervention via a mobile app for critical illness survivors.Design, Setting, and ParticipantsThis randomized clinical trial used a 2 × 2 × 2 factorial design and was conducted at 3 sites among survivors of critical illness with elevated postdischarge symptoms of depression. The study was conducted between August 2019 and July 2023.InterventionsParticipants were randomized to 1 of 8 different groups as determined by 3 two-level intervention component combinations: intervention introduction method (mobile app vs therapist call), mindfulness meditation dose (once daily vs twice daily), and management of increasing symptoms (mobile app vs therapist call).Main Outcomes and MeasuresThe primary outcome was the 9-item Patient Health Questionnaire (PHQ-9) depression scale score (range, 0-27) at 1 month. Secondary outcomes included anxiety (7-item Generalized Anxiety Disorder) and posttraumatic stress disorder (Posttraumatic Stress Scale) symptoms at 1 and 3 months, adherence, and feasibility. General linear models were used to compare main effects and interactions of the components among intervention groups. A formal decisional framework was used to determine an optimized intervention version.ResultsA total of 247 participants (mean [SD] age, 50.2 [15.4] years; 104 [42.1%] women) were randomized. Twice-daily meditation compared with once-daily meditation was associated with a 1.2 (95% CI, 0.04-2.4)–unit lower mean estimated PHQ-9 score at 1 month and a 1.5 (95% CI, 0.1-2.8)–unit lower estimated mean score at 3 months. The other 2 intervention components had no main effects on the PHQ-9. Across-group adherence was high (217 participants [87.9%] using the intervention at trial conclusion) and retention was strong (191 [77.3%] and 182 [73.7%] at 1 and 3 months, respectively).Conclusions and RelevanceA mindfulness intervention for survivors of critical illness that included an app-based introduction, twice-daily guided meditation, and app-based management of increasing depression symptoms was optimal considering effects on psychological distress symptoms, adherence, and feasibility.Trial RegistrationClinicalTrials.gov Identifier: NCT04038567

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Effect of a Nurse-Led Preventive Psychological Intervention on Symptoms of Posttraumatic Stress Disorder Among Critically Ill Patients

Cited by 82 publications

References 38 publications

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

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

Addressing the Psychological Symptoms of Critical Illness

Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors

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