Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Post-Traumatic Stress Disorder | Study protocol

Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial

Authors: Holly G. Prigerson, Martin Viola, Chris R. Brewin, Christopher Cox, Daniel Ouyang, Madeline Rogers, Cynthia X. Pan, Shayna Rabin, Jiehui Xu, Susan Vaughan, Janna S. Gordon-Elliot, David Berlin, Lindsay Lief, Wendy G. Lichtenthal

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience additional distress. EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients’ quality of life and death and dying as well as surrogates’ mental health.

Methods

Clinician stakeholder and surrogate participant feedback (n = 15), as well as results from an open trial (n = 10), will be used to refine the intervention, which will then be evaluated through a multisite randomized controlled trial (RCT) (n = 60) to examine clinical superiority to usual care. Feasibility, tolerability, and acceptability of the intervention will be evaluated through self-report assessments. Hierarchical linear modeling will be used to adjust for clustering within interventionists to determine the effect of EMPOWER on surrogate differences in the primary outcome, peritraumatic stress. Secondary outcomes will include symptoms of post-traumatic stress disorder, prolonged grief disorder, and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at 1 and 3 months from post-intervention assessment. Linear regression models will examine the effects of assignment to EMPOWER versus the enhanced usual care group on patient quality of life or quality of death and intensity of care the patient received during the indexed ICU stay assessed at the time of the post-intervention assessment. Participant exit interviews will be conducted at the 3-month assessment time point and will be analyzed using qualitative thematic data analysis methods.

Discussion

The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver outcomes in the setting of critical illness. The experimental intervention will be strengthened through the input of a variety of ICU stakeholders, including behavioral health clinicians, physicians, bereaved informal caregivers, and open trial participants. Results of the RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application.

Trial registration

ClinicalTrials.gov, NCT03276559. Retrospectively registered on 8 September 2017.
Appendix
Available only for authorised users
Literature
1.
Elliott D, Davidson JE, Harvey MA, Bemis-Dougherty A, Hopkins RO, Iwashyna TJ, et al. Exploring the scope of post-intensive care syndrome therapy and care: engagement of non-critical care providers and survivors in a second stakeholders meeting. Crit Care Med. 2014;42(12):2518–26.PubMedCrossRef
2.
Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome—family. Crit Care Med. 2012;40(2):618–24.PubMedCrossRef
3.
Anderson WG, Arnold RM, Angus DC, Bryce CL. Posttraumatic stress and complicated grief in family members of patients in the intensive care unit. J Gen Intern Med. 2008;23(11):1871–6.PubMedPubMedCentralCrossRef
4.
Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, et al. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005;171(9):987–94.PubMedCrossRef
5.
White DB, Buddadhumaruk P, Correspondence ARM. Family-support intervention in the ICU. N Engl J Med. 2018;379(13):1283–5.CrossRef
6.
Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, et al. Effect of palliative care-led meetings for families of patients with chronic critical illness: a randomized clinical trial. Jama. 2016;316(1):51–62.PubMedPubMedCentralCrossRef
7.
Kentish-Barnes N, Chevret S, Champigneulle B, Thirion M, Souppart V, Gilbert M, et al. Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial. Intensive Care Med. 2017;43(4):473–84.PubMedCrossRef
8.
Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, et al. Effects of a personalized web-based decision aid for surrogate decision makers of patients with prolonged mechanical ventilation: a randomized clinical trial. Ann Int Med. 2019;170(5):285-97. https://​doi.​org/​10.​7326/​M18-2335.CrossRef
9.
Seaman JB, Arnold RM, Buddadhumaruk P, Shields AM, Gustafson RM, Felman K, et al. Protocol and fidelity monitoring plan for four supports: a multicenter trial of an intervention to support surrogate decision makers in intensive care units. Ann Am Thorac Soc. 2018;15(9):1083–91.PubMedCrossRef
10.
White DB, Cua SM, Walk R, Pollice L, Weissfeld L, Hong S, et al. Nurse-led intervention to improve surrogate decision making for patients with advanced critical illness. Am J Crit Care. 2012;21(6):396–409.PubMedPubMedCentralCrossRef
11.
White DB, Angus DC, Shields A-M, Buddadhumaruk P, Pidro C, Paner C, et al. A randomized trial of a family-support intervention in intensive care units. N Engl J Med. 2018;378(25):2365–75.PubMedCrossRef
12.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Int Med. 2013;158(3):200–7.PubMedCrossRef
13.
Johnson JG, Vanderwerker LC, Bornstein RF, Zhang B, Prigerson HG. Development and validation of an instrument for the assessment of dependency among bereaved persons. J Psychopathol Behav Assess. 2006;28(4):261–70.CrossRef
14.
Cohen SR, Mount BM, Bruera E, Provost M, Rowe J, Tong K. Validity of the McGill Quality of Life Questionnaire in the palliative care setting: a multi-centre Canadian study demonstrating the importance of the existential domain. Palliat Med. 1997;11(1):3–20.PubMedCrossRef
15.
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168(12):1266–77.PubMedPubMedCentralCrossRef
16.
Chawla N, Ostafin B. Experiential avoidance as a functional dimensional approach to psychopathology: An empirical review. J Clin Psychol. 2007;63(9):871–90.PubMedCrossRef
17.
Hayes SC, Wilson KG, Gifford EV, Follette VM, Strosahl K. Experiential avoidance and behavioral disorders: a functional dimensional approach to diagnosis and treatment. J Consul Clin Psychol. 1996;64(6):1152.CrossRef
18.
Litz BT, Schorr Y, Delaney E, Au T, Papa A, Fox AB, et al. A randomized controlled trial of an internet-based therapist-assisted indicated preventive intervention for prolonged grief disorder. Behav Res Ther. 2014;61:23–34.PubMedPubMedCentralCrossRef
19.
Bryant RA, Kenny L, Joscelyne A, Rawson N, Maccallum F, Cahill C, et al. Treating prolonged grief disorder: a randomized clinical trial. JAMA psychiatry. 2014;71(12):1332–9.PubMedCrossRef
20.
Boelen PA, de Keijser J, van den Hout MA, van den Bout J. Treatment of complicated grief: a comparison between cognitive-behavioral therapy and supportive counseling. J Consult Clin Psychol. 2007;75(2):277.PubMedCrossRef
21.
Walser RD, Westrup D. Acceptance and commitment therapy for the treatment of post-traumatic stress disorder and trauma-related problems: a practitioner's guide to using mindfulness and acceptance strategies. Oakland, CA: New Harbinger Publications; 2007.
22.
Kelly MM, Sido H, Forsyth JP, Ziedonis DM, Kalman D, Cooney JL. Acceptance and commitment therapy smoking cessation treatment for veterans with posttraumatic stress disorder: a pilot study. J Dual Diagn. 2015;11(1):50–5.PubMedCrossRef
23.
McLean C, Follette VM. Acceptance and commitment therapy as a nonpathologizing intervention approach for survivors of trauma. J Trauma Dissociation. 2016;17(2):138–50.PubMedCrossRef
24.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.PubMedCrossRef
25.
R Development Core Team. R: A language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2008.
26.
Higgins PC, Prigerson HG. Caregiver evaluation of the quality of end-of-life care (CEQUEL) scale: the caregiver's perception of patient care near death. PLoS One. 2013;8(6):e66066.PubMedPubMedCentralCrossRef
27.
Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, et al. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. Jama. 2008;300(14):1665–73.PubMedPubMedCentralCrossRef
28.
Prigerson HG, Horowitz MJ, Jacobs SC, Parkes CM, Aslan M, Goodkin K, et al. Prolonged grief disorder: psychometric validation of criteria proposed for DSM-V and ICD-11. PLoS Med. 2009;6(8):e1000121.PubMedPubMedCentralCrossRef
29.
Prigerson HG, Vanderwerker LC, Maciejewski PK. A case for inclusion of prolonged grief disorder in DSM-V. In: Stroebe MS, Hansson RO, Schut H, Stroebe W, editors. Handbook of bereavement research and practice: advances in theory and intervention. Washington: American Psychological Association; 2008. p. 165–86.CrossRef
30.
Zhang B, El-Jawahri A, Prigerson HG. Update on bereavement research: evidence-based guidelines for the diagnosis and treatment of complicated bereavement. J Palliat Med. 2006;9(5):1188–203.PubMedCrossRef
31.
Brunet A, Weiss DS, Metzler TJ, Best SR, Neylan TC, Rogers C, et al. The Peritraumatic Distress Inventory: a proposed measure of PTSD criterion A2. Am J Psychiatry. 2001;158(9):1480–5.PubMedCrossRef
32.
Marmar CR, Weiss DS, Metzler TJ. The Peritraumatic Dissociative Experiences Questionnaire. In: Wilson JP, Keane TM, editors. Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 412–28.
33.
Marmar CR, Weiss DS. The impact of event scale-revised In: Wilson JP, Keane TM, editors. Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399–411.
34.
Gamez W, Chmielewski M, Kotov R, Ruggero C, Suzuki N, Watson D. The brief experiential avoidance questionnaire: development and initial validation. Psych Assess. 2014;26(1):35–45.PubMedCrossRef
35.
Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory (Form Y). Palo Alto: Consulting Psychologists Press; 1983.
36.
Kroenke K, Spitzer RL, Williams JB. The PHQ‐9: validity of a brief depression measure. J G Intern Med. 2001;16(9):606–13.CrossRef
37.
Simons JS, Gaher RM. The distress tolerance scale: development and validation of a self-report measure. Motiv Emot. 2005;29(2):83–102.CrossRef
38.
Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, et al. Validation of a decision regret scale. Med Decis Mak. 2003;23(4):281–92.CrossRef
39.
40.
Schafer JL, Olsen MK. Multiple imputation for multivariate missing-data problems: a data analyst's perspective. Multivariate Behav Res. 1998;33(4):545–71.PubMedCrossRef
41.
Denzin NK, Lincoln YS. The SAGE Handbook of Qualitative Research. Thousand Oaks: SAGE; 2011.
42.
Wasser T, Matchett S. Final version of the critical care family satisfaction survey questionnaire. Crit Care Med. 2001;29(8):1654–5.PubMedCrossRef
43.
Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017;17(1):88.PubMedPubMedCentralCrossRef
44.
Chiambretto P, Moroni L, Guarnerio C, Bertolotti G. Italian validation of the prolonged grief disorder questionnaire (PG-12). Giornale italiano di medicina del lavoro ed ergonomia. 2008;30(1 Suppl A):A105–10.PubMed
45.
Coelho A, Silva C, Barbosa A. Portuguese validation of the Prolonged Grief Disorder Questionnaire—Predeath (PG-12): psychometric properties and correlates. Palliat Support Care. 2017;15(5):544–53.PubMedCrossRef
46.
Pohlkamp L, Kreicbergs U, Prigerson HG, Sveen J. Psychometric properties of the Prolonged Grief Disorder-13 (PG-13) in bereaved Swedish parents. Psychiatry Res. 2018;267:560–5.PubMedCrossRef
Metadata
Title
Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial
Authors
Holly G. Prigerson
Martin Viola
Chris R. Brewin
Christopher Cox
Daniel Ouyang
Madeline Rogers
Cynthia X. Pan
Shayna Rabin
Jiehui Xu
Susan Vaughan
Janna S. Gordon-Elliot
David Berlin
Lindsay Lief
Wendy G. Lichtenthal
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3515-0

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Piloting and evaluating feasibility of a training program to improve patient safety for inter-professional inpatient care teams – study protocol of a cluster randomized controlled trial

Study protocol

Manual therapy as a prophylactic treatment for migraine: design of a randomized controlled trial

Study protocol

Ovarian function after the use of various hemostatic techniques during treatment for endometrioma: protocol for a randomized clinical trial

Study protocol

Use of a smartphone app combined with gamification to increase the level of physical activity of adults and older adults: protocol of a sequential multiple assignment randomized trial

Study protocol

Manual therapy versus therapeutic exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial

Study protocol

Effect of ultrasound-guided lumbar plexus block on emergence agitation in children undergoing hip surgery: study protocol for a randomized controlled trial