Improving Patient and Family Centered Care in Advanced Critical Illness

NCT01844492 | Completed DMC

• 1 other identifier: PRO13020304
• Study Type: interventional
• Target: 1,420
• Locations: 1 country
• Sites: 1

Brief Summary

One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care unit (ICU), typically following decisions made by surrogate decision makers to forego life prolonging treatment. A large body of empirical research has identified deficiencies in care processes that contribute to three important problems: 1) family members often experience poor quality communication with ICU clinicians, leading to lasting psychological distress associated with the ICU experience; 2) patients near the end of life frequently receive invasive, expensive treatment that is inconsistent with their values and preferences, and 3) end-of-life care is a major contributor to health care costs.\[8, 9\] Although advance care planning can prevent some unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis is uncertain, and therefore it seems likely that the need for interventions to improve "in-the-moment" decisions by surrogates will persist.\[10, 11\] In a pilot project, the investigators developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to existing ICU staff (local nurse leaders and social work members of the ICU team); 2) changes care "defaults" to ensure frequent clinician-family meetings; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. The objective of this proposal is to conduct a stepped wedge randomized controlled trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced critical illness and their surrogates.

Conditions

Anxiety; Depression

Keywords

decision making for incapacitated patients; intensive care; surrogate decision making; patient centered care; Palliative Care; End of Life; Quality of Communication

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

  Symptom burden of anxiety and depression in family members in a telephone interview 6 months after enrollment using the validated 14-item Hospital Anxiety and Depression scale (HADS).

  At 6 months

Secondary Outcomes (5)

• Quality of Communication (QOC) scale

  At 6 months

• Patient-and Family Centeredness of Care Scale

  At 6 months

• Intensive Care Unit Length of Stay

  Participants will be followed for duration of ICU stay, an expected average of 21 days.

• Total Hospitalization costs

  Duration of hospital stay, an expected average of 4 weeks

• Impact of Events Scale of Care Scale

  At 6 months

Other Outcomes (4)

• Mortality

  At 6 months

• Katz Activities of Daily Living Scale

  At 6 months

• Hospital Length of Stay

  Participants will be followed for duration of hosptial stay, an expected average of 4 weeks.

Study Arms (2)

ICU Usual Care Control

ACTIVE COMPARATOR

described below

Other: ICU Usual Care Control

The PARTNER Intervention

EXPERIMENTAL

described below

Behavioral: The PARTNER Intervention

Interventions

The PARTNER Intervention BEHAVIORAL

The PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building) consists of: 1) institution of a clinical pathway for family support overseen by ICU staff nurses; 2) advanced communication skills training for ICU staff nurses; 3) a multifaceted strategy to support implementation of the clinical pathway for family support.

The PARTNER Intervention

ICU Usual Care Control OTHER

The control group will receive usual care, in which the frequency and content of clinician-family communication is determined by the clinical team according to their usual practice. No study ICU has a protocolized approach to family communication and instead clinicians determine the timing and frequency of communication with families. All sites have palliative care services.

ICU Usual Care Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Surrogate decision maker for ICU patient in one of 5 UPMC ICU's

You may not qualify if:

• Non-English Speaking
• Surrogate's loved one is for organ transplantation
• Not physically able to participate in family meeting

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Centers

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (15)

• Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. doi: 10.1097/01.ccm.0000114816.62331.08.

  PMID: 15090940 BACKGROUND

• Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7. doi: 10.1164/ajrccm.158.4.9801108.

  PMID: 9769276 BACKGROUND

• Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.

  PMID: 15665319 BACKGROUND

• Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011 Mar 1;154(5):336-46. doi: 10.7326/0003-4819-154-5-201103010-00008.

  PMID: 21357911 BACKGROUND

• Lynn J, Teno JM, Phillips RS, Wu AW, Desbiens N, Harrold J, Claessens MT, Wenger N, Kreling B, Connors AF Jr. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Ann Intern Med. 1997 Jan 15;126(2):97-106. doi: 10.7326/0003-4819-126-2-199701150-00001.

  PMID: 9005760 BACKGROUND

• Murphy DJ, Burrows D, Santilli S, Kemp AW, Tenner S, Kreling B, Teno J. The influence of the probability of survival on patients' preferences regarding cardiopulmonary resuscitation. N Engl J Med. 1994 Feb 24;330(8):545-9. doi: 10.1056/NEJM199402243300807.

  PMID: 8302322 BACKGROUND

• Weeks JC, Cook EF, O'Day SJ, Peterson LM, Wenger N, Reding D, Harrell FE, Kussin P, Dawson NV, Connors AF Jr, Lynn J, Phillips RS. Relationship between cancer patients' predictions of prognosis and their treatment preferences. JAMA. 1998 Jun 3;279(21):1709-14. doi: 10.1001/jama.279.21.1709.

  PMID: 9624023 BACKGROUND

• Riley GF, Lubitz JD. Long-term trends in Medicare payments in the last year of life. Health Serv Res. 2010 Apr;45(2):565-76. doi: 10.1111/j.1475-6773.2010.01082.x. Epub 2010 Feb 9.

  PMID: 20148984 BACKGROUND

• Hogan C, Lunney J, Gabel J, Lynn J. Medicare beneficiaries' costs of care in the last year of life. Health Aff (Millwood). 2001 Jul-Aug;20(4):188-95. doi: 10.1377/hlthaff.20.4.188.

  PMID: 11463076 BACKGROUND

• Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med. 2002 Apr 4;346(14):1061-6. doi: 10.1056/NEJMsa012528.

  PMID: 11932474 BACKGROUND

• Sudore RL, Fried TR. Redefining the "planning" in advance care planning: preparing for end-of-life decision making. Ann Intern Med. 2010 Aug 17;153(4):256-61. doi: 10.7326/0003-4819-153-4-201008170-00008.

  PMID: 20713793 BACKGROUND

• Schneiderman LJ, Gilmer T, Teetzel HD, Dugan DO, Blustein J, Cranford R, Briggs KB, Komatsu GI, Goodman-Crews P, Cohn F, Young EW. Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: a randomized controlled trial. JAMA. 2003 Sep 3;290(9):1166-72. doi: 10.1001/jama.290.9.1166.

  PMID: 12952998 BACKGROUND

• Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.

  PMID: 17267907 BACKGROUND

• Andersen SK, Chang CH, Arnold RM, Pidro C, Darby JM, Angus DC, White DB; Pairing Re-engineered Intensive Care Teams with Nurse-driven Emotional Support, Relationship building (PARTNER) Investigators. Impact of a family support intervention on hospitalization costs and hospital readmissions among ICU patients at high risk of death or severe functional impairment. Ann Intensive Care. 2024 Jul 2;14(1):103. doi: 10.1186/s13613-024-01344-9.

  PMID: 38954149 DERIVED

• White DB, Angus DC, Shields AM, Buddadhumaruk P, Pidro C, Paner C, Chaitin E, Chang CH, Pike F, Weissfeld L, Kahn JM, Darby JM, Kowinsky A, Martin S, Arnold RM; PARTNER Investigators. A Randomized Trial of a Family-Support Intervention in Intensive Care Units. N Engl J Med. 2018 Jun 21;378(25):2365-2375. doi: 10.1056/NEJMoa1802637. Epub 2018 May 23.

  PMID: 29791247 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Death

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas B. White, MD,MAS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Sample size listed is for patients (n=1420), for whom 809 surrogates completed long-term follow-up

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 1, 2013
• Study Start: July 23, 2012
• Primary Completion: February 18, 2016
• Study Completion: February 18, 2016
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

US (1)