PARTNER II: Improving Patient and Family Centered Care in Advanced Critical Illness

This is a stepped wedged randomized controlled trial comparing the PARTNER intervention with usual care in 5 Intensive Care Units. The overarching goal of this research project to ensure patient-centered decisions about the use of intensive treatments for patients with advanced critical illness. In a prior project, the investigators developed the PARTNER program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs, including: 1) changing care "defaults" to ensure clinician-family meetings within 48 hours of enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, 3) increased use of palliative care services for patients with a poor prognosis. The investigators propose to begin deployment of the PARTNER II program in the spring of 2015 enrolling 690 surrogate decision makers in 5 ICUs using a stepped wedge design. The investigators expect to achieve the following project goals: To increase the patient-centeredness of end-of-life decisions, and to increase the quality of clinician-family communication. To decrease the psychological burden on family members acting as surrogates. To reduce total health care costs by decreasing the duration of use of burdensome, invasive treatments at the end of life.

decision making for incapacitated patients, intensive care, surrogate decision making, patient centered care, palliative care

The control group will receive usual care, in which the frequency and content of physician-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.

The PARTNER intervention is a multifaceted intervention delivered by a trained "PARTNER Champion" who has undergone 16 hours of intense communication training, with audit and feedback, quarterly booster training, and expert implementation support. Additionally, there is academic detailing of ICU physicians and ICU bedside nurses to augment the intervention. The PARTNER Intervention deploys three strategies to improve: 1) the timeliness and frequency of clinician-family communication, 2) the emotional and decision support provided to families and 3) the appropriate involvement of palliative care specialists.

The PARTNER intervention is a multifaceted intervention delivered by a trained "PARTNER Champion" who has undergone 16 hours of intense communication training, with audit and feedback, quarterly booster training, and expert implementation support. Additionally, there is academic detailing of ICU physicians and ICU bedside nurses to augment the intervention. The PARTNER Intervention deploys three strategies to improve: 1) the timeliness and frequency of clinician-family communication, 2) the emotional and decision support provided to families and 3) the appropriate involvement of palliative care specialists.

We will assess quality of communication in family members in a telephone interview 6 months after enrollment using the validated13 item Quality of Communication Scale.

We will assess 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).

We will assess Patient Centeredness of Care, using the 12-item Patient-Perceived Patient-Centeredness of Care Scale (PPPC) adapted for use by surrogates.

We will assess the Intensive Care Unit length of stay as assessed by abstraction of this information from the medical record.

We will assess symptoms of post-traumatic stress in family members in a telephone interview 6 months after enrollment using the validated 22 item Impact of Events Scale.

We will assess Decisional Regret by family members in a telephone interview 6 months after enrollment using the validated 5 item Decision Regret Scale across treatment groups.

We will assess hospital mortality and 6-month mortality using hospital records, 6 month follow-up with surrogates, and the National Death Index in cases in which participants are lost to telephone follow up.

We will assess functional status of the patient using the validated Katz Activities of Daily Living Scale at 6 months.

We will assess hospital length of stay by abstraction of this information from the medical record at hospital discharge.

We will measure total hospitalization costs by aggregating each patient's total service specific costs, generated from hospital administrative records.

We will assess patient health care utilization using hospital records and through validated methods to assess utilization using standardized interviews with surrogates at 6 months.

Inclusion Criteria: 18 years of age or older Surrogate decision maker for ICU patient in one of 5 UPMC ICU's Exclusion Criteria: Non-English Speaking Surrogate's loved one is for organ transplantation Not physically able to participate in family meeting

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.

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.

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.

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.

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.

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.

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. Erratum In: JAMA 2000 Jan 12;283(2):203.

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.

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.

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.

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.

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.

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. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.

Bedell SE, Pelle D, Maher PL, Cleary PD. Do-not-resuscitate orders for critically ill patients in the hospital. How are they used and what is their impact? JAMA. 1986 Jul 11;256(2):233-7.

Eidelman LA, Jakobson DJ, Pizov R, Geber D, Leibovitz L, Sprung CL. Foregoing life-sustaining treatment in an Israeli ICU. Intensive Care Med. 1998 Feb;24(2):162-6. doi: 10.1007/s001340050539.

Faber-Langendoen K. The clinical management of dying patients receiving mechanical ventilation. A survey of physician practice. Chest. 1994 Sep;106(3):880-8. doi: 10.1378/chest.106.3.880.

Keenan SP, Busche KD, Chen LM, McCarthy L, Inman KJ, Sibbald WJ. A retrospective review of a large cohort of patients undergoing the process of withholding or withdrawal of life support. Crit Care Med. 1997 Aug;25(8):1324-31. doi: 10.1097/00003246-199708000-00019.

Koch KA, Rodeffer HD, Wears RL. Changing patterns of terminal care management in an intensive care unit. Crit Care Med. 1994 Feb;22(2):233-43. doi: 10.1097/00003246-199402000-00013.

Smedira NG, Evans BH, Grais LS, Cohen NH, Lo B, Cooke M, Schecter WP, Fink C, Epstein-Jaffe E, May C, et al. Withholding and withdrawal of life support from the critically ill. N Engl J Med. 1990 Feb 1;322(5):309-15. doi: 10.1056/NEJM199002013220506.

Vernon DD, Dean JM, Timmons OD, Banner W Jr, Allen-Webb EM. Modes of death in the pediatric intensive care unit: withdrawal and limitation of supportive care. Crit Care Med. 1993 Nov;21(11):1798-802. doi: 10.1097/00003246-199311000-00035.

Vincent JL, Parquier JN, Preiser JC, Brimioulle S, Kahn RJ. Terminal events in the intensive care unit: review of 258 fatal cases in one year. Crit Care Med. 1989 Jun;17(6):530-3. doi: 10.1097/00003246-198906000-00009.

Youngner SJ, Lewandowski W, McClish DK, Juknialis BW, Coulton C, Bartlett ET. 'Do not resuscitate' orders. Incidence and implications in a medical-intensive care unit. JAMA. 1985 Jan 4;253(1):54-7. doi: 10.1001/jama.253.1.54.

Sprung CL, Cohen SL, Sjokvist P, Baras M, Bulow HH, Hovilehto S, Ledoux D, Lippert A, Maia P, Phelan D, Schobersberger W, Wennberg E, Woodcock T; Ethicus Study Group. End-of-life practices in European intensive care units: the Ethicus Study. JAMA. 2003 Aug 13;290(6):790-7. doi: 10.1001/jama.290.6.790.

Prendergast TJ, Luce JM. Increasing incidence of withholding and withdrawal of life support from the critically ill. Am J Respir Crit Care Med. 1997 Jan;155(1):15-20. doi: 10.1164/ajrccm.155.1.9001282.

Kirchhoff KT, Walker L, Hutton A, Spuhler V, Cole BV, Clemmer T. The vortex: families' experiences with death in the intensive care unit. Am J Crit Care. 2002 May;11(3):200-9.

Tilden VP, Tolle SW, Garland MJ, Nelson CA. Decisions about life-sustaining treatment. Impact of physicians' behaviors on the family. Arch Intern Med. 1995 Mar 27;155(6):633-8.

Tilden VP, Tolle SW, Nelson CA, Fields J. Family decision-making to withdraw life-sustaining treatments from hospitalized patients. Nurs Res. 2001 Mar-Apr;50(2):105-15. doi: 10.1097/00006199-200103000-00006.

A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8. Erratum In: JAMA 1996 Apr 24;275(16):1232.

Hofmann JC, Wenger NS, Davis RB, Teno J, Connors AF Jr, Desbiens N, Lynn J, Phillips RS. Patient preferences for communication with physicians about end-of-life decisions. SUPPORT Investigators. Study to Understand Prognoses and Preference for Outcomes and Risks of Treatment. Ann Intern Med. 1997 Jul 1;127(1):1-12. doi: 10.7326/0003-4819-127-1-199707010-00001.

Curtis JR, Engelberg RA, Bensink ME, Ramsey SD. End-of-life care in the intensive care unit: can we simultaneously increase quality and reduce costs? Am J Respir Crit Care Med. 2012 Oct 1;186(7):587-92. doi: 10.1164/rccm.201206-1020CP. Epub 2012 Aug 2.

Luce JM, Rubenfeld GD. Can health care costs be reduced by limiting intensive care at the end of life? Am J Respir Crit Care Med. 2002 Mar 15;165(6):750-4. doi: 10.1164/ajrccm.165.6.2109045. No abstract available.

White DB, Arnold RM. The evolution of advance directives. JAMA. 2011 Oct 5;306(13):1485-6. doi: 10.1001/jama.2011.1430. No abstract available.

Hawkins NA, Ditto PH, Danks JH, Smucker WD. Micromanaging death: process preferences, values, and goals in end-of-life medical decision making. Gerontologist. 2005 Feb;45(1):107-17. doi: 10.1093/geront/45.1.107.

Song MK, Ward SE, Happ MB, Piraino B, Donovan HS, Shields AM, Connolly MC. Randomized controlled trial of SPIRIT: an effective approach to preparing African-American dialysis patients and families for end of life. Res Nurs Health. 2009 Jun;32(3):260-73. doi: 10.1002/nur.20320.

Danis M. Improving end-of-life care in the intensive care unit: what's to be learned from outcomes research? New Horiz. 1998 Feb;6(1):110-8.

Institute of Medicine (US) Committee on Identifying Priority Areas for Quality Improvement; Adams K, Corrigan JM, editors. Priority Areas for National Action: Transforming Health Care Quality. Washington (DC): National Academies Press (US); 2003. Available from http://www.ncbi.nlm.nih.gov/books/NBK221294/

Institute of Medicine (US) Committee on the Robert Wood Johnson Foundation Initiative on the Future of Nursing, at the Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK209880/

Lincoln T, Shields AM, Buddadhumaruk P, Chang CH, Pike F, Chen H, Brown E, Kozar V, Pidro C, Kahn JM, Darby JM, Martin S, Angus DC, Arnold RM, White DB. Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs. BMJ Open. 2020 Mar 29;10(3):e033521. doi: 10.1136/bmjopen-2019-033521.