A Randomized Trial of a Family-Support Intervention in Intensive Care Units

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1 The new england journal of medicine Original Article A Randomized Trial of a Family-Support Intervention in Intensive Care Units D.B. White, D.C. Angus, A.-M. Shields, P. Buddadhumaruk, C. Pidro, C. Paner, E. Chaitin, C.-C.H. Chang, F. Pike, L. Weissfeld, J.M. Kahn, J.M. Darby, A. Kowinsky, S. Martin, and R.M. Arnold, for the PARTNER Investigators* N Engl J Med.2018 Jun 21;378(25): ICU 2018/8/21

2 51ICUICU Crit Care Med 2004;32: JAMA 2003;290: N Engl J Med 2010;362:

3 ICU ICU90% ICU3540 Crit Care Med, (10): p moral distress Am J Crit Care, (5): p

4 ICU Crit Care Med 2013; 41: Crit Care Med 2012;40: Am J Respir Crit Care Med 2005;171: Crit Care Med 2007;35: JAMA 2016;315:

5 Am J Respir Crit Care Med 2005;171: Ann Intern Med 2011;154: JAMA Intern Med 2017;177: J Am Geriatr Soc 2002;50:930-4.

6 ICU 1) PTSD 1/3 Ann Intern Med, (5): p Am J Respir Crit Care Med, (9): p

7 ICU 2) SUPPORT trial JAMA, : p ) 25% Health Serv Res, (2): p

8 Crit Care Med 2017;45: Crit Care Med 2016;44: Crit Care Med 2008;36: Crit Care Med 2012;40: ICU

9 -PARTNER intervention- Mitigating effect PARTNER Intervention Supplement protocol

10 --

11 -- ICU PARTNER (Pairing Re-engineered ICU Teams with Nurse- Driven Emotional Support and Relationship-Building) trial 6 IRBquality-improvement project

12 PARTNER trial ICU ICU ICU 2 ICU

13 -- UPMCUniversity of Pittsburgh Medical Center Health System55ICU 2ICU ü 2ICUICU üattending physician 5ICU

14 Stepped Wedge cluster-randomized trial ICUphasephase wedge 6phase ICU ICUICU Table 4. Stepped Wedge Deployment Schedule Study B1 B2 B3 B4 B5 B6 ICU ICU 1 UC P P P P P ICU 2 UC UC P P P P ICU 3 UC UC UC P P P ICU 4 UC UC UC UC P P ICU 5 UC UC UC UC UC P B1, B2, etc= Block 1, Block 2; UC= Usual care; P= PARTNER intervention

15 -Participants- Ø Inclusion criteria 18 ü ü 40 %( ü 40% Exclusion criteria Ø 18

16 -Outcome- Primary outcome HADS(Hospital Anxiety and Depression Scale Secondary outcome IES Impact of Event Scale PTSD QOCQuality of Communication PPPC(Modified Patient Perception of Patient Centeredness ICU

17 Primary outcome HADS(Hospital Anxiety and Depression Scale 147/ ü 07 ü 810 ü 11 HADS

18 Secondary outcome IES Impact of Event Scale PTSDPost Traumatic Stress Disorder 157 /8 50:4: 30PTSD

19 Secondary outcome QOCQuality of Communication / 13 0 the very worst 10 the very best11 wash- ington.edu /eolcare /instruments /index. Html J Palliat Med, (5): p

20 Secondary outcome mpppc(modified Patient Perception of Patient Centeredness PPPC /Wellness /Wellness Patient Experience Journal , pp

21 -- PARTNER ICU46 ICU ICU

22 ICU Charge nurse, clinical nurse specialists, care coordinators/ social workers website

23 PARTNER Before Interdisciplinary Meeting with Family Provides emotional support Explains what to expect in the meeting Elicits main concerns and completes question prompt list Before Interdisciplinary Meeting with Family Provides emotional support Explains what to expect in the meeting Elicits main concerns and completes question prompt list Identifies Patient as Eligible for Enrollment Interdisciplinary Meeting with Family Provides emotional support Ensures that the family s main questions are answered Brings the conversation back to the patient as an individual Ensures that the treatment options are discussed Ensures that there is a clear follow-up plan Interdisciplinary Meeting with Family Provides emotional support Ensures that the family s main questions are answered Brings the conversation back to the patient as an individual Ensures that the treatment options are discussed Ensures that there is a clear follow-up plan First Meeting with Family Performs introduction Provides emotional support using NURSE behaviors Gets to know the family and the patient as individuals Orients the family to the ICU After Interdisciplinary Meeting with Family Attends to emotions raised during the meeting Elicits questions Corrects any misunderstandings of issues addressed during the meeting Check-In Checks in on a daily basis to see how the family is doing Updates the family on the plan for the day Provides emotional support Elicits questions and concerns After Interdisciplinary Meeting with Family Attends to emotions raised during the meeting Elicits questions Corrects any misunderstandings of issues addressed during the meeting Continued Care Performs the check-in on a daily basis Conducts the interdisciplinary meeting with the family at least every 5 to 7 days Patient s ICU Admission Day 1 Day 2 (within 48 hr after enrollment) 2 Days 3 6 Day 7 Day >7 57 Patient s Death or Discharge Figure 1. Activities of the PARTNER Nurse in the Family-Support Pathway. ICU denotes intensive care unit; NURSE naming, understanding, respecting, supporting, exploring; and PARTNER Pairing Re-engineered ICU Teams with Nurse-Driven Emotional Support and Relationship-Building.

24 Table 6 PARTNER Nurses Activities in Care Pathway for Family Support Component of Care Pathway Core Activities First meeting with family 6. Introduce the PARTNER Program and role of PARTNER nurse. 7. Provide emotional support using NURSE behaviors. 8. Get to know the family and the patient as individuals. 9. Elicit questions and concerns. 10. Orient family to the ICU. Pre-meeting with family 4. Provide emotional support 5. Explain what to expect in interdisciplinary family meeting. 6. Elicit main concerns and complete question prompt list. Interdisciplinary family meeting (IDFM) 7. Provide emotional support 8. Ensure that the family s main questions are answered. 9. Bring the conversation back to the patient as a person. 10. Ensure that prognosis is discussed. 11. Ensure that treatment options are discussed. 12. Ensure that there is a clear follow-up plan. Post-meeting with family 4. Attend to emotions raised during IDFM. 5. Elicit questions 6. Correct any misunderstandings by family of information that the physician conveyed during IDFM. Daily check-in 5. Check in to see how family is doing. 6. Update family on plan for the day. 7. Provide emotional support. 8. Elicit question and concerns. PARTNERPARTNE prompt list /

25 PARTNER Question Prompt List Questions About My Loved One It s normal for families to have questions about what is happening with their loved one s illness and treatment. Please check the questions that you would like the doctor or ICU team to answer. Disease Information What is wrong with my loved one? What treatments is my loved one receiving? Prognosis What happens to most people with the kind of illness my loved one has? My Loved One s Values How can I make sure the doctors know about my loved one s values and treatment preferences? What should my role be in making treatment decisions? Options What are the different treatment options that we should be thinking about? Milestones How can we tell if my loved one is getting better or worse? Social How do people cope with having a loved one in the ICU? How do most people discuss the stress of having someone in the ICU with their family and friends? Who can provide information about insurance and financial issues? Is there a chaplain or other spiritual support available in the hospital? What should I do if I get conflicting information from the different doctors? Please write any other questions you have for the care team: Prompt list Questions the Doctor May Ask You: Have you ever made decisions for a loved one who was too sick to make decisions? What was your loved one like before this hospitalization. What does he or she do/enjoy? Has your loved one ever talked about treatment preferences and values if he or she were very sick? What role would you like to play in major medical decisions for your loved one?

26 Schedule of PARTNER Program 12- Hour Communication Skills Training Schedule of PARTNER Program 12-Hour Communication Skills Training DAY 2 8:00--8:15 a.m. Registration and Breakfast 8:15--8:30 a.m. Overview of Today - Intervention Training Day 2 --Pre Meeting with Doctors --Family Meetings --Post-Family Meeting DAY 1 8:15--8:30 a.m. Registration and Breakfast 8:30--9:00 a.m. PARTNER Overview 9:00--9:30 a.m. Overview of Core Communication Skills 9:30--10:00 a.m. First Meeting with Family (Didactic/modeling) 10:00 10:45 a.m. Skills Practice I: First Meeting with Family 10:45--11:00 a.m. BREAK 11:00 11:45 a.m. Skills Practice ll: First Meeting with Family 11:45 am--12:15 p.m. LUNCH 12:15--12:30 p.m. Making Family Meetings Happen 12:30--1:00 p.m. Pre-Family Meeting (Didactic/modeling) 1:00--2:00 p.m. Skills Practice lll: Pre-Family Meeting 2:00--2:15 p.m. BREAK 2:15--2:30 p.m. Daily Check-in (Didactic/modeling) 2:30--3:00 p.m. Skills Practice lv: Daily Check-in 3:00--3:15 p.m. Taking the Skills Home 3:15--3:30 p.m. Next steps and Program Evaluation 8:30--8:45 a.m. 8:45--9:00 a.m. 9:00 9:30 a.m. 9:30--9:45 a.m. 9:45--10:45 a.m. 10:45 a.m.--11:15 a.m. 11: :45 a.m. 11:45 12:15 p.m. 12:15 12:30 p.m. 12:30 12:45 p.m. Review and Model Key Activities of PARTNER Program (Intervention Training Day 1) -- First Meeting with Family --Pre-Family Meeting --Daily Check-in --Making Family Meetings Happen Pre Meeting with Doctors -- Didactic Talk -- Role Model Skills Pre Meeting with Doctors --Skills Practice Gently Intervening in Family Meetings -- Didactic Talk -- Role Model Skills Gently Intervening: Skills Practice --Practice Activities/Skills --Gently Intervening Skills Practice LUNCH Review and Model Skills for Post-Family Meeting --Skills Practice Documentation Q & A Program Evaluation

27 ICUPARTNER ICU PARTNER ICUPARTNER ICUICU 35/1ICU ICUPARTNER2 health system s Quality Improvement department 23 ü

28 -- 6 ü primaryicuicu SAPS Karz Index0-6 4scaleHADS,IES,QOC,mPPPC Social Security Death Master File

29 HADS 1.54 Health Qual Life Out- comes 2008;6: % 625% Intention-to-treat Primary/Secondary outcome 6Gray 2 SAPS

30

31 Table 1. Characteristics of the Patients and Surrogates at Baseline.* Characteristic Intervention Control P Value Patients Total no Age yr 67.5± ±15.5 <0.001 Female sex no. (%) 290 (53.0) 405 (46.4) 0.02 Primary diagnosis no. (%) <0.01 Cardiovascular cause 33 (6.0) 36 (4.1) Pulmonary cause 107 (19.6) 138 (15.9) Gastrointestinal cause 49 (9.0) 94 (10.8) Toxicologic cause 18 (3.3) 38 (4.4) Infection or sepsis 159 (29.1) 212 (24.4) Neurologic cause 106 (19.4) 173 (19.9) Oncologic cause 18 (3.3) 59 (6.8) Other 56 (10.3) 118 (13.6) Source of admission to the ICU no. (%) <0.001 Direct admission 50 (9.1) 224 (25.7) Transfer from emergency department 422 (77.2) 549 (62.9) Transfer from other hospital 73 (13.4) 100 (11.5) Transfer from skilled nursing facility 2 (0.4) 0 Modified SAPS III 51.0± ± Elixhauser Comorbidity Index score 5.8± ±2.5 <0.001 Use of mechanical ventilation during hospitalization no. (%) Surrogates 479 (87.6) 759 (86.9) 0.73 Total no Age yr 57.1± ± Female sex no. (%) 284 (66.2) 480 (70.9) 0.06 Relationship to patient no. (%) 0.04 Spouse or partner 161 (37.5) 295 (43.6) Parent 28 (6.5) 63 (9.3) Child 163 (38.0) 197 (29.1) Sibling 53 (12.4) 81 (12.0) Other 24 (5.6) 41 (6.1) ICU SAPS * Plus minus values are means ±SD. Percentages may not sum to 100 because of rounding. ICU denotes intensive care

32 6 Table S3. Comparison of characteristics of patients whose surrogate completed versus did not consent to 6-month interview Patient characteristics Did not complete 6 month followup (n=611) Completed 6 month follow up (n=809) p-value a Total Age, mean (SD) 64.9 (15.2) 64.9 (15.6) (15.4) Female, No. (%) 309 (50.6) 386 (47.7) (48.9) Race, No. (%) White Black Hispanic Other Not documented Primary Diagnosis, count (%) Cardiovascular Pulmonary GI Toxicology Infection/Sepsis Neurological Oncological Other Not documented Admission source, No. (%) Direct Emergency Other hospital SNF 538 (81.0) 66 (9.9) 1 (0.2) 8 (1.2) 51 (7.7) 28 (4.6) 102 (16.7) 61 (10.0) 27 (4.4) 174 (28.5) 115 (18.8) 35 (5.7) 66 (10.8) 3 (0.5) 674 (83.3) 48 (5.9) 1 (0.1) 5 (0.6) 81 (10.0) 41 (5.1) 143 (17.7) 82 (10.1) 29 (3.6) 197 (24.4) 164 (20.3) 42 (5.2) 108 (13.4) 3 (0.4) (82.3) 114 (7.7) 2 (0.1) 13 (0.9) 132 (9.0) 69 (4.9) 245 (17.3) 143 (10.1) 56 (3.9) 371 (26.1) 279 (19.7) 77 (5.4) 174 (12.3) 6 (0.4) 109 (17.8) 422 (69.1) 80 (13.1) (20.4) 549 (67.9) 93 (11.5) 2 (0.3) (19.3) 971 (68.4) 173 (12.2) 2 (0.1) Modified SAP II score, mean (SD) 50.2 (12.1) 49.8 (11.8) (11.9) Elixhauser comorbidity index score (0-29), mean (SD) 5.5 (2.6) 5.3 (2.5) (2.5) Received mechanical ventilation during the hospitalization, No. (%) 526 (86.1) 712 (88.0) (87.1) a From Student s t-test or Pearson's chi-squared test 6 :809 ICU SAPS

33 Stepped Wedge cluster-randomized trial Figure S1. Stepped Wedge Allocation of Trial Patients and Surrogates Study ICU Step 0 Step 1 Step 2 Step 3 Step 4 Step 5 Total 1 65 Patients enrolled 52 Surrogates agreed to follow-up 36 Completed follow up Patients enrolled 103 Surrogates agreed to follow-up 65 Completed follow up Patients enrolled 168 Surrogates agreed to follow-up 127 Completed follow up Patients enrolled 197 Surrogates agreed to follow-up 158 Completed follow up 208 Patients enrolled 159 Surrogates agreed to follow-up 119 Completed follow up 106 Patients enrolled a 75 Surrogates agreed to follow-up 53 Completed follow up 114 Patients enrolled 108 Surrogates agreed to follow-up 72 Completed follow up 67 Patients enrolled b 41 Surrogates agreed to follow-up 28 Completed follow up 273 Patients enrolled 211 Surrogates agreed to follow-up 155 Completed follow up 242 Patients enrolled 178 Surrogates agreed to follow-up 118 Completed follow up 337 Patients enrolled 276 Surrogates agreed to follow-up 199 Completed follow up 322 Patients enrolled 238 Surrogates agreed to follow-up 186 Completed follow up Patients enrolled 157 Surrogates agreed to follow-up 115 Completed follow up White shading= usual care; Blue shading = intervention a Last patient enrolled on 7/1/2014 because this ICU was closed by the hospital administration. b ICU decreased in size from 28 beds to 20 beds on 7/1/2014. Phase 52 Patients enrolled 46 Surrogates agreed to follow-up 36 Completed follow up Phase 246 Patients enrolled 203 Surrogates agreed to follow-up 151 Completed follow up TOTAL 1420 Patients enrolled 1106 Surrogates agreed to follow-up 809 Completed follow up ICUphase phasewedge

34 Primary /Secondary Outcomes Table 2. Primary and Secondary Outcomes.* Outcome Unadjusted Analysis Adjusted Analysis Intervention Control Intervention Control Estimated Effect of Intervention (95% CI) P Value mean (95% CI) Surrogates burden of psychological symptoms No. of surrogates assessed HADS score 11.7± ± (10.7 to 12.7) 12.0 (11.3 to 12.8) 0.34 ( 1.67 to 0.99) 0.61 IES score 20.5± ± (19.3 to 23.2) 20.3 (18.8 to 21.9) 0.90 ( 1.66 to 3.47) 0.49 Quality of decision making and communication No. of surrogates assessed QOC score 69.7± ± (66.2 to 72.0) 62.7 (60.4 to 65.0) 6.39 (2.57 to 10.20) Modified PPPC score** 1.6± ± (1.6 to 1.7) 1.8 (1.8 to 1.9) 0.15 ( 0.26 to 0.04) Health care utilization No. of patients assessed Length of ICU stay days 8.1± ± (6.1 to 7.2) 7.4 (7.0 to 7.9) 0.90 (0.81 to 1.00) Length of hospital stay days 11.8± ± (9.5 to 11.3) 13.5 (12.6 to 14.4) 0.77 (0.69 to 0.87) <0.001 * Plus minus values are means ±SD. HADS,IESPTSD QOC,mPPPC ICU

35 Patients Clinical Outcomes Table 3. Patients Clinical Outcomes. Outcome Unadjusted Analysis Adjusted Analysis* Intervention (N = 547) Control (N = 873) Intervention (N = 547) Control (N = 873) Odds Ratio (95% CI) P Value no. of patients (%) % (95% CI) In-hospital death 208 (38.0) 264 (30.2) 36.0 (26.2 to 45.7) 28.5 (20.1 to 36.9) 1.43 (1.10 to 1.87) Death at 6 mo 339 (62.0) 472 (54.1) 60.4 (56.0 to 64.9) 55.4 (51.9 to 59.0) 1.18 (0.93 to 1.50) 0.17 Living independently at home at 6 mo 3 (1.0) 13 (2.6) 0.8 ( 0.5 to 2.2) 0.7 ( 0.2 to 1.6) 1.15 (0.13 to 9.89) 0.90 * Adjusted analyses were performed with regression models. All models were adjusted for patient s age, modified SAPS III, Elixhauser 66

36 TABLE S1. Costs to Deploy the Intervention 12-hour communication skills training course for staff nurses at each site. Ten daily site visits by QI specialist at beginning of intervention phase at each site (4 hours each). Description of Expenses Hourly wages for nurses being trained, time of 2 medical actors, 1 instructor, and QI implementation specialist; printed training materials, facility rental, and meals for all attendees. Hourly wage of QI implementation specialist; parking and travel expenses. Cost (in U.S.D) $23, $11, ICU Weekly site visits by QI implementation specialist throughout intervention phase at each site (4 hours each). 170 Hourly wage of QI implementation specialist; parking and travel expenses. $58, TOTAL COST $92, Costs per patient who received the $ intervention (N=547)

37 -Primary outcome- Primary outcome6hads 2 JAMA 2016;316: Am J Respir Crit Care Med 2016;193: ) ICU ICU J Palliat Med 2006;9: ) Ann Intern Med 2011;154: ) N Engl J Med 2007; 356:

38 -- ICU ICU 6 6 -

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42 The new england journal of medicine Editorial Nurse-Led Communication in the Intensive Care Unit Daniela Lamas, M.D.

43 N Engl J Med 2010;362: Crit Care Med 2013;41: Crit Care Med 2012;40: Am J Respir Crit Care Med 2005;171:

44 12 6 /

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47 ü 2 Before-after RCT 5ICUPhase ü ICU QOL EDITORIAL

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