Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial (2024)

Bernacki, R., Paladino, J., Neville, B., Hutchings, M., Kavanagh, J., Geerse, O. P., Lakin, J., Sanders, J., Miller, K., Lipsitz, S., Gawande, A., & Block, S. (2019). Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial. Jama Internal Medicine, 179(6), 751-759. https://doi.org/10.1001/jamainternmed.2019.0077

Bernacki, Rachelle ; Paladino, Joanna ; Neville, Bridget et al. / Effect of the Serious Illness Care Program in Outpatient Oncology : A Cluster Randomized Clinical Trial. In: Jama Internal Medicine. 2019 ; Vol. 179, No. 6. pp. 751-759.

@article{7c36c67b65834475a97b75852edd11cf,

title = "Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial",

abstract = "Importance High-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently.Objective To examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes.Design, Setting, and Participants A cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat.Interventions Tools, training, and system changes.Main Outcomes and Measures The coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated.Results Data from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups.Conclusions and Relevance The results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study.",

author = "Rachelle Bernacki and Joanna Paladino and Bridget Neville and Mathilde Hutchings and Jane Kavanagh and Geerse, {Olaf P.} and Joshua Lakin and Justin Sanders and Kate Miller and Stuart Lipsitz and Atul Gawande and Susan Block",

year = "2019",

month = jun,

doi = "10.1001/jamainternmed.2019.0077",

language = "English",

volume = "179",

pages = "751--759",

journal = "Jama Internal Medicine",

issn = "2168-6106",

publisher = "AMER MEDICAL ASSOC",

number = "6",

}

Bernacki, R, Paladino, J, Neville, B, Hutchings, M, Kavanagh, J, Geerse, OP, Lakin, J, Sanders, J, Miller, K, Lipsitz, S, Gawande, A & Block, S 2019, 'Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial', Jama Internal Medicine, vol. 179, no. 6, pp. 751-759. https://doi.org/10.1001/jamainternmed.2019.0077

Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial. / Bernacki, Rachelle; Paladino, Joanna; Neville, Bridget et al.
In: Jama Internal Medicine, Vol. 179, No. 6, 06.2019, p. 751-759.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Effect of the Serious Illness Care Program in Outpatient Oncology

T2 - A Cluster Randomized Clinical Trial

AU - Bernacki, Rachelle

AU - Paladino, Joanna

AU - Neville, Bridget

AU - Hutchings, Mathilde

AU - Kavanagh, Jane

AU - Geerse, Olaf P.

AU - Lakin, Joshua

AU - Sanders, Justin

AU - Miller, Kate

AU - Lipsitz, Stuart

AU - Gawande, Atul

AU - Block, Susan

PY - 2019/6

Y1 - 2019/6

N2 - Importance High-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently.Objective To examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes.Design, Setting, and Participants A cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat.Interventions Tools, training, and system changes.Main Outcomes and Measures The coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated.Results Data from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups.Conclusions and Relevance The results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study.

AB - Importance High-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently.Objective To examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes.Design, Setting, and Participants A cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat.Interventions Tools, training, and system changes.Main Outcomes and Measures The coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated.Results Data from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups.Conclusions and Relevance The results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study.

U2 - 10.1001/jamainternmed.2019.0077

DO - 10.1001/jamainternmed.2019.0077

M3 - Article

SN - 2168-6106

VL - 179

SP - 751

EP - 759

JO - Jama Internal Medicine

JF - Jama Internal Medicine

IS - 6

ER -

Bernacki R, Paladino J, Neville B, Hutchings M, Kavanagh J, Geerse OP et al. Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial. Jama Internal Medicine. 2019 Jun;179(6):751-759. doi: 10.1001/jamainternmed.2019.0077