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The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis <12 months: protocol for a mixed-methods study including a randomized controlled trial.
Trials. 2018 Aug 14; 19(1):438.T

Abstract

BACKGROUND

The care needs of patients with a limited prognosis (<12 months median) are complex and dynamic. Patients and caregivers must cope with many challenges, including physical symptoms and disabilities, uncertainty. and compromised self-efficacy. Healthcare is often characterized by disruptions in the transition between healthcare providers. The Milestones Communication Approach (MCA) is a structured, proactive, interprofessional concept that involves physicians and nurses and is aimed at providing coherent care across the disease trajectory. This study aims to evaluate these aspects of MCA: (1) the training of healthcare professionals, (2) implementation context and outcomes, (3) patient outcomes, and (4) effects on interprofessional collaboration.

METHODS/DESIGN

A multiphase mixed-methods design will be used for the study. A total of 100 patients and 120 healthcare professionals in a specialized oncology hospital will be involved. The training outcomes will be documented using a questionnaire. Implementation context and outcomes will be explored through semi-structured interviews and written questionnaires with healthcare professionals and with the training participants and through a content analysis of patient files. Patient outcomes will be assessed in a pragmatic non-blinded randomized controlled trial and in qualitative interviews with patients and caregivers. Trial outcomes are supportive care needs (SCNS-SF34-G), quality of life (SeiQol and Fact-L), depression and anxiety symptoms (PHQ-4), and distress (Distress Thermometer). Qualitative semi-structured interviews on patients' views will focus on shared decision-making, communication needs, feeling empathy, and further utilization of healthcare services. Interprofessional collaboration will be explored using the UWE-IP-D before the implementation of MCA (t0) and after 3 (t1), 9 (t2), and 12 (t3) months.

DISCUSSION

Using guideline-concordant early palliative care, MCA aims to foster patient-centered communication with shared decision-making and facilitation of advance care planning including end-of-life decisions, thus increasing patient quality of life and decreasing aggressive medical care at the end of life. It is assumed that the communication skills training and interprofessional coaching will improve the communication behavior of healthcare providers and influence team communications and team processes.

TRIAL REGISTRATION

German Clinical Trials Register, DRKS00013649 and DRKS00013469. Registered on 22 December 2017.

Authors+Show Affiliations

Department of Thoracic Oncology, Thoraxklinik Heidelberg, Heidelberg University Hospital, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL), Röntgenstraβe 1, D-69126, Heidelberg, Germany. anja.siegle@med.uni-heidelberg.de. German Cancer Research Center, Im Neuenheimer Feld 280, 69120, Heidelberg, Germany. anja.siegle@med.uni-heidelberg.de.Department of Thoracic Oncology, Thoraxklinik Heidelberg, Heidelberg University Hospital, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL), Röntgenstraβe 1, D-69126, Heidelberg, Germany.Department of General Practice and Health Services Research, Heidelberg University Hospital, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.Department of General Practice and Health Services Research, Heidelberg University Hospital, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.Department of Thoracic Oncology, Thoraxklinik Heidelberg, Heidelberg University Hospital, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL), Röntgenstraβe 1, D-69126, Heidelberg, Germany. German Cancer Research Center, Im Neuenheimer Feld 280, 69120, Heidelberg, Germany.Institute of Medical Biometry and Informatics, Heidelberg University Hospital, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.Department of Thoracic Oncology, Thoraxklinik Heidelberg, Heidelberg University Hospital, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL), Röntgenstraβe 1, D-69126, Heidelberg, Germany.The German National Institute for State Examinations in Medicine, Pharmacy and Psychotherapy, Groβe Langgasse 8, 55116, Mainz, Germany.The German National Institute for State Examinations in Medicine, Pharmacy and Psychotherapy, Groβe Langgasse 8, 55116, Mainz, Germany.Department of General Practice and Health Services Research, Heidelberg University Hospital, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.Department of Thoracic Oncology, Thoraxklinik Heidelberg, Heidelberg University Hospital, Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research (DZL), Röntgenstraβe 1, D-69126, Heidelberg, Germany.

Pub Type(s)

Journal Article
Pragmatic Clinical Trial
Randomized Controlled Trial

Language

eng

PubMed ID

30107809

Citation

Siegle, Anja, et al. "The Heidelberg Milestones Communication Approach (MCA) for Patients With Prognosis <12 Months: Protocol for a Mixed-methods Study Including a Randomized Controlled Trial." Trials, vol. 19, no. 1, 2018, p. 438.
Siegle A, Villalobos M, Bossert J, et al. The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis <12 months: protocol for a mixed-methods study including a randomized controlled trial. Trials. 2018;19(1):438.
Siegle, A., Villalobos, M., Bossert, J., Krug, K., Hagelskamp, L., Krisam, J., Handtke, V., Deis, N., Jünger, J., Wensing, M., & Thomas, M. (2018). The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis <12 months: protocol for a mixed-methods study including a randomized controlled trial. Trials, 19(1), 438. https://doi.org/10.1186/s13063-018-2814-1
Siegle A, et al. The Heidelberg Milestones Communication Approach (MCA) for Patients With Prognosis <12 Months: Protocol for a Mixed-methods Study Including a Randomized Controlled Trial. Trials. 2018 Aug 14;19(1):438. PubMed PMID: 30107809.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis <12 months: protocol for a mixed-methods study including a randomized controlled trial. AU - Siegle,Anja, AU - Villalobos,Matthias, AU - Bossert,Jasmin, AU - Krug,Katja, AU - Hagelskamp,Laura, AU - Krisam,Johannes, AU - Handtke,Violet, AU - Deis,Nicole, AU - Jünger,Jana, AU - Wensing,Michel, AU - Thomas,Michael, Y1 - 2018/08/14/ PY - 2018/04/26/received PY - 2018/07/18/accepted PY - 2018/8/16/entrez PY - 2018/8/16/pubmed PY - 2018/12/12/medline KW - Communication KW - Complex intervention KW - Implementation KW - Interprofessional relations KW - Multiphase mixed method KW - Palliative care KW - Prognosis KW - Prognostic awareness KW - Randomized controlled trial SP - 438 EP - 438 JF - Trials JO - Trials VL - 19 IS - 1 N2 - BACKGROUND: The care needs of patients with a limited prognosis (<12 months median) are complex and dynamic. Patients and caregivers must cope with many challenges, including physical symptoms and disabilities, uncertainty. and compromised self-efficacy. Healthcare is often characterized by disruptions in the transition between healthcare providers. The Milestones Communication Approach (MCA) is a structured, proactive, interprofessional concept that involves physicians and nurses and is aimed at providing coherent care across the disease trajectory. This study aims to evaluate these aspects of MCA: (1) the training of healthcare professionals, (2) implementation context and outcomes, (3) patient outcomes, and (4) effects on interprofessional collaboration. METHODS/DESIGN: A multiphase mixed-methods design will be used for the study. A total of 100 patients and 120 healthcare professionals in a specialized oncology hospital will be involved. The training outcomes will be documented using a questionnaire. Implementation context and outcomes will be explored through semi-structured interviews and written questionnaires with healthcare professionals and with the training participants and through a content analysis of patient files. Patient outcomes will be assessed in a pragmatic non-blinded randomized controlled trial and in qualitative interviews with patients and caregivers. Trial outcomes are supportive care needs (SCNS-SF34-G), quality of life (SeiQol and Fact-L), depression and anxiety symptoms (PHQ-4), and distress (Distress Thermometer). Qualitative semi-structured interviews on patients' views will focus on shared decision-making, communication needs, feeling empathy, and further utilization of healthcare services. Interprofessional collaboration will be explored using the UWE-IP-D before the implementation of MCA (t0) and after 3 (t1), 9 (t2), and 12 (t3) months. DISCUSSION: Using guideline-concordant early palliative care, MCA aims to foster patient-centered communication with shared decision-making and facilitation of advance care planning including end-of-life decisions, thus increasing patient quality of life and decreasing aggressive medical care at the end of life. It is assumed that the communication skills training and interprofessional coaching will improve the communication behavior of healthcare providers and influence team communications and team processes. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00013649 and DRKS00013469. Registered on 22 December 2017. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/30107809/The_Heidelberg_Milestones_Communication_Approach__MCA__for_patients_with_prognosis_<12_months:_protocol_for_a_mixed_methods_study_including_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2814-1 DB - PRIME DP - Unbound Medicine ER -