Background
The care of patients with a limited prognosis is complex and demanding. Moreover, the process of care is often interrupted by quick transitions between healthcare settings and providers, especially for cancer patients [
1], leading to a lack of continuity in care. Throughout the disease trajectory, patients and caregivers must deal with receiving bad news at short intervals. The terminal character of a limited prognosis means that patients need to engage in advance care planning and end-of-life decision-making. Therefore, patients and their caregivers must deal with several dimensions of burden (physical, psychological, social, financial, and spiritual) [
2].
The quality of care for patients with advanced cancer hinges, among other factors, on the communication skills of the healthcare professionals involved. Delivering bad news, discussing prognoses and possible disease trajectories (best case and worst case), and preparing others for the end of life are challenging communication topics and demand highly skilled professionals [
3]. Yet, patients, caregivers, and the healthcare professionals themselves often perceive these skills to be insufficient [
4,
5].
The German National Cancer Plan [
6] and other medical societies recommend that healthcare providers should improve their communication skills [
6‐
8]. Indeed, different communication training programs have been developed and evaluated successfully for the medical curriculum [
9,
10]. Yet, most of these programs focus on basic communication skills in specific situations [
11‐
14] without considering the whole disease trajectory. Furthermore, communication modules concerning palliative care have been developed but refer mainly to the transition to the best supportive care for the terminally ill [
15]. The positive results of trials regarding the early integration of palliative care [
16,
17] additionally challenge patient–physician communications as they leave the oncologist with the task of addressing palliative care early in the course of disease.
These trials and others that evaluate the training of communication skills in oncology have shown multiple benefits: improvement of quality of life and advance care planning for patients, improvement in job satisfaction, and decrease of burden on professionals [
12,
13,
18‐
21]. Additionally, different studies on palliative care show that multi-professional approaches are more effective [
16,
22‐
24].
For advanced lung cancer, forward-thinking communication has been described for the German setting [
25]. This introduces standardized steps of communication at turning points of treatment, such as first disclosure of diagnosis, disease progression, and transition to best supportive care. Based on findings from interviews with patients and caregivers and focus groups with healthcare professionals, a structured longitudinal concept has been developed: the Heidelberg Milestones Communication Approach (MCA) [
5,
26,
27].
MCA is a pro-active, interprofessional concept that involves physicians and nurses and is aimed at providing coherent care that integrates palliative care early and across the disease trajectory. It provides intervention-based communication to develop patient-centered care further through increasingly integrating patient preferences. Metastatic lung cancer has been used as a model disease in developing MCA. Not only is there a limited prognosis with a median survival of less than 12 months but it is also associated with a substantial existential uncertainty and a high symptom burden with detrimental impact on patients and caregivers [
27,
28]. However, institutional strategies for implementing longitudinally structured communication concepts such as MCA and knowledge about the effects of implementation are still lacking.
Many interventions in clinical and health services research fail to translate into practice and policy [
29]. Implementation processes are complex, take a long time, and are cost intensive [
30,
31]. Therefore, the effects and implementation of an intervention need to be evaluated concurrently. Furthermore, implementations are influenced by individual health, professional factors, patient factors, professional interactions, incentives and resources, capacity for organizational change, as well as by social, political, and legal factors [
32].
Aims and objective
This study aims to evaluate these aspects of MCA:
1.
training of healthcare professionals
2.
implementation context and outcomes
4.
effects on interprofessional collaboration.
Methods/design
Multiphase mixed-methods design
Since several perspectives (patient, family caregiver, and healthcare professional) and different interventions (communication concept, training, and implementation) at different stages (development, implementation, and evaluation) are relevant, a mixed-methods design has been chosen [
33‐
35]. Our aims contain complex multidimensional processes (social, cognitive, and cultural) and multiple stakeholders (patients, caregivers, and healthcare professionals). To evaluate outcomes, a randomized controlled trial (RCT) and interviews with patients and caregivers are planned. To evaluate processes and context, a combination of quantitative and qualitative methods will be applied [
35]. The multiphase mixed-methods design allows a comprehensive understanding of the effects of MCA [
34].
Phase 1: development of the Heidelberg MCA
Our previous studies in phase 1 included a qualitative exploration of patients’ and caregivers’ experiences over the disease trajectory and the assessment of healthcare professionals’ views of a hypothetical structured and forward-thinking communication approach [
5,
26,
27]. Based on these results, Heidelberg MCA was developed as a complex intervention: (a) to address the communication needs of patients and caregivers, (b) to improve continuity of care, (c) to improve individual quality of life of patients and their caregivers, (d) to foster shared decision-making including end-of-life decisions, and (e) to enhance communication competencies and team processes of the interprofessional oncology team.
In a second step, we led in-depth interviews with nurses and focus group interviews with physicians at our institution to explore the enablers and barriers of implementation as well as interprofessional collaboration concerning all four components of MCA. Based on the results of these interviews, MCA was adapted and now contains the following components (see Table
1):
Table 1
MCA complex intervention components
Communication training | Two training sessions with simulated patients and video assessment Two training sessions in a clinical setting including individualized feedback Coaching | MCA conversation components Communication skills Attitude Empathy Prognostic awareness |
Milestone conversations | Diagnosis | Breaking bad news Treatment options Outlining follow-up and contact with nurse |
Stable phase | Question-prompt-list Prognostic awareness Advance care planning Palliative care needs |
Progression | Question-prompt-list Breaking bad news Prognostic awareness Treatment options Advance care planning Palliative care needs |
Transition to best supportive care | Question-prompt-list Breaking bad news Prognostic awareness Advance care planning Symptom treatment Palliative care needs |
Follow-up sessions | Patient is contacted every month by telephone or during a routine clinic visit by a nurse | Palliative care assessment Prognostic awareness Answering patient questions Referrals if necessary |
Material | Communication manual for milestone conversations | Content of milestone conversations Training material |
Memory cards | Quick overview of milestone conversations |
Managing symptoms guidebook | Brochure for patients on symptom management |
Question-prompt-list | Questions patients could ask |
1. Interprofessional (physician and nurse) communication training
2. Planned, structured nurse-physician-patient and caregiver conversations at four points within the disease trajectory, the so-called milestone conversations
3. Monthly follow-up sessions for outpatient and ambulatory patients and their caregivers (nurse)
4. Supportive materials (question-prompt-list, managing symptoms guidebook for patients and caregivers, and communication manual and memory cards for nurses and physicians)
For a more detailed description of the intervention, see Additional file
1.
No harm is anticipated from the intervention. If any harm is identified, a referral to psycho-oncology services is possible.
The complete project consists of three phases: (1) further development, (2) implementation, and (3) evaluation. Phase 1 (further development) had a separate ethical approval (ethics committee University of Heidelberg S-139/2017) and is already completed. This study protocol is for phase 2 (implementation) and phase 3 (evaluation). Implementation and evaluation are based on the results of phase 1. During the implementation phase, communication training will be conducted and evaluated. Implementation of MCA will be adapted according to participant experiences. The evaluation phase includes a monocentric non-blinded RCT measuring the effects of MCA in patients with a limited prognosis. In a cohort study, the longitudinal effects on interprofessional collaboration of clinical staff will be observed. Experiences with the concept will be evaluated in qualitative semi-structured interviews with patients and their caregivers (see Table
2).
Table 2
Study aim, method, type of data, and outcome
Phase 2 implementation | Evaluation of communication training | Questionnaire | Physicians and nurses | Training success | Quantitative |
Evaluation of implementation context and outcomes | Interview and focus group interviews | Physicians and nurses | Fidelity and adherence enablers and factors associated with implementation | Qualitative |
Quantitative content analysis of patient electronic files | | Adherence | Quantitative |
Phase 3 outcome evaluation | Impact of MCA on patient outcomes | Pragmatic RCT using questionnaire | Patients and caregivers | Supportive care needs Patient quality of life Patient distress | Quantitative |
Semi-structured interviews | Patients and caregivers | Patient reported outcomes | Qualitative |
Evaluation of effects on interprofessional collaboration | Questionnaire | Healthcare professionals | Attitudes towards interprofessional collaboration | Quantitative |
To implement MCA, it is important to understand how MCA works within a real-life clinical setting. This implementation implies working with healthcare professionals who will be affected by MCA and investigating the context of the intervention. A hospital context is not a fixed organizational structure but an unstable, unfolding process [
36]. Thus, implementation of MCA will be conducted using a plan-do-check-act (PDCA) cycle [
37].
-
Plan: Plan communication training and a theory-based implementation
-
Do: Conduct communication training and make first attempts at using MCA
-
Check: Investigate experiences with trained nurses and physicians
-
Act: Reintegrate evaluation results into everyday MCA practice
If necessary, the PDCA cycle will be used several times. This approach ensures that the adaptability, usability, and feasibility of MCA are incorporated [
32].
Setting
The project will be conducted at the Department of Thoracic Oncology, University Hospital Heidelberg, which is one of the largest lung cancer centers in Germany. Every year, about 600 patients are newly diagnosed with metastatic lung cancer. The physicians involved in the project are oncologists and residents in advanced oncology, working mainly at the outpatient clinic. Their daily consultations include the first disclosure of diagnosis and prognosis, disclosure of progression, and transition to best supportive care (breaking bad news). The nurses have working experience in oncology and palliative care in both inpatient and outpatient settings.
Phase 2: implementation
Evaluation of communication training outcomes
Evaluation of implementation context and outcomes
Phase 3: outcome evaluation
Impact of MCA on patient outcomes
The effects of MCA on patients and caregivers will be determined in a RCT. Their experiences with the concept will be assessed in semi-structured interviews. The effects on interprofessional collaboration will be evaluated in a longitudinal observational study with healthcare professionals.
Effects on patients and caregivers (pragmatic RCT)
In the RCT, the effects of MCA on patients and caregivers will be assessed and evaluated with a focus on shared decision-making and on early and proactive advance care planning. Patients and their caregivers will report on daily life activities and the identification and treatment of palliative care needs. The impact of the concept regarding empathy, quality of life, and distress in patients with metastatic lung cancer will also be examined. Furthermore, needs-based use of services and the impact of further contacts in the German healthcare system will be assessed.
Instruments
All instruments are validated in German. Table
3 provides an overview of the assessment instruments. The supportive care needs of patients will be assessed using SCNS-SF34-G. The questionnaire comprises 34 items and covers five domains: (1) health system and information, (2) psychological, (3) physical and daily living, (4) patient care and support, and (5) sexual needs. Patients indicate on a five-point scale if and to what degree they are in need of support (1 not applicable; 2 no need, satisfied; 3 low need; 4 moderate need; or 5 high need) [
42]. Subscale scores are obtained by calculating the mean of scale items. The higher the subscale score, the higher the need for support in the respective domain [
43].
Table 3
Outcomes and instruments
Supportive care needs | SCNS-SF34-G (for patients) [ 42] SCNS-P&C-G (for caregivers) [ 44] |
Patient quality of life | |
Depression and anxiety | PHQ-4 [47] |
Patient distress | Distress thermometer [ 56] |
The supportive care needs of caregivers will be measured using the German version of the Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C-G). The multidimensional questionnaire consists of 45 items in four domains: (1) healthcare service needs, (2) psychological and emotional needs, (3) work and social needs and (4) information needs, which are assessed on a five-point scale (1 I have no problems, 2 I am already supported, 3 low need, 4 moderate need, and 5 high need). Answers 1 and 2 are grouped together so that 1 stands for “there is no need for support.” For supportive care needs domains, the mean of the respective items will be calculated, ranging from 1 to 5 [
44], and standardized on a 0–100 scale [
45].
A patient’s quality of life will be assessed using the Schedule for the Evaluation of Individual Quality of Life (SEIQoL-Q) [
46], the Functional Assessment of Chronic Illness Therapy (basic module, FACT-G, and additional questions on lung diseases, FACT-L) [
47,
48]. The Patient Health Questionnaire (PHQ-4) [
49] will be used to assess depression and anxiety in patients. The SEIQoL-Q measures each patient’s quality of life by choosing, rating, and weighting five domains that patients consider important, such as family, health, or social life/other relations [
50]. The five-point scale ranges from not at all (0) to extremely (100) important. Following this, patients must evaluate their overall satisfaction with the areas of life on the same scale [
51].
FACT-G consists of 27 items in four domains: (1) physical well-being, (2) social well-being, (3) emotional well-being, and (4) functional well-being. All domains, except emotional well-being, consist of seven items, each with a score in the range 0–28. Emotional well-being contains six items and has a score range of 0–24. For all questions in FACT-G, a five-point rating scale from 0 to 4 (0 not at all, 1 a little bit, 2 somewhat, 3 quite a bit, and 4 very much) is used. The total score for FACT-G is calculated as the sum of the four subscale scores, provided that the overall item response is at least 80% (i.e., at least 22 of the 27 items were answered) and takes values between 0 and 108. Negatively expressed items are reverse scored prior to summing so that higher subscale and total scores indicate a better quality of life [
47,
48,
52]. FACT-L contains the four domains of FACT-G and one lung cancer symptom-specific subscale. The seven items of the lung cancer subscale assess patient-reported symptoms, like shortness of breath and loss of weight. FACT-L is also rated on a five-point Likert-scale ranging from 0 (not at all) to 4 (very much) with a score ranging from 0 to 28 [
53].
PHQ-4 is an ultra-brief self-report questionnaire that contains a two-item depression scale (PHQ-2) and a two-item anxiety scale (GAD-2) [
49]. Patients assess how many times over the past 2 weeks they have felt a loss of interest and happiness, depression, melancholy or hopelessness, nervousness, anxiety or concern, and restlessness. The ordinal-scaled answer options are not at all (0), several days (1), more than half the day (2), and nearly every day (3) [
54]. The total score for PHQ-4 ranges from 0 to 12, with categories of psychological distress being none (0–2), mild (3–5), moderate (6–8), and severe (9–12) [
55].
Patient distress will be measured using the NCCN Distress Thermometer. This assessment technique was developed by the National Comprehensive Cancer Network (NCCN) and is a brief self-reported screening instrument for recording psycho-social stress in oncological patients. It consists of a scale from 0 to 10 and a problem list. A score of 5 or higher indicates that a patient is conspicuously stressed and needs assistance [
56]. If the burden is low (0–4), no additional professional support is required [
56].
Effects on patients and caregivers (semi-structured interviews)
Experiences with the MCA concept regarding empathy and shared decision-making will be evaluated through interviews with patients and caregivers.
Evaluation of interprofessional collaboration
Clinical employees will assess the effects of the approach on interprofessional collaboration and on the understanding of their own role within their team.
Data integration
A framework analysis will be used to integrate the data from the quantitative and qualitative research collected from different teams of researchers [
64]. The following steps are taken: familiarization with the material, identifying a thematic framework, indexing, charting, mapping, and interpretation [
64,
65]. Emerging themes will be related to a priori identified domains [
32,
64,
65]. Findings from all the phases will be merged using an integrative analysis [
35].
Ethical aspects
Written informed consent will be obtained from each participant. Ethical approval has been given by the Ethics Committee of the University Hospital Heidelberg (S-561/2017). Participants can withdraw their consent at any time. Only investigators will have access to the final trial dataset. There are no contractual agreements that limit such access. Personal information and the confidentiality, coding, security, and storage of the data are in line with German privacy protection law (Bundesdatenschutzgesetz or BDSG) and the privacy policy of University Hospital Heidelberg.
Discussion
In routine practice, the care of and communication with patients with a limited prognosis is still characterized by discontinuity and lack of coordination. Inadequate communication makes coping with the realities and choices of a complex incurable disease more difficult. A longitudinal communication approach with a focus on the disease trajectory that comprises specific milestones can serve to integrate early palliative care into routine practice and can facilitate care that is individualized to patients’ needs and preferences. While there are international guidelines for advanced cancer care [
3,
7], comprehensive implementation strategies are still lacking. As many structural and organizational aspects of national healthcare systems differ substantially, any transfer of guidelines to the German healthcare system should happen according to the specific situation and needs in Germany.
The MCA project includes the conceptualization of a communication strategy that focuses on a process in which patients and their caregivers are equally involved. The improved communication support should foster prognostic awareness and therefore, facilitate advance care planning and end-of-life decision-making.
Expected impact
The structured integrated tandem approach (physician and nurse) with interprofessional training and coaching is innovative. Consequently, the strengthening of interprofessional collaborations can be expected. The stepwise approach of the MCA project supports the communication skills and strategies of interprofessional healthcare teams involved in the care of patients with a limited prognosis. It will also enhance patients’ quality of life and improve the continuity and coordination of care. The mixed-methods design will provide a detailed insight into this context, including the perspectives of professionals, patients, and their caregivers.
Limitations and strengths
A strength of this study is that it simultaneously embeds implementation and evaluation, using a strong design (randomized trial) to assess outcomes. The mixed-methods process evaluation will help in gaining a comprehensive understanding of what works and why. The weaknesses of the quantitative methods are balanced by the qualitative methods and vice versa. This exploration of a complex intervention is characterized by multiple methods and multiple stakeholders in two phases. This complexity requires a mix of researchers from different research fields with experience in qualitative and quantitative research. The phases of the MCA project build upon each other. Determining the degree to which MCA is implemented in a real-world setting will give a better understanding of the measured effects. Adaption of the interventions throughout the implementation will ensure the practicability and transferability into everyday practice.
The sample sizes of the different investigations are small but sufficient for an initial exploration of MCA in a real-world setting. However, for a definitive assessment of the effectiveness of MCA, a larger multicenter RCT is necessary. Since the same physicians will be treating patients in the intervention arm as well as the control arm, there is a potential for bias and cross-contamination between the trial arms. However, the nurses participating in the milestone conversations and offering follow-up for patients and caregivers are exclusively in the intervention arm. Our primary end point is a subjective (non-blind) patient-reported outcome, so there is a potential for bias since patients know they are in a trial and they know the purpose of the trial.
Implementing MCA and identifying relevant determinants will be explored using the example of metastatic lung cancer patients. Positive effects will be used to implement an applicable version of the concept to other medical facilities and patients with a limited prognosis.
Trial status
The beginning of recruitment for phase 2 and phase 3 is planned for May 2018, and will be completed approximately by November 2019.
Funding
This research was funded by the Federal Ministry of Health, Germany (1504–54401), and the National Center for Tumor Diseases (NCT 3.0, G835), Heidelberg, Germany.