Participants
Between December 2019 and March 2020, 200 patients meeting the inclusion criteria were invited to participate. Among those invited, 70 patients consented to participate, giving a recruitment rate of 35% (Fig. 2). Though men predominated among the invitees, women (12/30, 40%) were slightly more willing to participate than men (58/170, 34%) (Fig. 2). There was no loss to follow-up.
A large majority of the patients included in the study were men (58/70, 83%); the mean age of all participants was 62.0 years (SD 13.7) (Table 1). The majority of the patients (45/70, 64%) had a reduced (≤ 40%) left ventricular ejection fraction (LVEF). Among the remaining 25 patients, three had a borderline (41–49%) LVEF, and the LVEF was preserved (≥ 50%) in 22. Half of the patients were classified as NYHA II, while none was classified as NYHA IV.
Table 1
General characteristics of the population included in the study
Sociodemographic characteristics | n (%) or median (IQR) |
Women | 12 (17%) |
Age | 62 (54–72) |
Marital status | |
Single | 12 (17%) |
Widowed | 2 (3%) |
Divorced | 13 (19%) |
Married/partnership | 43 (61%) |
Religion | |
Protestant | 37 (55%) |
Roman catholic | 19 (28%) |
Non-denominational | 11 (17%) |
Clinical characteristics |
NYHA functional class | |
I | 22 (31%) |
II | 35 (50%) |
III | 13 (19%) |
LVEF (%) | 35 (20–50) |
ICD | 38 (54%) |
VAD | 12 (17%) |
Transplant list | 9 (13%) |
COPD | 11 (16%) |
CAD | 30 (43%) |
CKD | 32 (46%) |
Palliative care-related characteristics |
Presence of caregiver | 67 (95%) |
Caregiver | |
Couple | 49 (73%) |
Son or daughter | 6 (9%) |
Sibling | 4 (6%) |
Parent | 3 (4%) |
Other | 5 (8%) |
Had asked to palliative care referral before | 0 (0.0%) |
Have an advance directive | 25 (36%) |
IQR: interquartile rate; LVEF: left ventricular ejection fraction; ICD: implantable cardioverter defibrillator; VAD: ventricular assist device; COPD: chronic obstructive pulmonary disease; CAD: coronary artery disease, CKD: chronic kidney disease |
The interviews took an average of 24.1 minutes (SD 9.7) and the frequency of answers for each question is presented in Supplementary Table 1. Almost all the patients (67/70) reported the availability of an informal caregiver in case of need, the majority of whom are their partners (49/67, 73%). Patients were also asked about their need for more information about the course and prognosis of the disease and about treatment. Twenty-six reported a need for more information about one or more of seven aspects of living with HF; the largest need reported was that for information on legal and financial issues (Supplementary Table 1).
Tool translation
The culturally adapted German translation of the NAT: PD-HF is presented in Supplementary Material 1.
Psychometric characteristics of the German NAT: PD-HF
Internal consistency
With a Cronbach’s alpha of 0.83, the internal consistency was high. Furthermore, when removing each question to evaluate how the alpha changed without each item Cronbach’s alpha ranged from 0.80 and 0.84. Details of the psychometric characteristics are presented in Table 2.
Table 2
Inter-rater and test-retest reliability
| Inter-rater reliability | Test-retest reliability |
| Cohen´s kappa | PABAK | Cohen´s kappa | PABAK |
Section 2. Patient wellbeing | | | | |
1. Is the patient experiencing unresolved physical symptoms (including problems with breathlessness, pain, fatigue, nausea, edema, insomnia, or cough)? | 0.43 | 0.49 | 0.94 | 0.94 |
2. Does the patient have problems with daily living activities? | 0.59 | 0.79 | 0.99 | 0.98 |
3. Does the patient have psychological symptoms that are interfering with well-being or relationships? | 0.69 | 0.76 | 0.94 | 0.94 |
4. Does the patient have concerns about how to manage his/her medication and treatment regimens? | 0.48 | 0.94 | 1.00 | 1.00 |
5. Does the patient have concerns about spiritual or existential issues? | 0.88 | 0.96 | 0.90 | 0.97 |
6. Does the patient have financial or legal concerns that are causing distress or require assistance? | 0.85 | 0.89 | 0.93 | 0.94 |
7. From the health delivery point of view, are there health beliefs, cultural, or social factors involving the patient or family that are making care more complex? | 0.17 | 0.80 | 0.90 | 0.97 |
Section 3. Ability of caregiver or family to care for patient | | | | |
1. Is the caregiver or family distressed about the patient’s physical symptoms? | 0.83 | 0.98 | 0.83 | 0.98 |
2. Is the caregiver or family having difficulty providing physical care? | 0.78 | 0.84 | 0.82 | 0.87 |
3. Is the caregiver or family having difficulty coping? | 0.82 | 0.88 | 0.97 | 0.98 |
4. Is the caregiver having difficulty managing the patient’s medication and treatment regimens? | 1.00 | 1.00 | 1.00 | 1.00 |
5. Does the caregiver or family have financial or legal concerns that are causing distress or require assistance? | 0.66 | 0.87 | 1.00 | 1.00 |
6. Is the family currently experiencing problems that are interfering with their functioning or interpersonal relationships or is there a history of such problems? | 0.57 | 0.79 | 0.96 | 0.97 |
Section 4. Caregiver wellbeing | | | | |
1. Is the caregiver or family experiencing physical, practical, spiritual, existential, or psychological problems that are interfering with their well-being or functioning? | 0.73 | 0.89 | 0.85 | 0.93 |
Inter-rater reliability
Overall, based on Cohen´s kappa 13 out of the 14 questions reached at least moderate agreement (defined as a kappa value ≥ 0.41). Three questions about patient´s wellbeing in Sect. 2 had an almost perfect, three had substantial and only one had poor agreement. This last question, that is the last one of the section, aims to identify the health beliefs of patients and cultural or social factors that might be barriers to health delivery. Among the six questions assessing the ability of the caregiver to take care of the patient in Sect. 3, three questions were in almost perfect agreement, two had substantial agreement, and the remaining one moderate agreement. The question from Sect. 4 about the caregiver´s well-being had substantial agreement (Table 2).
We observed no differences in the performance of the different first and second evaluators. Therefore, there was no need to account for second evaluators’ differences in the analyses (Supplementary Table 2).
Test-retest reliability
The median time between the two appointments was 15 days (IQR 14–20) and none of the patients reported any significant change in his or her condition between the two appointments. Test-retest reliability of the German NAT: PD-HF was very high and all questions had almost perfect agreement, with Cohen`s kappa ranging from 0.82 to 1.00 (Table 2).
Survey of patients
All of the 70 participants agreed that the tool questions were easy to understand and answer. Sixty-one patients (87%) thought that discussing the issues raised in the questions may improve quality of care. Only three patients reported these questions being routinely asked or discussed during clinical consultations (Table 3).
Table 3
Results of the survey applied to patients and health care personnel
| Agree | Neither agree nor disagree | Disagree |
Survey to patients n = 70 |
1.The questions were, generally, easy to understand (n = 69) | 69 (100%) | | |
2.The questions were, generally, easy to answer (n = 69) | 69 (100%) | | |
3.If my doctor asks me these questions, it may help to improve the quality of my care (n = 68) | 61 (90%) | 6 (9%) | 1 (1%) |
4.The questions asked in the questionnaire are usually dealt with during the clinical consultation (n = 70) | 3 (4%) | 38 (54%) | 29 (42%) |
Survey to health care personnel n = 27 |
1.In general, the questions were easy to understand for the patient (n = 27) | 13 (48%) | 14 (52%) | |
2.In general, the questions were easy to answer for the patient (n = 27) | 10 (37%) | 16 (59%) | 1 (4%) |
3.The quality of the care is improved by applying this tool (n = 27) | 23 (85%) | 4 (15%) | |
4.The questions asked in the questionnaire are usually dealt with during the clinical consultation (n = 25) | 11 (44%) | 14 (56%) | |
Regarding other questions that should be included in the tool, the most frequently mentioned topics were lifestyle habits and sexuality. More specifically, patients suggested inquiry about exercise and nutrition habits, and whether there have been changes in a couple’s sex life and there are side effects of medication that interfere with it.
Survey of health care personnel
We interviewed 27 health care professionals. These included eight cardiologists, five cardiology nurses, four PC specialists, three PC nurses, three psychologists from the HF clinic, two general practitioners, and two social workers. Among the 27 interviewees, 21 were women, and 14 of the interviewees have worked in the profession for more than 10 years.
In general, the health care personnel rated the questions easy for patients to understand, but not to answer. Most (23 of the 27 professionals) considered the tool helpful for improving the quality of patient care. Eleven of the health care personnel reported that the questions in the tool are usually asked during a clinical consultation, while the remaining 16 responded in a neutral manner, neither agreeing nor disagreeing. The four PC specialists agreed that topics from the tool are discussed during a routine consultation with a PC specialist. In contrast to that, only two of the cardiologists said topics from the tool are discussed in consultations, while the remaining six said that most “are not addressed,” and that “psychosocial aspects are not discussed” (Table 3).
Face validity, applicability, relevance and acceptability
Face validity
Face validity was rated high, with most of the health care personnel (23 of 27) agreeing that the tool appears to measure unmet needs of both patients with HF and their caregivers. The remaining four interviewees partially agreed, but thought that to properly assess caregiver needs the caregiver needs to be present in the interview (Table 4).
Applicability
Among the 27 health care personnel, 17 (63%) consider the tool easy to use, and all but two consider the written instructions on use the tool helpful. However, some thought the tool and its instructions were too long and too detailed.
PC specialists, psychologists, and social workers think that doctors (general practitioners, cardiologists, PC specialists) as well as nurses can use the tool, while cardiology staff think that mainly nurses should use it.
Relevance
Two PC specialists, one general practitioner and a psychologist, each questioned the relevance of some elements of the tool. One of the PC specialist was not sure what question 2.5 should cover. The other PC specialist said that question 2.7 is not very useful since it collapses different factors into a single question, and suggested that section three, which is about the ability of caregiver to care for the patient, and section four, about caregiver well-being, should be merged. The GP thought question 3.6 is not very clear and should be rephrased, and the psychologist thought that questions 2.3 and 2.5 have similar content (Table 4).
Acceptability
There was no consensus on either when or how often the NAT: PD-HF should be employed in clinical practice. Some believe that it should be used early, at the first or second consultation, while others believe that it is better not to use it early, but only after a basis of trust has been built with the interviewer and the patient has already dealt with the disease. Some respondents think it should be used at regular intervals such as every six months or at annual check-ups, while others think it should be used again after major changes in health status or after hospitalization (Table 4).
The main concerns about accepting the NAT: PD-HF are lack of time to use it, and that being able to use it requires some training or at least a very thorough introduction to using it and its value (Table 4).
Another reservation about using the NAT: PD-HF reported by cardiologists and cardiology nurses was that some staff members do not feel comfortable discussing emotional, spiritual, or financial issues with their patients (Table 4).