Improving quality of life for south Tyrolean palliative patients in home care

Health-related quality of life (HRQOL) of patients.
Measurements are taken three times:
1. Baseline,
2. Two months after baseline (during intervention, between intervention 1 and intervention 2)
3. Six months after baseline (after intervention)
HRQOL of Patients measured by:
FACT-G (Functional Assessment of Cancer Therapy - general; Version 4): This patient self-reported questionnaire is the core instrument of the Functional Assessment of Chronical Illness (FACIT) for patients with any form of cancer. It consists of 27 items which can be classified to four QOL domains: Physical Well-Being (7 items; range 0 - 28), Social/Family Well-Being (7 items; range 0 - 28), Emotional Well-Being (6 items; range 0 - 24), and Functional Well-Being (7 items; range 0 - 28). Patients rate items using a five-point Likert scale (0 – 4). For each of these domains a summary score can be calculated, where high scores indicate a high level of well-being. A total score can be obtained by summarising all individual subscale scores (Webster, Cella & Yost, 2003).

1. Quality of care: POS (Palliative care Outcome Scale)
The questionnaire is a Patient-Reported Outcome Scale which measures outcomes and assesses quality of care in palliative care patients. The questionnaire consists of two almost identical scales – one for patients and one for health professionals and caregiver - each of them consists of 11 items, which can be rated on a Likert scale from 0 to 4. Physical, psychosocial, spiritual, organizational and practical domains of palliative care can be measured with it. With the last item, an open question, patients and health professionals or caregivers are asked to indicate the ‘main problem of the care process’ (Hearn & Higginson, 1999).

2. Patient-related secondary outcomes:
2.1. Symptom control measured by the scales of the FACT-G and POS
2.2. Anxiety and depression measured by the HADS (Hospital Anxiety and Depression Scale). This self-assessment questionnaire consists of 14 items, rated on a Likert scale from 0 – 3. Two scores can be calculated: HADS-A (7 items) and HADS-D (7 items) which range from 0 to 21 (Snaith, 2003).
2.3. Satisfaction with care (incl. communication and support) measured by a self-constructed Visual Analogue Scale (VAS); scale items can be rated along a continuous line between the two end-points 0 = unsatisfied and 100 = satisfied.
2.4. Sense of Coherence measured by the short-form of the Sense of Coherence Scale (SOC – 13). This instrument consists of 13 items, which can be rated on a 7-point Likert scale. The theory of the Sense of Coherence is based on Antonovsky’s salutogenic approach. The Sense of Coherence as a personal resource is composed of the following three components: Comprehensibility, Manageability and Meaningfulness. The 13 items can be assigned to one of the three components (Antonovsky, 1987).
3. Family caregiver-related secondary outcomes:
3.1. HRQOL of family caregivers measured by the SF-12 (Short-Form Health Survey - 12 items). The Short-Form Health Survey is a self-reported generic health status measure. The questionnaire consists of 12 items assigned to eight subdomains: physical functioning (2 items), role physical (2 items), bodily pain (1 item), general health (1 item), vitality (1 item), social functioning (1 item), role-emotional (2 items), and mental health (2 items). In sum, two main quality of life scores can be assessed: physical and mental health (Ware et. al., 1996).
3.2. Depression measured by the Becks Depression Inventory (BDI-II). This self-reported questionnaire, consisting of 21 items, is an instrument to detect depression. Each of the items corresponds to a symptom of depression listed in the DSM-IV Classification. 19 items can be rated on a 4-point scale (0 to 3), whereas for the two items regarding appetite and sleep there are seven options to assess changes indicating an increase or decrease of the behaviour (Beck et. al., 1996).
3.3. Care-related burden: measured by the German adapted version of the Burden Scale for Family Caregivers (BSFC). This self-reported instrument, consisting of 28 items, is used to measure potential burden among family caregivers caring for a relative at home (Gräßel, 2001).
3.4. Satisfaction with care (incl. communication and support) measured by a self-constructed Visual Analogue Scale (VAS). Scale items can be rated along a continuous line between the two end-points 0 = unsatisfied and 100 = satisfied (the last measurements are taken also after the patients’ death).
3.5. Sense of Coherence: SOC – 13
4. Health professionals-related secondary outcomes:
4.1. HRQOL of health professionals measured by the SF-12
4.2. Emotional Strain, Depression, Burnout measured by the work-related instrument COPSOQ (Copenhagen Psychosocial Questionnaire). The questionnaire is applied to assess psychosocial factors at work and is based on the consistence of 87 items which can be assigned to 25 scales. Four distinctive main constructs can be summarized: ‘demands’, ‘influence and possibilities for development’, ‘interpersonal relations and leadership’, and ‘strain (effects/outcomes)’. A broad range of theoretical aspects are integrated in the questionnaire: (1) The job characteristics model. (2) The Michigan organizational stress model. (3) The demand-control-(support) model. (4) The sociotechnical approach. (5) The action-theoretical approach. (6) The effort-reward-imbalance model. (7) The vitamin model (Nübling, Stößel, Hasselhorn, Michaelis, Hofmann, 2006).
4.3. Teamwork measured by the COPSOQ and a self-constructed Visual Analogue Scale (VAS). Scale items can be rated along a continuous line between two end-points 0 = worst and 100 = best.
4.4. Sense of coherence: SOC - 13

Statistical methods: to test differences between the intervention and the control group, independent tests will be computed if the dataset is normally distributed, otherwise the Mann-Whitney U-Test will be used.
To test bivariate relationships, Pearson correlation coefficient will be used when normal distribution is assumed, otherwise the Spearman’s rho will be calculated.
Chi-Square test will be used to test frequency differences between nominally scaled variables of the two study groups.
Covariance analysis will be performed to control possible distortion effects caused by the assumed deterioration of the patients’ diseases. Therefore, effects of severity and progression of the diseases will be considered as intervening variables in the analysis.