Does the mode of care delivery affect therapeutic alliance, patient care satisfaction or patient reported outcomes? Psycho-oncological care evaluation data collected during the COVID-19 pandemic.

PURPOSE: Since the COVID-19 pandemic, psycho-oncological care has increasingly been provided virtually and/or telephonically. We examined whether patients' therapeutic alliance (TA) - an essential processual outcome - differs due to altered modes of care delivery (MOCD) and assessed, if MOCD impacts patients' care satisfaction and patient reported outcomes. METHODS: Survey and documentation data from newly diagnosed cancer patients that were cared for in the new form of care 'isPO' in Germany, were analyzed. Patients were surveyed after completing the one-year psycho-oncological care program. MOCD was operationalized by the ratio of patients' face-to-face, telephonic or video-based consultations to all their consultations. Regression analyzes were conducted to determine a possible relationship between MOCD and TA, between MOCD and patients' care satisfaction ('subjective effectiveness' and 'satisfaction and needs-orientation') and patient reported outcomes (anxiety and depression, sense of coherence, global health status). FINDINGS: MOCD does not significantly influence TA. Regression models on the possible effect on subjective effectiveness and satisfaction and needs-orientation do not show statistical significance with only MOCD as the predictor. MOCD does not predict any of the patient reported outcomes. CONCLUSIONS: During the pandemic, neither TA, care satisfaction nor patient reported outcomes were affected by the MOCD in the new form of care 'isPO'. Therefore, the MOCD didn't negatively affect quality of care, which indicates that telephone or video consultations seem to be useful alternatives for psycho-oncological care in Germany.

The Implementation of an Electronic Medical Record in a German Hospital and the Change in Completeness of Documentation: Longitudinal Document Analysis.

BACKGROUND: Electronic medical records (EMR) are considered a key component of the health care system's digital transformation. The implementation of an EMR promises various improvements, for example, in the availability of information, coordination of care, or patient safety, and is required for big data analytics. To ensure those possibilities, the included documentation must be of high quality. In this matter, the most frequently described dimension of data quality is the completeness of documentation. In this regard, little is known about how and why the completeness of documentation might change after the implementation of an EMR. OBJECTIVE: This study aims to compare the completeness of documentation in paper-based medical records and EMRs and to discuss the possible impact of an EMR on the completeness of documentation. METHODS: A retrospective document analysis was conducted, comparing the completeness of paper-based medical records and EMRs. Data were collected before and after the implementation of an EMR on an orthopaedical ward in a German academic teaching hospital. The anonymized records represent all treated patients for a 3-week period each. Unpaired, 2-tailed t tests, chi-square tests, and relative risks were calculated to analyze and compare the mean completeness of the 2 record types in general and of 10 specific items in detail (blood pressure, body temperature, diagnosis, diet, excretions, height, pain, pulse, reanimation status, and weight). For this purpose, each of the 10 items received a dichotomous score of 1 if it was documented on the first day of patient care on the ward; otherwise, it was scored as 0. RESULTS: The analysis consisted of 180 medical records. The average completeness was 6.25 (SD 2.15) out of 10 in the paper-based medical record, significantly rising to an average of 7.13 (SD 2.01) in the EMR (t178=-2.469; P=.01; d=-0.428). When looking at the significant changes of the 10 items in detail, the documentation of diet (P<.001), height (P<.001), and weight (P<.001) was more complete in the EMR, while the documentation of diagnosis (P<.001), excretions (P=.02), and pain (P=.008) was less complete in the EMR. The completeness remained unchanged for the documentation of pulse (P=.28), blood pressure (P=.47), body temperature (P=.497), and reanimation status (P=.73). CONCLUSIONS: Implementing EMRs can influence the completeness of documentation, with a possible change in both increased and decreased completeness. However, the mechanisms that determine those changes are often neglected. There are mechanisms that might facilitate an improved completeness of documentation and could decrease or increase the staff's burden caused by documentation tasks. Research is needed to take advantage of these mechanisms and use them for mutual profit in the interests of all stakeholders. TRIAL REGISTRATION: German Clinical Trials Register DRKS00023343; https://drks.de/search/de/trial/DRKS00023343.

Patients' perspectives on the quality of care of a new complex psycho-oncological care programme in Germany - external mixed methods evaluation results.

BACKGROUND: Guideline-compliant provision of psycho-oncological (PO) care is still challenging in Germany. Hence, a new care programme, called integrated cross-sectoral psycho-oncology (isPO), was implemented to improve the integration of needs-oriented PO care. Quality of care (QoC) was externally evaluated from the patient's perspective. We aim to gain insight into patients' experiences with isPO and how their assessment affects relevant patient-reported outcomes (anxiety and depression, health status, and work ability). METHODS: An explanatory, sequential mixed-methods design was applied. Patients were surveyed twice during their 1-year care trajectory: after 3 (T1) and 12 (T2) months. Data sets were matched using pseudonyms. Care documentation data, including sociodemographic characteristics and the primary outcome variable (anxiety and depression), were matched. In the survey, patients rated their satisfaction with respective isPO service providers and the programme in general (QoC). Health status (EORTC-QLQ-C30) and work ability (WAS) were measured. Descriptive analyses and t-tests for dependent samples were conducted to assess changes in outcome variables over time. Linear regression analyses were conducted to assess whether care satisfaction predicted outcome variables. Patients who completed their isPO care trajectory were asked to participate in semi-structured telephone interviews to share their experiences. Purposeful sampling was applied. All 23 interviews were audiotaped, transcribed, and analysed via content-structuring method. RESULTS: Patients reported medium-to-high satisfaction with their isPO care. All patient-related outcomes significantly improved over time and QoC measures predicted those outcomes. Needs orientation (e.g., care intensity or mode of delivery) was perceived as essential for high QoC, and outpatient care with fixed contact persons as highly important for care continuity. Furthermore, patients identified programme optimisation needs, such as period of care or extension of care to relatives. CONCLUSIONS: Patients assessed the isPO programme's QoC positively. They identified facilitators for QoC and optimisation needs. Therefore, data on QoC can function as an indicator for a programme's feasibility and maturity within care reality. As patients' care satisfaction positively influences important patient-related outcomes, it may be routinely considered for quality management. Based on patients' perspectives, isPO seems to be recommendable for routine psycho-oncological care in Germany, if ongoing programme optimisation within structured quality management is guaranteed. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (No. DRKS00015326) on 30.10.2018.

Integrating one-to-one peer support into psycho-oncological care in Germany: multi-perspective, mixed-methods evaluation of the isPO onco-guide service.

PURPOSE: One-to-one peer supporters called isPO onco-guides (isPO OGs) are an integral part of the new German psycho-oncological form of care 'integrated, cross-sectoral Psycho-Oncology' (isPO), additionally to professional care. The isPO OGs are cancer survivors with experiential knowledge, offering information on local support services and answering questions 'all around cancer' to newly diagnosed cancer patients. We aimed to evaluate the isPO OG service from three perspectives: patients, isPO OGs, and professional service providers. METHODS: A mixed-methods approach was pursued. We conducted interviews and focus groups with the three person groups, and applied qualitative content analysis on the reported resources, processes and outcomes regarding the isPO OG service. Relations with patients' utilisation and isPO OGs' work satisfaction were identified with regression and correlation analyses of questionnaire and isPO care data. We compared isPO care networks (CN) with X2-tests or ANOVA. Qualitative and quantitative results were integrated during interpretation phase. RESULTS: Qualitatively, the three person groups agreed on the benefits of the isPO OG service. The implementation's maturity differed between the CN concerning established processes and resource availability. Attitudes of professional service providers appeared to be crucial for patients' utilisation of the isPO OG service. Quantitative results emphasised the differences between the CN. CONCLUSION: Beyond differences in the CN, the isPO OG service has two psychosocial benefits: providing relevant, reliable, and understandable information; and offering the encouraging example that surviving and living with cancer is possible. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (No. DRKS00015326) on 30.10.2018.

The impact of COVID-19 on the interpretation of psycho-oncological support trial results: a quasi-experimental approach using the data from the new form of care "Integrated cross-sectoral psycho-oncology (nFC-isPO)".

OBJECTIVE: In addition to the common difficulties of ongoing trials, the COVID-19 pandemic posed several challenges to scientists worldwide and created an additional burden for vulnerable patient groups. In the nFC-isPO of individualised treatment for anxiety and depression in newly diagnosed patients with cancer caregivers (e.g. psycho-oncologists) reported elevated HADS scores in newly enrolled patients after the outbreak of the COVID-19 pandemic. Accordingly, the question arises whether the pandemic affected HADS scores. Therefore, stratified analyses by the time of enrolment (T1) were performed for patients with 12 months of care (T3). METHODS: Patients with 12 months of care (N = 1,140) were analysed. A comparison within the regression discontinuity design according to the time points at which patients completed the baseline (T1) HADS questionnaire was conducted to examine differences between patients recruited before Q2/2020 (pre-pandemic) and after the coronavirus outbreak. Furthermore, mean HADS scores at T1 and T3 for all quarters during the study were compared. RESULTS: Mean T1 and T3 HADS scores of patients with cancer during the pandemic are only slightly higher than those of the pre-pandemic group. No significant treatment effect was observed in either the pre-pandemic (p = 0.5495, Late = 1.7711) or the post-pandemic group (p = 0.9098, LATE=-0.2933). In contrast, the average local treatment effect in the post-pandemic group suggests a minimal decrease in HADS score in the predefined range and thus a positive treatment effect for isPO. Comparison of mean HADS scores at T1 and T3 did not show a large increase by pandemic-related timepoints, however, a decrease of approximately 2-3 points over each quarter at 12 months compared to baseline is observed. CONCLUSION: The existing nFC-isPO care is resilient to crisis and may counteract external influences such as the Corona pandemic. Accordingly, the pandemic had little influence on the fears of patients with cancer in the nFC-isPO. This emphasises that psycho-oncology is vital for the reduction of stress, anxiety and depression in patients with cancer. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Registry on 30 October 2018 under the ID "DRKS00015326".