Measuring patients' medical treatment preferences in advance care planning: development and validation of the Treat-Me-ACP instrument - a secondary analysis of a cluster-randomized controlled trial.

BACKGROUND: Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated early stage outcome instruments are lacking. Therefore, the Treatment-Preference-Measure-Advance Care Planning (Treat-Me-ACP) instrument was developed and validated as part of the cluster-randomized controlled trial STADPLAN (Study on Advance Care Planning in care-dependent community-dwelling older persons) to assess the effects of Advance Care Planning interventions on patients' medical treatment preferences. METHODS: The design of Treat-Me-ACP is based on the Emanuel Medical Directive and the Life Support Preferences Questionnaires. Using a multi-stage team approach a preliminary version of the Treat-Me-ACP was developed and pre-tested. The pre-tested instrument consists of one global medical care goal-item, five hypothetical scenarios with five hypothetical treatments, and one how would you feel-item within each scenario. A total of five scenario preference scores and five treatment preference scores can be formed. This version was subsequently applied to a subsample of the STADPLAN project (n = 80) to assess patient's preferences at baseline (T0) and at 12-month follow-up (T2). The further validation steps were based on this subsample and included: (1) acceptance by using completion rate and frequencies of missing data, (2) internal consistency by using Cronbach's α to test whether it was possible to create preference scores by scenario and treatment, (3) concurrent validation examining the association between the global medical care goal-item and the preference scores and the association between the how would you feel-items and the scenario preference scores, and (4) responsiveness of the instrument to changes in preferences for life-sustaining treatments by comparing preference scores from T0 to T2 between study groups. RESULTS: Acceptance of the instrument was high. Results of concurrent validation indicate that the five scenarios represent the global medical care goal well. The preference scores showed an average tendency for decreasing preferences for life-sustaining treatments across all scales for the intervention group during study follow-up. CONCLUSIONS: The Treat-Me-ACP can be used to evaluate the dynamics of patients' medical treatment preferences in Advance Care Planning. It has been validated for care-dependent community-dwelling older persons and can be used as an additional outcome measure in evaluating the effectiveness of ACP interventions. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 on 04/06/2019.

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.

Effects of advance care planning in care dependent community-dwelling older persons (STADPLAN): A cluster-randomised controlled trial.

BACKGROUND: Most randomised controlled trials on advance care planning were conducted in people with advanced, life-limiting illnesses or in institutional settings. There are few studies on its effect in older people living in the community. AIM: To determine the effects of advance care planning in older community dwelling people. DESIGN: The STADPLAN study was a cluster-randomised trial with 12 months follow-up. The complex intervention comprised a 2-days training for nurse facilitators that delivered a formal advance care planning counselling and a written information brochure. Patients in the control group received optimised usual care, that is, provision of a short information brochure. SETTING/PARTICIPANTS: Home care services in three regions of Germany were randomised using concealed allocation. Care dependent clients of participating home care services, aged 60 years or older, and rated to have a life-expectancy of at least 4 weeks were included. Primary outcome was active participation in care at 12 months, assessed by blinded investigators using the Patient Activation Measure (PAM-13). RESULTS: Twenty-seven home care services and 380 patients took part. Three hundred seventy-three patients were included in the primary analysis (n = 206 in the intervention and n = 167 in the control group). There was no statistically significant difference between the intervention and control group with regard to the PAM-13 after 12 months (75.7 vs 78.4; p = 0.13). No differences in quality of life, anxiety and depression, advance care planning engagement, and in proportion of participants with advance directives were found between groups. CONCLUSIONS: The intervention showed no relevant effects on patient activation or quality of life in community dwelling older persons, possibly indicating the need for more tailored interventions. However, results are limited by a lack of statistical power. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886.

Cost-effectiveness of case management: a systematic review.

OBJECTIVES: In this time of aging and increasingly multimorbid populations, effective and efficient case management approaches play a crucial role in supporting patients who are navigating complex health care systems. Until now, no rigorous systematic review has synthesized studies about the cost-effectiveness of case management. STUDY DESIGN: A systematic review was performed. METHODS: The bibliographic databases PubMed and CINAHL Plus were systematically searched using key blocks and synonyms of the terms case management, effectiveness, and costs. The methodological quality of the studies was assessed using the Consensus Health Economic Criteria list. RESULTS: A total of 29 studies were included. In 3 studies, the intervention was less effective and more costly than the control group and can therefore be considered not cost-effective. Two studies found that the intervention was less effective and less costly. A more effective and less costly intervention, and therefore a strong recommendation for case management, was found in 6 studies. In 17 studies, the intervention was more effective while being more costly. Nearly half of the studies met most of the quality criteria, with 16 or more points out of 19. CONCLUSIONS: Existing studies often have adequate quality and, in many cases, show cost-effective or even cost-saving results. Case management appears to be a promising method to support patients facing complex care situations. However, variation among case management approaches is very high, and the topic needs further study to determine the most cost-effective way of providing such care coordination.

The Analyzation of Change in Documentation due to the Introduction of Electronic Patient Records in Hospitals-A Systematic Review.

The major impact on healthcare through the ongoing digital transformation and new technologies results in opportunities for improving quality of care. Electronic patient records (EPR) are a substantial part in this transformation, even though their influence on documentation remains often unclear. This review aims to answer the question of which effect the introduction of the EPR has on the documentation proper in hospitals. To do this, studies are reviewed that analyze the documentation itself, rather than merely conducting interviews or surveys about it. Several databases were searched in this systematic review (PubMed including PubMed, PubMed Central and Medline; PDQ Evidence; Web of Science Core Collection; CINHAL). To be included, studies needed to analyze written documentation and empirical data, be in either German or English language, published between 2010 and 2020, conducted in a hospital setting, focused on transition from paper-based to electronic patient records, and peer reviewed. Quantitative, qualitative and mixed methods studies were included. Studies were independently screened for inclusion by two researchers in three stages (title, abstract, full text) and, in case of disagreement, discussed with a third person from the research team until consensus was reached. The main outcome assessed was whether the studies indicated a negative or positive effect on documentation (e.g. changing the completeness of documentation) by introducing an EPR. Mixed Methods Appraisal Tool was used to assess the individual risk of bias in the included studies. Overall, 264 studies were found. Of these, 17 met the inclusion criteria and were included in this review. Of all included studies, 11 of 17 proved a positive effect of the introduction of the EPR on documentation such as an improved completeness or guideline adherence of the documentation. Six of 17 showed a mixed effect with positive and negative or no changes. No study showed an exclusively negative effect. Most studies found a positive effect of EPR introduction on documentation. However, it is difficult to draw specific conclusions about how the EPR affects or does not affect documentation since the included studies examined a variety of outcomes. As a result, various scenarios are conceivable with higher or reduced burden for practitioners. Additionally, the impact on treatment remains unclear.

Electronic patient record and its effects on social aspects of interprofessional collaboration and clinical workflows in hospitals (eCoCo): a mixed methods study protocol.

BACKGROUND: The need for and usage of electronic patient records within hospitals has steadily increased over the last decade for economic reasons as well as the proceeding digitalization. While there are numerous benefits from this system, the potential risks of using electronic patient records for hospitals, patients and healthcare professionals must also be discussed. There is a lack in research, particularly regarding effects on healthcare professionals and their daily work in health services. The study eCoCo aims to gain insight into changes in interprofessional collaboration and clinical workflows resulting from introducing electronic patient records. METHODS: eCoCo is a multi-center case study integrating mixed methods from qualitative and quantitative social research. The case studies include three hospitals that undergo the process of introducing electronic patient records. Data are collected before and after the introduction of electronic patient records using participant observation, interviews, focus groups, time measurement, patient and employee questionnaires and a questionnaire to measure the level of digitalization. Furthermore, documents (patient records) as well as structural and administrative data are gathered. To analyze the interprofessional collaboration qualitative network analyses, reconstructive-hermeneutic analyses and document analyses are conducted. The workflow analyses, patient and employee assessment analyses and classification within the clinical adoption meta-model are conducted to provide insights into clinical workflows. DISCUSSION: This study will be the first to investigate the effects of introducing electronic patient records on interprofessional collaboration and clinical workflows from the perspective of healthcare professionals. Thereby, it will consider patients' safety, legal and ethical concerns and quality of care. The results will help to understand the organization and thereby improve the performance of health services working with electronic patient records. TRIAL REGISTRATION: The study was registered at the German clinical trials register (DRKS00023343, Pre-Results) on November 17, 2020.