Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial.

BACKGROUND: Previous studies have demonstrated the efficacy of rehabilitation after a cardiovascular procedure. Especially older and multimorbid patients benefit from rehabilitation after a cardiac procedure. Prehabilitation prior to cardiac procedures may also have positive effects on patients' pre- and postoperative outcomes. Results of a current meta-analysis show that prehabilitation prior to cardiac procedures can improve perioperative outcomes and alleviate adverse effects. Germany currently lacks a structured cardiac prehabilitation program for older patients, which is coordinated across healthcare sectors. METHODS: In a randomized, controlled, two-arm parallel group, assessor-blinded multicenter intervention trial (PRECOVERY), we will randomize 422 patients aged 75 years or older scheduled for an elective cardiac procedure (e.g., coronary artery bypass graft surgery or transcatheter aortic valve replacement). In PRECOVERY, patients randomized to the intervention group participate in a 2-week multimodal prehabilitation intervention conducted in selected cardiac-specific rehabilitation facilities. The multimodal prehabilitation includes seven modules: exercise therapy, occupational therapy, cognitive training, psychosocial intervention, disease-specific education, education with relatives, and nutritional intervention. Participants in the control group receive standard medical care. The co-primary outcomes are quality of life (QoL) and mortality after 12 months. QoL will be measured by the EuroQol 5-dimensional questionnaire (EQ-5D-5L). A health economic evaluation using health insurance data will measure cost-effectiveness. A mixed-methods process evaluation will accompany the randomized, controlled trial to evaluate dose, reach, fidelity and adaptions of the intervention. DISCUSSION: In this study, we investigate whether a tailored prehabilitation program can improve long-term survival, QoL and functional capacity. Additionally, we will analyze whether the intervention is cost-effective. This is the largest cardiac prehabilitation trial targeting the wide implementation of a new form of care for geriatric cardiac patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00030526). Registered on 30 January 2023.

Cost-Effectiveness of Inter-Professional Collaboration to Reduce Hospitalisations in Nursing Home Residents: Results from the German Interprof ACT Trial.

Background: The German multi-centre cluster-randomised controlled trial interprof ACT investigated interventions to increase inter-professional collaboration between nursing home (NH) staff and local general practitioners to reduce hospitalisations and improve nursing homes residents' (NHRs) quality of life. The trial was funded by the German Health Care Innovation Fund. Methods: Cost-effectiveness of interprof ACT interventions was evaluated and compared to current standard of care (SOC) over 12 months, including 622 NHRs in 34 NHs in Germany. Multiplying resource use of healthcare services with German-specific unit costs generated costs. Health outcome was measured in quality-adjusted life-years QALYs), utility by multiplying EQ-5D-5L values with German-specific utility weights. Incremental cost-effectiveness analysis used an intention-to-treat approach and scenario analyses (SAs). Net-benefit-regression and cost-effectiveness acceptability curves addressed uncertainty. A German healthcare insurance perspective was assumed. Results: Base case results showed non-significant cost savings of 851.88€ and non-significant QALY loss of -0,056. Discussion: Dependency levels at baseline were non-significantly higher in IG compared to control group (CG). Lack of baseline costing data eliminated possibility to evaluate changes in costs due to the interprof ACT measures for both groups. Conclusion: Interprof ACT interventions are not cost-effective compared to current SOC.

General practitioners' concepts on issuing out-of-pocket prescriptions for hypnotics and sedatives in Germany.

BACKGROUND: In Germany, almost 50% of prescriptions for benzodiazepines and drugs as Zolpidem and Zopiclone are as out-of-pocket (OOP) prescriptions-requiring patients to buy the drug at their own expense-although almost 90% of the population has statutory health insurance covering medication costs. OBJECTIVE: To understand why general practitioners (GPs) choose this prescribing method since needed medications are insurance covered, and unnecessary drugs should not be prescribed at all. METHODS: In this qualitative study, 17 semi-structured interviews with GPs were conducted, audio recorded and transcribed verbatim. Transcripts were analysed with grounded theory to extract a model explaining the described behaviour. RESULTS: Knowing the significant medical risks and insecurity about regulations makes GPs wish to avoid hypnotics and sedatives. They achieve this by 'Creating a barrier' (central phenomenon) and employing the strategy 'Using an out-of-pocket prescription', which not only generates costs for the patient but also reduces the physicians´ legal and financial accountability. The perceived patient type, expected problem duration and diagnosis influence the decision about the prescription form: patients with an alcohol or drug addiction or those with 'uncomplicated' insomnia are more likely to receive an OOP prescription. Patients with any psychiatric diagnosis will likely receive a statutory health insurance prescription. DISCUSSION: Current regulations do not provide guidance to GPs regarding hypnotics and sedatives. A clear regulatory framework and guidelines could possibly reduce physicians' defensive attitudes about these drugs and their use of OOP prescriptions. The approach to use OOP prescriptions as a barrier to reduce patients' medication use lacks evidence regarding effectiveness.

Home visits - central to primary care, tradition or an obligation? A qualitative study.

BACKGROUND: Home visits are claimed to be a central element of primary care. However, the frequency with which home visits are made is declining both internationally and in Germany despite the increase in the number of chronically ill elderly patients. Given this, the question arises as to how to ensure sufficient primary health care for this vulnerable patient group. The aim of this study was to explore German general practitioners' (GPs) attitudes with regard to the feasibility, burden and outlook of continued home visits in German primary care. METHODS: Qualitative semi-structured interviews were carried out with 24 GPs from the city of Hannover, Germany, and its rural surroundings. Data was analysed using qualitative content analysis. RESULTS: The GPs indicated that they frequently conduct home visits, but not all of them were convinced of their benefit. Most were not really motivated to undertake home visits but some felt obliged to. The basic conditions covering home visits were described as unsatisfactory, in particular with respect to reimbursement and time constraints. House calls for vulnerable, elderly people remained undisputed, whereas visits of a social nature were mostly deleted. Urgent house calls were increasingly delegated to the emergency services. Visits to nursing homes were portrayed as being emotionally distressing. GPs considered good cooperation with nursing staff the key factor to ensure a successful nursing home visit. The GPs wanted to ease their work load while still ensuring quality home care but were unable to suggest how this might be achieved. Better financial compensation was proposed most often. The involvement of specially trained nurses was considered possible, but viewed with resentment. CONCLUSIONS: Home visits are still an integral aspect of primary care in Germany and impose a considerable workload on many practices. Though the existing situation was generally perceived as unsatisfactory, German GPs could not envisage alternatives if asked to consider whether the current arrangements were sustainable in the future. To guarantee an unaltered quality of primary home care, German GPs and health care policy makers should actively initiate a debate on the need for and nature of home visits in the future.

Disclosure of new health problems and intervention planning using a geriatric assessment in a primary care setting.

AIM: To determine the prevalence of health problems uncovered by a Standardized Assessment for Elderly Patients in a Primary Care Setting (STEP), to explore how often STEP uncovered conditions new to general practitioners (GP) and ascertain how often STEP results led GPs to plan further interventions. METHODS: This descriptive, interim analysis was based on the data of 189 elderly patients (median age, 78 years; interquartile range [IQ], 74-81) and their 20 GPs collected in Hannover region, Germany, between June 2008 and April 2009. Study nurses in the practice setting applied the 44-item STEP instrument, based mainly on self-reporting, as well as a standardized patient interview. Subsequently, GPs indicated whether the problems were new to them, and whether they planned further action or health interventions on the basis of the problems identified by STEP. RESULTS: A median of 11 health problems (IQ, 8-14) were uncovered per patient, of which a median of 2 (IQ, 1-4) were new to the GP and interventions were planned for a median of 2 problems (IQ, 0-4). Many of the identified health problems are typical of old age. The following health problems uncovered by STEP were often new to the GPs (percentages differ to numbers due to missing GP ratings): cognitive impairment (33 of 64 affected by this problem, 73%), missing or unknown immunization status (84 of 160, 55%), and recent chest pain (19 of 37, 53%). Alcohol misuse was new in all 4 affected patients (100%) and recent falls were new in 5 of 7 patients (83%). Interventions for affected patients were frequently planned for problems of immunization (for 83 patients of 160 reporting the problem, 57%), current anxiety (4 of 9, 50%), and chest pain (14 of 37, 44%). Moreover, further management was frequently planned for depression (10 of 29, 39%) and cognitive impairment (16 of 64, 38%). CONCLUSION: Using a geriatric assessment in primary care discloses relevant heath problems and treatment needs that GPs may otherwise overlook.