Outcome registry of early intensive neurorehabilitation in patients with disorders of consciousness: study protocol of a prospective cohort study.

BACKGROUND: Prolonged disorders of consciousness (PDOC) may occur after severe brain injury. Two diagnostic entities are distinguished within PDOC: unresponsive wakefulness syndrome (UWS, previously known as vegetative state) and minimally conscious state (MCS). Patients with PDOC may benefit from early intensive neurorehabilitation (EIN). In the Netherlands, the EIN programme is provided by one designated expert rehabilitation centre and forms the starting point of a dedicated chain of specialised rehabilitation and care for this group. This study project, called DOCTOR: Disorders of Consciousness; Treatment and Outcomes Registry, sets up a registry and systematically investigates multiple short- and long-term outcomes of patients with PDOC who receive EIN. METHODS: Single-centre prospective cohort study with a 2-year follow-up period. Patients with PDOC due to acute brain injury who receive EIN, aged 16 years and older are included. Measurements will take place at start EIN, in week 5, 10, and at discharge from the EIN programme (duration = max 14 weeks) and at week 28, 40, 52, and 104 after admission to the EIN programme, following patients through the health-care chain. Outcome measures are the changes over time in level of consciousness, using the Coma Recovery Scale-Revised; the frequency and type of medical complications; the mortality rate; level of disability, including the level of motor, cognitive, behavioural and emotional functioning; participation; and quality of life. Secondary outcomes include self-efficacy of caregivers, caregivers' strain and cost-effectiveness of the programme. DISCUSSION: The DOCTOR study will provide insight in the recovery patterns and predictors of recovery for multiple outcomes in PDOC patients after following EIN. The results of the study will enable us to benchmark and improve EIN and the organisation of the health-care chain, both for patients with PDOC and for their families. TRIAL REGISTRATION: Netherlands Trial Register, NL 8138 . Retrospectively registered 6 November 2019.

Should I stay or should I go home? A latent class analysis of a discrete choice experiment on hospital-at-home.

OBJECTIVES: This study aimed 1) to quantify the strength of patient preferences for different aspects of early assisted discharge in The Netherlands for patients who were admitted with a chronic obstructive pulmonary disease exacerbation and 2) to illustrate the benefits of latent class modeling of discrete choice data. This technique is rarely used in health economics. METHODS: Respondents made multiple choices between hospital treatment as usual (7 days) and two combinations of hospital admission (3 days) followed by treatment at home. The latter was described by a set of attributes. Hospital treatment was constant across choice sets. Respondents were patients with chronic obstructive pulmonary disease in a randomized controlled trial investigating the cost-effectiveness of early assisted discharge and their informal caregivers. The data were analyzed using mixed logit, generalized multinomial logit, and latent-class conditional logit regression. These methods allow for heterogeneous preferences across groups, but in different ways. RESULTS: Twenty-five percent of the respondents opted for hospital treatment regardless of the description of the early assisted discharge program, and 46% never opted for the hospital. The best model contained four latent classes of respondents, defined by different preferences for the hospital and caregiver burden. Preferences for other attributes were constant across classes. Attributes with the strongest effect on choices were the burden on informal caregivers and co-payments. Except for the number of visits, all attributes had a significant effect on choices in the expected direction. CONCLUSIONS: Considerable segments of respondents had fixed preferences for either treatment option. Applying latent class analysis was essential in quantifying preferences for attributes of early assisted discharge.

The use of research evidence on patient preferences in pharmaceutical coverage decisions and clinical practice guideline development: exploratory study into current state of play and potential barriers.

BACKGROUND: The patient perspective is increasingly considered in healthcare policy decisions. The use of research on patient preferences seems however limited. Using the available research on patient preferences would make healthcare policy decisions more evidence-based regarding the patient perspective. Objective of this study is to investigate whether and how results of research on patient preferences are incorporated in current procedures for pharmaceutical coverage decisions and clinical practice guideline (CPG) development. METHODS: A document analysis on procedure descriptions was combined with case studies. Analyses were performed for five European countries. In the document analysis we systematically checked whether the procedure provides guidance on the systematic use of research on patient preferences, and whether the search and use of research on patient preferences is mentioned in the decision making procedure. In the case studies, which were for exploratory purposes, we scored whether or not research question on patient preferences were formulated, whether or not a search strategy including terms relating to patient preferences was mentioned, whether results of this search strategy were shown and finally, how many references with preference-related terms were included in the reference list of the case. RESULTS: None of the procedures for pharmaceutical coverage decisions mentions the systematic consideration of research on patient preferences. For CPG development, the Scottish procedure refers to a mandatory literature search. In the Netherlands this step is optional. In the case studies for pharmaceutical coverage decisions only one reference related to patient preferences was found. Some of the case studies for CPG included research questions, search strategies and references relating to patient preferences. CONCLUSIONS: This study illustrates that systematic consideration of research on patient preferences in pharmaceutical coverage decisions and guideline development is limited, or if taken into account, this is not visible. This contrasts the strong movement towards patient involvement in health care. Several potential barriers may explain the limited use of research on patient preferences.

Short-term outcomes of early intensive neurorehabilitation for prolonged disorders of consciousness: A prospective cohort study.

BACKGROUND: Advances in medical care have increased survival in people with severe brain injuries and with that the number of survivors with prolonged disorders of consciousness (PDOC) has increased. In the literature, early intensive neurorehabilitation (EIN) for people with PDOC is recommended to achieve the best possible outcomes. OBJECTIVES: To evaluate the frequency and extent of recovery of consciousness, mortality, complications, pain and discomfort, and medication during a nationwide EIN programme in people with PDOC after acquired brain injury. We hypothesized that level of consciousness would improve in half of people with PDOC. METHODS: Prospective cohort study. People with PDOC aged 16 years and older admitted to the EIN department centralized in a single rehabilitation centre in the Netherlands (Libra Rehabilitation & Audiology) were included. The EIN delivers a subacute medical level of care and rehabilitation for a maximum duration of 14 weeks. The outcome measures were level of consciousness (CRS-R), mortality, number of complications, medication and pain/discomfort (NCS-R). RESULTS: Of the 104 people included, 68 % emerged to a minimal conscious state with command-following or higher during EIN and 44 % regained consciousness. Mortality during EIN was 6 %, and 50 % of deaths followed a non-treatment decision or withdrawal of life-sustaining treatment. Almost all participants had at least 1 medical complication, leading to hospital readmission for 30 %. 73 % showed no pain or discomfort. During EIN, cardiovascular medication and analgesics were reduced by 15 %. CONCLUSIONS: During the EIN programme, a large percentage of people with PDOC regained at least a minimal conscious state or even consciousness. These outcomes and the frequent medical complications in these people suggest that intensive specialized care should be offered to all people with PDOC. The outcomes of this study might help health professionals to better inform the families of people with PDOC about the short-term prognosis of PDOC. PROTOCOL REGISTRATION NUMBER: The Dutch Trial Register, NL 8138.

Cost-effectiveness of early assisted discharge for COPD exacerbations in The Netherlands.

OBJECTIVES: Hospital admissions for exacerbations of chronic obstructive pulmonary disease are the main cost drivers of the disease. An alternative is to treat suitable patients at home instead of in the hospital. This article reports on the cost-effectiveness and cost-utility of early assisted discharge in The Netherlands. METHODS: In the multicenter randomized controlled Assessment of GOing Home under Early Assisted Discharge trial (n = 139), one group received 7 days of inpatient hospital treatment (HOSP) and one group was discharged after 3 days and treated at home by community nurses for 4 days. Health care resource use, productivity losses, and informal care were recorded in cost questionnaires. Microcosting was performed for inpatient day costs. RESULTS: Seven days after admission, mean change from baseline Clinical Chronic Obstructive Pulmonary Disease Questionnaire score was better for HOSP, but not statistically significantly: 0.29 (95% confidence interval [CI]-0.04 to 0.61). The difference in the probability of having a clinically relevant improvement was significant in favor of HOSP: 19.0%-point (95% CI 0.5%-36.3%). After 3 months of follow-up, differences in effectiveness had almost disappeared. The difference in quality-adjusted life-years was 0.0054 (95% CI-0.021 to 0.0095). From a health care perspective, early assisted discharge was cost saving:-€244 (treatment phase, 95% CI-€315 to-€168) and-€168 (3 months, 95% CI-€1253 to €922). Societal perspective:-€65 (treatment phase, 95% CI-€152 to €25) and €908 (3 months, 95% CI-€553 to €2296). The savings per quality-adjusted life-year lost were €31,111 from a health care perspective. From a societal perspective, HOSP was dominant. CONCLUSIONS: No clear evidence was found to conclude that either treatment was more effective or less costly.

Evaluation of health care providers' role transition and satisfaction in hospital-at-home for chronic obstructive pulmonary disease exacerbations: a survey study.

BACKGROUND: Hospital-at-home is an accepted alternative for usual hospital treatment for patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation. The introduction of hospital-at-home may lead to changes in health care providers' roles and responsibilities. To date, the impact on providers' roles is unknown and in addition, little is known about the satisfaction and acceptance of care providers involved in hospital-at-home. METHODS: Objective of this survey study was to investigate the role differentiation, role transitions and satisfaction of professional care providers (i.e. pulmonologists, residents, hospital respiratory nurses, generic and specialised community nurses and general practitioners) from 3 hospitals and 2 home care organisations, involved in a community-based hospital-at-home scheme. A combined multiple-choice and open-end questionnaire was administered in study participants. RESULTS: Response rate was 10/17 in pulmonologists, 10/23 in residents, 9/12 in hospital respiratory nurses, 15/60 in generic community nurses, 6/10 in specialised community nurses and 25/47 in general practitioners. For between 66% and 100% of respondents the role in early discharge was clear and between 57% and 78% of respondents was satisfied with their role in early discharge. For nurses the role in early discharge was different compared to their role in usual care. 67% of generic community nurses felt they had sufficient knowledge and skills to monitor patients at home, compared to 100% of specialised community nurses. Specialised community nurses felt they should monitor patients. 60% of generic community nurses responded they should monitor patients at home. 78% of pulmonologists, 12% of general practitioners, 55% of hospital respiratory nurses and 48 of community nurses was satisfied with early discharge in general. For coordination of care 29% of community nurses had an unsatisfied response. For continuity of care this was 12% and 10% for hospital respiratory nurses and community nurses, respectively. CONCLUSION: A community-based early assisted discharge for COPD exacerbations is possible and well accepted from the perspective of health care providers' involved. Satisfaction with the different aspects is good and the transfer of patients in the community while supervised by generic community nurses is possible. Attention should be paid to coordination and continuity of care, especially information transfer between providers.

Effectiveness and cost-effectiveness of early assisted discharge for chronic obstructive pulmonary disease exacerbations: the design of a randomised controlled trial.

BACKGROUND: Exacerbations of chronic obstructive pulmonary disease (COPD) are the main cause for hospitalisation. These hospitalisations result in a high pressure on hospital beds and high health care costs. Because of the increasing prevalence of COPD this will only become worse. Hospital at home is one of the alternatives that has been proved to be a safe alternative for hospitalisation in COPD. Most schemes are early assisted discharge schemes with specialised respiratory nurses providing care at home. Whether this type of service is cost-effective depends on the setting in which it is delivered and the way in which it is organised. METHODS/DESIGN: GO AHEAD (Assessment Of Going Home under Early Assisted Discharge) is a 3-months, randomised controlled, multi-centre clinical trial. Patients admitted to hospital for a COPD exacerbation are either discharged on the fourth day of admission and further treated at home, or receive usual inpatient hospital care. Home treatment is supervised by general nurses. Primary outcome is the effectiveness and cost effectiveness of an early assisted discharge intervention in comparison with usual inpatient hospital care for patients hospitalised with a COPD exacerbation. Secondary outcomes include effects on quality of life, primary informal caregiver burden and patient and primary caregiver satisfaction. Additionally, a discrete choice experiment is performed to provide insight in patient and informal caregiver preferences for different treatment characteristics. Measurements are performed on the first day of admission and 3 days, 7 days, 1 month and 3 months thereafter. Ethical approval has been obtained and the study has been registered. DISCUSSION: This article describes the study protocol of the GO AHEAD study. Early assisted discharge could be an effective and cost-effective method to reduce length of hospital stay in the Netherlands which is beneficial for patients and society. If effectiveness and cost-effectiveness can be proven, implementation in the Dutch health care system should be considered. TRIAL REGISTRATION: Netherlands Trial Register NTR1129.

How to integrate research evidence on patient preferences in pharmaceutical coverage decisions and clinical practice guidelines: A qualitative study among Dutch stakeholders.

UNLABELLED: Despite the increasing number of research publications on patient preferences, their use in healthcare policy-making is limited. Integrating research evidence on patient preferences in policy-making is advocated by some, but several issues are put forward as well. There has been no systematic investigation of the stakeholders' view on this matter so far. Objective is to explore the opinions of Dutch stakeholders on how to integrate evidence on patient preferences in pharmaceutical coverage decisions and clinical practice guideline (CPG) development, and which issues may be encountered. METHODS: Qualitative study with semi-structured interviews with Dutch researchers (N=7), policy-makers and CPG developers (N=4) and patient representatives (N=4) involved in pharmaceutical coverage decisions and/or CPG development. The interview scheme focused on the definition of patient preferences; how to integrate evidence on patient preferences in decision-making; and barriers and facilitators. RESULTS: Respondents mentioned various barriers and facilitators for integration, of conceptual, normative, procedural, methodological and practical nature. There is also variety in the terms and definitions used for preferences, complicating searching and synthesising evidence. It is not clear how to integrate evidence on patient preferences in different decision contexts, and what weight preferences should have in relation to other decision criteria. CONCLUSIONS: This study revealed important issues that need guidance when integrating evidence on patient preferences in healthcare policy decisions.

Informal caregiver strain, preference and satisfaction in hospital-at-home and usual hospital care for COPD exacerbations: results of a randomised controlled trial.

BACKGROUND: Informal caregivers play an important role in hospital-at-home schemes. However they may increase their burden, especially chronic diseases, like COPD. In the absence of clear differences in effectiveness and cost-effectiveness between hospital-at-home and usual hospital care, informal caregiver preferences play an important role. This study investigated informal caregiver strain, satisfaction and preferences for place of treatment with a community-based hospital-at-homes scheme for COPD exacerbations. METHOD: The study was part of a larger randomised controlled trial. By randomisation, patients were allocated to usual hospital care or hospital-at-home, which included discharge at day 4 of admission, followed by home treatment with homes visits by community nurses until day 7 of treatment. Patients allocated to usual hospital care received care as usual in the hospital and were discharged at day 7. Patients were asked if they had an informal caregiver and who this was. Patients and their caregivers were followed for 90 days. Informal caregiver strain was assessed with the caregiver strain index. Satisfaction and preference were assessed using questionnaires. All measurements were performed at the end of the 7-day treatment and the end of the 90-days follow-up. FINDINGS: Of the 139 patients, 124 had an informal caregiver, of whom three-quarter was the patients' spouse. There was no significant difference in caregiver strain between hospital-at-home and usual hospital care at both time points (mean difference at T+4 days 0.47 95% CI -0.96 to 1.91, p=0.514; mean difference at T+90 days 0.36 95% CI -1.85 to 1.35, p=0.634). At the end of the 7-day treatment, 33% (N=15) of caregivers of patients allocated to hospital treatment and 71% (N=37) of caregivers of patients allocated to home treatment preferred home treatment, if they could choose. Caregivers were satisfied with the treatment the patient received within hospital-at-home. CONCLUSION: There were no differences in caregiver strain between the community-based hospital-at-home scheme and usual hospital care. Most caregivers were satisfied with the treatment. In addition to other outcomes, our results support the wider implementation of hospital-at-home for COPD exacerbations.

Patient preference and satisfaction in hospital-at-home and usual hospital care for COPD exacerbations: results of a randomised controlled trial.

BACKGROUND: In the absence of clear differences in effectiveness and cost-effectiveness between hospital-at-home schemes and usual hospital care, patient preference plays an important role. This study investigates patient preference for treatment place, associated factors and patient satisfaction with a community-based hospital-at-home scheme for COPD exacerbations. METHODS: The study is part of a larger randomised controlled trial. Patients were randomised to usual hospital care or early assisted discharge which incorporated discharge at day 4 and visits by a home care nurse until day 7 of treatment (T+4 days). The hospital care group received care as usual and was discharged from hospital at day 7. Patients were followed for 90 days (T+90 days). Patient preference for treatment place and patient satisfaction (overall and per item) were assessed quantitatively and qualitatively using questionnaires at T+4 days and T+90 days. Factors associated with patient preference were analysed in the early assisted discharge group. RESULTS: 139 patients were randomised. No difference was found in overall satisfaction. At T+4 days, patients in the early assisted discharge group were less satisfied with care at night and were less able to resume normal daily activities. At T+90 days there were no differences for the separate items. Patient preference for home treatment at T+4 days was 42% in the hospital care group and 86% in the early assisted discharge group and 35% and 59% at T+90 days. Patients' mental state was associated with preference. CONCLUSION: Results support the wider implementation of early assisted discharge for COPD exacerbations and this treatment option should be offered to selected patients that prefer home treatment.

Care delivery pathways for Chronic Obstructive Pulmonary Disease in England and the Netherlands: a comparative study.

INTRODUCTION: A remarkable difference in care delivery pathways for Chronic Obstructive Pulmonary Disease (COPD) is the presence of hospital-at-home for COPD exacerbations in England and its absence in the Netherlands. The objective of this paper is to explain this difference. METHODS: Descriptive COPD statistics and care delivery pathways on all care levels within the institutional context, followed by a comparison of care delivery pathways and an explanation of the difference with regard to hospital-at-home. RESULTS: The Netherlands and England show broad similarities in their care delivery pathways for COPD patients. A major difference is the presence of hospital-at-home for COPD exacerbations in England and its absence in the Netherlands. Three possible explanations for this difference are presented: differences in the urgency for alternatives (higher urgency for alternative treatment models in England), the differences in funding (funding in England facilitated the development of hospital-at-home) and the differences in the substitution of tasks to nurses (substitution to nurses has taken place to a larger extent in England). DISCUSSION AND CONCLUSION: The difference between the Netherlands and England regarding hospital-at-home for COPD exacerbations can be explained in three ways. Hospital-at-home has proved to be a safe alternative for hospital care for selected patients, and should be considered as a treatment option for COPD exacerbations in the Netherlands.

Early assisted discharge with generic community nursing for chronic obstructive pulmonary disease exacerbations: results of a randomised controlled trial.

OBJECTIVES: To determine the effectiveness of early assisted discharge for chronic obstructive pulmonary disease (COPD) exacerbations, with home care provided by generic community nurses, compared with usual hospital care. DESIGN: Prospective, randomised controlled and multicentre trial with 3-month follow-up. SETTING: Five hospitals and three home care organisations in the Netherlands. PARTICIPANTS: Patients admitted to the hospital with an exacerbation of COPD. Patients with no or limited improvement of respiratory symptoms and patients with severe unstable comorbidities, social problems or those unable to visit the toilet independently were excluded. INTERVENTION: Early discharge from hospital after 3 days inpatient treatment. Home visits by generic community nurses. Primary outcome measure was change in health status measured by the Clinical COPD Questionnaire (CCQ). Treatment failures, readmissions, mortality and change in generic health-related quality of life (HRQL) were secondary outcome measures. RESULTS: 139 patients were randomised. No difference between groups was found in change in CCQ score at day 7 (difference in mean change 0.29 (95% CI -0.03 to 0.61)) or at 3 months (difference in mean change 0.04 (95% CI -0.40 to 0.49)). No difference was found in secondary outcomes. At day 7 there was a significant difference in change in generic HRQL, favouring usual hospital care. CONCLUSIONS: While patients' disease-specific health status after 7-day treatment tended to be somewhat better in the usual hospital care group, the difference was small and not clinically relevant or statistically significant. After 3 months, the difference had disappeared. A significant difference in generic HRQL at the end of the treatment had disappeared after 3 months and there was no difference in treatment failures, readmissions or mortality. Early assisted discharge with community nursing is feasible and an alternative to usual hospital care for selected patients with an acute COPD exacerbation. TRIAL REGISTRATION: NetherlandsTrialRegister NTR 1129.