ABSTRACT
INTRODUCTION: The small-scale healthcare in Saxony-Anhalt is described as disparate, as regions with good healthcare structures and increasingly undersupplied regions face each other. Deficits in cross-sectoral therapy management jeopardizes ambulatory care after hospital stay in rural areas. This study aims to analyze cross-sectoral care trajectories of patients with colorectal cancer in Saxony-Anhalt over the period from diagnosis up to one year post-discharge and to identify differences in care between patients from urban vs. rural regions. Routine data of the statutory health insurance were used for this study. METHODS: The study population comprised 13,218 insured patients of AOK Saxony-Anhalt with colorectal cancer treated in 2010-2014. Services billed by hospitals and outpatient physicians were considered in relation to patients' residence (urban vs. rural). Survival times were determined according to Kaplan & Meier and explanatory variables for survival were analyzed using regression analysis according to the Cox proportional hazards model. RESULTS: Differences between urban and rural regions were evident in the use of certified hospitals and outpatient treatment. In addition, an undersupply of adjuvant or neoadjuvant treatment became apparent, so that compliance with the guidelines can only be assumed to a limited extent. Overall survival was significantly higher in patients living in urban regions as compared to those from rural areas, which is mainly due to earlier diagnosis, younger age, fewer comorbidities and more adequate cancer therapy. CONCLUSION: There is an urgent need to optimize healthcare structures and processes to enable early diagnosis and barrier-free use of adequate therapies.
Subject(s)
Aftercare , Colorectal Neoplasms , Humans , Patient Discharge , Germany/epidemiology , Comorbidity , Colorectal Neoplasms/epidemiologyABSTRACT
OBJECTIVE: This study aims to examine the effects of the individually tailored complex intervention Participation Enabling Care in Nursing (PECAN) on activities and participation of residents with joint contractures. DESIGN: Multicentre pragmatic cluster-randomised controlled trial. SETTING: 35 nursing homes in Germany (August 2018-February 2020). PARTICIPANTS: 562 nursing home residents aged ≥65 years with ≥1 major joint contracture (303 intervention group, 259 control group). INTERVENTIONS: Nursing homes were randomised to PECAN (18 clusters) or optimised standard care (17 clusters) with researcher-concealed cluster allocation by facsimile. The intervention targeted impairments in activities and participation. Implementation included training and support for selected staff. Control group clusters received brief information. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint PaArticular Scales combined residents' activities and participation at 12 months. The secondary outcome comprised quality of life. Safety measures were falls, fall-related consequences and physical restraints. Residents, staff and researchers were unblinded. Data collection, data entry and statistical analysis were blinded. Primary analyses were intention-to-treat at cluster level and individual level using a generalised mixed-effect regression model and imputation of missing data. RESULTS: Primary outcome analyses included 301 intervention group residents and 259 control group residents. The mean change on the Activities Scale was -1.47 points (SD 12.2) in the intervention group and 0.196 points (SD 12.5) in the control group and -3.87 points (SD 19.7) vs -3.18 points (SD 20.8) on the Participation Scale. The mean differences of changes between the groups were not statistically significant: Activities Scale: -1.72 (97.5% CI -6.05 to 2.61); Participation Scale: -1.24 (97.5% CI -7.02 to 4.45). We found no significant difference in the secondary outcome and no effects on safety measures. CONCLUSION: The complex intervention did not improve the activities and participation of nursing home residents on the PaArticular Scales at 12 months. Current nursing conditions in Germany may hamper implementation. TRIAL REGISTRATION NUMBER: DRKS00015185.
Subject(s)
Contracture , Quality of Life , Humans , Accidental Falls/prevention & control , Nursing Homes , Restraint, PhysicalABSTRACT
BACKGROUND: Joint contractures in frail older people are associated with serious restrictions in participation. We developed the Participation Enabling CAre in Nursing (PECAN) intervention, a complex intervention to enable nurses to promote participation in nursing home residents with joint contractures. The aim of this study was to examine the feasibility of the implementation strategy and to identify enablers and barriers for a successful implementation. METHODS: The implementation of PECAN was investigated in a 6-month pilot cluster-randomised controlled trial (c-RCT). As a key component of the implementation strategy, nominated nurses were trained as facilitators in a one-day workshop and supported by peer-mentoring (visit, telephone counselling). A mixed-methods approach was conducted in conjunction with the pilot trial and guided by a framework for process evaluations of c-RCTs. Data were collected using standardised questionnaires (nursing staff), documentation forms, problem-centred qualitative interviews (facilitators, therapists, social workers, relatives, peer-mentors), and a group discussion (facilitators). A set of predefined criteria on the nursing home level was examined. Quantitative data were analysed using descriptive statistics. Qualitative data were analysed using directed content analysis. RESULTS: Seven nursing homes (n = 4 intervention groups, n = 3 control groups) in two regions of Germany took part in the study. Facilitators responded well to the qualification measures (workshop participation: 14/14; workshop rating: "good"; peer-mentor visit participation: 10/14). The usage of peer-mentoring via telephone varied (one to seven contacts per nursing home). Our implementation strategy was not successful in connection with supplying the intervention to all the nurses. The clear commitment of the entire nursing home and the respect for the expertise of different healthcare professionals were emphasised as enablers, whereas a lack of impact on organisational conditions and routines and a lack of time and staff competence were mentioned as barriers. CONCLUSION: The PECAN intervention was delivered as planned to the facilitators but was unable to produce comprehensive changes in the nursing homes and subsequently for the residents. Strategies to systematically include the management and the nursing team from the beginning are needed to support the facilitators during implementation in the main trial. TRIAL REGISTRATION: German clinical trials register, DRKS00010037 . Registered 12 February 2016.
Subject(s)
Contracture , Homes for the Aged , Aged , Aged, 80 and over , Germany , Humans , Nursing Homes , Pilot Projects , Quality of LifeABSTRACT
BACKGROUND: Acquired joint contractures have a significant impact on functioning and quality of life in nursing home residents. There is very limited evidence on measures for prevention and treatment of disability due to joint contractures. We have developed the PECAN intervention (Participation Enabling CAre in Nursing) to improve social participation in nursing home residents. A cluster-randomised pilot trial was conducted to assess the feasibility of study procedures in preparation for a main trial according to the UK Medical Research Council (MRC) framework. METHODS: Nursing homes in two regions of Germany were randomly allocated either to the intervention or optimised standard care (control group). All residents with joint contractures aged > 65 years were eligible for the study. The residents' data were collected through structured face-to-face interviews by blinded assessors at baseline, after 3 and 6 months. The primary outcome was social participation, measured by a subscale of the PaArticular Scales. Secondary outcomes included activities and instrumental activities of daily living, health-related quality of life, falls and fall-related consequences. Data on the trial feasibility were collected via documentation forms. RESULTS: Seven out of 12 nursing homes agreed to participate and remained in the trial. Of 265 residents who fulfilled the inclusion criteria, 129 were randomised either to the intervention (n = 64) or control group (n = 65) and analysed. A total of 109 (85%) completed the trial after 6 months. The mean age was 85.7 years (SD 7.0), 80% were women. The severity of the residents' disability differed across the clusters. The completion rate was high (> 95%), apart from the Instrumental Activities of Daily Living Scale. Some items of the PaArticular Scales were not easily understood by residents. The frequency of falls did not differ between study groups. CONCLUSION: Our data confirmed the feasibility of the overall study design. We also revealed the need to improve the procedures for the recruitment of residents and for data collection before implementation into a main trial. The next step will be an adequately powered main trial to assess the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION: German clinical trials register, ID: DRKS00010037 . Registered on 12 February 2016.
Subject(s)
Contracture/therapy , Homes for the Aged , Joints/physiopathology , Nursing Homes , Social Participation , Accidental Falls/prevention & control , Activities of Daily Living , Age Factors , Aged , Aged, 80 and over , Aging/psychology , Contracture/diagnosis , Contracture/physiopathology , Contracture/psychology , Feasibility Studies , Female , Geriatric Assessment , Germany , Humans , Male , Pilot Projects , Quality of Life , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Nursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be evaluated in the present study. METHODS/DESIGN: This multicentre cluster-randomised controlled trial will be conducted in 32 nursing homes spread over two regions of Germany. A total of 578 residents over 65 years old with joint contractures will be included. To compare the effect of the PECAN intervention with optimised standard care (usual care and an information session), randomisation will take place at a cluster level. The individually tailored intervention was designed using the biopsychosocial model in the International Classification of Functioning, Disability and Health (ICF) to reduce activity limitations and participation restrictions resulting from existing joint contractures by addressing barriers and by strengthening supportive factors on an individual level and an organisational level. The implementation strategy comprises a facilitators' workshop, a peer mentoring approach including a peer mentor visit and telephone peer counselling, an in-house information event, an information session for the nursing team and a training session on collegial consultation for the facilitators. The in-house information event will also take place in the nursing homes of the control group. The primary outcome is the residents' participation and activities after 12 months of follow-up as assessed using the PaArticular Scales. The secondary outcome is the residents' quality of life. A cost-effectiveness analysis (costs per additional resident who experienced a decrease of ten points in the participation or activities subscale of the PaArticular Scales) and a cost-utility analysis (costs per additional quality adjusted life year) will be conducted. We will investigate barriers and facilitators in a comprehensive process evaluation. DISCUSSION: We expect a clinically relevant improvement of participation and activities in residents with joint contractures. Our findings will provide important insights regarding participation in the situation of the affected individuals. TRIAL REGISTRATION: DRKS, DRKS00015185 . Registered on 1 August 2018. Universal Trial Number U1111-1218-1555. Registered on 26 July 2018.
Subject(s)
Contracture/psychology , Joint Diseases/psychology , Nursing Homes , Randomized Controlled Trials as Topic , Social Participation , Cluster Analysis , Cost-Benefit Analysis , Humans , Outcome Assessment, Health Care , Patient Participation , Quality of Life , Sample SizeABSTRACT
BACKGROUND: Joint contractures in nursing home residents limit the capacity to perform daily activities and restrict social participation. The purpose of this study was to develop a complex intervention to improve participation in nursing home residents with joint contractures. METHODS: The development followed the UK Medical Research Council framework using a mixed-methods design with re-analysis of existing interview data using a graphic modelling approach, group discussions with nursing home residents, systematic review of intervention studies, structured 2-day workshop with experts in geriatric, nursing, and rehabilitation, and group discussion with professionals in nursing homes. RESULTS: Graphic modelling identified restrictions in the use of transportation, walking within buildings, memory functions, and using the hands and arms as the central target points for the intervention. Seven group discussions with 33 residents revealed various aspects related to functioning and disability according the International Classification of Functioning, Disability and Health domains body functions, body structures, activities and participation, environmental factors, and personal factors. The systematic review included 17 studies with 992 participants: 16 randomised controlled trials and one controlled trial. The findings could not demonstrate any evidence in favour of an intervention. The structured 2-day expert workshop resulted in a variety of potential intervention components and implementation strategies. The group discussion with the professionals in nursing homes verified the feasibility of the components and the overall concept. The resulting intervention, Participation Enabling CAre in Nursing (PECAN), will be implemented during a 1-day workshop for nurses, a mentoring approach, and supportive material. The intervention addresses nurses and other staff, residents, their informal caregivers, therapists, and general practitioners. CONCLUSIONS: In view of the absence of any robust evidence, the decision to use mixed methods and to closely involve both health professionals and residents proved to be an appropriate means to develop a complex intervention to improve participation of and quality of life in nursing home residents. We will now evaluate the PECAN intervention for its impact and feasibility in a pilot study in preparation for an evaluation of its effectiveness in a definitive trial. TRIAL REGISTRATION: German clinical trials register, reference number DRKS00010037 (12 February 2016).
Subject(s)
Contracture/epidemiology , Contracture/psychology , Nursing Homes/trends , Patient Participation/psychology , Patient Participation/trends , Social Participation/psychology , Aged , Aged, 80 and over , Contracture/therapy , Female , Health Personnel/psychology , Humans , Male , Pilot Projects , Quality of Life/psychologyABSTRACT
Background: acquired joint contractures have significant effects on quality of life and functioning. Objective: to determine the effects of interventions to prevent and treat disabilities in older people with acquired joint contractures. Methods: systematic search (last 8/2016) via Cochrane Library, PubMed, EMBASE, PEDro, CINAHL, trial registries, reference lists of retrieved articles and scientific congress pamphlets. Controlled and randomised controlled trials in English or German comparing an intervention with another intervention or standard care were included. Two independent researchers performed the selection of publications, data extraction and critical appraisal. Results: seventeen studies with 992 participants met the inclusion criteria: 16 randomised controlled trials and 1 controlled trial (nursing homes = 4, community settings = 13). The methodological quality of the studies varied. Splints were examined in four studies, stretching exercises in nine studies, and ultrasound, passive movement therapy, bed-positioning and group exercise were each examined in one study. Studies on splints revealed inconclusive results regarding joint mobility or spasticity. Five of seven studies that assessed active stretching programmes for healthy older people reported statistically significant effects on joint mobility in favour of the intervention. Pain, quality of life, activity limitations and participation restrictions were rarely assessed. Conclusion: the evidence for the effectiveness of interventions to prevent and treat disability due to joint contractures is weak, particularly for established nursing interventions such as positioning and passive movement. Better understanding is required regarding the delivery of interventions, such as their intensity and duration. In addition to functional issues, activities and social participation should also be studied as outcomes.
Subject(s)
Contracture/therapy , Disability Evaluation , Joint Deformities, Acquired/therapy , Joints/physiopathology , Orthopedic Procedures/instrumentation , Physical Therapy Modalities , Activities of Daily Living , Aged , Aged, 80 and over , Biomechanical Phenomena , Contracture/diagnosis , Contracture/physiopathology , Female , Humans , Joint Deformities, Acquired/diagnosis , Joint Deformities, Acquired/physiopathology , Male , Middle Aged , Orthopedic Procedures/adverse effects , Physical Therapy Modalities/instrumentation , Predictive Value of Tests , Quality of Life , Range of Motion, Articular , Recovery of Function , Splints , Treatment OutcomeABSTRACT
BACKGROUND: Joint contractures are common problems in frail older people in nursing homes. Irrespective of the exact extent of older individuals in geriatric care settings living with joint contractures, they appear to be a relevant problem. Also, the new emphasis on the syndrome of joint contractures, e. g. by the German statutory long term care insurance, led to an increase in assessment and documentation efforts and preventive interventions in clinical care. However, more attention should be paid to the actual situation of older individuals in nursing homes with prevalent joint contractures, particularly their experience of related activity limitations and participation restrictions. Thus, the aim of this study is 1) to develop a tailored intervention to improve functioning, and especially participation and quality of life in older residents with joint contractures in nursing homes and 2) to test the feasibility of the intervention accompanied by a rigorous process evaluation. METHODS: The complex intervention, which will be developed in this project follows the UK Medical Research Council (MRC) framework and integrates the perspectives of all potentially relevant user groups, from the affected individuals to clinicians and researchers. The development process will comprise a systematic literature review, reanalysis of existing data and the integration of the knowledge of the affected individuals and experts. The developed intervention including a comprehensive process evaluation will be pilot tested with residents with joint contractures in three nursing homes. DISCUSSION: The projected study will provide a tailored intervention to improve functioning, participation and quality of life in older residents with joint contractures in nursing homes. With this focus, the intervention will support patient relevant outcomes. The pilot study including process evaluation will offer a first opportunity to indicate the size of the intervention's effect and prepare further studies.
Subject(s)
Contracture/rehabilitation , Frail Elderly , Homes for the Aged , Nursing Homes , Patient Participation , Quality of Life , Aged , Biomedical Research/methods , Contracture/psychology , Frail Elderly/psychology , Goals , Humans , Pilot Projects , Research Design , Systematic Reviews as TopicABSTRACT
BACKGROUND: Most older adults want to live independently in a familiar environment instead of moving to a nursing home. Preventive home visits based on multidimensional geriatric assessment can be one strategy to support this preference and might additionally reduce health care costs, due to the avoidance of costly nursing home admissions. The purpose of this study was to analyse the cost-effectiveness of preventive home visits from a societal perspective in Germany. METHODS: This study is part of a multi-centre, non-blinded, randomised controlled trial aiming at the reduction of nursing home admissions. Participants were older than 80 years and living at home. Up to three home visits were conducted to identify self-care deficits and risk factors, to present recommendations and to implement solutions. The control group received usual care. A cost-utility analysis using quality-adjusted life years (QALY) based on the EQ-5D was performed. Resource utilization was assessed by means of the interview version of a patient questionnaire. A cost-effectiveness acceptability curve controlled for prognostic variables was constructed and a sensitivity analysis to control for the influence of the mode of QALY calculation was performed. RESULTS: 278 individuals (intervention group: 133; control group: 145) were included in the analysis. During 18 months follow-up mean adjusted total cost (mean: +4,401 EUR; bootstrapped standard error: 3,019.61 EUR) and number of QALY (mean: 0.0061 QALY; bootstrapped standard error: 0.0388 QALY) were higher in the intervention group, but differences were not significant. For preventive home visits the probability of an incremental cost-effectiveness ratio <50,000 EUR per QALY was only 15%. The results were robust with respect to the mode of QALY calculation. CONCLUSIONS: The evaluated preventive home visits programme is unlikely to be cost-effective. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT00644826.
Subject(s)
Cost-Benefit Analysis , Health Care Costs/statistics & numerical data , Health Services for the Aged/economics , Home Nursing/economics , House Calls/economics , Self Care/economics , Aged, 80 and over , Female , Germany , Humans , Male , Quality-Adjusted Life Years , Surveys and QuestionnairesABSTRACT
BACKGROUND: Falls in older people are a major public health issue, but the underlying causes are complex. We sought to evaluate the effectiveness of preventive home visits as a multifactorial, individualized strategy to reduce falls in community-dwelling older people. METHODS: Data were derived from a prospective randomized controlled trial with follow-up examination after 18 months. Two hundred and thirty participants (≥80 years of age) with functional impairment were randomized to intervention and control groups. The intervention group received up to three preventive home visits including risk assessment, home counseling intervention, and a booster session. The control group received no preventive home visits. Structured interviews at baseline and follow-up provided information concerning falls in both study groups. Random-effects Poisson regression evaluated the effect of preventive home visits on the number of falls controlling for covariates. RESULTS: Random-effects Poisson regression showed a significant increase in the number of falls between baseline and follow-up in the control group (incidence rate ratio 1.96) and a significant decrease in the intervention group (incidence rate ratio 0.63) controlling for age, sex, family status, level of care, and impairment in activities of daily living. CONCLUSION: Our results indicate that a preventive home visiting program can be effective in reducing falls in community-dwelling older people.
Subject(s)
Accidental Falls/prevention & control , Geriatric Assessment , House Calls , Activities of Daily Living , Aged, 80 and over , Chi-Square Distribution , Counseling , Female , Humans , Independent Living , Male , Poisson Distribution , Prospective Studies , Risk Assessment , Risk Factors , Statistics, Nonparametric , Treatment OutcomeABSTRACT
BACKGROUND: Prolonged urinary catheterization is common amongst people in long-term care settings and this carries a high risk of developing a catheter-related urinary tract infection and associated complications. A variety of different kinds of urethral catheters are available. Some have been developed specifically to lower the risk of catheter-associated infection, for example antiseptic or antibiotic impregnated catheters. Ease of use, comfort and handling for the caregivers and patients, and cost-effectiveness are also important factors influencing choice. OBJECTIVES: The primary objective was to determine which type of indwelling urinary catheter is best to use for long-term bladder drainage in adults. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register (last searched 31 March 2011), which includes searches of CENTRAL, MEDLINE and handsearching of journals and conference proceedings, and the reference lists of relevant articles. SELECTION CRITERIA: All randomised trials comparing types of indwelling urinary catheters for long-term catheterization in adults. Long-term catheterization was defined as more than 30 days. DATA COLLECTION AND ANALYSIS: Data extraction has been undertaken by two review authors working independently and simultaneously. Any disagreement has been resolved by a third review author. The included trial data were handled according to the methods of the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: Three trials were included, involving 102 adults in various settings. Two trials had a parallel group design and one was a randomised cross-over trial.Only two of the six targeted comparisons were assessed by these trials: antiseptic impregnated catheters versus standard catheters (one trial) and one type of standard catheter versus another standard catheter (two trials).The single small cross-over trial was inadequate to assess the value of silver alloy (antiseptic) impregnated catheters. In the two trials comparing different types of standard catheters, estimates of differences were all imprecise because the trials also had small sample sizes; confidence intervals (CI) were too wide to rule out clinically important differences. One trial did suggest, however, that the use of a hydrogel coated latex catheter rather than a silicone catheter may be better tolerated (risk ratio (RR) for need for early removal 0.41, 95% CI 0.22 to 0.77). AUTHORS' CONCLUSIONS: The updated search could not reveal any additional evidence. Very few trials have compared different types of catheter for long-term bladder drainage. All trials were small and showed methodological weaknesses. Therefore, the evidence was not sufficient as a reliable basis for practical conclusions. Further, better quality trials are needed to address the current lack of evidence in this clinically important area.
Subject(s)
Catheters, Indwelling/standards , Drainage/instrumentation , Urinary Bladder , Urinary Catheterization/instrumentation , Adult , Humans , Long-Term Care , Randomized Controlled Trials as Topic , Time Factors , Urinary Catheterization/standardsABSTRACT
BACKGROUND: Regarding demographic changes in Germany it can be assumed that the number of elderly and the resulting need for long term care is increasing in the near future. It is not only an individual's interest but also of public concern to avoid a nursing home admission. Current evidence indicates that preventive home visits can be an effective way to reduce the admission rate in this way making it possible for elderly people to stay longer at home than without home visits. As the effectiveness and cost-effectiveness of preventive home visits strongly depends on existing services in the social and health system existing international results cannot be merely transferred to Germany. Therefore it is necessary to investigate the effectiveness and cost-effectiveness of such an intervention in Germany by a randomized controlled trial. METHODS: The trial is designed as a prospective multi-center randomized controlled trial in the cities of Halle and Leipzig. The trial includes an intervention and a control group. The control group receives usual care. The intervention group receives three additional home visits by non-physician health professionals (1) geriatric assessment, (2) consultation, (3) booster session. The nursing home admission rate after 18 months will be defined as the primary outcome. An absolute risk reduction from a 20% in the control-group to a 7% admission rate in the intervention group including an assumed drop out rate of 30% resulted in a required sample size of N = 320 (n = 160 vs. n = 160). Parallel to the clinical outcome measurement the intervention will be evaluated economically. The economic evaluation will be performed from a society perspective. DISCUSSION: To the authors' knowledge for the first time a trial will investigate the effectiveness and cost-effectiveness of preventive home visits for people aged 80 and over in Germany using the design of a randomized controlled trial. Thus, the trial will contribute to the existing evidence on preventive home visits especially in Germany.
