Special features of health services and register based trials - experiences from a randomized trial of childbirth classes. A randomized trial of assertive community treatment for homeless persons with severe mental illness. Heavy users of acute psychiatric beds: randomized controlled trial of enhanced community management in an outer London borough. A randomized control trial of nursing-based case management for patients with chronic obstructive pulmonary disease. Telehomecare: quality, perception, satisfaction. Cluster randomized controlled trial of the effectiveness of audit and feedback and educational outreach on improving nursing practice and patient outcomes. Effects of a multidisciplinary, post-discharge continuance of care intervention on quality of life, discharge satisfaction, and hospital length of stay: a randomized controlled trial. An experimental evaluation of residential and nonresidential treatment for dually diagnosed homeless adults. Controlled evaluation of a hospital-originated community transitional system.
Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services.
                The example intervention was education to public health nurses (PHN) (childbirth classes) to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC) were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers). The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR). Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence.
                It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial.
                Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health service providers is a challenging intervention.
                not registered (see Results). This experiment evaluated the effectiveness of an innovative program of assertive community treatment (ACT) for homeless persons with severe and persistent mental illnesses.
                One hundred fifty-two homeless persons with severe and persistent mental illness were randomized to either the experimental ACT program or to usual community services. Baseline assessments included the Structured Clinical Interview for DSM-III-R, Quality-of-Life Interview, Colorado Symptom Index, and the Medical Outcomes Study 36-Item Short Form Health Survey. All assessments (except the Structured Clinical Interview) were repeated at the 2-, 6-, and 12-month follow-up evaluations.
                Subjects in the ACT program used significantly fewer psychiatric inpatient days, fewer emergency department visits, and more psychiatric outpatient visits than the comparison subjects. The ACT subjects also spent significantly more days in stable community housing, and they experienced significantly greater improvements in symptoms, life satisfaction, and perceived health status.
                Relative to usual community care, the ACT program for homeless persons with severe and persistent mental illness shifts the locus of care from crisis-oriented services to ongoing outpatient care and produces better housing, clinical, and life satisfaction outcomes. Heavy users of psychiatric services, often defined as the population that uses the most beds, consume a large part of the resources used by the whole service, despite being relatively small in number. Any intervention that reduces heavy use is therefore likely to lead to significant savings, and enhancement of standard care using a form of intensive case management akin to assertive community treatment was thought to be a pragmatic strategy for testing in this group.
                The effectiveness of enhanced community management (ECM) was compared with standard care alone in heavy users, who represented the 10% of patients with the highest number of hospital admissions and occupied bed days over the previous 6.5 years in an outer London borough. One hundred and ninety-three patients were randomly assigned to ECM or standard care and their use of services was determined after 1 and 2 years, with assessments of costs, clinical symptoms, needs, and social function made before entry into the study and after 1 and 2 years.
                Despite a 24 fold increase in community contacts in the study group, there were no significant differences between the two groups in any of the main outcome measures. Small savings on in-patient and day-hospital service costs were counterbalanced by the increased costs of outpatient and community care for the subjects assigned to ECM. Clinical outcome data derived from interviews in two-thirds of the subjects were similar in both groups.
                Providing additional intensive community focused care to a group of heavy users of psychiatric in-patient services in an outer London borough does not lead to any important clinical gains or reduced costs of psychiatric care. This study assessed the impact of a randomized trial of nursing-based case management for patients with chronic obstructive pulmonary disease, their caregivers, and nursing and medical staff. Sixty-six patients were matched by FEV on admission to hospital, and randomized into an intervention or control group. Intervention group patients reported significantly less anxiety at 1 month postdischarge; however, this effect was not sustained. There was little difference between groups in terms of unplanned readmissions, depression, symptoms, support, and subjective well being. Interviews with patients and caregivers found that the case management improved access to resources and staff-patient communication. Interviews with nursing and medical staff found that case management improved communication between staff and enhanced patient care.(1) The aim of this study was to demonstrate that telehomecare linking homebound patients with their home health-care nurses over the plain old telephone system (POTS) provides high-quality, clinically useful, and patient satisfactory interactions. Congestive heart failure, chronic obstructive pulmonary disease, and chronic wound-care patients receiving skilled home nursing care were randomized into control (standard home health care, HHC) and two intervention (standard care plus video conferencing/Internet access; the above plus physiological monitoring) groups. Virtual visits (VVs), consisting of two-way audio and video interactions between the central site HHC nurse and the subject at home, were compared for technical quality and clinical usefulness by the HHC nurses who performed the VVs. Subject perception of telehomecare and satisfaction with their HHC were assessed over the course of the project. There were a total of 567 virtual and 1,057 actual visits conducted for the 53 subjects completing the study. The technical quality of VVs were rated at 94.7%. They were considered to be as useful as actual visits in 90.7% of cases. Subject telehomecare perception increased after experiencing the process. All subjects were satisfied with their HHC; satisfaction increased with an increasing level of telehomecare intervention. Subjects receiving physiological monitoring and video conferencing/Internet access in addition to standard care were most satisfied with their care. VVs can be conducted over POTS. Patients can use telehomecare with moderate levels of training. These programs can provide timely and quality home health nursing care with VVs augmenting traditional home visits. Current understanding of implementation methods is limited, and research has focused on changing doctors' behaviors.
                Our aim was to evaluate the impact of audit and feedback and educational outreach in improving nursing practice and patient outcomes.
                Using a factorial design, cluster randomized controlled trial, we evaluated 194 community nurses in 157 family practices and 1078 patients with diagnosis of urinary incontinence (UI) for nurses compliance with evidence-linked review criteria for the assessment and management of UI and impact on psychologic and social well-being and symptoms. In the outreach arms, nurses' self-reported barriers informed development of tailored strategies.
                In comparison with educational materials alone, the implementation methods tested did not improve care at 6 months follow-up. Moderate rates of improvement (10-17% of patients) in performance for the assessment of UI and greater rates of improvement (20-30% of patients) for the management of care were found but effects were similar across arms. Improvement in patient outcomes was more consistently positive for educational outreach than for audit and feedback but differences were not significant. Adjustment for caseload size, severity or duration of UI and patients' age did not alter results.
                Printed educational materials alone may be as effective as audit and feedback and educational outreach in improving nurses' performance and outcomes of care for people with UI. Greater understanding of the underlying processes in improving performance within multidisciplinary teams through further, theory-driven studies with "no intervention" control groups and longer follow-up are needed. To determine the impact of a hospital-coordinated discharge care plan, involving a multidisciplinary team of primary health care providers, on hospital length of stay, quality of life, and both patient and general practitioner inclusion in, and satisfaction with, discharge procedures.
                This investigation comprised a prospective, randomized, controlled, clinical trial.
                This multicentre and cross-jurisdictional study focused on areas of tertiary and primary health care as well as community allied health in Western Australia.
                Patients (n = 189) with chronic cardiorespiratory diagnoses were recruited from respiratory, cardiovascular, and general medical wards at two tertiary hospitals.
                Subjects were randomly assigned to one of two groups. Intervention group patients received a discharge care plan in accordance with that outlined in the Australian Enhanced Primary Care Package, completed before discharge and sent to the patient's general practitioner and other community service providers for review. Control patients were discharged under existing hospital processes. Outcome measures. Patients and general practitioners were surveyed pre-discharge and 7 days post-discharge for quality of life and opinion of discharge procedures. Hospital length of stay was also determined.
                Significant improvements in discharge planning involvement, health service access, confidence with discharge procedures, and opinion of discharge based on previous experience were seen for patients who received the discharge care plan. Further, improved perceptions of mental quality of life were observed within the first week post-discharge for intervention patients. Length of stay showed no difference between groups. Extent and speed of hospital-general practitioner communication were significantly improved via the intervention.
                Our results indicate that a multidisciplinary discharge care plan, initiated before separation, improves quality of life, involvement, and satisfaction with discharge care, and hospital-general practitioner integration. As such, it possesses benefits over current Western Australian hospital discharge procedures for the care of chronically ill populations. Homeless adults with both a serious mental illness and substance dependence (N = 276) were randomly assigned to: (1) a social model residential program providing integrated mental health and substance abuse treatment; (2) a community-based nonresidential program using the same social model approach; or (3) a control group receiving no intervention but free to access other community services. Interventions were designed to provide 3 months of intensive treatment, followed by 3 months of nonresidential maintenance. Subjects completed baseline interviews prior to randomization and reinterviews 3, 6, and 9 months later. Results showed that, while substance use, mental health, and housing outcomes improved from baseline, subjects assigned to treatment conditions differed little from control subjects. Examination of the relationship between length of treatment exposure and outcomes suggested that residential treatment had positive effects on outcomes at 3 months, but that these effects were eroded by 6 months. The effect of a treatment program (E) providing inpatient care, a day hospital, community housing, and sheltered work are compared with a program (C) emphasizing rapid discharge. A group of 94 male general psychiatric patients were randomized to the two units. Outcome data collected at 18 months from admission revealed small but significant differences between the total samples in employment, maintenance of treatment contact, use of medication, and social adjustment. More C than E patients were in the hospital after the 14th month. Program effects varied considerably with patient type. Patients with less social disability had somewhat better employment outcomes with the E program, but no differences in use of services. Patients with a better prognosis by measure of psychopathology (Minnesota Multiphasic Personality Inventory cluster and diagnosis of schizophrenia) spent less inpatient time in the E program, but were not helped to better employment outcomes. Patients with greater social handicap were not differentially affected. More E patients than C with a poorer prognosis stayed in outpatient treatment and used antipsychotic medications. Patients in the E group with better previous employment and more social isolation used the E day hospital and community housing more heavily than other E subgroups.
IHCAs appear to have largely positive effects on users, in that users tend to become more knowledgeable, feel better socially supported, and may have improved behavioural and clinical outcomes compared to non-users. There is a need for more high quality studies with large sample sizes to confirm these preliminary findings, to determine the best type and best way to deliver IHCAs, and to establish how IHCAs have their effects for different groups of people with chronic illness.