Dataset Information

Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial.

ABSTRACT:

Background

In the healthcare system in Germany, different institutions and actors play specific roles in the discharge and transition of patients from hospitals into primary care (Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen, Wettbewerb an der Schnittstelle zwischen ambulanter und stationärer Gesundheitsversorgung, 2012). However, there are shortcomings in these intersectoral transitions. Especially in older people with cognitive impairment (PCI), discharge management often lacks coordination and cooperation between healthcare providers. This frequently results in higher rates of unscheduled readmission. The project intersec-CM is a randomised controlled trial (RCT) that aims to explore up to what extent an intersectoral care management (ICM) can improve this transition. This ICM is delivered by nurses with special training in care management. The objective of this paper is to describe a mixed-methods process evaluation of the intersectoral care management intervention and the factors that facilitate and inhibit its implementation.

Methods

Different study designs for process evaluations from previous literature were collected and analysed according to the dimension implementation fidelity, satisfaction with the intervention, feasible transfer into routine care, optimum point of time, frequency and execution of the intervention, and context factors.

Results

The actor-network theory was chosen as the theoretic framework for the process evaluation. Based on this theory, a mixed-methods design was developed to combine and integrate qualitative and quantitative evaluation methods. The qualitative part includes semi-structured interviews using topic guides (phase 1) and later in-depth interviews with narrative portions (phase 3), which will be analysed by using the qualitative content analysis according to Kuckartz. The quantitative survey (phase 2) is conducted with standardised questionnaires.

Discussion

Challenges in data collection include the development of interview guidelines, which require different terminologies depending on every specific actor targeted in the intervention. Conducting the interviews, there is a risk of misunderstanding the older PCI by the interviewer and vice versa. However, the combination of qualitative and quantitative approaches as different techniques of process evaluation may help to capture, integrate and analyse data on different dimensions of the intervention.

Conclusions

The results of our process evaluation may serve as an implementation guideline for intersectoral care management in the German healthcare system. Furthermore, the approach to evaluate the process of a complex intervention in health care for older PCI may serve as a stimulus to broaden the evidence base also of other complex intervention studies to improve health care for this vulnerable group. The study was ethically approved by the Ethics Committee of the Ernst-Moritz-Arndt University of Greifswald. The study has been registered at the U.S. National Library of Medicine.

Trial registration

ClinicalTrials.gov NCT03359408 . Registered on 2 December 2017. The approximate date when recruitment to the process evaluation of the study will be completed is 31 May 2021.

SUBMITTER: Dehl T

PROVIDER: S-EPMC7819226 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial.

Dehl Terese T Sauerbrey Ulf U Dreier-Wolfgramm Adina A Nikelski Angela A Chikhradze Nino N Keller Armin A Laufer Jessica J Schumacher-Schoenert Fanny F Kreisel Stefan S Thyrian Jochen René JR Hoffmann Wolfgang W Vollmar Horst Christian HC

Trials 20210121 1

<h4>Background</h4>In the healthcare system in Germany, different institutions and actors play specific roles in the discharge and transition of patients from hospitals into primary care (Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen, Wettbewerb an der Schnittstelle zwischen ambulanter und stationärer Gesundheitsversorgung, 2012). However, there are shortcomings in these intersectoral transitions. Especially in older people with cognitive impairment (PCI), discharge ma ...[more]

PMID: 33478583

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Project description:BackgroundThe sectorization of health-care systems leads to inefficient treatment, especially for elderly people with cognitive impairment. The transition from hospital care to primary care is insufficiently coordinated, and communication between health-care providers is often lacking. Consequences include a further deterioration of health, higher rates of hospital readmissions, and institutionalization. Models of collaborative care have shown their efficacy in primary care by improving patient-related outcomes. The main goal of this trial is to compare the effectiveness of a collaborative care model with usual care for people with cognitive impairment who have been admitted to a hospital for treatment due to a somatic illness. The aim of the intervention is to improve the continuity of treatment and care across the transition between the in-hospital and adjoining primary care sectors.Methods/designThe trial is a longitudinal multisite randomized controlled trial with two arms (care as usual and intersectoral care management). Inclusion criteria at the time of hospital admission due to a somatic illness are age 70+ years, cognitive impairment (Mini Mental State Examination, MMSE ≤26), living at home, and written informed consent. Each participant will have a baseline assessment at the hospital and two follow-up assessments at home (3 and 12 months after discharge). The estimated sample size is n = 398 people with cognitive inmpairement plus their respective informal caregivers (where available). In the intersectoral care management group, specialized care managers will develop, implement, and monitor individualized treatment and care based on comprehensive assessments of the unmet needs of the patients and their informal caregivers. These assessments will occur at the hospital and in participants' homes. Primary outcomes are (1) activities of daily living, (2) readmission to the hospital, and (3) institutionalization. Secondary outcomes include (a) frailty, (b) delirium, (c) quality of life, (d) cognitive status, (e) behavioral and psychological symptoms of dementia, (f) utilization of services, and (g) informal caregiver burden.DiscussionIn the event of proving efficacy, this trial will deliver a proof of concept for implementation into routine care. The cost-effectiveness analyses as well as an independent process evaluation will increase the likelihood of meeting this goal. The trial will enable an in-depth analysis of mediating and moderating effects for different health outcomes at the interface between hospital care and primary care. By highlighting treatment and care, the study will provide insights into unmet needs at the time of hospital admission, and the opportunities and barriers to meeting those needs during the hospital stay and after discharge.Trial registrationClinicalTrials.gov, NCT03359408 ; December 2, 2017.

Project description:BackgroundCognitive impairment is an important determinant in health care. In the acute hospital setting cognition has a strong impact on treatment and care. Cognitive impairment can negatively affect diagnostics and treatment success. However, little is known about the individual situation and specific risks of people with cognitive impairments during hospital stays. The aim of the present research is to describe and analyze the treatment needs of people with cognitive impairments in acute hospital care.MethodsThe analyses use baseline data of the ongoing multisite, longitudinal, randomized controlled intervention trial intersec-CM (Supporting elderly people with cognitive impairment during and after hospital stays with Intersectoral Care Management), which recruited 402 participants at baseline. We assessed sociodemographic aspects, cognitive status, functional status, frailty, comorbidities, level of impairment, formal diagnosis of dementia, geriatric diagnoses, delirium, depression, pharmacological treatment, utilization of health care services and health care related needs.ResultsThe sample under examination had been on average mildly cognitively impaired (MMSE M = 22.3) and had a mild to moderate functional impairment (Barthel Index M = 50.4; HABAM M = 19.1). The Edmonton Frail Scale showed a mean of 7.4 and half of the patients (52.3%) had been assigned a care level. About 46.9% had a geriatric diagnosis, 3.0% had a diagnosis of dementia. According to DSM-V 19.2% of the patients had at least one main symptom of depression. The mean number of regularly taken drugs per patient was 8.2. Utilization of health care services prior to the hospital stay was rather low. On average, the sample showed 4.38 care related needs in general, of which 0.60 needs were unaddressed at the time of assessment.ConclusionsDescriptive analyses highlight an in-depth insight into impairments and different care needs of people with cognitive impairments. The results emphasize the need for gender-specific analyses as well as an increased attention to the heterogeneity of needs of people with cognitive impairments related to specific wards, settings and regions where they are admitted. Our results indicate also that people with cognitive impairments represent a high proportion of older patients in acute hospital care.Trial registrationThe intersec-CM trial is registered at ClinicalTrials.gov ( NCT03359408 ).

Project description:ObjectiveTo develop and evaluate a best practice model of general hospital acute medical care for older people with cognitive impairment.DesignRandomised controlled trial, adapted to take account of constraints imposed by a busy acute medical admission system.SettingLarge acute general hospital in the United Kingdom.Participants600 patients aged over 65 admitted for acute medical care, identified as "confused" on admission.InterventionsParticipants were randomised to a specialist medical and mental health unit, designed to deliver best practice care for people with delirium or dementia, or to standard care (acute geriatric or general medical wards). Features of the specialist unit included joint staffing by medical and mental health professionals; enhanced staff training in delirium, dementia, and person centred dementia care; provision of organised purposeful activity; environmental modification to meet the needs of those with cognitive impairment; delirium prevention; and a proactive and inclusive approach to family carers.Main outcome measuresPrimary outcomenumber of days spent at home over the 90 days after randomisation.Secondary outcomesstructured non-participant observations to ascertain patients' experiences; satisfaction of family carers with hospital care. When possible, outcome assessment was blind to allocation.ResultsThere was no significant difference in days spent at home between the specialist unit and standard care groups (median 51 v 45 days, 95% confidence interval for difference -12 to 24; P=0.3). Median index hospital stay was 11 versus 11 days, mortality 22% versus 25% (-9% to 4%), readmission 32% versus 35% (-10% to 5%), and new admission to care home 20% versus 28% (-16% to 0) for the specialist unit and standard care groups, respectively. Patients returning home spent a median of 70.5 versus 71.0 days at home (-6.0 to 6.5). Patients on the specialist unit spent significantly more time with positive mood or engagement (79% v 68%, 2% to 20%; P=0.03) and experienced more staff interactions that met emotional and psychological needs (median 4 v 1 per observation; P<0.001). More family carers were satisfied with care (overall 91% v 83%, 2% to 15%; P=0.004), and severe dissatisfaction was reduced (5% v 10%, -10% to 0%; P=0.05).ConclusionsSpecialist care for people with delirium and dementia improved the experience of patients and satisfaction of carers, but there were no convincing benefits in health status or service use. Patients' experience and carers' satisfaction might be more appropriate measures of success for frail older people approaching the end of life.Trial registrationClinical Trials NCT01136148.

Project description:ObjectiveCompassionate care continues to be a focus for national and international attention, but the existing evidence base lacks the experimental methodology necessary to guide the selection of effective interventions for practice. This study aimed to evaluate the Creating Learning Environments for Compassionate Care (CLECC) intervention in improving compassionate care.SettingWard nursing teams (clusters) in two English National Health Service hospitals randomised to intervention (n=4) or control (n=2). Intervention wards comprised two medicines for older people (MOPs) wards and two medical/surgical wards. Control wards were both MOPs.ParticipantsData collected from 627 patients and 178 staff.Exclusion criteriareverse barrier nursed, critically ill, palliative or non-English speaking. All other patients and all nursing staff and Health Care Assistant HCAs were invited to participant, agency and bank staff were excluded.InterventionCLECC, a workplace intervention focused on developing sustainable leadership and work-team practices to support the delivery of compassionate care.ControlNo educational activity.Primary and secondary outcome measuresPrimary-Quality of Interaction Schedule (QuIS) for observed staff-patient interactions. Secondary-patient-reported evaluations of emotional care in hospital (PEECH); nurse-reported empathy (Jefferson Scale of Empathy).ResultsTrial proceeded as per protocol, randomisation was acceptable. Some but not all blinding strategies were successful. QuIS observations achieved 93% recruitment rate with 25% of patient sample cognitively impaired. At follow-up there were more total positive (78% vs 74%) and less total negative (8% vs 11%) QuIS ratings for intervention wards versus control wards. Sixty-three per cent of intervention ward patients scored lowest (ie, more negative) scores on PEECH connection subscale, versus 79% of control. This was not a statistically significant difference. No statistically significant differences in nursing empathy were observed.ConclusionsUse of experimental methods is feasible. The use of structured observation of staff-patient interaction quality is a promising outcome measure inclusive of hard to reach groups.Trial registration numberISRCTN16789770.

Project description:BackgroundHome exercise can prevent falls in the general older community but its impact in people recently discharged from hospital is not known. The study aimed to investigate the effects of a home-based exercise program on falls and mobility among people recently discharged from hospital.Methods and findingsThis randomised controlled trial (ACTRN12607000563460) was conducted among 340 older people. Intervention group participants (n?=?171) were asked to exercise at home for 15-20 minutes up to 6 times weekly for 12 months. The control group (n?=?169) received usual care. Primary outcomes were rate of falls (assessed over 12 months using monthly calendars), performance-based mobility (Lower Extremity Summary Performance Score, range 0-3, at baseline and 12 months, assessor unaware of group allocation) and self-reported ease of mobility task performance (range 0-40, assessed with 12 monthly questionaries). Participants had an average age of 81.2 years (SD 8.0) and 70% had fallen in the past year. Complete primary outcome data were obtained for at least 92% of randomised participants. Participants in the intervention group reported more falls than the control group (177 falls versus 123 falls) during the 12-month study period and this difference was statistically significant (incidence rate ratio 1.43, 95% CI 1.07 to 1.93, p?=?0.017). At 12-months, performance-based mobility had improved significantly more in the intervention group than in the control group (between-group difference adjusted for baseline performance 0.13, 95% CI 0.04 to 0.21, p?=?0.004). Self-reported ease in undertaking mobility tasks over the 12-month period was not significantly different between the groups (0.49, 95% CI -0.91 to 1.90, p?=?0.488).ConclusionsAn individualised home exercise prescription significantly improved performance-based mobility but significantly increased the rate of falls in older people recently discharged from hospital.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12607000563460.

Project description:BackgroundOne in three hospital acute medical admissions is of an older person with cognitive impairment. Their outcomes are poor and the quality of their care in hospital has been criticised. A specialist unit to care for older people with delirium and dementia (the Medical and Mental Health Unit, MMHU) was developed and then tested in a randomised controlled trial where it delivered significantly higher quality of, and satisfaction with, care, but no significant benefits in terms of health status outcomes at three months.ObjectiveTo examine the cost-effectiveness of the MMHU for older people with delirium and dementia in general hospitals, compared with standard care.MethodsSix hundred participants aged over 65 admitted for acute medical care, identified on admission as cognitively impaired, were randomised to the MMHU or to standard care on acute geriatric or general medical wards. Cost per quality adjusted life year (QALY) gained, at 3-month follow-up, was assessed in trial-based economic evaluation (599/600 participants, intervention: 309). Multiple imputation and complete-case sample analyses were employed to deal with missing QALY data (55%).ResultsThe total adjusted health and social care costs, including direct costs of the intervention, at 3 months was £7714 and £7862 for MMHU and standard care groups, respectively (difference -£149 (95% confidence interval [CI]: -298, 4)). The difference in QALYs gained was 0.001 (95% CI: -0.006, 0.008). The probability that the intervention was dominant was 58%, and the probability that it was cost-saving with QALY loss was 39%. At £20,000/QALY threshold, the probability of cost-effectiveness was 94%, falling to 59% when cost-saving QALY loss cases were excluded.ConclusionsThe MMHU was strongly cost-effective using usual criteria, although considerably less so when the less acceptable situation with QALY loss and cost savings were excluded. Nevertheless, this model of care is worthy of further evaluation.Trial registrationClinicalTrials.gov NCT01136148.

Dataset Information

Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial.

Background

Methods

Results

Discussion

Conclusions

Trial registration

Publications

Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial.

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