Process evaluation of a complex intervention evaluating the effectiveness of home-based rehabilitation in the chronic phase of traumatic brain injury.

PURPOSE: To perform a process evaluation of a randomized controlled trial (RCT) evaluating a manualized intervention aiming to ameliorate long-term symptoms of traumatic brain injury (TBI) by assessing implementation fidelity, delivery context and acceptability of the intervention. METHODS: Data from 60 participants were collected during recruitment, intervention delivery and outcome data collection in the RCT. Enrollment records, logs and checklists documented the delivery of the intervention (implementation fidelity) and the collaboration with family members and outside collaborators (delivery context). Attendance-rate, self-reported acceptability and willingness to participate in future studies were used to assess the acceptability of the intervention. RESULTS: The main elements and dose of the intervention were delivered as intended with an excellent adherence to the manual items. Family members co-participated in the intervention for 39 (65%) of the participants. Outside collaborators were contacted for 32 (53%) of the participants. Acceptability scores were high for participants, family members and therapists. CONCLUSIONS: The intervention was successfully delivered with high acceptability. This process evaluation informs researchers, clinicians and stakeholders about important factors influencing the outcomes of the intervention that should be considered in clinical implementation of rehabilitation interventions. TRIAL REGISTRATION: Pre-registered 4th of June 2018 at clinicaltrials.gov (NCT03545594).

Patient-reported nausea after implementation of an enhanced recovery after surgery protocol for gynae-oncology patients.

OBJECTIVES: This study aimed to analyze the adherence to strategies to prevent post-operative nausea and vomiting after implementation of an enhanced recovery after surgery (ERAS) protocol for gynae-oncology patients. Patient-reported nausea before and after ERAS was also studied. METHODS: This prospective observational study included all patients undergoing laparotomy for a suspicious pelvic mass or confirmed advanced ovarian cancer before (pre-ERAS) and after the implementation of ERAS (post-ERAS) at Oslo University Hospital, Norway. Patients were a priori stratified according to the planned extent of surgery into two cohorts (Cohort 1: Surgery of advanced disease; Cohort 2: Surgery for a suspicious pelvic tumor). Clinical data including baseline characteristics and outcome data were prospectively collected. RESULTS: A total of 439 patients were included, 243 pre-ERAS and 196 post-ERAS. At baseline, 27% of the patients reported any grade of nausea. In the post-ERAS cohort, statistically significantly more patients received double post-operative nausea and vomiting prophylaxis (64% pre-ERAS vs 84% post-ERAS, p<0.0001). There was no difference in the need for rescue medication (82% pre-ERAS vs 79% post-ERAS; p=0.17) and no statistically significant difference between pre- and post-ERAS or between the surgical cohorts in patient-reported nausea of any grade on day 2. Patients who reported none/mild nausea on day 2 had significantly less peri-operative fluid administered during surgery than those who reported moderate or severe nausea (median 12.5 mL/kg/hour vs 16.5 mL/kg/hour, p=0.045) but, in multivariable analysis, fluid management did not remain significantly associated with nausea. CONCLUSION: Implementation of an ERAS protocol increased the adherence to post-operative nausea and vomiting prevention guidelines. Nausea, both before and after laparotomy, remains an unmet clinical need of gynae-oncology patients also in an ERAS program. Patient-reported outcome measures warrant further investigation in the evaluation of ERAS.

Early warning scores and trigger recommendations must be used with care in older home nursing care patients: Results from an observational study.

AIMS: To explore modified early warning scores (MEWSs) and deviating vital signs among older home nursing care patients to determine whether the MEWS trigger recommendations were adhered to in cases of where registered nurses (RNs) suspected acute functional decline. DESIGN: Prospective observational study with a descriptive, explorative design. METHODS: Participants were included from April 2018 to February 2019. Demographic, health-related and clinical data were collected over a 3-month period. RESULTS: In all, 135 older patients participated. Median MEWS (n = 444) was 1 (interquartile range (IQR) 1-2). Frequently deviating vital signs were respiratory (88.8%) and heart rate (15.3%). Median habitual MEWS (n = 51) was 1 (IQR 0-1). Deviating vital signs were respiratory (72.5%) and heart rate (19.6%). A significant difference between habitual MEWS and MEWS recorded in cases of suspected functional decline was found (p = 0.002). MEWS' trigger recommendations were adhered to in 68.9% of all MEWS measurements.

Understanding support systems for Parkinson's disease management in community settings: A cross-national qualitative study.

BACKGROUND: Health and social care systems face difficulties in managing multimorbidity, disease burden and complex needs in long-term conditions such as Parkinson's disease. OBJECTIVE: This study aimed to develop a European understanding of how health and social care professionals can collaborate with stakeholders from different organizations and sectors to enhance the management of Parkinson's disease in a community setting by identifying the existing gaps in this process and how people with Parkinson's disease and their family carers could benefit from these partnerships. METHODS: A mixed-methods sequential study was conducted in Denmark, Norway, Spain and the United Kingdom. The findings from the qualitative phase are presented. Individual semistructured interviews were analysed using Braun's and Clarke's thematic analysis. A meta-ethnography approach was used to analyse and synthesize cross-national findings. RESULTS: A total of 41 healthcare professionals and 39 stakeholders from different disciplines and sectors were interviewed in the four countries. The participants acknowledged a lack of awareness of available resources and poor communication between the different support systems in the management of Parkinson's disease. To promote multiagency collaborations, the participants highlighted the need to organize services along the Parkinson's disease journey, patient involvement and strategic involvement of carers in organizing resources and Parkinson's disease care pathways. According to the participants, the benefits from multiagency partnerships could lead to an enhanced continuity of care and specialized knowledge, mobilization of resources in the community, personalized support and improved access to services. CONCLUSIONS: Policymakers are called upon to create formal structures that facilitate multisectoral collaborations to promote an integrated system of care for the management of Parkinson's disease in the community. To address this challenge, we propose five strategies showing how organizations can work together to optimize the use of resources and enhance the management of Parkinson's disease throughout the illness trajectory. PATIENT OR PUBLIC CONTRIBUTION: Patient and Public Involvement groups made up of stakeholders, healthcare professionals, patients with Parkinson's disease and family carers participated in the design of the study, the development of the interview guides and the validation of the findings.

Assessing acute functional decline in older patients in home nursing care settings using the Modified Early Warning Score: A qualitative study of nurses' and general practitioners' experiences.

AIMS AND OBJECTIVES: The study describes experiences of registered nurses and general practitioners when using the Modified Early Warning Score (MEWS) to assess acute functional decline in older home nursing care patients. BACKGROUND: Acute functional decline is common among older home nursing care patients; typically characterised by nonspecific symptoms and a mix of manifestations. Early warning score systems for detecting clinical deterioration have been thoroughly evaluated in hospital settings, but few studies have evaluated these systems used with older people in a community care setting. METHODS: A descriptive exploratory research design and a qualitative approach. 36 nurses and eight general practitioners were purposively sampled. Data were collected in seven mixed focus groups and analysed using an inductive thematic content analysis in an iterative process that moved between text, codes, categories and themes. The COREQ checklist was used. RESULTS: Two main themes were developed in the analysis. The first theme derived, was that the MEWS along with medical-technical equipment and clinical judgement, was used to support nurses' and general practitioners' clinical decisions in assessing older deteriorating patients. The second theme referred to nurses' and general practitioners' experiences with several adjustments when using the MEWS with the older patient group and in complying with its trigger recommendations. CONCLUSION: The use of the MEWS when assessing older patients in home nursing care is potentially useful in supporting clinical reasoning. However, the tool's usefulness is limited because it is not experienced as sufficiently adapted to neither the home nursing care services nor to older patients. IMPLICATIONS FOR PRACTICE: This study increases our knowledge of how the MEWS tool is used in a community care setting and highlights the importance of adjustment of assessment procedures for older persons with acute functional decline.

Perceived study-induced influence on the control group in a randomized controlled trial evaluating a complex intervention to promote psychosocial well-being after stroke: a process evaluation.

BACKGROUND: A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is "usual care." The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants' reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors. METHODS: Fifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur's interpretation theory guided the analysis. RESULTS: The perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants' feelings of control and their ability to cope. Other participants' statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way. CONCLUSIONS: RCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02338869. Registered on October 4, 2014.

Effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke in Norway: A randomized controlled trial.

OBJECTIVE: To evaluate the effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke. DESIGN: Multicentre, prospective, randomized controlled trial. SUBJECTS: Adults (aged ≥ 18 years) who had their first or recurrent stroke within the last month, were medically stable, had sufficient cognitive functioning to participate and understood and spoke Norwegian. METHODS: A total of 322 participants were randomly assigned to the intervention (n = 166) or control (n = 156) group. Participants in the intervention group received up to 8 individual sessions aimed at supporting the coping and life skills of stroke survivors in addition to usual care. The primary outcome was the proportion of participants with normal mood measured by the General Health Questionnaire-28 (GHQ-28). The secondary outcomes included health-related quality of life (Stroke and Aphasia Quality of Life Scale; SAQOL-39g), depression (Yale-Brown single-item questionnaire; Yale) and sense of coherence (SOC-13). RESULTS: After controlling for the baseline values, no significant benefit was found in the intervention group over the control group (odds ratio (OR): 0.898: 95% confidence interval (95% CI): 0.54-1.50, p = 0.680) 6 months post-stroke. CONCLUSION: Psychosocial well-being improved during the first 6 months after stroke in both arms of the trial, but no statistically significant benefit of the dialogue-based intervention was found compared with usual care.

Finding the Way Forward: The Lived Experience of People With Stroke After Participation in a Complex Psychosocial Intervention.

Stroke patients' well-being is threatened after stroke. A psychosocial intervention was developed for Norwegian stroke patients living in the community. Eight individual sessions between people with stroke and a trained health care professional were conducted 1 to 6 months post-stroke with one group of participants and 6 to 12 months post-stroke with another group. Subsequently, 19 of these stroke patients were interviewed to gain an in-depth understanding of their lived experience of the influence of the intervention on their adjustment process. Interview texts were analyzed using Ricoeur's interpretation theory. Two participants did not personally find the intervention useful. The remaining participants greatly appreciated dialogues with the empathetic intervention personnel, feeling free to discuss their fears and worries. The intervention raised these participants' awareness of their needs and resources. They were guided to resume their everyday life and adopt a future-oriented attitude. The intervention facilitated their meaning-making endeavors and post-stroke adjustment.

ICNP.

The International Classification for Nursing Practice (ICNP®) terminology was in 2016 implemented in three Norwegian municipalities through the introduction of five standardized care plans in the Electronic Patient Record (EPR) system. This poster provides results from an exploratory, qualitative study, investigating how nurses in these municipalities applied the care plans into their daily informational work.