Study protocol for Attachment & Child Health (ATTACHTM) program: promoting vulnerable Children's health at scale.

BACKGROUND: Children's exposure to toxic stress (e.g., parental depression, violence, poverty) predicts developmental and physical health problems resulting in health care system burden. Supporting parents to develop parenting skills can buffer the effects of toxic stress, leading to healthier outcomes for those children. Parenting interventions that focus on promoting parental reflective function (RF), i.e., parents' capacity for insight into their child's and their own thoughts, feelings, and mental states, may understand help reduce societal health inequities stemming from childhood stress exposures. The Attachment and Child Health (ATTACHTM) program has been implemented and tested in seven rapid-cycling pilot studies (n = 64) and found to significantly improve parents' RF in the domains of attachment, parenting quality, immune function, and children's cognitive and motor development. The purpose of the study is to conduct an effectiveness-implementation hybrid (EIH) Type II study of ATTACHTM to assess its impacts in naturalistic, real-world settings delivered by community agencies rather than researchers under more controlled conditions. METHODS: The study is comprised of a quantitative pre/post-test quasi-experimental evaluation of the ATTACHTM program, and a qualitative examination of implementation feasibility using thematic analysis via Normalization Process Theory (NPT). We will work with 100 families and their children (birth to 36-months-old). Study outcomes include: the Parent Child Interaction Teaching Scale to assess parent-child interaction; the Parental Reflective Function and Reflective Function Questionnaires to assess RF; and the Ages and Stages Questionnaire - 3rd edition to examine child development, all administered pre-, post-, and 3-month-delayed post-assessment. Blood samples will be collected pre- and post- assessment to assess immune biomarkers. Further, we will conduct one-on-one interviews with study participants, health and social service providers, and administrators (total n = 60) from each collaborating agency, using NPT to explore perceptions and experiences of intervention uptake, the fidelity assessment tool and e-learning training as well as the benefits, barriers, and challenges to ATTACHTM implementation. DISCUSSION: The proposed study will assess effectiveness and implementation to help understand the delivery of ATTACHTM in community agencies. TRIAL REGISTRATION: Name of registry: https://clinicaltrials.gov/. REGISTRATION NUMBER: NCT04853888 . Date of registration: April 22, 2021.

Silver-impregnated, antibiotic-impregnated or non-impregnated ventriculoperitoneal shunts to prevent shunt infection: the BASICS three-arm RCT.

BACKGROUND: Insertion of a ventriculoperitoneal shunt to treat hydrocephalus is one of the most common neurosurgical procedures worldwide. Shunt infection affects up to 15% of patients, resulting in long hospital stays, multiple surgeries and reduced cognition and quality of life. OBJECTIVES: The aim of this trial was to determine whether or not antibiotic-impregnated ventriculoperitoneal shunts (hereafter referred to as antibiotic shunts) (e.g. impregnated with rifampicin and clindamycin) or silver-impregnated ventriculoperitoneal shunts (hereafter referred to as silver shunts) reduce infection compared with standard ventriculoperitoneal shunts (hereafter referred to as standard shunts). DESIGN: This was a three-arm, superiority, multicentre, parallel-group randomised controlled trial. Patients and a central primary outcome review panel, but not surgeons or operating staff, were blinded to the type of ventriculoperitoneal shunt inserted. SETTING: The trial was set in 21 neurosurgical wards across the UK and the Republic of Ireland. PARTICIPANTS: Participants were patients with hydrocephalus of any aetiology who were undergoing insertion of their first ventriculoperitoneal shunt. INTERVENTIONS: Participants were allocated 1 : 1 : 1 by pressure-sealed envelope to receive a standard non-impregnated, silver-impregnated or antibiotic-impregnated ventriculoperitoneal shunt at the time of insertion. Ventriculoperitoneal shunts are medical devices, and were used in accordance with the manufacturer's instructions for their intended purpose. MAIN OUTCOME MEASURES: The primary outcome was time to ventriculoperitoneal shunt failure due to infection. Secondary outcomes were time to failure for any cause, reason for failure (infection, mechanical), types of ventriculoperitoneal shunt infection, rate of infection after first clean (non-infected) revision and health economics. Outcomes were analysed by intention to treat. RESULTS: Between 26 June 2013 and 9 October 2017, 1605 patients from neonate to 91 years of age were randomised to the trial: n = 36 to the standard shunt, n = 538 to the antibiotic shunt and n = 531 to the silver shunt. Patients who did not receive a ventriculoperitoneal shunt (n = 4) or who had an infection at the time of insertion (n = 7) were not assessed for the primary outcome. Infection occurred in 6.0% (n = 32/533) of those who received the standard shunt, in 2.2% (n = 12/535) of those who received the antibiotic shunt and in 5.9% (n = 31/526) of those who received the silver shunt. Compared with the standard shunt, antibiotic shunts were associated with a lower rate of infection (cause-specific hazard ratio 0.38, 97.5% confidence interval 0.18 to 0.80) and a decreased probability of infection (subdistribution hazard ratio 0.38, 97.5% confidence interval 0.18 to 0.80). Silver shunts were not associated with a lower rate of infection than standard shunts (cause-specific hazard ratio 0.99, 97.5% confidence interval 0.56 to 1.74). The ventriculoperitoneal shunt failure rate attributable to any cause was 25.0% overall and did not differ between arms. Antibiotic shunts save £135,753 per infection avoided. There were no serious adverse events. LIMITATIONS: It was not possible to blind treating neurosurgeons to the ventriculoperitoneal shunt type. The return rate for patient-reported outcomes was low. Limitations to the economic evaluation included failure to obtain Hospital Episode Statistics data from NHS Digital, as per protocol. Reliance on patient-level information and costing systems data mitigated these limitations. CONCLUSIONS: Antibiotic shunts have a reduced infection rate compared with standard shunts, whereas silver shunts do not. Antibiotic shunts are cost-saving. FUTURE WORK: A sample collection has been established that will enable the study of surrogate markers of ventriculoperitoneal shunt infection in cerebrospinal fluid or blood using molecular techniques. A post hoc analysis to study factors related to shunt failure will be performed as part of a future study. An impact analysis to assess change in practice is planned. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49474281. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 17. See the NIHR Journals Library website for further project information.

Hydrocephalus (commonly known as 'water on the brain') is a condition that can affect all age groups, from babies to the elderly. In hydrocephalus, there is an accumulation of the normal brain fluid in the fluid cavities (ventricles) of the brain. Untreated, hydrocephalus can be life-threatening. The most common treatment involves an operation to insert a tube into the swollen ventricles to drain off the excess fluid. This is called a ventriculoperitoneal shunt. In the UK, 3000­3500 shunt operations are performed each year. The main risks of a shunt operation are infection (surgical meningitis) and blockage without infection. Infection results in the need for at least two further surgeries, antibiotic treatment and a prolonged hospital stay (minimum of 2 weeks). Shunt infections can affect mental abilities and can be life-threatening. People who have blockages without infection, on the other hand, usually need only a single operation to replace the blocked part and only a few days in hospital. Two new types of shunt catheter have been introduced to try to reduce shunt infection: antibiotic-impregnated shunts and silver-impregnated shunts. This study was designed to assess whether or not either of these new shunts reduce infection compared with standard shunts. This study also included an analysis of the cost and health benefits of the different shunts used. A total of 1605 children and adults, who were treated in neurosurgical units across the UK and the Republic of Ireland, participated in this study. Consent was provided by all participants in the trial. Each participant had an equal chance of receiving one of the three shunt types. Shunt infection occurred in 6% of participants receiving standard shunts, 5.9% of participants receiving silver-impregnated shunts and 2.2% of participants receiving antibiotic-impregnated shunts. This study has demonstrated a major reduction in shunt infections in new shunts when using antibiotic-impregnated shunts compared with standard or silver-impregnated shunts. A health economic analysis has indicated that antibiotic-impregnated shunts are cost-saving.

Self-Management of Type 2 Diabetes in Adult Haitian Immigrants: A Qualitative Study.

Introduction: A large body of literature exists on self-management of type 2 diabetes (T2D) in a variety of populations. However, research is limited on how Haitian immigrants self-manage their T2D despite a prevalence of 6.9% in Haiti. The purpose of this study was to explore and describe the lived experience of adult Haitian immigrants managing T2D living in the United States. Methodology: Moustakas's phenomenological approach guided this qualitative study. Adult Haitian immigrants diagnosed with T2D for at least 1 year were interviewed. Individual interviews were audio-recorded, transcribed verbatim, uploaded into NVivo, and analyzed using Moustakas's existential data analysis process. Results: We interviewed 16 participants (mean age 56;12 females; an average of 11 years living in the United States; mean hemoglobin A1c 8.1%). Four themes emerged: self-reliance, spirituality, nostalgia for home, and a desire for positive patient-provider relationships. Cultural influences and health beliefs may affect individual self-management of T2D in this population. Conclusions: These results may assist clinicians in identifying factors that contribute to suboptimal self-management in Haitian immigrants and help patients reach glycemic control. Culturally competent assessment and interventions for Haitian immigrants with T2D may not be provided without considering these four themes.

Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation.

BACKGROUND: Insertion of a ventriculoperitoneal shunt for hydrocephalus is one of the commonest neurosurgical procedures worldwide. Infection of the implanted shunt affects up to 15% of these patients, resulting in prolonged hospital treatment, multiple surgeries, and reduced cognition and quality of life. Our aim was to determine the clinical and cost-effectiveness of antibiotic (rifampicin and clindamycin) or silver shunts compared with standard shunts at reducing infection. METHODS: In this parallel, multicentre, single-blind, randomised controlled trial, we included patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland. Patients were randomly assigned (1:1:1 in random permuted blocks of three or six) to receive standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician. All patients and investigators who recorded and analysed the data were masked for group assignment, which was only disclosed to the neurosurgical staff at the time of operation. Participants receiving a shunt without evidence of infection at the time of insertion were followed up for at least 6 months and a maximum of 2 years. The primary outcome was time to shunt failure due the infection and was analysed with Fine and Gray survival regression models for competing risk by intention to treat. This trial is registered with ISRCTN 49474281. FINDINGS: Between June 26, 2013, and Oct 9, 2017, we assessed 3505 patients, of whom 1605 aged up to 91 years were randomly assigned to receive either a standard shunt (n=536), an antibiotic-impregnated shunt (n=538), or a silver shunt (n=531). 1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up). 32 (6%) of 533 evaluable patients in the standard shunt group had a shunt revision for infection, compared with 12 (2%) of 535 evaluable patients in the antibiotic shunt group (cause-specific hazard ratio [csHR] 0·38, 97·5% CI 0·18-0·80, p=0·0038) and 31 (6%) of 526 patients in the silver shunt group (0·99, 0·56-1·74, p=0·96). 135 (25%) patients in the standard shunt group, 127 (23%) in the antibiotic shunt group, and 134 (36%) in the silver shunt group had adverse events, which were not life-threatening and were mostly related to valve or catheter function. INTERPRETATION: The BASICS trial provides evidence to support the adoption of antibiotic shunts in UK patients who are having their first ventriculoperitoneal shunt insertion. This practice will benefit patients of all ages by reducing the risk and harm of shunt infection. FUNDING: UK National Institute for Health Research Health Technology Assessment programme.

The Quality of Family Relationships, Diabetes Self-Care, and Health Outcomes in Older Adults.

The purpose of the study was to investigate the relationship between family support, diabetes self-care, and health outcomes in older, community-dwelling adults. Using the theoretical framework of the Self-Care of Chronic Illness Theory and a cross-sectional design, 60 participants completed questionnaires related to diabetes self-care activities of the individual, supportive and nonsupportive diabetes behaviors of the family, and the quality of family relations. Participants indicated that diabetes self-care behaviors were performed frequently, with exercise reported as the least-performed behavior. Multiple regression analyses revealed that the quality of family relations as measured by the Family Relationship Index contributed significantly (26.0%) to the variability in A1C levels (R 2 = 0.260, F(1, 40) = 14.037, P = 0.001). Neither family supportive behavior nor the quality of family relations contributed to diabetes self-care. It is recommended that health care providers include family members to assess diabetes family support and family relationships in the care of older adults with diabetes.

Implementation Analysis of a Nurse-Led Observation Unit.

OBJECTIVE: This implementation analysis of a nurse-led observation unit describes the development process and analyzes patients' characteristics, patient satisfaction, and provider perceptions. BACKGROUND: A nurse-led observation unit was developed to create more inpatient bed capacity and place patients in the clinical area best suited to their needs. METHODS: Descriptive statistics and content analysis were used for analysis. RESULTS: The average length of stay of 467 patients was 1.1 days; 68.1% (n = 318) were female. Elective surgery was the most frequent reason for admission. All of the patients rated the observation unit patient feedback survey factors favorably except for noise. All healthcare providers (n = 64) reported that they communicated well with each other and had resources to provide quality care but rated the environment less favorably. CONCLUSIONS: A nurse-led observation unit was found to be an effective and efficient approach to providing postoperative and postprocedure care, which was generally well received by patients and healthcare providers.

Cardiac acute care nurse practitioner and 30-day readmission.

BACKGROUND: The utilization outcomes of nurse practitioners (NPs) in the acute care setting have not been widely studied. OBJECTIVE: The purpose of this study was to determine the impact on utilization outcomes of NPs on medical teams who take care of patients admitted to a cardiovascular intensive care unit. METHODS: A retrospective 2-group comparative design was used to evaluate the outcomes of 185 patients with ST- or non ST-segment elevation myocardial infarction or heart failure who were admitted to a cardiovascular intensive care unit in an urban medical center. Patients received care from a medical team that included a cardiac acute care NP (n = 109) or medical team alone (n = 76). Patient history, cardiac assessment, medical interventions, discharge disposition, discharge time, and 3 utilization outcomes (ie, length of stay, 30-day readmission, and time of discharge) were compared between the 2 treatment groups. Logistic regression was used to identify predictors of 30-day readmission. RESULTS: Patients receiving care from a medical team that included an NP were rehospitalized approximately 50% less often compared with those receiving care from a medical team without an NP. Thirty-day hospital readmission (P = .011) and 30-day return rates to the emergency department (P = .021) were significantly lower in the intervention group. Significant predictors for rehospitalization included diagnosis of heart failure versus myocardial infarction (odds ratio [OR], 3.153, P = 0.005), treatment by a medical team without NP involvement (OR, 2.905, P = 0.008), and history of diabetes (OR, 2.310, P = 0.032). CONCLUSIONS: The addition of a cardiac acute care NP to medical teams caring for myocardial infarction and heart failure patients had a positive impact on 30-day emergency department return and hospital readmission rates.

The influence of social environmental factors on rehospitalization among patients receiving home health care services.

Guided by Orem's theory, this study examined the influence of social environmental factors on rehospitalization among home health care patients. Living arrangement, frequency of caregiving, and type of primary informal care were found to be related to functional ability. Measurable differences in clinical status and functional ability were related to the duration that patients received home health care services until rehospitalization, with the likelihood of rehospitalization increasing proportionately to the magnitude of the differences. Social environmental factors contributed to rehospitalization (self-care deficit) through functional ability (self-care agency) by altering the balance between self-care demand (clinical status) and self-care agency.

Application of the Cloutterbuck Minimum Data Matrix to a community health nursing course.

The Cloutterbuck Minimum Data Matrix (CMDM) is an effective model to prepare nursing students for practice in the 21st century. Use of the CMDM challenges students to think critically, reflect on the changes occurring in the structure and financing of the health care system, and consider the "big picture view" of health and the many factors that impinge on it, all within the context of an increasingly diverse and independent consumer population. This article describes how the CMDM was used to guide the selection and organization of content and teaching-learning strategies for a senior-level community health nursing course in a baccalaureate program. The CMDM provided direction for the curriculum, nature and sequence of the content, practicum settings, student requirements, and teaching-learning strategies for the course.

Client-caregiver-nurse coalition formation in decision-making situations during home visits.

AIMS: The purpose of this paper is to report the findings of an exploratory study designed to test a portion of the Theory of Collaborative Decision-Making in Nursing Practice for Triads by examining the relation between types of decisions and formation of coalitions during triadic interactions among older home healthcare clients, their caregivers and home healthcare nurses during seven admission visits for home health care. BACKGROUND: Although home healthcare nurses include clients and family members in decision-making about care, few publications address the nature of interactions among triads of clients, caregivers and nurses in home health care and the association between decision-making and those interactions. METHOD: The data presented in this paper are a secondary analysis of data originally collected in 1994. The sample included 157 decision-making situations identified from interactions of seven triads of older home healthcare clients, their caregivers and nurses. Qualitative data were collected by participant observation and audio-recording of admission visit interactions among clients, caregivers and nurses. Content analysis, augmented by Ethnograph software, was used to analyse the data. FINDINGS: Coalitions were evident in just eight of the 157 decision-making situations. All of the theoretically possible types of nursing care decisions (programme, operational control, agenda) were observed. Each coalition involved one nursing care decision; two coalitions formed in one triad. Seven coalitions formed between nurse and caregiver against client during two programme and five operational control decisions. One coalition formed between client and caregiver against nurse during an agenda decision. No coalitions formed between client and nurse against caregiver. CONCLUSIONS: Although the study sample was small, the findings expand understanding of the relation between types of decisions and formation of coalitions during triadic interactions in home health care, and provided empirical support for a portion of the Theory of Collaborative Decision-Making in Nursing Practice for Triads.

Identifying outcomes of care for the home care patient with diabetes.

Although existing agency data can be an excellent source for outcomes, there are positive and negative aspects of using such data (Dalton, 2004). For example, one positive aspect is that the data already have been collected and the burden on agency, staff, and patients is reduced. Negative aspects may include that the reliability of data such as OASIS must be tested, and the best method of measurement of blood sugar control may not be available (Hemoglobin A1C) (Goldstein, Little, Lorenz, Malone, Nathan, & Peterson, 2003; Setter, Corbett, Campbell, & Gates, 2003). A1Cs are not usually required for discharge from home care patients. In addition, the OASIS items include only two diabetes self care behaviors: the patient's ability to administer oral medication and to administer injectable medications. There are many other patient self care behaviors that are important outcomes for home care diabetes patients, such as glucose monitoring and diet adherence that are not measured by the OASIS. However, every home care agency can evaluate selected outcomes to measure patients' diabetes self-care ability using the available OASIS and clinical data. Agencies are encouraged to use the outcomes presented to evaluate patient self-care.

Development and testing of the theory of collaborative decision-making in nursing practice for triads.

BACKGROUND: Although nurses depend heavily on informal family caregivers to provide care to clients and to be involved in care planning and decision-making, no nursing theories that include the client, the caregiver, and the nurse were available to guide collaborative care planning and decision-making. AIM: The purpose of this paper is to describe the construction and initial testing of the theory of collaborative decision-making in nursing practice for a triad. The theory represents an extension of Kim's theory of collaborative decision-making in nursing practice. Kim's theory was developed to describe and explain collaborative decision-making in a dyad (client and nurse). The inclusion of a third person (family caregiver) in the theory required the addition of concepts about the caregiver, coalition formation, and nurse and caregiver outcomes. The expansion of Kim's dyadic theory to a triadic theory was achieved by means of a modified version of the theory derivation process described by Walker and Avant. CONCLUSIONS: The theory of collaborative decision-making in nursing practice for a triad can be used to guide further research and clinical practice. The theory provides a framework for researchers who are interested in studying the effects of collaboration regarding decision-making among nurses, family caregivers, and clients. The initial testing of the new theory in home health care nursing revealed variety in the nature of the client-caregiver-nurse relationships, the many processes used by the nurses in proceeding with the home visits, a multitude of decisions considered and different collaborative, noncollaborative, and coalition-forming interactions. The limited evidence of the empirical adequacy of the theory precludes development of definitive guidelines for clinical practice at this time. More studies are required before clinical practice guidelines can be developed.