scholarly journals Coached, Coordinated, Enhanced Neonatal Transition (CCENT): protocol for a multicentre pragmatic randomised controlled trial of transition-to-home support for parents of high-risk infants

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e046706
Author(s):  
Julia Orkin ◽  
Nathalie Major ◽  
Kayla Esser ◽  
Arpita Parmar ◽  
Elise Couture ◽  
...  
Keyword(s):  
High Risk ◽  
Research Ethics ◽  
Parental Stress ◽  
Life Years ◽  
Nurse Navigator ◽  
High Risk Infants ◽  
Randomised Controlled ◽  
The Impact ◽  
Neonatal Transition

IntroductionHaving an infant admitted to the neonatal intensive care unit (NICU) is associated with increased parental stress, anxiety and depression. Enhanced support for parents may decrease parental stress and improve subsequent parent and child outcomes. The Coached, Coordinated, Enhanced Neonatal Transition (CCENT) programme is a novel bundled intervention of psychosocial support delivered by a nurse navigator that includes Acceptance and Commitment Therapy-based coaching, care coordination and anticipatory education for parents of high-risk infants in the NICU through the first year at home. The primary objective is to evaluate the impact of the intervention on parent stress at 12 months.Methods and analysisThis is a multicentre pragmatic randomised controlled superiority trial with 1:1 allocation to the CCENT model versus control (standard neonatal follow-up). Parents of high-risk infants (n=236) will be recruited from seven NICUs across three Canadian provinces. Intervention participants are assigned a nurse navigator who will provide the intervention for 12 months. Outcomes are measured at baseline, 6 weeks, 4, 12 and 18 months. The primary outcome measure is the total score of the Parenting Stress Index Fourth Edition Short Form at 12 months. Secondary outcomes include parental mental health, empowerment and health-related quality of life for calculation of quality-adjusted life years (QALYs). A cost-effectiveness analysis will examine the incremental cost of CCENT versus usual care per QALY gained. Qualitative interviews will explore parent and healthcare provider experiences with the intervention.Ethics and disseminationResearch ethics approval was obtained from Clinical Trials Ontario, Children’s Hospital of Eastern Ontario Research Ethics Board (REB), The Hospital for Sick Children REB, UBC Children’s and Women’s REB and McGill University Health Centre REB. Results will be shared with Canadian level III NICUs, neonatal follow-up programmes and academic forums.Trial registration numberClinicalTrials.gov Registry (NCT03350243).

scholarly journals Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)

2021 ◽  
pp. annrheumdis-2020-219091 ◽  
Author(s):  
Gary J Macfarlane ◽  
Marcus Beasley ◽  
Neil Scott ◽  
Huey Chong ◽  
Paul McNamee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Primary Outcome ◽  
Population Based ◽  
Behavioural Therapy ◽  
Short Course ◽  
Life Years ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveCognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.MethodsA population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.Results996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.ConclusionsA short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.Trial registration numberClinicalTrials.gov Registry (NCT02668003).

scholarly journals A randomised controlled trial exploring the impact of a dedicated Health and Social Care Professionals team in the Emergency Department on the quality, safety, clinical and cost-effectiveness of care for older adults: Study Protocol

2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

Abstract Background : Older people are frequent Emergency Department (ED) users who present with complex issues that are linked to poorer health outcomes post-index visit, often have increased ED length of stay and tend to have raised healthcare costs. Encouraging evidence suggests that ED teams involving health and social care professionals (HSCPs) can contribute to enhanced patient flow and improved patient experience by improving care decision-making and thus promoting timely and effective care. However, the evidence supporting the impact of HSCPs teams assessing and intervening with older adults in the ED is limited and identifies important methodological limitations, highlighting the need for more robust and comprehensive investigations of this model of care. This study aims to evaluate the impact of a dedicated ED-based HSCP team on the quality, safety, clinical and cost-effectiveness of care of older adults when compared to usual care. Methods : The study is a single-site randomised controlled trial whereby patients aged ≥65 years who present to the ED of a large Irish hospital will be randomised to the experimental group (ED-based HSCP assessment and intervention) or the control group (usual ED care). The recruitment target is 320 participants. The HSCP team will provide a comprehensive functional assessment as well as interventions to promote a safe discharge for the patient. The primary outcome is ED length of stay (from arrival to discharge). Secondary outcomes include: rates of hospital admissions from the ED, ED re-visits, unplanned hospital admissions and healthcare utilisation at 30-days, four and six-month follow-up; patient functional status and quality of life (at baseline and follow-up); patient satisfaction; costs-effectiveness in terms of costs associated with ED-based HSCP compared to usual care; and perceptions on implementation by ED staff members. Discussion : This is the first randomised controlled trial testing the impact of HSCPs working in teams in the ED on the quality, safety, clinical and cost-effectiveness of care for older patients. The findings of the study will provide important information on the effectiveness of this model of care for future implementation. Trial registration : ClinicalTrials.gov, NCT03739515; registered on 12 th November 2018. Protocol version 1. URL: https://clinicaltrials.gov/ct2/show/NCT03739515

Auditory Brainstem Responses and Clinical Follow-up of High-Risk Infants

PEDIATRICS ◽  
1989 ◽  
Vol 83 (3) ◽  
pp. 385-392
Author(s):  
Steven J. Kramer ◽  
Dianne R. Vertes ◽  
Marie Condon
Keyword(s):  
High Risk ◽  
Auditory Brainstem ◽  
Sensorineural Hearing ◽  
Auditory Brainstem Responses ◽  
Hearing Level ◽  
Hearing Impairments ◽  
Brainstem Response ◽  
Infant Program ◽  
High Risk Infants

Auditory brainstem response (ABR) evaluations were performed on 667 high-risk infants from an infant special care unit. Of these infants, 82% passed the ABR. Those infants who failed the ABR were classified into two groups, those who failed at 30 dB hearing level and those who failed at 45 dB hearing level. All of the infants were encouraged to return for otologic/audiologic follow-up in 1, 3, or 6 months, depending on the initial ABR results. All of the infants with severe hearing impairments came from the group who failed at 45 dB hearing level. The incidence of severe sensorineural hearing impairment in this population was estimated to be 2.4%. For the group that failed at 30 dB hearing level, 80% of those who were abnormal at follow-up were considered to have conductive hearing disorders and 20% had mild sensorineural hearing impairments. In addition, infants enrolled in a parent-infant program for hearing impaired by 6 months of age were from the ABR program; however, several infants entered the parent-infant program at a relatively late age because they did not meet the high-risk criteria, they were from other hospitals, or they were not detected by the ABR program.

WHO IS LOST TO FOLLOW-UP?

PEDIATRICS ◽  
1989 ◽  
Vol 84 (5) ◽  
pp. A38-A38
Author(s):  
Student
Keyword(s):  
High Risk ◽  
Major Effect ◽  
Dropout Rates ◽  
Time Interval ◽  
Environmental Characteristics ◽  
Developmental Status ◽  
Loss To Follow Up ◽  
High Risk Infants ◽  
Lost To Follow Up

The belief that impaired infants are more likely to continue in follow-up is. . .not supported. The infant's developmental status significantly influenced loss to follow-up only between the 18-to 36-month time interval. Here, more babies in the dubious (vs abnormal) category withdrew. In general our findings suggest that environmental characteristics exert the major effect on dropout rates in high risk infants and their controls.

scholarly journals Community-based aftercare following an emergency department presentation for attempted suicide or high risk for suicide: study protocol for a non-randomised controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Vida V. Bliokas ◽  
Alex R. Hains ◽  
Jonathan A. Allan ◽  
Luise Lago ◽  
Rebecca Sng
Keyword(s):  
Emergency Department ◽  
High Risk ◽  
Suicide Attempt ◽  
Repeated Measures ◽  
Hospital Emergency Department ◽  
Hospital Emergency ◽  
Community Based ◽  
Treatment As Usual ◽  
The Impact

Abstract Background Suicide is a major public health issue worldwide. Those who have made a recent suicide attempt are at high risk for dying by suicide in the future, particularly during the period immediately following departure from a hospital emergency department. As such the transition from hospital-based care to the community is an important area of focus in the attempt to reduce suicide rates. There is a need for evaluation studies to test the effectiveness of interventions directed to this stage (termed ‘aftercare’ interventions). Methods A controlled non-randomised two group (intervention vs treatment-as-usual control) design, using an intention-to-treat model, will evaluate the effectiveness of a suicide prevention aftercare intervention providing follow-up after presentations to a hospital emergency department as a result of a suicide attempt or high risk for suicide. The intervention is a community-based service, utilising two meetings with a mental health clinician and follow-up contacts by peer workers via a combination of face-to-face and telephone for four weeks, with the option of extension to 12 weeks. Seventy-five participants of the intervention service will be recruited to the study and compared to 1265 treatment-as-usual controls. The primary hypotheses are that over 12 months, those who participate in the aftercare follow-up intervention are less likely than controls to present to a hospital emergency department for a repeat suicide attempt or because of high risk for suicide, will have fewer re-presentations during this period and will have lower all-cause mortality. As a secondary aim, the impact of the intervention on suicide risk factors for those who participate in the service will be evaluated using pre- and post-intervention repeated measures of depression, anxiety, stress, hopelessness, belongingness, burdensomeness, and psychological distress. Enrolments into the study commenced on 1 November 2017 and are anticipated to cease in November 2019. Discussion The study aims to contribute to the understanding of effective interventions for individuals who have presented to a hospital emergency department as a result of a suicide attempt or at high risk for suicide and provide evidence in relation to interventions that incorporate peer-workers. Trial registration ACTRN12618001701213. Registered on 16 October 2018. Retrospectively registered.

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