scholarly journals Attempting to prevent postnatal depression by targeting the mother–infant relationship: a randomised controlled trial

2014 ◽  
Vol 16 (04) ◽  
pp. 383-397 ◽  
Author(s):  
Peter J. Cooper ◽  
Leonardo De Pascalis ◽  
Matthew Woolgar ◽  
Helena Romaniuk ◽  
Lynne Murray
Keyword(s):  
At Risk ◽  
Randomised Controlled Trial ◽  
Child Development ◽  
Postnatal Depression ◽  
Controlled Trial ◽  
Maternal Sensitivity ◽  
Maternal Mood ◽  
Health Visitors ◽  
Randomised Controlled

AimThe purpose of the study was to investigate whether an intervention which focused on enhancing the quality of the mother-infant relationship would prevent the development of postnatal depression (PND) and the associated impairments in parenting and adverse effects on child development.BackgroundRecent meta-analyses indicate modest preventive effects of psychological treatments for women vulnerable to the development of PND. However, given the strong evidence for an impact of PND on the quality of the mother–infant relationship and child development, it is notable that there are limited data on the impact of preventive interventions on these outcomes. This is clearly a question that requires research attention. Accordingly, a randomised controlled trial (RCT) was conducted of such a preventive intervention.MethodsA large sample of pregnant women was screened to identify those at risk of PND. In an RCT 91 were randomly assigned to receive the index intervention from research health visitors, and 99 were assigned to a control group who received normal care. In an adjacent area 76 women at risk of PND received the index intervention from trained National Health Service (NHS) health visitors. The index intervention involved 11 home visits, two antenatally and nine postnatally. They were supportive in nature, with specific measures to enhance maternal sensitivity to infant communicative signals, including items from the Neonatal Behavioral Assessment Scale. Independent assessments were made at 8 weeks, 18 weeks, and 12 and 18 months postpartum. Assessments were made of maternal mood, maternal sensitivity in mother–infant engagement, and infant behaviour problems, attachment and cognition.FindingsThe RCT revealed that the index intervention had no impact on maternal mood, the quality of the maternal parenting behaviours, or infant outcome, although there were suggestions, on some self-report measures, that those with a lower level of antenatal risk experienced benefit. This was also the case for the intervention delivered by trained NHS health visitors. The findings indicate that the approach investigated to preventing PND and its associated problems cannot be recommended.

scholarly journals Study protocol for the TRUSt trial: a pragmatic randomised controlled trial comparing the standard of care with a transitional pain service for patients at risk of chronic postsurgical pain undergoing surgery

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e049676
Author(s):  
Manouk Admiraal ◽  
Henning Hermanns ◽  
Jeroen Hermanides ◽  
Carin G.C.L. Wensing ◽  
Soe L. Meinsma ◽  
...  
Keyword(s):  
At Risk ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Opioid Use ◽  
Quality Of Recovery ◽  
Chronic Postsurgical Pain ◽  
Patients At Risk ◽  
Randomised Controlled

IntroductionPatients with either surgery-related or patient-related risk factors are at an increased risk of acute and chronic postsurgical pain (CPSP) and long-term opioid use. To improve recovery, prevent CPSP and decrease opioid use, we need to identify these patients before surgery and provide a multidisciplinary pain management strategy throughout hospital admission and follow-up in the postdischarge period. We hypothesise that a multidisciplinary transitional pain service (TPS) improves quality of recovery and reduce the incidence of CPSP and opioid consumption.Methods and analysisWe aim to investigate the effectiveness of implementation of a TPS for patients at risk of developing CPSP. The trial design is a pragmatic, open-label, randomised controlled trial (RCT). After stratification for sex, patients are randomly assigned to the TPS or standard of care (SOC) group. Our primary outcome is the quality of recovery, measured at the morning of the third postoperative day, employing the quality of recovery (QoR)-15 questionnaire. Secondary outcomes are the incidence of CPSP, opioid consumption and patient-reported outcome measures at 3 and 6 months postoperatively. We need to enrol 176 patients to detect a minimal clinical important difference of 8 points on the QoR-15 score.Ethics and disseminationEthics approval was obtained by the accredited medical research ethics committee of the Academic Medical Center in Amsterdam (2020_211) on 15 October 2020. Protocol version 3.2 was approved on 25 January 2020. The trial is registered with the Netherlands Trial Register, NL9115. The results will be disseminated by open access publication in a peer-reviewed journal.Trial registration number NL9115

scholarly journals Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025692 ◽  
Author(s):  
Corita R Grudzen ◽  
Deborah J Shim ◽  
Abigail M Schmucker ◽  
Jeanne Cho ◽  
Keith S Goldfeld
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Randomised Controlled ◽  
End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

scholarly journals Comparison of the effects of intravenous propofol and inhalational desflurane on the quality of early recovery after hand-assisted laparoscopic donor nephrectomy: a prospective, randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e039881
Author(s):  
Jaesik Park ◽  
Minhee Kim ◽  
Yong Hyun Park ◽  
Jung-Woo Shim ◽  
Hyung Mook Lee ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Early Recovery ◽  
Total Hospital ◽  
Kidney Donors ◽  
Living Kidney Donors ◽  
Total Hospital Stay ◽  
Randomised Controlled

ObjectivesWe compared early recovery outcomes between living kidney donors who received total intravenous (IV) propofol versus inhalational desflurane during hand-assisted laparoscopic nephrectomy.DesignA single-centre, prospective randomised controlled trial.SettingUniversity hospital.ParticipantsStudy participants were enrolled between October 2019 and February 2020. A total of 80 living donors were randomly assigned to an intravenous propofol group (n=40) or a desflurane group (n=40).InterventionPropofol group received intravenous propofol and desflurane group received desflurane, as a maintenance anaesthetic.Primary and secondary outcome measuresThe quality of postoperative functional recovery was primarily assessed using the Korean version of the Quality of Recovery-40 (QoR-40K) questionnaire on postoperative day 1. Secondarily, ambulation, pain score, rescue analgesics, complications and total hospital stay were assessed postoperatively.ResultsOur study population included 35 males and 45 females. The mean age was 46±13 years. The global QoR-40K score (161 (154–173) vs 152 (136–161) points, respectively, p=0.001) and all five subdimension scores (physical comfort, 49 (45–53) vs 45 (42–48) points, respectively, p=0.003; emotional state, 39 (37–41) vs 37 (33–41) points, respectively, p=0.005; psychological support, 30 (26–34) vs 28 (26–32) points, respectively, p=0.04; physical independence, 16 (11–18) vs 12 (8-14) points, respectively, p=0.004; and pain, 31 (28–33) vs 29 (25-31) points, respectively, p=0.021) were significantly higher in the intravenous propofol group than the desflurane group. The early ambulation success rate and numbers of early and total steps were higher, but the incidence of nausea/vomiting was lower, in the intravenous propofol group than the desflurane group. The total hospital stay after surgery was shorter in the intravenous propofol group than the desflurane group.ConclusionsIntravenous propofol may enhance the quality of postoperative recovery in comparison to desflurane in living kidney donors.Trial registration numberKCT0004365.

scholarly journals Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046600
Author(s):  
Anne-Marie Hill ◽  
Rachael Moorin ◽  
Susan Slatyer ◽  
Christina Bryant ◽  
Keith Hill ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Care Recipient ◽  
Care At Home ◽  
Randomised Controlled

IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers’ health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers’ health-related quality of life (HRQOL) after care recipients’ hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient’s discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30–45 min telephone support sessions over 6 months. The primary outcome is caregivers’ HRQOL measured using the Assessment of Quality of Life—eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

scholarly journals E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e041548
Author(s):  
Cristian Ochoa-Arnedo ◽  
Joan Carles Medina ◽  
Aida Flix-Valle ◽  
Dimitra Anastasiadou
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Emotional Distress ◽  
Controlled Trial ◽  
Psychosocial Care ◽  
Cost Utility ◽  
Psychosocial Services ◽  
Randomised Controlled

IntroductionPsychosocial interventions for patients with breast cancer (BC) have demonstrated their effectiveness at reducing emotional distress and improving quality of life. The current digitisation of screening, monitoring and psychosocial treatment presents the opportunity for a revolution that could improve the quality of care and reduce its economic burden. The objectives of this study are, first, to assess the effectiveness of an e-health platform with integrated and stepped psychosocial services compared with usual psychosocial care, and second, to examine its cost–utility.Methods and analysisThis study is a multicentre randomised controlled trial with two parallel groups: E-health intervention with integrated and stepped psychosocial services vs usual psychosocial care. An estimated sample of 338 patients with BC in the acute survival phase will be recruited from three university hospitals in Catalonia (Spain) and will be randomly assigned to one of two groups. All participants will be evaluated at the beginning of the study (T1: recruitment), 3 months from T1 (T2), 6 months from T1 (T3) and 12 months from T1 (T4). Primary outcome measures will include number of clinical cases detected, waiting time from detection to psychosocial intervention and proportion of cases successfully treated in the different steps of the intervention, as well as outcomes related to emotional distress, quality of life, post-traumatic stress and growth, treatment adherence and therapeutic alliance. Secondary outcomes will include the acceptability of the platform, patients’ satisfaction and usability. For the cost–utility analysis, we will assess quality-adjusted life years and costs related to healthcare utilisation, medication use and adherence, work absenteeism and infrastructure-related and transport-related costs.Ethics and disseminationThis study was approved by the Ethics committee of the Institut Català d’Oncologia network in Hospitalet, Spain. Findings will be disseminated through peer-reviewed journals, reports to the funding body, conferences among the scientific community, workshops with patients and media press releases.Trial registration numberOnline Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors (ICOnnectat-B),NCT04372459.

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