scholarly journals Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study

BMJ Open ◽  
2015 ◽  
Vol 5 (10) ◽  
pp. e007981 ◽  
Author(s):  
Stephen A Stansfeld ◽  
Sally Kerry ◽  
Tarani Chandola ◽  
Jill Russell ◽  
Lee Berney ◽  
...  
2015 ◽  
Vol 3 (9) ◽  
pp. 1-114 ◽  
Author(s):  
Stephen A Stansfeld ◽  
Lee Berney ◽  
Kamaldeep Bhui ◽  
Tarani Chandola ◽  
Céire Costelloe ◽  
...  

BackgroundPsychosocial work environments influence employee well-being. There is a need for an evaluation of organisational-level interventions to modify psychosocial working conditions and hence employee well-being.ObjectiveTo test the acceptability of the trial and the intervention, the feasibility of recruitment and adherence to and likely effectiveness of the intervention within separate clusters of an organisation.DesignMixed methods: pilot cluster randomised controlled trial and qualitative study (in-depth interviews, focus group and observation).ParticipantsEmployees and managers of a NHS trust. Inclusion criteria were the availability of sickness absence data and work internet access. Employees on long-term sick leave and short-term contracts and those with a notified pregnancy were excluded.InterventionE-learning program for managers based on management standards over 10 weeks, guided by a facilitator and accompanied by face-to-face meetings. Three clusters were randomly allocated to receive the guided e-learning intervention; a fourth cluster acted as a control.Main outcome measuresRecruitment and participation of employees and managers; acceptability of the intervention and trial; employee subjective well-being using the Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS); and feasibility of collecting sickness absence data.ResultsIn total, 424 employees out of 649 approached were recruited and 41 managers out of 49 were recruited from the three intervention clusters. Of those consenting, 350 [83%, 95% confidence interval (CI) 79% to 86%] employees completed the baseline assessment and 291 (69%, 95% CI 64% to 73%) completed the follow-up questionnaires. Sickness absence data were available from human resources for 393 (93%, 95% CI 90% to 95%) consenting employees. In total, 21 managers adhered to the intervention, completing at least three of the six modules. WEMWBS scores fell slightly in all groups, from 50.4 to 49.0 in the control group and from 51.0 to 49.9 in the intervention group. The overall intervention effect was 0.5 (95% CI –3.2 to 4.2). The fall in WEMWBS score was significantly less among employees whose managers adhered to the intervention than among those employees whose managers did not (–0.7 vs. 1.6, with an adjusted difference of 1.6, 95% CI 0.1 to 3.2). The intervention and trial were acceptable to managers, although our study raises questions about the widely used concept of ‘acceptability’. Managers reported insufficient time to engage with the intervention and lack of senior management ‘buy-in’. It was thought that the intervention needed better integration into organisational processes and practice.ConclusionsThe mixed-methods approach proved valuable in illuminating reasons for the trial findings, for unpacking processes of implementation and for understanding the influence of study context. We conclude from the results of our pilot study that further mixed-methods research evaluating the intervention and study design is needed. We found that it is feasible to carry out an economic evaluation of the intervention. We plan a further mixed-methods study to re-evaluate the intervention boosted with additional elements to encourage manager engagement and behaviour change in private and public sector organisations with greater organisational commitment.Study registrationCurrent Controlled Trials ISRCTN58661009.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 9. See the NIHR Journals Library website for further project information.


BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036416
Author(s):  
Laura Green ◽  
Jahnavi Daru ◽  
Julie Dodds ◽  
Francisco Jose Gonzalez Carreras ◽  
Doris Lanz ◽  
...  

IntroductionThe incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment.MethodsACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes.Ethics and disseminationThe trial has approvals from the London—Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020.Trial registration numberISRCTN12146519.


2020 ◽  
Vol 7 ◽  
Author(s):  
Silindweyinkosi Chinoda ◽  
Abigail Mutsinze ◽  
Victoria Simms ◽  
Rhulani Beji-Chauke ◽  
Ruth Verhey ◽  
...  

Abstract Background Adolescents living with HIV (ALHIV) experience a high burden of mental health disorder which is a barrier to antiretroviral therapy adherence. In Zimbabwe, trained, mentored peer supporters living with HIV (Community Adolescent Treatment Supporters – CATS) have been found to improve adherence, viral suppression and psychosocial well-being among ALHIV. The Friendship Bench is the largest integrated mental health programme in Africa. We hypothesise that combining the CATS programme and Friendship Bench will improve mental health and virological suppression among ALHIV compared with the CATS programme alone. Methods We will conduct a cluster-randomised controlled trial in 60 clinics randomised 1:1 in five provinces. ALHIV attending the control arm clinics will receive standard CATS support and clinic support following the Ministry of Health guidelines. Those attending the intervention arm clinics will receive Friendship Bench problem-solving therapy, delivered by trained CATS. Participants with the signs of psychological distress will be referred to the clinic for further assessment and management. The primary outcome is HIV virological failure (≥1000 copies/ml) or death at 48 weeks. Secondary outcomes include the proportion of adolescents with common mental disorder symptoms (defined as Shona Symptom Questionnaire (SSQ-14) score ≥8), proportion with depression symptoms (defined as Patient Health Questionnaire (PHQ-9) score ≥11), symptom severity (mean SSQ-14 and PHQ-9 scores) and EQ-5D score for health-related quality of life. Conclusions This trial evaluates the effectiveness of peer-delivery of mental health care on mental health and HIV viral load among ALHIV. If effective this intervention has the potential to be scaled-up to improve these outcomes. Trial registration: PACTR201810756862405. 08 October 2018.


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