scholarly journals Reducing the use of sleep-inducing drugs during hospitalization by a multi-faceted intervention - a pilot study

2021 ◽  
Author(s):  
Stephanie Heinemann ◽  
Jonas Klemperer ◽  
Eva Hummers ◽  
Roland Nau ◽  
Wolfgang Himmel
Keyword(s):  
Pilot Study ◽  
Neurological Disorder ◽  
Controlled Trial ◽  
Prescription Data ◽  
Exact Test ◽  
Sleeping Problems ◽  
Before And After ◽  
Quasi Experimental ◽  
Hospital Director ◽  
Randomised Controlled

Objectives. Many patients receive benzodiazepines or Z-drugs during hospitalization due to sleeping problems. In a pilot study, we aimed to find out whether, and to what degree, a multi-faceted intervention can reduce the use of these drugs, especially in older patients and those without a psychiatric or neurological disorder. The results of this pilot study should inform the design of a randomised controlled trial (RCT). Methods. In a quasi-experimental design, we implemented the intervention in a German hospital with the support of the hospital director, medical and nursing staff and employee representatives. We compared prescription data for sleep-inducing drugs before and after the intervention by Fisher's exact test and used Odds-Ratios (ORs) with their 95 % confidence intervals (CI) as measure of effect size. Results. The data from 960 patients aged 65 and older before intervention and 1049 patients after in-tervention were analysed. Before intervention, 483 (50.3%) of the patients received sleep-inducing drugs at some time during their hospital stay. After the intervention, 381 (36.3%) patients received a sleep-inducing drug, resulting in an OR of 0.56 (95% CI: 0.47 to 0.68; p <0.001). The reduction was particularly pronounced in patients without a psychiatric or neurological disorder (from 45.0% to 28.8%). Especially benzodiazepines were significantly reduced (from 24.3% to 8.5%; OR: 0.31 (0.23-0.4); <0.001). Conclusions. A multi-faceted intervention to change the practice of the use of sleep-inducing drugs in one hospital was successful in terms of drug reduction, particularly for benzodiazepines. The interven-tion was effective especially for target persons, i.e. those without a psychiatric or neurological disease. Being aware of the magnitude of the change and the role of important stakeholders could help researchers, hospital physicians and hospital pharmacists to design a large RCT, including control hospitals, to evaluate the success of a multi-faceted intervention on a scientifically sound basis.

Auricular Acupuncture for Pre-Exam Anxiety in Medical Students: A Prospective Observational Pilot Investigation

2016 ◽  
Vol 34 (2) ◽  
pp. 90-94 ◽  
Author(s):  
Catharina Klausenitz ◽  
Thomas Hesse ◽  
Henriette Hacker ◽  
Klaus Hahnenkamp ◽  
Taras Usichenko
Keyword(s):  
Medical Students ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Final Analysis ◽  
Auricular Acupuncture ◽  
Before And After ◽  
Pilot Investigation ◽  
Exam Anxiety ◽  
Randomised Controlled ◽  
To Receive

Objective Auricular acupuncture (AA) is effective for the treatment of preoperative anxiety. We aimed to study the feasibility and effects of AA on exam anxiety in a prospective observational pilot study. Methods Healthy medical students received bilateral AA using indwelling fixed needles at points MA-IC1, MA-TF1, MA-SC, MA-AH7, and MA-T on the day before an anatomy exam. The needles were removed after the exam. Anxiety levels were measured using the State-Trait-Anxiety Inventory (STAI) and a 100 mm visual analogue scale (VAS-100) before and after the AA intervention and once again immediately before the exam. The duration of sleep on the night before the exam was recorded and compared to that over the preceding 1 week and 6 months (all through students’ recollection). In addition, blood pressure, heart rate and the acceptability of AA to the students were recorded. Results Ten students (all female) were included in the final analysis. All tolerated the needles well and stated they would wish to receive AA again for exam anxiety in the future. Exam anxiety measured using both STAI and VAS-100 decreased by almost 20% after AA. Conclusions AA was well accepted, the outcome measurement was feasible, and the results have facilitated the calculation of the sample size for a subsequent randomised controlled trial.

Randomised controlled trial of extraarticular gold bead implantation for treatment of knee osteoarthritis: a pilot study

2008 ◽  
Vol 27 (11) ◽  
pp. 1363-1369 ◽  
Author(s):  
Kirsten Nejrup ◽  
Niels de Fine Olivarius ◽  
Judith L. Jacobsen ◽  
Volkert Siersma
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Gold Bead ◽  
Randomised Controlled

scholarly journals The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: A protocol for a cross-border pilot cluster randomised controlled trial

2021 ◽  
Author(s):  
Lisa Hynes ◽  
Andrew W Murphy ◽  
Nigel Hart ◽  
Collette Kirwan ◽  
Sarah Mulligan ◽  
...  
Keyword(s):  
Primary Care ◽  
Decision Making ◽  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Medication Reviews ◽  
Randomised Controlled

AbstractBackgroundWhile international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically-informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)).MethodsA pilot cluster randomised controlled trial will be conducted, using a mixed methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention. A total of 16 practices will be recruited (eight in ROI; eight in NI) and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of GPs in ROI, and a GP and Practice Based Pharmacist (PBP) in NI. The GPs/GP and PBP will schedule time to review medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment, and 4- and 8-months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention, and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed.DiscussionThe findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies.Trial registrationRegistry: ISRCTN, ISRCTN80017020; Date of confirmation 4/11/2019; Retrospectively registered; http://www.isrctn.com/ISRCTN80017020.

scholarly journals Analysis of the components of cancer risk perception and links with intention and behaviour: A UK-based study

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0262197
Author(s):  
Christiane Riedinger ◽  
Jackie Campbell ◽  
William M. P. Klein ◽  
Rebecca A. Ferrer ◽  
Juliet A. Usher-Smith
Keyword(s):  
Factor Analysis ◽  
Risk Perception ◽  
Cancer Risk ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Distinct Component ◽  
Cancer Risk Perception ◽  
Before And After ◽  
Randomised Controlled ◽  
The Uk

Risk perception refers to how individuals interpret their susceptibility to threats, and has been hypothesised as an important predictor of intentions and behaviour in many theories of health behaviour change. However, its components, optimal measurement, and effects are not yet fully understood. The TRIRISK model, developed in the US, conceptualises risk perception as deliberative, affective and experiential components. In this study, we aimed to assess the replicability of the TRIRISK model in a UK sample by confirmatory factor analysis (CFA), explore the inherent factor structure of risk perception in the UK sample by exploratory factor analysis (EFA), and assess the associations of EFA-based factors with intentions to change behaviour and subsequent behaviour change. Data were derived from an online randomised controlled trial assessing cancer risk perception using the TRIRISK instrument and intention and lifestyle measures before and after communication of cancer risk. In the CFA analysis, the TRIRISK model of risk perception did not provide a good fit for the UK data. A revised model developed using EFA consisted of two separate “numerical” and “self-reflective” factors of deliberative risk perception, and a third factor combining affective with a subset of experiential items. This model provided a better fit to the data when cross-validated. Using multivariable regression analysis, we found that the self-reflective and affective-experiential factors of the model identified in this study were reliable predictors of intentions to prevent cancer. There were no associations of any of the risk perception factors with behaviour change. This study confirms that risk perception is clearly a multidimensional construct, having identified self-reflective risk perception as a new distinct component with predictive validity for intention. Furthermore, we highlight the practical implications of our findings for the design of interventions incorporating risk perception aimed at behaviour change in the context of cancer prevention.

scholarly journals An assets-based intervention before and after birth to improve breastfeeding initiation and continuation: the ABA feasibility RCT

2020 ◽  
Vol 8 (7) ◽  
pp. 1-156
Author(s):  
Joanne L Clarke ◽  
Jenny Ingram ◽  
Debbie Johnson ◽  
Gill Thomson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Public Health ◽  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Public Health Research ◽  
Breastfeeding Initiation ◽  
Before And After ◽  
Randomised Controlled

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

scholarly journals Deprescribing intervention activities mapped to guiding principles for use in general practice: a scoping review

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e052547
Author(s):  
Amy Coe ◽  
Catherine Kaylor-Hughes ◽  
Susan Fletcher ◽  
Elizabeth Murray ◽  
Jane Gunn
Keyword(s):  
General Practice ◽  
Family Practice ◽  
Data Extraction ◽  
Controlled Trial ◽  
Future Research ◽  
Original Research ◽  
Practice Staff ◽  
Quasi Experimental ◽  
Guiding Principles ◽  
Randomised Controlled

ObjectiveTo identify and characterise activities for deprescribing used in general practice and to map the identified activities to pioneering principles of deprescribing.SettingPrimary care.Data sourcesMedline, EMBASE (Ovid), CINAHL, Australian New Zealand Clinical Trials Registry (ANZCTR), Clinicaltrials.gov, ISRCTN registry, OpenGrey, Annals of Family Medicine, BMC Family Practice, Family Practice and British Journal of General Practice (BJGP) from inception to the end of June 2021.Study selectionIncluded studies were original research (randomised controlled trial, quasi-experimental, cohort study, qualitative and case studies), protocol papers and protocol registrations.Data extractionScreening and data extraction was completed by one reviewer; 10% of the studies were independently reviewed by a second reviewer. Coding of full-text articles in NVivo was conducted and mapped to five deprescribing principles.ResultsFifty studies were included. The most frequently used activities were identification of appropriate patients for deprescribing (76%), patient education (50%), general practitioners (GP) education (48%), and development and use of a tapering schedule (38%). Six activities did not align with the five deprescribing principles. As such, two principles (engage practice staff in education and appropriate identification of patients, and provide feedback to staff about deprescribing occurrences within the practice) were added.ConclusionActivities and guiding principles for deprescribing should be paired together to provide an accessible and comprehensive guide to deprescribing by GPs. The addition of two principles suggests that practice staff and practice management teams may play an instrumental role in sustaining deprescribing processes within clinical practice. Future research is required to determine the most of effective activities to use within each principle and by whom.

scholarly journals Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019142 ◽  
Author(s):  
Kate Jolly ◽  
Jenny Ingram ◽  
Joanne Clarke ◽  
Debbie Johnson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Feasibility Study ◽  
Breast Feeding ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Study Results ◽  
Service Staff ◽  
Before And After ◽  
Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

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