scholarly journals Nasal fentanyl and buccal midazolam carer administration ‘as needed’ for breakthrough symptom control in a specialist palliative care unit: a nested qualitative study

2021 ◽  
Vol 11 (4) ◽  
pp. 440-443
Author(s):  
Paul Perkins ◽  
Anne Parkinson ◽  
Vanessa Taylor ◽  
Emma Husbands
Keyword(s):  
Healthcare Professionals ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Symptom Control ◽  
Drug Efficacy ◽  
Ease Of Use ◽  
Symptom Intensity ◽  
Dying At Home ◽  
Randomised Controlled ◽  
At Home

IntroductionWhen people are dying and unable to take oral medication, injectable medication is commonly used, usually administered by healthcare professionals. There may be delays to symptom relief due to travel to the person’s home. In a randomised controlled trial (RCT) previously reported, nasal fentanyl (NF) or buccal midazolam (BM) were administered by lay carers in a hospice.Objective(1) To report experiences of lay carers who administered NF and BM for symptom control and (2) To use feedback to develop guidance informing a future definitive RCT to determine whether NF and BM administered by lay carers can lead to timely, improved symptom control for people dying at home and fewer ‘emergency’ community nursing visits than standard breakthrough medication administered by healthcare professionals.Material and methodsSemistructured interviews with lay carers who gave trial medication were conducted. Interview data were analysed using a stage by stage method to code and categorise transcripts.FindingsThe six themes were: (1) Participation—lay carers welcomed the opportunity to administer medication; (2) Ease of use—lay carers found preparations easy to use; (3) How things could have been done differently—lay carers would have liked access to trial drugs at home; (4) Training—lay carers were happy with the training they received; (5) Timing—lay carers liked the immediacy of trial drugs and (6) Evaluation—assessing symptom intensity and drug efficacy.ConclusionsParticipation was acceptable to patients and lay carers, and beneficial for symptom relief. The findings will inform planning for a future community-based study.

scholarly journals Nasal fentanyl alone plus buccal midazolam: an open-label, randomised, controlled feasibility study in the dying

2020 ◽  
Vol 10 (3) ◽  
pp. 300-303
Author(s):  
Paul Perkins ◽  
Anne Parkinson ◽  
Ralph Kwame Akyea ◽  
Emma Husbands
Keyword(s):  
Controlled Trial ◽  
Symptom Control ◽  
Drop Out ◽  
Terminal Phase ◽  
Open Label ◽  
Study Planning ◽  
Registration Number ◽  
Dying At Home ◽  
Randomised Controlled ◽  
At Home

IntroductionMany patients want to stay at home to die. They invariably become unable to take oral medication during their terminal phase. Symptoms are usually controlled by subcutaneous medications. There have been no studies on nasal fentanyl (NF) or buccal midazolam (BM) to control symptoms in the dying.ObjectiveTo establish how best to conduct a definitive, randomised controlled trial (RCT) to determine whether NF and BM administered by families, for patients dying at home, lead to faster and better symptom control and fewer community nursing visits than standard breakthrough medication by healthcare professionals.MethodsThis open-label mixed-method feasibility RCT compared the efficacy of NF and BM by family members to standard breakthrough medication by nurses for the terminally ill in a specialist palliative care unit. Partway through the study, a third observational arm was introduced where BM alone was used. The primary outcomes were whether recruitment and randomisation were possible, assessment of withdrawal and drop-out, and whether the methods were acceptable and appropriate.ResultsAdministration of NF and BM was acceptable to patients and families. Both were well tolerated. We were unable to obtain quality of life data consistently but did get time period data for dose-controlled symptoms.ConclusionsStudy participation in a hospice population of the dying was acceptable. The results will help guide future community study planning.Trial registration numberNCT02009306.

scholarly journals CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial

2018 ◽  
Author(s):  
Marlise Poolman ◽  
Jessica Roberts ◽  
Anthony Byrne ◽  
Paul Perkins ◽  
Zoe Hoare ◽  
...  
Keyword(s):  
Ethical Issues ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Symptom Control ◽  
Pilot Trial ◽  
Life Care ◽  
Dying Patients ◽  
Wish To Die ◽  
The Uk ◽  
At Home

Abstract Background: Whilst the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them. Dying people are usually unable to take oral medication. When top-up symptom relief medication is required, a clinician travels to the home to administer injectable medication, with attendant delays. The administration of subcutaneous injections by lay carers, though not widespread practice in the UK, has proven key in achieving home deaths in other countries. Our aim is to determine if carer-administration of as-needed subcutaneous medication for four frequent breakthrough symptoms (pain, nausea, restlessness and noisy breathing) in home-based dying patients is feasible and acceptable in the UK. Methods: The paper describes a randomised pilot trial across three UK sites, with an embedded qualitative study. Dyads of adult patients/carers are eligible, where patients are in the last weeks of life, wish to die at home, and lay carers who are willing to be trained to give subcutaneous medication. Dyads who do not meet strict risk assessment criteria (including known history of substance abuse or carer ability to be trained to competency) will not be approached. Carers in the intervention arm will receive a manualised training package delivered by their local nursing team. Dyads in the control arm will receive usual care. The main outcomes of interest are feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Interviews with carers and healthcare professionals will explore attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The study has obtained full ethical approval. Discussion: This study will rehearse the procedures and logistics which will be undertaken in a future definitive randomised controlled trial, and will inform the design of such a study. Findings will illuminate methodological and ethical issues pertaining to researching last days of life care. The study is funded by the National Institute for Health Research (Health Technology Assessment [HTA] project 15/10/37). Trial registration: ISRCTN, ISRCTN 11211024. Assigned 27 September 2016, http://www.isrctn.com/ISRCTN11211024. Keywords: End-of-life care, Care of the dying, Palliative care, Symptom control, Carer administration, Randomised pilot trial

scholarly journals CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial

2019 ◽  
Author(s):  
Marlise Poolman ◽  
Jessica Roberts ◽  
Anthony Byrne ◽  
Paul Perkins ◽  
Zoe Hoare ◽  
...  
Keyword(s):  
Ethical Issues ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Symptom Control ◽  
Pilot Trial ◽  
Life Care ◽  
Dying Patients ◽  
Wish To Die ◽  
The Uk ◽  
At Home

Abstract Background: Whilst the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them. Dying people are usually unable to take oral medication. When top-up symptom relief medication is required, a clinician travels to the home to administer injectable medication, with attendant delays. The administration of subcutaneous injections by lay carers, though not widespread practice in the UK, has proven key in achieving home deaths in other countries. Our aim is to determine if carer-administration of as-needed subcutaneous medication for four frequent breakthrough symptoms (pain, nausea, restlessness and noisy breathing) in home-based dying patients is feasible and acceptable in the UK. Methods: The paper describes a randomised pilot trial across three UK sites, with an embedded qualitative study. Dyads of adult patients/carers are eligible, where patients are in the last weeks of life, wish to die at home, and lay carers who are willing to be trained to give subcutaneous medication. Dyads who do not meet strict risk assessment criteria (including known history of substance abuse or carer ability to be trained to competency) will not be approached. Carers in the intervention arm will receive a manualised training package delivered by their local nursing team. Dyads in the control arm will receive usual care. The main outcomes of interest are feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Interviews with carers and healthcare professionals will explore attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The study has obtained full ethical approval. Discussion: This study will rehearse the procedures and logistics which will be undertaken in a future definitive randomised controlled trial, and will inform the design of such a study. Findings will illuminate methodological and ethical issues pertaining to researching last days of life care. The study is funded by the National Institute for Health Research (Health Technology Assessment [HTA] project 15/10/37). Trial registration: ISRCTN, ISRCTN 11211024. Assigned 27 September 2016, http://www.isrctn.com/ISRCTN11211024. Keywords: End-of-life care, Care of the dying, Palliative care, Symptom control, Carer administration, Randomised pilot trial

Habits-GDM mobile application in managing gestational diabetes in Singapore: A mixed-methods study (Preprint)

2020 ◽  
Author(s):  
Shilpa Surendran ◽  
Chang Siang Lim ◽  
Gerald Choon Huat Koh ◽  
Tong Wei Yew ◽  
E Shyong Tai ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Perceived Usefulness ◽  
Mixed Methods Study ◽  
Automatic Data ◽  
Glucose Testing ◽  
Randomised Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing in Singapore and the cost of providing traditional care for GDM is high. Mobile health (mHealth) applications may act as useful tools in the management of GDM. OBJECTIVE The objective of this mixed-methods study was to measure the usage behaviour and explore users’ perceived usefulness of the Habits-GDM application when managing GDM in a randomised controlled trial. METHODS We conducted a quantitative analysis of the application usage behaviour in 170 Habits-GDM application users and 14 semi-structured interviews with users from a randomised controlled trial. RESULTS The convenience of automatic data transfer of weight values to the Habits-GDM application helped users (116/170, 68%) log their weight at least once a week. However, when the application had usability challenges, users avoided using that feature, i.e. users logged only an average of less than one meal/week out of the recommended six meals/week. Of the usability challenges, many users (12/14, 85.7%) mentioned food items not worded in the commonly known way and limited ethnic food database as the primary barriers. Only half of the users (84/170, 49.4%) accessed the educational lessons, but many (9/14, 64%) identified the provision of always available, valuable health-related information as an advantage of the educational lessons. ‘Healthy eating’ and ‘Why exercise’ were the most (56/84, 66.67%) and least (38/84, 45.24%) frequently accessed educational lessons, respectively. Users (10/14, 71.4%) reported sending messages to the coach via the chat interface only when they faced logistic issues and 86.45% of all the coach messages were replies typed by the research coordinator in response to the logistics issues (i.e. a request for blood glucose testing strips and appointment confirmation) raised by the users. Healthcare professionals lack of access to the coach’s dashboard discouraged users from asking queries related to GDM via the e-coaching feature. CONCLUSIONS The findings suggest that mHealth application acts as a useful tool in managing GDM. Culturally sensitive mHealth applications with a provision for women to interact with healthcare professionals should be developed in cooperation with the users. CLINICALTRIAL Not applicable.

scholarly journals Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e042101
Author(s):  
Saba Aijaz ◽  
Sana Sheikh ◽  
Asad Pathan
Keyword(s):  
Randomised Controlled Trial ◽  
Radial Artery ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Ease Of Use ◽  
P Value ◽  
Radial Compression ◽  
Open Label ◽  
Scientific Publications ◽  
Randomised Controlled

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals Healthcare professionals’ views of the use of oral morphine and transmucosal diamorphine in the management of paediatric breakthrough pain and the feasibility of a randomised controlled trial: A focus group study (DIPPER)

2021 ◽  
pp. 026921632110087
Author(s):  
Liz Jamieson ◽  
Emily Harrop ◽  
Margaret Johnson ◽  
Christina Liossi ◽  
Christine Mott ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Healthcare Professionals ◽  
Breakthrough Pain ◽  
Controlled Trial ◽  
Oral Morphine ◽  
Oral Route ◽  
Focus Group Study ◽  
Framework Approach ◽  
Randomised Controlled ◽  
The Uk

Background: Oral morphine is frequently used for breakthrough pain but the oral route is not always available and absorption is slow. Transmucosal diamorphine is administered by buccal, sublingual or intranasal routes, and rapidly absorbed. Aim: To explore the perspectives of healthcare professionals in the UK caring for children with life-limiting conditions concerning the assessment and management of breakthrough pain; prescribing and administration of transmucosal diamorphine compared with oral morphine; and the feasibility of a comparative clinical trial. Design/ participants: Three focus groups, analysed using a Framework approach. Doctors, nurses and pharmacists ( n = 28), caring for children with life-limiting illnesses receiving palliative care, participated. Results: Oral morphine is frequently used for breakthrough pain across all settings; with transmucosal diamorphine largely limited to use in hospices or given by community nurses, predominantly buccally. Perceived advantages of oral morphine included confidence in its use with no requirement for specific training; disadvantages included tolerability issues, slow onset, unpredictable response and unsuitability for patients with gastrointestinal failure. Perceived advantages of transmucosal diamorphine were quick onset and easy administration; barriers included lack of licensed preparations and prescribing guidance with fears over accountability of prescribers, and potential issues with availability, preparation and palatability. Factors potentially affecting recruitment to a trial were patient suitability and onerousness for families, trial design and logistics, staff time and clinician engagement. Conclusions: There were perceived advantages to transmucosal diamorphine, but there is a need for access to a safe preparation. A clinical trial would be feasible provided barriers were overcome.

Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis

2012 ◽  
Vol 50 (4) ◽  
pp. 417-426
Author(s):  
R. Jund ◽  
M. Mondigler ◽  
H. Steindl ◽  
H. Stammer ◽  
P. Stierna ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Symptom Relief ◽  
Secondary Outcome ◽  
Number Needed To Treat ◽  
Symptom Duration ◽  
Serious Adverse Events ◽  
Dry Extract ◽  
End Of Treatment ◽  
Bno 1016 ◽  
Randomised Controlled

Objective: A herbal drug combination (Dry Extract BNO 1016) has been assessed for efficacy and tolerability in patients with acute viral rhinosinusitis. Methodology: In this randomised, controlled trial patients with symptom duration of up to 3 days, mild to moderate facial pain and a Major Symptom Score (MSS) between 8 and 12 were treated for 15 days with BNO 1016 or placebo (coated tablets administered orally). Primary efficacy endpoint was mean MSS at end of treatment. Secondary outcome measures included treatment response and changes in paranasal sinuses assessed by ultrasonography. Results: Treatment resulted in clinically relevant, significant differences in mean MSS for BNO 1016 versus placebo. BNO 1016 provided symptom relief two days earlier than placebo. The number needed to treat for healing is 8. BNO 1016 was superior regarding responder rates at Day 10 and Day 14 and percentage of patients without signs of acute viral rhinosinusitis assessed by ultrasonography at end of treatment. BNO 1016 was well tolerated; no serious adverse events were reported. Conclusion: The herbal dry extract BNO 1016 is efficacious and well tolerated in patients with acute viral rhinosinusitis. Trial registration: ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT01146860; EudraCT: 2009-016682-28).

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