Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

scholarly journals Evaluation of a Collaborative Protocolized Approach by Community Pharmacists and General Medical Practitioners for an Australian Minor Ailments Scheme: Protocol for a Cluster Randomized Controlled Trial

10.2196/13973 ◽  
2019 ◽  
Vol 8 (8) ◽  
pp. e13973 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia-Cardenas ◽  
Kris Rogers ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
General Practices ◽  
Cluster Randomized

Background Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MASs) promote efficiencies within the health care system. The cost savings and health outcomes demonstrated in the United Kingdom and Canada open up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. Objective This trial aims to evaluate the clinical, economic, and humanistic impact of an Australian Minor Ailments Service (AMAS) compared with usual pharmacy care in a cluster randomized controlled trial (cRCT) in Western Sydney, Australia. Methods The cRCT design has an intervention group and a control group, comparing individuals receiving a structured intervention (AMAS) with those receiving usual care for specific health ailments. Participants will be community pharmacies, general practices, and patients located in Western Sydney Primary Health Network (WSPHN) region. A total of 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments: reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhea, or low back pain. Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The coprimary outcomes are rates of appropriate recommendation of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, health services resource utilization, and EuroQoL Visual Analogue Scale. Differences in primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost-utility and cost-effectiveness analysis compared with usual care. Results The study began in July 2018. Thirty community pharmacies were recruited. Pharmacists from the 15 intervention pharmacies were trained. A total of 27 general practices consented. Pharmacy patient recruitment began in August 2018 and was completed on March 31, 2019. Conclusions This study may demonstrate the efficacy of a protocolized intervention to manage minor ailments in the community and will assess the clinical, economic, and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and appropriate self-medication may contribute to greater efficiency of health care resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a national MAS service in Australia, using a robust framework for management and referral for common ailments. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000286246; http://www.anzctr.org.au/ACTRN12618000286246.aspx International Registered Report Identifier (IRRID) DERR1-10.2196/13973

scholarly journals Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isabella Bablok ◽  
◽  
Harald Binder ◽  
Dominikus Stelzer ◽  
Klaus Kaier ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Dementia Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Care Model ◽  
Randomized Controlled ◽  
Individual Needs ◽  
Cluster Randomized ◽  
The Individual

Abstract Background Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers. Methods/design In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients’ care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers’ burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs’ attitudes and sensitivity towards dementia, among others. Discussion The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation. Trial registration German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560. Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals A Cluster Randomized Controlled Trial Feasibility Study of a WhatsApp-Delivered Intervention to Promote Healthy Eating Habits in Male Firefighters

2021 ◽  
Vol 18 (12) ◽  
pp. 6633
Author(s):  
Winnie Wing Man Ng ◽  
Anthony Siu Wo Wong ◽  
Kin Cheung
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Eating Habits ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Healthy Eating Habits ◽  
Cluster Randomized

This cluster randomized controlled trial (CRCT)-designed study aimed to explore the feasibility of a promotion pamphlet and/or WhatsApp as a suitable mode of delivery to promote healthy eating habits with fruit and vegetables (F&V) among firefighters. Convenience and snowball sampling methods were used. Forty-five firefighters from 23 fire stations were recruited and they all received the printed pamphlet, while the intervention group participants (n = 20) received additional teaching material through WhatsApp every two weeks for eight weeks. Feasibility outcomes included retention, practicality, and implementation. The participants reported high levels of satisfaction with the intervention. There were significant improvements in the mean numbers of days consuming F&V (p = 0.002; p = 0.031) in the intervention group, and for fruit consumption (p = 0.033) in the control group between the baseline (T0) and 3 months after completion of intervention (T1). High levels of participants’ satisfaction with the intervention revealed that a full-scale CRCT of the WhatsApp-delivered intervention promoting healthy eating could be feasible, especially as a means of increasing the numbers of days they consumed F&V and the numbers of servings of these consumed per day.

scholarly journals Healthy Pregnancies Project: Cluster Randomized Controlled Trial of a Community Intervention to Reduce Tobacco Use among Alaska Native Women

2020 ◽  
Vol 17 (24) ◽  
pp. 9302
Author(s):  
Christi A. Patten ◽  
Harry A. Lando ◽  
Chris A. Desnoyers ◽  
Martha J. Bock ◽  
Lucinda Alexie ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Tobacco Use ◽  
Alaska Native ◽  
Controlled Trial ◽  
Study Groups ◽  
Cluster Randomized Controlled Trial ◽  
Community Level ◽  
Randomized Controlled ◽  
Cluster Randomized

Substantial gaps remain in the evidence base for prenatal tobacco use interventions among Indigenous women. Using a cluster randomized controlled trial (RCT), the Healthy Pregnancies Project evaluated a community-level intervention for Alaska Native (AN) women in rural western Alaska. Sixteen villages were randomly assigned to usual care (control, n = 8 villages) or usual care plus a community-level intervention delivered by local AN “Native Sisters” (n = 8 villages). Outcomes were tobacco use rate at delivery and at 2 and 6 months postpartum, with biochemical confirmation obtained at 6 months. The program had high reach, enrolling 73% of all eligible women screened. Of the 352 participants, 67% used tobacco at baseline. No significant differences emerged between study groups on follow-up in tobacco use rates. More intervention than control participants made a quit attempt at 2 months postpartum (70% vs. 51%, respectively, p = 0.012). Participants in both study groups reported the program helped to raise awareness of healthy pregnancies in the study villages. This trial supports the reach of a community-level intervention, but not its efficacy for reducing tobacco use during pregnancy or postpartum. Efforts to sustain early quit attempts appear warranted. The community involvement, and reported impact on raising awareness of the importance of healthy pregnancies, supports the value of the research program in this community.

scholarly journals The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial

2019 ◽  
Author(s):  
Esther Steenaart ◽  
Rik Crutzen ◽  
Math JJM Candel ◽  
Nanne K de Vries
Keyword(s):  
Randomized Controlled Trial ◽  
Organ Donation ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Post Test ◽  
Cluster Randomized ◽  
And Control ◽  
Experimental Group

Abstract Background: Organ donation registration rates remain low, especially among people with lower educational levels. An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation. This article reports on the effects of this intervention on the intention to register (i.e. the primary outcome in the study at hand) and beliefs regarding organ donation. Methods: The effectiveness was investigated in a post-test only cluster randomized controlled trial, in which the intervention was offered to the experimental group and after measurement also to the control group. Randomization to the experimental and control groups took place at a class level. Teachers of schools for intermediate vocational education who taught a course on Citizenship delivered three intervention elements (i.e. video fragments and discussion, quizzes with tailored feedback and exercise filling out a registration form) to their students during two 50-minute lessons. Results: A total of 1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes). Compared to the control group, students in the experimental group had higher odds of having positive registration intentions (OR=1.81; 95%CI [1.10-2.96]), their perceived knowledge was higher (B=.62; 95%CI [.23-1.01]) and they had higher intentions to talk to family members (B=.68; 95%CI [.28-1.08]) and friends (B=.36; 95%CI [.07-.66]) about organ donation. There were no effects on the choice students intended to register (OR=1.08; 95%CI [.67-1.73]). Conclusions: Providing education in a classroom setting is an effective tool in increasing registration intentions. Despite uncertainties about the effects on actual registration behavior, a larger scale dissemination of this intervention is recommended. Providing clear information and opening the discussion about organ donation is an important and promising first step towards higher registration rates. Trial registration: The Dutch Trial Register, NTR6771. Registered on 24 October 2017. https://www.trialregister.nl/trial/6557

Abstract 137: Efficacy and Safety of a TIA Electronic Support Tool (FASTEST): A Cluster Randomized Controlled Trial

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Annemarei Ranta ◽  
Susan Dovey ◽  
John Gommans ◽  
Mark Weatherall
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Cluster Randomization ◽  
Inter Quartile Range ◽  
Randomized Controlled ◽  
Quartile Range ◽  
Cluster Randomized

Introduction: The risk of stroke after a transient ischaemic attack (TIA) is greatest within the first few days of the TIA and then tapers over time. It is known that early initiation of best medical therapy significantly reduces this risk. Hypothesis: To test whether a TIA/Stroke Electronic Decision Support (EDS) tool in primary care promotes faster access to optimal TIA management and reduces the risk of recurrent stroke and vascular events. Methods: A cluster randomized controlled trial (FASTEST Trial ACTRN12611000792921) with general practitioner (GP) practices randomized to use an EDS tool versus usual care. Results: The study period was 28 February 2012 to 15 May 2013 and 46 GP practices (145 GPs) registered 373 patients. Eligibility criteria were met by 291/373 (78%) patients of whom 178 received GP care using the EDS and 113 usual care. Ninety day follow up was completed on 13 August 2013. Stroke occurred in 2/178 (1.1%) of the intervention group and 5/113 (4.4%) in the usual care group; odds ratio (95% CI), unadjusted for cluster randomization, 0.25 (0.05 to 1.29), p=0.073. Any vascular event or death occurred in 7/178 (3.9%) of the EDS group and 14/113 (12.4%) of the control group, unadjusted OR (95% CI) 0.29 (0.11 to 0.74), p=0.007. The time to starting anti-platelet medication, in those not previously using these, was similar in the two groups, median (inter-quartile range) of 0 days (0 to 0) and 0 days (0 to 1) in the EDS and usual care groups. Statin and anti-hypertensive prescription, in those not previously using these, occurred more quickly in the EDS group compared to usual care; median (inter-quartile range) 2 days (0 to 7) versus 3 days (0 to7) for statin and 3 days (0 to 7) versus 5 days (1.5 to 37) for anti-hypertensive prescription. Conclusion: The preliminary analysis of this trial supports improved outcomes and process of care with EDS versus usual care for TIA management in primary care. The full analysis, adjusted for the cluster randomization, will be presented at the meeting.

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