scholarly journals Addition of Lymphatic Stimulating Self-Care Practices Reduces Acute Attacks among People Affected by Moderate and Severe Lower-Limb Lymphedema in Ethiopia, a Cluster Randomized Controlled Trial

2020 ◽  
Vol 9 (12) ◽  
pp. 4077
Author(s):  
Jan Douglass ◽  
Fikre Hailekiros ◽  
Sarah Martindale ◽  
Hayley Mableson ◽  
Fikre Seife ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Trial ◽  
Northern Ethiopia ◽  
Randomized Controlled ◽  
Care Groups ◽  
Secondary Infections ◽  
Care Practices ◽  
Acute Attacks ◽  
Cluster Randomized

Lymphedema causes disability and exacerbates poverty in many countries. The management of lymphatic filariasis (LF) and podoconiosis-related lymphedema involves daily hygiene to reduce secondary infections, but self-massage and deep-breathing, which have proven beneficial in cancer-related lymphedema, are not included. A cluster randomized trial in northern Ethiopia investigated the effects of lymphatic stimulation for people affected by moderate to severe lymphedema. Participants were allocated to either standard (control n = 59) or enhanced (intervention n = 67) self-care groups. Primary outcomes were lymphedema stage, mid-calf circumference, and tissue compressibility. Secondary outcomes were the frequency and duration of acute attacks. After 24 weeks, fewer patients were assessed as severe (control −37.8%, intervention −42.4%, p = 0.15) and there were clinically relevant changes in mid-calf tissue compressibility but not circumference. There was a significant between-group difference in patients who reported any acute attacks over the study period (control n = 22 (38%), intervention n = 7 (12%), p = 0.014). Daily lymphedema self-care resulted in meaningful benefits for all participants with a greater reduction in acute episodes among people performing lymphatic stimulation. Observations of a change in lymphedema status support earlier findings in Bangladesh and extend the demonstrated benefits of enhanced self-care to people affected by podoconiosis.

scholarly journals Effect of an Enhanced Self-Care Protocol on Lymphedema Status among People Affected by Moderate to Severe Lower-Limb Lymphedema in Bangladesh, a Cluster Randomized Controlled Trial

2020 ◽  
Vol 9 (8) ◽  
pp. 2444 ◽  
Author(s):  
Janet Douglass ◽  
Hayley Mableson ◽  
Sarah Martindale ◽  
Sanya Tahmina Jhara ◽  
Mohammad Jahirul Karim ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Self Care ◽  
Care Group ◽  
Cluster Randomization ◽  
Randomized Controlled ◽  
Care Groups ◽  
Care Protocol ◽  
Secondary Infections ◽  
Acute Attacks ◽  
Cluster Randomized

Background: Lymphatic filariasis (LF) is a major cause of lymphedema, affecting over 16 million people globally. A daily, hygiene-centered self-care protocol is recommended and effective in reducing acute attacks caused by secondary infections. It may also reverse lymphedema status in early stages, but less so as lymphedema advances. Lymphatic stimulating activities such as self-massage and deep-breathing have proven beneficial for cancer-related lymphedema, but have not been tested in LF-settings. Therefore, an enhanced self-care protocol was trialed among people affected by moderate to severe LF-related lymphedema in northern Bangladesh. Methods: Cluster randomization was used to allocate participants to either standard- or enhanced-self-care groups. Lymphedema status was determined by lymphedema stage, mid-calf circumference, and mid-calf tissue compressibility. Results: There were 71 patients in each group and at 24 weeks, both groups had experienced significant improvement in lymphedema status and reduction in acute attacks. There was a significant and clinically relevant between-group difference in mid-calf tissue compressibility with the biggest change observed on legs affected by severe lymphedema in the enhanced self-care group (∆ 21.5%, −0.68 (−0.91, −0.45), p < 0.001). Conclusion: This study offers the first evidence for including lymphatic stimulating activities in recommended self-care for people affected by moderate and severe LF-related lymphedema.

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 Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Abdou Amza ◽  
Boubacar Kadri ◽  
Beido Nassirou ◽  
Ahmed M. Arzika ◽  
Ariana Austin ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Signs ◽  
Cluster Randomized Trial ◽  
World Health ◽  
Baseline Assessment ◽  
Randomized Controlled ◽  
Registration Number ◽  
Cluster Randomized ◽  
Health Organization

Abstract Background The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation—follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines. Methods The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3 years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission. Discussion The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. Trial registration number This study is registered at clinicaltrials.gov (NCT04185402). Registered December 4, 2019; prospectively registered pre-results.

Cluster randomized trial of an antibiotic time-out led by a team-based pharmacist

2020 ◽  
Vol 41 (11) ◽  
pp. 1266-1271
Author(s):  
Trevor C. Van Schooneveld ◽  
Mark E. Rupp ◽  
R. Jenifer Cavaleiri ◽  
Elizabeth Lyden ◽  
Kiri Rolek
Keyword(s):  
Controlled Trial ◽  
Early Period ◽  
Cluster Randomized Trial ◽  
Antibiotic Use ◽  
Effective Strategies ◽  
Randomized Controlled ◽  
Time Out ◽  
Academic Medical ◽  
Cluster Randomized ◽  
Medicine Team

AbstractObjective:Antibiotic time-outs (ATOs) have been advocated to improve antibiotic use without dedicated stewardship resources, but their utility is poorly defined. We sought to evaluate the effectiveness of an ATO led by a team-based pharmacist.Design:Cluster randomized controlled trial.Setting:Six medicine teams at an academic medical facility.Patients:Inpatients who received antibiotics and were cared for by a medicine team.Intervention:In phase A (2 months) pharmacist-led ATOs were implemented on 3 medicine teams (ATO-A) while 3 teams maintained usual care (UC-A). In phase B (2 months), ATOs were continued in the ATO group (ATO-B) and ATOs were initiated in the UC group (UC ATO-B). We targeted 2 ATO points: early (<72 hours after antibiotics were initiated) and late (after the early period but ≤5 days after antibiotic initiation).Results:In total, 290 ATOs were documented (181 early, 87 late, and 22 subsequent) among 538 admissions. The most common ATO recommendations were narrow therapy (148 of 290), no change (124 of 290), and change to oral (30 of 290). ATO initiation was lower in the UC ATO-B group than in either ATO group (21.8% UC ATO-B vs 69.2% ATO-A and -B). Overall antibiotic use was not different between the groups (P = .51), although intravenous (IV) levofloxacin use decreased in the UC group after ATO implementation (49 DOT/1,000 PD vs 20 DOT/1,000 PD; P = .022). The ratio of oral (PO) to intravenous (IV) DOT was lower in the UC group than in any of the ATO groups (P = .032). We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.Conclusions:Implementation of a pharmacist-led ATO was feasible and well accepted but did not change overall antibiotic use. An ATO may promote increased use of oral antibiotics, but more effective strategies for self-stewardship are needed.

scholarly journals Effects of Self-Care for Older PErsons (SCOPE) on Functional and Physiological Measures: A Cluster Randomized Controlled Trial

2020 ◽  
Vol 9 (3) ◽  
pp. 885
Author(s):  
Ted Kheng Siang Ng ◽  
David Bruce Matchar ◽  
Rehena Sultana ◽  
Angelique Chan
Keyword(s):  
Older Adults ◽  
Older Persons ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Care ◽  
Community Dwelling ◽  
Physiological Measures ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Community Dwelling Older Adults

Background: Population aging poses unprecedented demands on the healthcare system. There is also a scarcity of evidence on self-care intervention to improve objective measures of morbidity and aging-associated functional and physiological measures in a low-income multi-ethnic population setting. Methods: We conducted a cluster randomized controlled trial (ClinicalTrials.gov Identifier: NCT01672177) to examine the effects of the Self-Care for Older PErsons (SCOPE) program. We randomized 14 Senior Activity Centers and randomly selected older adults within these centers. Functional and physiological measurements were performed at baseline, 10-month, and 18-month periods. The primary outcome was a composite of three morbidity-specific measures, which include hemoglobin A1c (HbA1C), peak expiratory flow, and systolic blood pressure. Aging-associated functional and physiological measures were examined as secondary outcomes. Repeated-measure mixed models were employed to examine the effects of SCOPE on these measures. Results: 378 community-dwelling older adults participated in either the treatment (n= 164) or the control arm (n = 214). The primary outcome was not significantly improved. For the secondary outcomes, SCOPE participants demonstrated slower oxygen desaturation at an 18-month period (p = 0.001), improved time to complete the chair-stand test (p < 0.001) at a 10-month period with the effect persisting at the 18-month period (p < 0.001). SCOPE participants also had significantly improved vitamin B12 levels at the 18-month period (p < 0.001), increased hemoglobin concentration (p < 0.001), decreased mean corpuscular volume (p = 0.001), and decreased creatinine (p = 0.002) at the 10-month period. Conclusions: SCOPE did not improve morbidity-specific measures. However, it improved several aging-associated measures implicated in geriatric syndromes. This study highlights the potential of a self-care program in the prevention of geriatric syndromes in community-dwelling older adults, while emphasizing self-management to manage existing morbidities.

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 Use of Asthma APGAR Tools in Primary Care Practices: A Cluster-Randomized Controlled Trial

2018 ◽  
Vol 16 (2) ◽  
pp. 100-110 ◽  
Author(s):  
Barbara P. Yawn ◽  
Peter C. Wollan ◽  
Matthew A. Rank ◽  
Susan L. Bertram ◽  
Young Juhn ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Care Practices ◽  
Cluster Randomized ◽  
Primary Care Practices
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