scholarly journals Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial

10.2196/14705 ◽  
2019 ◽  
Vol 8 (7) ◽  
pp. e14705 ◽  
Author(s):  
Judith Schlaeger ◽  
Hui Yan Cai ◽  
Alana D Steffen ◽  
Veronica Angulo ◽  
Adhir R Shroff ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stable Angina ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Attention Control ◽  
Chinese Patients ◽  
Control Group ◽  
Mcgill Pain Questionnaire ◽  
Analgesic Effects ◽  
Randomized Controlled

BackgroundAcupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha.ObjectiveThis study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables.MethodsWe are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non–pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life.ResultsThis study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020.ConclusionsWe will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication.International Registered Report Identifier (IRRID)DERR1-10.2196/14705

scholarly journals Acupuncture to Improve Symptoms for Stable Angina (AIMS-A): Study Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Judith Schlaeger ◽  
Hui Yan Cai ◽  
Alana D. Steffen ◽  
Veronica Angulo ◽  
Adhir R. Shroff ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stable Angina ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Attention Control ◽  
Chinese Patients ◽  
Control Group ◽  
Mcgill Pain Questionnaire ◽  
Analgesic Effects ◽  
Randomized Controlled

BACKGROUND Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for analgesic effects is the downregulation of M1 macrophages, Interleukin-1β, Interleukin-6, Interleukin-18, and tumor necrosis factor alpha (TNF-α). OBJECTIVE The purpose of this study is to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in healthcare systems and other salient variables. METHODS We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. Primary outcomes are anginal pain and quality of life. RESULTS Results will be available upon completion of the randomized controlled trial and the analysis of the data. CONCLUSIONS We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a pro-inflammatory state and/or hyperalgesia caused by multiple neural and immune processes not always relieved with medication. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02914834

scholarly journals Chinese Herbal Formula Xuefu Zhuyu for Stable Angina (CheruSA): Study Protocol for a Multicenter Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Shaojun Liao ◽  
Zhe Zhang ◽  
Geng Li ◽  
Li Zhou ◽  
Junwen Jiang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Heart Disease ◽  
Stable Angina ◽  
Controlled Trial ◽  
Routine Care ◽  
Control Group ◽  
Herbal Formula ◽  
Chinese Herbal Formula ◽  
Randomized Controlled ◽  
Chinese Herbal

Introduction. Stable angina (SA) in coronary heart disease is a common ischemic heart disease endangering the patient’s quality of life and longevity. Clinical trials have demonstrated that the Chinese herbal formula Xuefu Zhuyu (XFZY) has benefits for SA patients. However, there remains a lack of high-quality evidence to support clinical decision-making. Therefore, we designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of XFZY for SA. Methods and Analysis. This multicenter, double-blinded RCT will be conducted in China. 152 eligible participants will be randomly assigned to either an XFZY group or a control group at a 1 : 1 ratio. Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care. The study period is 26 weeks, including a 2-week run-in period, a 12-week treatment period, and a 12-week follow-up. The primary outcome is the change in visual analogue scale score for angina pain intensity from baseline to 12 weeks. The secondary outcomes are the angina attack frequency and duration, the nitroglycerin dosage consumed, the Canadian Cardiovascular Society grading of effort angina, the Seattle Angina Questionnaire, the EuroQol-5-Dimensions-5-Level, the incidence of major adverse cardiac events, health cost evaluation, and overall assessment for study drugs. Ethics and Dissemination. The study has been approved by the ethics committee of Guangdong Provincial Hospital of Chinese Medicine (approval no. BF2019-175-01). Results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. This trial is registered with ChiCTR1900026899, registered on 26 October 2019.

scholarly journals Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial

2018 ◽  
Author(s):  
Shanshan Li ◽  
Ping Yin ◽  
Xuan Yin ◽  
Anna Bogachko ◽  
Tingting Liang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Depression Scale ◽  
Menopausal Transition ◽  
Syndrome Differentiation ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Rating ◽  
Menopausal Women

Abstract Background: China today has high occurrences of insomnia in perimenopausal women. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design: In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in a 1:1 ratio. Participants will receive a total of 18 sessions of treatment for eight consecutive weeks. Treatments will be given three times per week in the first four weeks, twice a week for the next two weeks and finally treatment once weekly for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, week four, week eight, and first and the third month following the end of treatment. Discussion: If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, this positive outcome could provide evidence for clinical application.

scholarly journals Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Shanshan Li ◽  
Ping Yin ◽  
Xuan Yin ◽  
Anna Bogachko ◽  
Tingting Liang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Depression Scale ◽  
Menopausal Transition ◽  
Syndrome Differentiation ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Rating ◽  
Menopausal Women

Abstract Background China today has high occurrences of insomnia in women experiencing menopausal transition. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in 1:1 ratio. Participants will receive 18 sessions of treatment in total for eight consecutive weeks. Treatments will be given three times per week in the first four weeks and then twice a week for the next two weeks followed by once a week treatment for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, four-week, eight-week, and first and the third month after the end of treatment. Discussion If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, they could provide evidence for clinical application.

scholarly journals Sharp-Hook Acupuncture (Feng Gou Zhen) for Patients with Periarthritis of Shoulder: A Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Laixi Ji ◽  
Haijun Wang ◽  
Yuxia Cao ◽  
Ping Yan ◽  
Xiaofei Jin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Shoulder Joint ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Acupuncture Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Mcgill Pain Questionnaire ◽  
Pain Questionnaire ◽  
Randomized Controlled

TheFeng Gou Zhen(sharp-hook acupuncture) as a traditional form of ancient acupuncture is said to be particularly effective for managing periarthritis of shoulder. We conducted this randomized controlled trial to evaluate the effectiveness ofFeng Gou Zhenas an add-on compared to conventional analgesics for patients with PAS. 132 patients were randomly assigned in a 1 : 1 ratio to either a acupuncture group receiving sharp-hook acupuncture plus acupoint injection with conventional analgesics or a control group. Patients from both groups were evaluated at week 0 (baseline), week 1, and week 4. The primary outcome measure was the change from baseline shoulder pain, measured by Visual Analogue Scale at 7 days after treatment. Secondary outcome measures include the (i) function of shoulder joint and (ii) McGill pain questionnaire. The results showed that patients in acupuncture group had better pain relief and function recovery compared with control group (P<0.05) at 1 week after treatment. Moreover, there were statistical differences between two groups in VAS and shoulder joint function and McGill pain questionnaire at 4 weeks after treatment (P<0.05). Therefore, the sharp-hook acupuncture helps to relieve the pain and restore the shoulder function for patients with periarthritis of shoulder.

scholarly journals Supporting Family Caregivers With Technology for Dementia Home Care: A Randomized Controlled Trial

2019 ◽  
Vol 3 (3) ◽  
Author(s):  
Kristine N Williams ◽  
Yelena Perkhounkova ◽  
Clarissa A Shaw ◽  
Maria Hein ◽  
Eric D Vidoni ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Family Caregivers ◽  
Controlled Trial ◽  
Dementia Care ◽  
Attention Control ◽  
Behavioral Symptoms ◽  
Control Group ◽  
Randomized Controlled ◽  
Available Technology ◽  
Attention Control Group

Abstract Background and Objectives The number of persons living with dementia (PLWD) in the United States will reach 16 million by 2050. Behavioral and psychological symptoms of dementia challenge family caregivers and contribute to negative caregiver outcomes such as burden and depression. Available technology can support the delivery of effective interventions to families providing dementia care at home. The Supporting Family Caregivers with Technology for Dementia Home Care (FamTechCare) randomized controlled trial evaluated the effects of a telehealth intervention on caregiver outcomes. Research Design and Methods The FamTechCare intervention provides tailored dementia-care strategies to in-home caregivers based on video recordings caregivers submit of challenging care situations. An expert team reviews the videos and provides individualized interventions weekly for the experimental group. In the telephone-support attention control group, caregivers receive feedback from an interventionist via the telephone based on caregiver retrospective recall of care challenges. Effects of the intervention on caregiver outcomes, including burden, depression, sleep disturbance, competence, desire to institutionalize the PLWD, and caregiver reaction to behavioral symptoms were evaluated by fitting linear mixed regression models to changes in the outcomes measured at 1 and 3 months. Results FamTechCare caregivers (n = 42) had greater reductions in depression (p = .012) and gains in competence (p = .033) after 3 months compared to the attention control group (n = 41). Living in rural areas was associated with a reduction in depression for FamTechCare caregivers (p = .002). Higher level of education was associated with greater improvements or lesser declines in burden, competence, and reaction to behavioral symptoms for both the FamTechCare and attention control caregivers. Discussion and Implications This research demonstrated benefits of using available technology to link families to dementia care experts using video-recording technology. It provides a foundation for future research testing telehealth interventions, tailored based on rich contextual data to support families, including those in rural or remote locations.

scholarly journals SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Jasvinder A. Singh ◽  
Amy Joseph ◽  
Joshua Baker ◽  
Joshua S. Richman ◽  
Terrence Shaneyfelt ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Attention Control ◽  
Control Group ◽  
Culturally Appropriate ◽  
Control Groups ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Gout Flares

Abstract Background Urate-lowering therapy (ULT) adherence is low in gout, and few, if any, effective, low-cost, interventions are available. Our objective was to assess if a culturally appropriate gout-storytelling intervention is superior to an attention control for improving gout outcomes in African-Americans (AAs). Methods In a 1-year, multicenter, randomized controlled trial, AA veterans with gout were randomized to gout-storytelling intervention vs. a stress reduction video (attention control group; 1:1 ratio). The primary outcome was ULT adherence measured with MEMSCap™, an electronic monitoring system that objectively measured ULT medication adherence. Results The 306 male AA veterans with gout who met the eligibility criteria were randomized to the gout-storytelling intervention (n = 152) or stress reduction video (n = 154); 261/306 (85%) completed the 1-year study. The mean age was 64 years, body mass index was 33 kg/m2, and gout disease duration was 3 years. ULT adherence was similar in the intervention vs. control groups: 3 months, 73% versus 70%; 6 months, 69% versus 69%; 9 months, 66% versus 67%; and 12 months, 61% versus 64% (p > 0.05 each). Secondary outcomes (gout flares, serum urate and gout-specific health-related quality of life [HRQOL]) in the intervention versus control groups were similar at all time points except intervention group outcomes were better for the following: (1) number of gout flares at 9 months were fewer, 0.7 versus 1.3 in the previous month (p = 0.03); (2) lower/better scores on two gout specific HRQOL subscales: gout medication side effects at 3 months, 32.8 vs. 39.6 (p = 0.02); and unmet gout treatment need at 3 months, 30.9 vs. 38.2 (p = 0.003), and 6 months, 29.5 vs. 34.5 (p = 0.03), respectively. Conclusions A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout. Trial registration Registered at ClinicalTrials.gov NCT02741700

scholarly journals Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Shanshan Li ◽  
Ping Yin ◽  
Xuan Yin ◽  
Anna Bogachko ◽  
Tingting Liang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Depression Scale ◽  
Menopausal Transition ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Rating ◽  
Menopausal Women

Abstract Background: China today has high occurrences of insomnia in perimenopausal women. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method: In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in a 1:1 ratio. Participants will receive a total of 18 sessions of treatment for eight consecutive weeks. Treatments will be given three times per week in the first four weeks, twice a week for the next two weeks and finally treatment once weekly for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, week four, week eight, and first and the third month following the end of treatment. Discussion: If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, this positive outcome could provide evidence for clinical application. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1800018645, Date: 2018-10-01. URL: http://www.chictr.org.cn/showproj.aspx?proj=31482. Keywords: Menopause; Insomnia; Acupuncture; Clinical trial.

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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.

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