scholarly journals The BEACON Study: Protocol for a cluster randomized controlled trial of a service to deliver smartphone-assisted problem-solving therapy compared to usual care in men who present with intentional self-harm to Emergency Departments in Ontario

2020 ◽  
Author(s):  
Simon Hatcher ◽  
Marnin Heisel ◽  
Oyedeji Ayonrinde ◽  
Julie Kathleen Campbell ◽  
Ian Colman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Problem Solving ◽  
Health System ◽  
Usual Care ◽  
Emergency Departments ◽  
Controlled Trial ◽  
Problem Solving Therapy ◽  
Randomized Controlled ◽  
Self Harm ◽  
Cluster Randomized

Abstract Background Patients who present to Emergency Departments (ED) after intentional self-harm receive variable levels care in Ontario. Many are not assessed by a mental health professional following discharge from ED and do not receive psychological services available in the community as many of these services are not covered by the provincial health insurance. Patients who present with intentional self-harm to hospital are more likely to die by suicide and premature death by other means compared to the general population. This risk is elevated in men, who represent two-thirds of those who die by suicide in Ontario. One way of potentially addressing this gap is to offer problem-solving therapy (PST) designed specifically for men, facilitated by the use of a patient facing smartphone application and a clinician facing dashboard. This attempts to blend the use of face to face therapy and technology to create an effective intervention after self-harm.Methods This is a pragmatic, multicentre pre- and post-design cluster randomized controlled trial (cRCT) comparing the provision of a suicide prevention intervention to usual care, in men who present to the ED with self-harm. The study intervention is composed of: 1) staff education; 2) resource materials for men who present to the ED with self-harm; and, 3) the option to refer patients to a blended PST service for the treatment of self-harm. The primary outcome to be assessed is a composite of the incidence of suicides and/or re-presentations to any ED in Ontario for self-harm in the year after presentation with self-harm. Secondary outcome measures include: total number of suicides; re-presentations to any ED in Ontario for the repetition of self-harm; re-presentations to any ED in Ontario for any reason; other health system use including use of primary care and hospital outpatient appointments; mortality not related to suicide; and, health system costs over one year. All outcomes will be measured from provincial health administrative databases available at the Institute for Clinical and Evaluative Sciences (IC/ES).

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 Efficacy of Problem‐Solving Therapy for Spouses of Men with Prostate Cancer: A Randomized Controlled Trial

2018 ◽  
Author(s):  
Vanessa L. Malcarne ◽  
Celine M. Ko ◽  
Scott C. Roesch ◽  
Rajni Banthia ◽  
Georgia Robins Sadler
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
Problem Solving ◽  
Controlled Trial ◽  
Problem Solving Therapy ◽  
Randomized Controlled

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 Problem-solving therapy for people who present to hospital with self-harm: Zelen randomised controlled trial

2011 ◽  
Vol 199 (4) ◽  
pp. 310-316 ◽  
Author(s):  
Simon Hatcher ◽  
Cynthia Sharon ◽  
Varsha Parag ◽  
Nicola Collins
Keyword(s):  
Problem Solving ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Effective Intervention ◽  
Number Needed To Treat ◽  
Problem Solving Therapy ◽  
Significant Difference ◽  
Self Harm ◽  
Randomised Controlled

BackgroundPresentations to hospital with self-harm are common, associated with suicide and have an increased mortality, yet there is no accepted effective intervention.AimsTo investigate whether problem-solving therapy would improve outcomes in adults presenting to hospital with self-harm, compared with usual care.MethodA Zelen randomised controlled trial was conducted in four district health boards in New Zealand. A second hospital presentation with self-harm at 1 year for all episodes, plus separate comparisons of first-time and repeat presentations at the index episode, were the a priori primary outcomes. The trial registration number was ACTRN12605000337673.ResultsIn an intention-to-treat analysis of all randomised patients (n = 1094) there was no significant difference at 12 months in the proportion of people who had presented again with self-harm when comparing all episodes (intervention 13.4%, usual care 14.1%; relative risk reduction RR = 0.05, 95% CI −0.28 to 0.30, P = 0.79) or where the index episode was the first episode (intervention 13.4%, usual care 9.4%, RR =–0.42, 95% CI −1.17 to 0.08, P = 0.37). Where the index episode was repeated self-harm, those who received therapy were less likely to present again with self-harm (intervention 13.5%, usual care 22.1%, RR = 0.39, 95% CI 0.07 to 0.60, number needed to treat 12, P = 0.03).ConclusionsProblem-solving therapy is not recommended for everyone who presents to hospital with self-harm. Among adults with a history of self-harm it may be an effective intervention.

scholarly journals Problem Solving Therapy During Outpatient Rehabilitation for Stroke: Short-term Results of a Randomized Controlled Trial

2014 ◽  
Vol 95 (10) ◽  
pp. e23-e24 ◽  
Author(s):  
Marieke M. Visser ◽  
Majanka H. Heijenbrok-Kal ◽  
Adriaan van 't Spijker ◽  
Jan J.V. Busschbach ◽  
Gerard M. Ribbers
Keyword(s):  
Randomized Controlled Trial ◽  
Problem Solving ◽  
Controlled Trial ◽  
Outpatient Rehabilitation ◽  
Short Term ◽  
Problem Solving Therapy ◽  
Randomized Controlled

scholarly journals Screening and patient-tailored care for emotional and cognitive problems compared to care as usual in patients discharged home after ischemic stroke (ECO-stroke): a protocol for a multicenter, patient-blinded, cluster randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
J. P. L. Slenders ◽  
R. M. Van den Berg-Vos ◽  
C. M. van Heugten ◽  
J. M. A. Visser-Meily ◽  
S. M. A. A. Evers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Emotional Problems ◽  
Clinical Effectiveness ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Ischemic stroke patients with a good outcome in terms of motor functioning and communication are likely to be discharged home without further rehabilitation. A significant number of these patients experience cognitive and emotional problems resulting in lower quality of life and decreased participation in society. This paper presents the protocol of a study examining the clinical effectiveness, cost-effectiveness and implementation of an intervention focused on screening and patient-tailored care for cognitive and emotional problems as compared to usual care in patients discharged home after ischemic stroke. Methods / design A multicenter, patient-blinded, cluster randomized controlled trial will be performed. Centers will be randomized (1:1) to the intervention group or the usual care group. Patients (> 18 years old) with a neurological confirmed diagnosis of ischemic stroke who can be discharged home without follow-up treatment at an outpatient rehabilitation clinic will be included. In the intervention group, patients will receive a short, individualized, semi-structured consultation by specialized nurses in addition to usual care. This consultation includes 1) screening for cognitive and emotional problems, 2) screening for restrictions in participation, 3) promotion of self-management strategies and 4) a decision tool for referral to rehabilitation services. The intervention will be performed approximately 6 weeks after the stroke at the neurology outpatient clinics and will take approximately 60 min. The control group will receive care as usual. Both groups will be followed-up at 6 weeks, 3 months and 12 months after stroke. The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-Participation-R) at 12 months. A cost-effectiveness analysis and process evaluation will be performed alongside. Discussion This trial is the first to evaluate clinical effectiveness, cost-effectiveness and implementation of screening and patient-tailored care for cognitive and emotional problems compared to care as usual in patients discharged home after ischemic stroke. Potentially, this will improve the outcomes for patients with frequently occurring cognitive and emotional problems after stroke. Trial registration Netherlands Trial Register: NL7295, registered 25 September 2018

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