Comparing effects of two higher intensity feedback interventions with simple feedback on improving staff communication in nursing homes—the INFORM cluster-randomized controlled trial

Abstract Background Effective communication among interdisciplinary healthcare teams is essential for quality healthcare, especially in nursing homes (NHs). Care aides provide most direct care in NHs, yet are rarely included in formal communications about resident care (e.g., change of shift reports, family conferences). Audit and feedback is a potentially effective improvement intervention. This study compares the effect of simple and two higher intensity levels of feedback based on goal-setting theory on improving formal staff communication in NHs. Methods This pragmatic three-arm parallel cluster-randomized controlled trial included NHs participating in TREC (translating research in elder care) across the Canadian provinces of Alberta and British Columbia. Facilities with at least one care unit with 10 or more care aide responses on the TREC baseline survey were eligible. At baseline, 4641 care aides and 1693 nurses cared for 8766 residents in 67 eligible NHs. NHs were randomly allocated to a simple (control) group (22 homes, 60 care units) or one of two higher intensity feedback intervention groups (based on goal-setting theory): basic assisted feedback (22 homes, 69 care units) and enhanced assisted feedback 2 (23 homes, 72 care units). Our primary outcome was the amount of formal communication about resident care that involved care aides, measured by the Alberta Context Tool and presented as adjusted mean differences [95% confidence interval] between study arms at 12-month follow-up. Results Baseline and follow-up data were available for 20 homes (57 care units, 751 care aides, 2428 residents) in the control group, 19 homes (61 care units, 836 care aides, 2387 residents) in the basic group, and 14 homes (45 care units, 615 care aides, 1584 residents) in the enhanced group. Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p = 0.021) and enhanced groups ([0.01; 0.33], p = 0.035). We found no difference in this outcome between the two higher intensity groups. Conclusions Theoretically informed feedback was superior to simple feedback in improving care aides’ involvement in formal communications about resident care. This underlines that prior estimates for efficacy of audit and feedback may be constrained by the type of feedback intervention tested. Trial registration ClinicalTrials.gov (NCT02695836), registered on March 1, 2016

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Comparing effects of two higher intensity feedback interventions with simple feedback on improving staff communication in nursing homes – The INFORM cluster-randomized controlled trial

10.21203/rs.3.rs-17993/v2 ◽

2020 ◽

Author(s):

Matthias Hoben ◽

Liane R Ginsburg ◽

Adam Easterbrook ◽

Peter G Norton ◽

Ruth A Anderson ◽

...

Keyword(s):

Controlled Trial ◽

Audit And Feedback ◽

Control Group ◽

Randomized Controlled ◽

Resident Care ◽

Setting Theory ◽

Care Aides ◽

Cluster Randomized ◽

Simple Feedback

Abstract Background: Effective communication among interdisciplinary healthcare teams is essential for quality healthcare, especially in nursing homes (NHs). Care aides provide most direct care in NHs, yet are rarely included in formal communications about resident care (e.g., change of shift reports, family conferences). Audit and feedback is a potentially effective improvement intervention. This study compares the effect of simple and two higher intensity levels of feedback based on Goal Setting Theory on improving formal staff communication in NHs.Methods: This pragmatic three-arm parallel cluster-randomized controlled trial included NHs participating in TREC (Translating Research in Elder Care) across the Canadian provinces of Alberta and British Columbia. Facilities with at least one care unit with 10 or more care aide responses on the TREC baseline survey were eligible. At baseline, 4,641 care aides and 1,693 nurses cared for 8,766 residents in 67 eligible NHs. NHs were randomly allocated to a simple (control) group (22 homes, 60 care units) or one of two higher intensity feedback intervention groups (based on Goal Setting Theory): basic assisted feedback (22 homes, 69 care units) and enhanced assisted feedback 2 (23 homes, 72 care units). Our primary outcome was the amount of formal communication about resident care that involved care aides, measured by the Alberta Context Tool and presented as adjusted mean differences [95% confidence interval] between study arms at 12-month follow-up.Results: Baseline and follow-up data were available for 20 homes (57 care units, 751 care aides, 2,428 residents) in the control group, 19 homes (61 care units, 836 care aides, 2,387 residents) in the basic group, and 14 homes (45 care units, 615 care aides, 1,584 residents) in the enhanced group. Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p=0.021) and enhanced groups ([0.01; 0.33], p=0.035). We found no difference in this outcome between the two higher intensity groups.Conclusions: Theoretically informed feedback was superior to simple feedback in improving care aides’ involvement in formal communications about resident care. This underlines that prior estimates for efficacy of audit and feedback may be constrained by the type of feedback intervention tested.Trial registration: ClinicalTrials.gov (NCT02695836), https://clinicaltrials.gov/ct2/show/NCT02695836, registered on March 1, 2016

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Comparing effects of two higher intensity feedback interventions with simple feedback on improving staff communication in nursing homes – The INFORM cluster-randomized controlled trial

10.21203/rs.3.rs-17993/v1 ◽

2020 ◽

Author(s):

Matthias Hoben ◽

Liane R Ginsburg ◽

Adam Easterbrook ◽

Peter G Norton ◽

Ruth A Anderson ◽

...

Keyword(s):

Goal Setting ◽

Controlled Trial ◽

Audit And Feedback ◽

Control Group ◽

Randomized Controlled ◽

Resident Care ◽

Care Aides ◽

Cluster Randomized ◽

Simple Feedback

Abstract BackgroundEffective communication among interdisciplinary healthcare teams is essential for quality healthcare, especially in nursing homes (NHs). Care aides provide most direct care in NHs, yet are rarely included in formal communications about resident care (e.g., change of shift reports, family conferences). Audit and feedback is a potentially effective improvement intervention. This study compares the effect on improving formal staff communication in NHs of simple and two higher intensity levels of feedback based on Goal Setting Theory.MethodsThis pragmatic three-arm parallel cluster-randomized controlled trial included NHs participating TREC (Translating Research in Elder Care) across the Canadian provinces of Alberta and British Columbia. Facilities with at least one care unit with 10 or more care aide responses on the TREC baseline survey were eligible. At baseline, 4,641 care aides and 1,693 nurses cared for 8,766 residents in 67 eligible NHs. NHs were randomly allocated to a simple (control) group (22 homes, 60 care units) or one of two higher intensity feedback intervention groups (based on Goal Setting Theory): basic assisted feedback (22 homes, 69 care units) and enhanced assisted feedback 2 (23 homes, 72 care units). Our primary outcome was the amount of formal communication about resident care that involved care aides, measured by the Alberta Context Tool and presented as adjusted mean differences [95% confidence interval] between study arms at 12-month follow-up.ResultsBaseline and follow-up data were available for 20 homes (57 care units, 751 care aides, 2,428 residents) in the control group, 19 homes (61 care units, 836 care aides, 2,387 residents) in the basic group, and 14 homes (45 care units, 615 care aides, 1,584 residents) in the enhanced group. Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p=0.021) and enhanced groups ([0.01; 0.33], p=0.035). We found no difference in this outcome between the two higher intensity groups.ConclusionsTheoretically informed feedback was superior to simple feedback. This underlines that prior estimates for efficacy of audit and feedback may be constrained by the type of feedback intervention tested.Trial registrationClinicalTrials.gov (NCT02695836), https://clinicaltrials.gov/ct2/show/NCT02695836, registered on March 1, 2016

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An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial

JMIR mhealth and uhealth ◽

10.2196/13519 ◽

2019 ◽

Vol 7 (8) ◽

pp. e13519 ◽

Cited By ~ 1

Author(s):

Peishan Ning ◽

Peixia Cheng ◽

David C Schwebel ◽

Yang Yang ◽

Renhe Yu ◽

...

Keyword(s):

Injury Prevention ◽

Controlled Trial ◽

Intervention Group ◽

Unintentional Injury ◽

Control Group ◽

Injury Incidence ◽

Child Injury ◽

Randomized Controlled ◽

Cluster Randomized

Background App-based interventions have the potential to reduce child injury in countries with limited prevention resources, but their effectiveness has not been rigorously examined. Objective This study aimed to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers. Methods A 6-month cluster randomized controlled trial was conducted from December 2017 to June 2018. Recruitment was conducted through preschools, which were randomly allocated to either the control group (ie, app-based parenting education excluding unintentional injury prevention) or the intervention group (ie, app-based parenting education including unintentional injury prevention). A total of 2920 caregivers of preschoolers aged 3-6 years from 20 preschools in Changsha, China, were recruited offline through the schools. The primary outcome was unintentional injury incidences among preschoolers in the past 3 months; this measure was assessed through an online caregiver-report at the baseline visit and at 3-month and 6-month follow-up visits. Secondary outcome measures included caregivers’ self-reported attitudes and behaviors concerning child supervision during the last week. Generalized estimating equations (GEEs) were used to assess the effectiveness of the app-based intervention on responses at 3 and 6 months after adjusting for sociodemographic variables, baseline level of the outcome variable, and engagement with interventions in the assigned group. All analyses were intention-to-treat. A per-protocol sensitivity analysis was also conducted. Results In total, 1980 of the 2920 caregivers completed the study. The mean age of participants was 32.0 years (SD 5.5) and 68.99% (1366/1980) of them were female. During the 6-month follow-up visit, unintentional injury incidence did not change significantly in either group: incidence in the intervention group went from 8.76% (94/1073) to 8.11% (87/1073), P=.59; incidence in the control group went from 9.4% (85/907) to 7.5% (69/907), P=.15. The changes did not differ between the groups (odds ratio [OR] 1.14, 95% CI 0.80-1.62). Changes in the average score in attitude concerning unintentional injury prevention were also similar between the groups (B .05, 95% CI -0.03 to 0.13). Changes in unintentional injury prevention behaviors were greater in the intervention group than in the control group after the intervention (B .87, 95% CI 0.33-1.42). Analyses of individual injury prevention behaviors showed that the intervention reduced three risky behaviors: unsafe feeding of children (OR 0.73, 95% CI 0.60-0.89); incorrectly placing children in cars (OR 0.73, 95% CI 0.57-0.93); and allowing children to ride bicycles, electric bicycles, or motorcycles unsupervised (OR 0.80, 95% CI 0.64-0.99). The intervention also improved scores on three safety-focused behaviors: testing water temperature before giving children a bath (OR 1.26, 95% CI 1.05-1.52); properly storing sharp objects (OR 1.24, 95% CI 1.01-1.52); and safely storing medicines, detergents, and pesticides (OR 1.24, 95% CI 1.02-1.51). Conclusions The app-based intervention did not reduce unintentional injury incidence among preschoolers but significantly improved caregivers’ safety behaviors. This app-based intervention approach to improve caregiver behaviors surrounding child injury risk offers promise to be modified and ultimately disseminated broadly. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 (Archived by WebCite at http://www.webcitation.org/75jt17X84) International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5790-1

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Five-year follow-up of a cluster-randomized controlled trial of a client-centred activities of daily living intervention for people with stroke

Clinical Rehabilitation ◽

10.1177/0269215518809791 ◽

2018 ◽

Vol 33 (2) ◽

pp. 262-276 ◽

Cited By ~ 3

Author(s):

Annicka Hedman ◽

Gunilla Eriksson ◽

Lena von Koch ◽

Susanne Guidetti

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Significant Others ◽

Control Group ◽

Randomized Controlled ◽

Stroke Impact Scale ◽

Impact Scale ◽

Cluster Randomized ◽

Changes Over Time

Objective: To compare five-year outcomes and changes over time of a client-centred activities of daily living (ADL) intervention versus usual ADL interventions for people with stroke and their significant others. Design: Five-year follow-up of a cluster-randomized controlled trial where a client-centred ADL intervention ( n = 129) or usual ADL interventions ( n = 151) were delivered to people with stroke. Setting: Multicentre study including 16 inpatient or home-based rehabilitation units. Participants: People with stroke and significant others. Intervention: The client-centred ADL intervention aimed at enabling agency in daily activities and participation in everyday life and at reducing caregiver burden. Main measures: For people with stroke, perceived participation (Stroke Impact Scale), independence in ADL, life satisfaction, and use of formal/informal care were measured. For significant others, caregiver burden, life satisfaction, and mood (Hospital Anxiety and Depression Scale) were assessed. Results: Five years post-intervention, data were collected from 145 people with stroke (intervention group: n = 71/control group: n = 74) and 75 significant others (intervention group: n = 36/control group: n = 39). For those with stroke, the Participation domain of the Stroke Impact Scale showed no group differences at year five (68.9 vs 75.4, P = 0.062) or in changes over time. At year five, the control group had better outcomes regarding Other help/supervision. Significant others in the control group were more likely to show signs of depression at year five (odds ratio = 22.3; P < 0.001). Conclusion: The client-centred ADL intervention appears to render similar long-term effects as usual ADL interventions for people with stroke, but for significant others signs of depression might be reduced.

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O7C.3 Effectiveness of a multi-faceted intervention to prevent musculoskeletal pain in nurses and aides: results of a cluster-randomized controlled trial

Occupational and Environmental Medicine ◽

10.1136/oem-2019-epi.174 ◽

2019 ◽

Vol 76 (Suppl 1) ◽

pp. A65.1-A65

Author(s):

Mercè Soler Font ◽

José Maria Ramada Rodilla ◽

Sander van Zon ◽

Josué Almansa Ortega ◽

Ute Bültmann ◽

...

Keyword(s):

Health Promotion ◽

Randomized Controlled Trial ◽

Occupational Health ◽

Sickness Absence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Cluster Randomized

BackgroundHealth workers are at high risk of developing musculoskeletal pain (MSP). This study aimed to evaluate a multi-faceted intervention in two public tertiary hospitals, encompassing three levels of prevention and health promotion to prevent and manage MSP.MethodsA two-armed cluster randomized controlled trial, with a late intervention control group was performed. Clusters were independent hospital units, and participants were the nursing staff. The intervention comprised three components: participatory ergonomics, case management, and health promotion. The control group received usual occupational health care. The intervention lasted one year and data were collected at baseline, 6 and 12 months follow-up. Primary outcomes were self-perceived MSP and its associated sickness absence. The process evaluation included recruitment, context, reach, dose administered and received, fidelity, satisfaction, implementation strategy, and discussion groups of experts and participants.ResultsEight clusters, including 445 participants, were randomized. In the intervention group a 20% statistically significant reduction of neck, shoulders and upper back pain compared to the control group (OR=0.37; 95% CI=0.14–0.96) was observed at 12 months follow-up. We found no significant differences in incidence and duration of sickness absence. Organizational culture (secondary outcome) improved significantly in the intervention group in the domains of ‘formal safety audits’, ‘availability of information for safety at work’, and ‘involvement of workers in decisions that affect their safety and health’ compared to the control group. The intervention was implemented with 96.6% fidelity, and participants’ adherence was 75.5%. Participant’s satisfaction was 9.1/10.ConclusionsThis intervention showed effectiveness to reduce MSP and improve organizational culture, through to an integral management of MSP. Although our results are modest, strategies should focus on multi-faceted interventions, and occupational health services might be excellent opportunity for.

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An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.13519 ◽

2019 ◽

Author(s):

Peishan Ning ◽

Peixia Cheng ◽

David C Schwebel ◽

Yang Yang ◽

Renhe Yu ◽

...

Keyword(s):

Injury Prevention ◽

Controlled Trial ◽

Intervention Group ◽

Unintentional Injury ◽

Control Group ◽

Injury Incidence ◽

Child Injury ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND App-based interventions have the potential to reduce child injury in countries with limited prevention resources, but their effectiveness has not been rigorously examined. OBJECTIVE This study aimed to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers. METHODS A 6-month cluster randomized controlled trial was conducted from December 2017 to June 2018. Recruitment was conducted through preschools, which were randomly allocated to either the control group (ie, app-based parenting education excluding unintentional injury prevention) or the intervention group (ie, app-based parenting education including unintentional injury prevention). A total of 2920 caregivers of preschoolers aged 3-6 years from 20 preschools in Changsha, China, were recruited offline through the schools. The primary outcome was unintentional injury incidences among preschoolers in the past 3 months; this measure was assessed through an online caregiver-report at the baseline visit and at 3-month and 6-month follow-up visits. Secondary outcome measures included caregivers’ self-reported attitudes and behaviors concerning child supervision during the last week. Generalized estimating equations (GEEs) were used to assess the effectiveness of the app-based intervention on responses at 3 and 6 months after adjusting for sociodemographic variables, baseline level of the outcome variable, and engagement with interventions in the assigned group. All analyses were intention-to-treat. A per-protocol sensitivity analysis was also conducted. RESULTS In total, 1980 of the 2920 caregivers completed the study. The mean age of participants was 32.0 years (SD 5.5) and 68.99% (1366/1980) of them were female. During the 6-month follow-up visit, unintentional injury incidence did not change significantly in either group: incidence in the intervention group went from 8.76% (94/1073) to 8.11% (87/1073), P=.59; incidence in the control group went from 9.4% (85/907) to 7.5% (69/907), P=.15. The changes did not differ between the groups (odds ratio [OR] 1.14, 95% CI 0.80-1.62). Changes in the average score in attitude concerning unintentional injury prevention were also similar between the groups (B .05, 95% CI -0.03 to 0.13). Changes in unintentional injury prevention behaviors were greater in the intervention group than in the control group after the intervention (B .87, 95% CI 0.33-1.42). Analyses of individual injury prevention behaviors showed that the intervention reduced three risky behaviors: unsafe feeding of children (OR 0.73, 95% CI 0.60-0.89); incorrectly placing children in cars (OR 0.73, 95% CI 0.57-0.93); and allowing children to ride bicycles, electric bicycles, or motorcycles unsupervised (OR 0.80, 95% CI 0.64-0.99). The intervention also improved scores on three safety-focused behaviors: testing water temperature before giving children a bath (OR 1.26, 95% CI 1.05-1.52); properly storing sharp objects (OR 1.24, 95% CI 1.01-1.52); and safely storing medicines, detergents, and pesticides (OR 1.24, 95% CI 1.02-1.51). CONCLUSIONS The app-based intervention did not reduce unintentional injury incidence among preschoolers but significantly improved caregivers’ safety behaviors. This app-based intervention approach to improve caregiver behaviors surrounding child injury risk offers promise to be modified and ultimately disseminated broadly. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 (Archived by WebCite at http://www.webcitation.org/75jt17X84) INTERNATIONAL REGISTERED REPOR RR2-10.1186/s12889-018-5790-1

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Effects of a health educational intervention on cardiovascular disease knowledge, motivation and behavioral skills: A cluster randomized controlled trial

10.21203/rs.2.12686/v1 ◽

2019 ◽

Author(s):

John Amoah ◽

Salmiah Md. ◽

Lekhraj Rampal ◽

Rosliza A Manaf ◽

Normala Ibrahim ◽

...

Keyword(s):

Risk Factors ◽

Health Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

School Students ◽

Behavioral Skills ◽

Randomized Controlled ◽

Cluster Randomized

Abstract Background Cardiovascular diseases (CVD) are the number one public health challenge of the 21st century. Globally, the disease causes more deaths than any other cause. Unfortunately, many people are not aware of CVDs and its risk factors and because of this the disease burden keeps on rising. Objective of this study was to develop, implement and evaluate the effects of a health education program to improve CVD knowledge, motivation, and behavioral skills among secondary school students in Ghana. Methods A parallel single-blind cluster randomized controlled trial was carried out for a period of six-months with baseline and post intervention evaluations. Participants (n=848) were secondary school students of ages of 14-19 years from four schools (clusters) in Brong Ahafo, Ghana. Students in the intervention group received health education intervention whereas those of the control group received no intervention. The intervention included information on cardiovascular diseases and its risk factors, motivation, and behavioral skills modules. At six months, a follow-up data using same questionnaire were collected after the intervention was completed. The generalized linear mixed model (GLMM) was used to assess the overall effects of the intervention. Results Of the 848 students, 836 completed the follow-up assessment immediately after six-month. The GLMM showed the intervention was significant in improving 6.85(p<0.001), 0.90(p<0.001), 0.94(p<0.001) higher total CVD knowledge, motivation, and behavioral skills scores respectively for the intervention group when compared to the control group. Conclusions The intervention was effective in increasing CVD knowledge, motivation, and behavioral skills of students in the intervention arm of the study. It is recommended that the health education module be implemented into secondary schools education curricula in Ghana to improve CVD knowledge, motivation, and behavioral skills. Equipping students with the IMB will reduce CVD risk factors and prevent the onset of CVDs in future.

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Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.12950 ◽

2018 ◽

Author(s):

Musheer Abdulwahid Al-Jaberi ◽

Muhamad Hanafiah Juni ◽

Hayati Kadir Shahar ◽

Siti Irma Fadhilah Ismail ◽

Murad Abdu Saeed ◽

...

Keyword(s):

International Students ◽

Acculturative Stress ◽

Educational Program ◽

Public Universities ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Policy Makers ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i><.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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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)

10.2196/preprints.13973 ◽

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

BMC Geriatrics ◽

10.1186/s12877-021-02114-z ◽

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.

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