Nurse home visits with or without alert buttons versus usual care in the frail elderly: a randomized controlled trial

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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Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

10.2196/preprints.17484 ◽

2019 ◽

Author(s):

Awathif Mackeen ◽

Danielle Downs ◽

Vonda Hetherington ◽

Shawnee Lutcher ◽

Jacob Mowery ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Weight Gain ◽

Gestational Diabetes ◽

Usual Care ◽

Gestational Weight Gain ◽

Perceived Stress ◽

Controlled Trial ◽

Household Food Security ◽

Gestational Weight ◽

Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

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Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use

BMC Geriatrics ◽

10.1186/s12877-021-02038-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

David Peter Neal ◽

Yvonne J. F. Kerkhof ◽

Teake P. Ettema ◽

Majon Muller ◽

Judith Bosmans ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cost Effectiveness ◽

Usual Care ◽

Social Participation ◽

Controlled Trial ◽

Community Dwelling ◽

Self Management ◽

Tablet Computer ◽

Randomized Controlled ◽

People With Dementia

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

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