scholarly journals Building family caregiver skills using a simulation-based intervention for care of patients with cancer: protocol for a randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Susan R. Mazanec ◽  
Eric Blackstone ◽  
Barbara J. Daly
Keyword(s):  
Randomized Controlled Trial ◽  
Radiation Therapy ◽  
Usual Care ◽  
Family Caregivers ◽  
Controlled Trial ◽  
Nursing Intervention ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Simulation Based ◽  
And Training

Abstract Background Family caregivers of patients with cancer undergoing radiation therapy experience significant distress and challenges related to high symptom burden and complex care demands. This is particularly true for caregivers of patients with head and neck, esophageal, anal, rectal, and lung cancers, who are often receiving combined-modality treatment and may have tracheostomy tubes, gastrostomy tubes, or colostomies/ileostomies. This study aims to evaluate a simulation-based nursing intervention to provide information, support, and training to caregivers during radiation therapy. Methods This randomized controlled trial will include a sample of 180 patients and their family caregivers. Caregivers assigned to the control group will receive usual care and an informational booklet from the National Cancer Institute (NCI). Those in the intervention group will receive usual care, the NCI booklet, and three meetings with a nurse interventionist during radiation treatment followed by a booster call two weeks posttreatment. Intervention sessions focus on themes consistent with the trajectory of radiation therapy: the patient experience/needs, the caregiver experience and dyad communication, and transition to survivorship. Outcomes are measured at baseline, end of treatment (T2), and 4 (T3) and 20 (T4) weeks posttreatment, with the primary outcome being caregiver anxiety at T4. Discussion This trial is innovative in its use of simulation in a psychoeducational intervention for family caregivers. The intervention is administered at point-of-care and aimed at feasibility for integration into clinical practice. Patient quality of life and healthcare utilization measures will assess how providing support and training to the caregiver may impact patient outcomes. Trial registration The trial was registered on 08/14/2019 at ClinicalTrials.gov (identifier NCT04055948).

A randomized controlled trial of a novel artificial-intelligence based smartphone application to optimize the management of cancer-related pain.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 76-76 ◽  
Author(s):  
Mihir M. Kamdar ◽  
Amanda Jayne Centi ◽  
Nils Fischer ◽  
Kamal Jethwani
Keyword(s):  
Artificial Intelligence ◽  
Randomized Controlled Trial ◽  
Cancer Pain ◽  
Cancer Treatment ◽  
Usual Care ◽  
Healthcare Utilization ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Patients With Cancer ◽  
Randomized Controlled

76 Background: Cancer pain affects 70-90% of advanced malignancy patients, resulting in impaired quality of life and increased healthcare utilization. Novel care delivery models are needed to optimize care for patients dealing with cancer-related pain in between clinic visits. ePAL is a smartphone application(app) that regularly monitors pain and uses artificial intelligence(AI) to differentiate urgent from non-urgent issues to intercede in real time. The purpose of this randomized controlled trial was to determine ePAL's impact on pain severity, attitudes toward cancer treatment, and healthcare utilization in patients with cancer pain. Methods: MGH Palliative Care Clinic Patients with pain from metastatic, solid-organ cancer (n=112) were recruited and randomized to either a control group (n=56) that received usual care or an intervention group (n=56) that used the ePAL app in addition to usual care for 8 weeks. The app assessed pain 3 times/week and questionnaires about pain (BPI), attitudes towards cancer treatment(BQ-II), and general anxiety(GAD-7) were given at 0, 4, and 8 weeks. A repeated measures mixed model approach assessed how outcome measures changed over time. Models controlled for baseline differences at enrollment and random slopes in addition to baseline depression score, age and sex(alpha=0.05). Results: Pain severity (BPI) and negative attitudes toward cancer pain treatment (BQ-II) decreased significantly for those using the app compared to controls(coeff. -0.09, 95% CI: -0.17, -0.007, p=0.034 and coeff. -0.037, 95% CI: -0.072, -0.001, p=0.042 respectively). Anxiety scores increased for those using ePAL compared to controls (coeff. 0.21, 95% CI: 0.039, 0.37, p=0.015). Over 8-weeks, ePAL users had 40% fewer inpatient hospital admissions compared to controls (n=15 vs. n=25, p=0.048). Conclusions: To our knowledge, this is the first mobile app to utilize AI and clinical algorithms to significantly decrease pain and reduce overall inpatient hospitalizations in patients with cancer-related pain. Clinical trial information: NCT02069743.

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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