Overall survival (OS) and healthcare utilization results of a randomized controlled trial (RCT) assessing a patient navigation (PN) intervention to increase early access to supportive care (SC) for patients with metastatic cancer in a resource-limited setting.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12112-12112
Author(s):  
Miguel Araujo ◽  
Yanin Chavarri Guerra ◽  
Wendy A Ramos-López ◽  
Mirza Alcalde Castro ◽  
Alfredo Covarrubias-Gómez ◽  
...  
Keyword(s):  
Usual Care ◽  
Healthcare Utilization ◽  
Metastatic Cancer ◽  
Controlled Trial ◽  
Limited Resource ◽  
Rank Test ◽  
Patient Navigator ◽  
Indwelling Catheter ◽  
Early Access ◽  
Resource Limited

12112 Background: We previously reported improvements in access to SC, advance directive completion, and pain control in a RCT comparing a patient navigator-led early SC intervention vs. usual care among patients with newly-diagnosed metastatic cancer in Mexico (NCT03293849). We now present results on healthcare utilization and OS. Methods: Patients were randomized to PN or usual oncology care. Patients in the PN arm received SC interventions by a navigator-led multidisciplinary team (palliative care, physical therapy, geriatrics, psychology) in the first 12 weeks after diagnosis. At 12-weeks, patients allocated to usual care were able to cross-over to PN and receive multidisciplinary SC. We analyzed the number (no.) of emergency room (ER) visits, their cause, and whether they were potentially avoidable (as determined by expert consensus), using descriptive statistics and X2 tests. OS was estimated using the Kaplan-Meier method and the log-rank test. Results: 133 patients (median age 60, range 23-93; 52% male) were randomized (66 PN, 67 control) from 08/17 to 04/18. Median follow-up was 22.8 months. 61% had gastrointestinal tumors, and 45% had a calculated life expectancy ≤6 months. 69% of patients randomized to usual care crossed-over to PN and received SC interventions. 80% of patients attended the ER ≥once (median no. of visits = 2). No difference was found between patients randomized to early SC or usual care in ER visits (2.4 vs. 2.3, p = 0.58). Out of a total 316 ER visits, the most common reason was infections (n = 69, 22%), followed by pain (n = 40, 13%), and indwelling catheter-related complications (n = 23, 7%). 41% of ER visits were considered as potentially avoidable, with no difference in avoidable visits found between arms (1.7 vs. 1.7, p = 0.49). No differences between arms were found in no. of hospitalizations (0.8 vs. 0.6 p = 0.82). Survival results were assessed after 64% of patients had died (n = 85), finding no statistically significant OS difference between the early SC intervention and the usual care arms (11.0 vs 13.0 months, p = 0.77) Conclusions: In the context of a limited-resource healthcare system, the early delivery of SC did not improve healthcare utilization, reduce avoidable ER visits, or prolong OS compared to the implementation of SC at a later time, which might be partially explained by the unavailability of hospice or home care, and by high rates of cross-over between arms. Clinical trial information: NCT03293849 .

Randomized controlled trial (RCT) of a patient navigation (PN) intervention to increase early access to supportive care (SC) for patients with metastatic cancer in a resource-limited setting.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11505-11505
Author(s):  
Enrique Soto Perez De Celis ◽  
Yanin Chavarri Guerra ◽  
Wendy Alicia Ramos-Lopez ◽  
Alfredo Covarrubias-Gómez ◽  
Africa Navarro-Lara ◽  
...  
Keyword(s):  
Metastatic Cancer ◽  
Controlled Trial ◽  
Resource Limited Setting ◽  
Early Integration ◽  
Early Access ◽  
Resource Limited ◽  
Lost To Follow Up ◽  
And Control ◽  
Limited Setting

11505 Background: Early integration of SC to the treatment of advanced cancer can improve outcomes, but this may be challenging in developing countries due to a lack of resources and knowledge. In this RCT, we examined whether PN could improve early access to SC among Mexican patients with metastatic solid tumors as recommended by ASCO guidelines. Methods: Adult patients with newly-diagnosed metastatic cancer were randomly assigned to PN or standard oncologic care. At baseline, a navigator assessed the patients’ SC needs (depression, anxiety, fatigue, pain, caregiver burden) using validated questionnaires administered with an electronic tablet. For those in the PN arm, a personalized SC plan was created and implemented by a multidisciplinary team (palliative care, physical therapy, geriatrics, psychology, psychiatry). The primary outcome was access to SC, defined as receipt of SC interventions in the first 3 months (mo) after diagnosis. Secondary outcomes included advanced directive (AD) completion (for patients with expected survival ≤6 mo in accordance to Mexican law), changes in SC needs, and changes in quality of life (assessed using FACT-G). Results: 133 patients (median age 60, range 23-93; 52% male) were randomized (66 PN, 67 control). 61% of patients had gastrointestinal tumors. 94% of patients in the PN arm completed baseline assessments and received recommendations from the navigator. At 3 mo, 37 patients died or were lost to follow-up (16 PN, 21 control; p = 0.45), and 96 completed assessments. SC interventions were provided to 73% of patients in the PN arm and 24% of controls (p < 0.01). In the PN arm, 48% of 29 eligible patients completed AD, compared to 0% of eligible controls (p < 0.01). At 3 mo, patients in the PN arm were significantly less likely to report moderate/severe pain than controls (10 vs 33%, p = 0.006). There were no significant differences in other symptoms or in FACT-G scores (76 vs 76.3, p = 0.46) between PN and control arms at 3 mo. Conclusions: PN can lead to significant improvements in early access to SC, AD completion, and pain control among patients with metastatic cancer treated in a resource-limited setting. Clinical trial information: NCT03293849.

scholarly journals Patient Navigation to Improve Early Access to Supportive Care for Patients with Advanced Cancer in Resource‐Limited Settings: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Enrique Soto‐Perez‐de‐Celis ◽  
Yanin Chavarri‐Guerra ◽  
Wendy Alicia Ramos‐Lopez ◽  
Jacqueline Alcalde‐Castro ◽  
Alfredo Covarrubias‐Gomez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Supportive Care ◽  
Advanced Cancer ◽  
Patient Navigation ◽  
Controlled Trial ◽  
Resource Limited Settings ◽  
Randomized Controlled ◽  
Early Access ◽  
Resource Limited

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.

Feasibility of a digital medicine program in optimizing opioid pain control in cancer patients (SWOG S1916).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS12126-TPS12126
Author(s):  
Sherry Shen ◽  
Riha Vaidya ◽  
Amy Darke ◽  
Joseph M. Unger ◽  
Mina S. Sedrak ◽  
...  
Keyword(s):  
Cancer Pain ◽  
Usual Care ◽  
Pain Control ◽  
Metastatic Cancer ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Clear Understanding ◽  
Directly Observed Therapy ◽  
Opioid Use ◽  
Digital Medicine

TPS12126 Background: The undertreatment of pain in patients with advanced or metastatic cancer is well described in cancer research. Overcoming barriers that prevent successful use of opioid analgesics for cancer pain requires a clear understanding of how individuals use oral medications at home. The Proteus Discover is a digital medicine program (DMP) consisting of an FDA-approved ingestible sensor made of dietary minerals co-encapsulated with patients’ medications, a wearable sensor patch, and a mobile device app that enables patients to electronically transmit their medication adherence patterns. Use of the DMP has demonstrated improved clinical outcomes vs. usual care in patients with diabetes and hypertension, shown superiority over directly-observed therapy in tuberculosis and has been studied in the treatment of patients with hepatitis C, HIV, cancer and severe mental illness, but it has not been previously studied with opioids or in monitoring cancer-related pain. Methods: We are conducting a multicenter pilot study at SWOG NCORP sites to test the feasibility of using the DMP to monitor opioid use in the treatment of metastatic cancer pain. Eligible patients must have a diagnosis of metastatic cancer, have a baseline Brief Pain Inventory worst pain score of ≥3, be deemed by their physician to need initiation or up-titration of oxycodone-acetaminophen for pain control, and be able to read English. Primary outcomes include: (1) study accrual of 60 patients within six months of study activation at all participating sites; (2) patient retention defined as ≥50 patients completing the study, and; (3) adherence to the DMP defined as ≥66% of patients wearing the sensor patch for ≥28 days of the 42-day observation period. Secondary outcomes include change in Brief Pain Inventory pain scores, opioid medication consumption, number of safety alert triggers for high consumption, hospital or emergency room visits for pain, activity levels, and frequency of changes to the pain control regimen. The study will enroll patients at six sites; the first patient was enrolled on 1/20/2020. If successful, this study will inform design of a randomized controlled trial of the DMP vs. usual care in optimizing medication utilization and controlling cancer-related pain. Clinical trial information: NCT04194528 .

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.

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

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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