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2019 45
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Randomized Controlled Trial
. 2020 May/Jun;35(3):258-264.
doi: 10.1177/1062860619869833. Epub 2019 Aug 30.

The Use of Online Physician Training Can Improve Patient Experience and Physician Burnout

Affiliations
Randomized Controlled Trial

The Use of Online Physician Training Can Improve Patient Experience and Physician Burnout

Susan Congiusta et al. Am J Med Qual. 2020 May/Jun.

Abstract

The authors tested the efficacy of an integrated approach to improving patient experience and physician burnout using a 24-week online training program coupled with a physician engagement strategy. Physicians from different disciplines were randomized to intervention (n = 30) and control (n = 33) groups. Patient experience, physician burnout, and satisfaction data were assessed using patient and provider surveys. Comparisons were made pre and post intervention, and between the groups. Intervention group mean scores increased (+1.40 points) while control group scores dropped (-0.11 points; P = .039). Scores on physician burnout surveys for the intervention group improved in all areas and changes in 2 domains were statistically significant. In all, 73.5% of physicians felt the program was effective. This integrated intervention enhanced patient experience scores and positively affected physicians' level of burnout, and physicians believed this exercise was useful.

Keywords: online training; patient experience; physician burnout; physician satisfaction.

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Randomized Controlled Trial
. 2020 Apr:104:103435.
doi: 10.1016/j.ijnurstu.2019.103435. Epub 2019 Sep 25.

Dealing with the behaviour of residents with dementia that challenges: A stepped-wedge cluster randomized trial of two types of dementia-specific case conferences in nursing homes (FallDem)

Affiliations
Randomized Controlled Trial

Dealing with the behaviour of residents with dementia that challenges: A stepped-wedge cluster randomized trial of two types of dementia-specific case conferences in nursing homes (FallDem)

Margareta Halek et al. Int J Nurs Stud. 2020 Apr.

Abstract

Background: The negative effects of behavioural changes among dementia residents and the consequences for caregivers are a major problem in the care of people with dementia. Case conferences (CC) are recommended as a useful method to understand the underlying causes of the behaviour and to plan tailored interventions OBJECTIVES: The aim of this article is to describe the effects of two dementia-specific CC models on the prevalence of behaviour that challenges and other secondary outcomes.

Design: Stepped-wedge cluster randomized trial.

Setting: Nursing homes: The inclusion criterion was the participation of at least two units with a minimum of 30 residents who were mainly cared for in the study units.

Participants: A total of 224 residents and 189 staff from six nursing homes in the IdA (Innovative dementia-orientated Assessment system) cohort and 241 residents and 284 staff from six nursing homes in the Neo (Narrative Approach) cohort were included in the study. The inclusion criteria were the following: medical diagnosis of dementia from nursing charts, FAST (Functional Assessment Staging) score > 1, living at least 15 days in the unit, and informed consent.

Methods: The nursing homes were randomized to the type of intervention and time point of intervention delivery. The two interventions in the form of the case conference models (Welcome-IdA and -Neo) differed in the type of behaviour analysis method. The intervention duration was seven months. The primary outcome was the change in the prevalence of behaviour that challenges. Secondary outcomes were residents' quality of life, prescription of psychotropic medications, formal caregiver burnout, dementia-related stress, and vocational action competence. The outcomes were measured on seven data points every three months. Linear mixed-effects models were used to analyze intervention effects between the control, intervention and follow-up periods.

Results: No differences were found concerning the primary outcome between the control and intervention cohorts for both CC models. Further exploratory data analyses showed a reduction in behaviours such as apathy (18%) and eating disturbances (29%) for the IdA cohort and hallucination (27%) and delusion (28%) in the NEO cohort. Only staff in the IdA cohort demonstrated a reduction in work-related burnout from the control phase to the intervention phase.

Conclusion: Specific CC for behaviour that challenges do not decrease the overall prevalence of residents showing changes in behaviour. However, there are indications that the case conferences influence some types of behaviour and reduce the risk factors for work-related burnout.

Keywords: BPSD; Behavioural symptoms; Clinical trial; Dementia; Nursing homes; Nursing staff.

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Controlled Clinical Trial
. 2020 Apr;28(4):1817-1827.
doi: 10.1007/s00520-019-04967-y. Epub 2019 Jul 23.

Promoting integrated care in prostate cancer through online prostate cancer-specific holistic needs assessment: a feasibility study in primary care

Affiliations
Controlled Clinical Trial

Promoting integrated care in prostate cancer through online prostate cancer-specific holistic needs assessment: a feasibility study in primary care

Amy L Clarke et al. Support Care Cancer. 2020 Apr.

Abstract

Purpose: This study assessed the feasibility of implementing a novel model of integrated prostate cancer care involving an online prostate cancer-specific holistic needs assessment (sHNA) and shared digital communication between patients and their healthcare professionals (HCPs). The sHNA produces a semi-automated care plan that is finalised in consultation between the patient and their practice nurse.

Methods: Men living with and beyond prostate cancer were invited to participate in a 9-month non-randomised cluster controlled feasibility study. The intervention group was asked to complete the sHNA on three occasions. Data were collected using Patient Reported Outcome Measures (PROMs) at baseline, 10 and 24 weeks, and 9 months. Outcomes included recruitment, retention, acceptability, and engagement with the sHNA and PROMs.

Results: Fourteen general practices (8 intervention and 6 control), and 41 men (29 intervention and 12 control) participated. Initial patient engagement with the sHNA was high, with all but one receiving practice nurse-led follow-up and an individualised care plan. The sHNA proved useful in identifying 'red flag' symptoms, and helping practice nurses decide when to seek further medical care for the patients. There was a high level of acceptability for patients and HCPs. However, integration of care did not occur as intended because of problems linking hospital and general practice IT systems.

Conclusion: While the study demonstrated the feasibility of implementing the sHNA, it did not meet the a priori progression criteria; as such, undertaking a definitive randomised controlled trial is not appropriate until the identified methodological and technical issues have been addressed.

Keywords: Cancer follow-up; Digital health; Holistic needs assessment; Primary care; Survivorship.

Conflict of interest statement

This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG -0214-33092). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The funder was not involved with the design of the study, data collection, analysis, interpretation of data, or in the writing of the manuscript. The authors declare no other conflicts of interests.

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Randomized Controlled Trial
. 2020 Feb 15;126(4):782-791.
doi: 10.1002/cncr.32541. Epub 2019 Nov 19.

Promoting colonoscopy screening among low-income Latinos at average risk of colorectal cancer: A randomized clinical trial

Affiliations
Randomized Controlled Trial

Promoting colonoscopy screening among low-income Latinos at average risk of colorectal cancer: A randomized clinical trial

Katherine N DuHamel et al. Cancer. .

Abstract

Background: Screening colonoscopy (SC) for colorectal cancer (CRC) is underused by Latino individuals. The current randomized clinical trial examined the impact of 3 interventions: 1) patient navigation; 2) patient navigation plus standard Centers for Disease Control and Prevention print materials; and 3) patient navigation plus culturally targeted print materials for Latinos referred for SC. Demographic, personal and health history, and psychometric factors associated with SC also were examined.

Methods: A total of 344 urban Latino individuals aged 50 to 85 years with no personal and/or immediate family history of CRC diagnosed before age 60 years, no personal history of a gastrointestinal disorder, no colonoscopy within the past 5 years, with insurance coverage, and with a referral for SC were consented. Participants were randomized to patient navigation (20%), patient navigation plus standard Centers for Disease Control and Prevention print materials (40%), and patient navigation plus culturally targeted print materials (40%). The completion of SC was assessed at 12 months.

Results: The interventions had an overall SC rate of 82%. Counterintuitively, patients with an average income of <$10,000 were found to have higher SC rates (87%) than those with a greater income (75%).

Conclusions: The addition of standard or culturally targeted print materials did not appear to increase SC rates above those for patient navigation. Indeed, after controlling for other variables, culturally targeted print materials were found to be associated with lower SC rates among Puerto Rican individuals.

Keywords: Latinos; cancer screening; colonoscopy; culturally targeted; patient navigation.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

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Randomized Controlled Trial
. 2020 Jan;29(1):3-9.
doi: 10.1158/1055-9965.EPI-19-0797. Epub 2019 Oct 30.

Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial

Affiliations
Randomized Controlled Trial

Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial

Electra D Paskett et al. Cancer Epidemiol Biomarkers Prev. 2020 Jan.

Abstract

Background: First-degree relatives (FDR) of patients with colorectal cancer are at risk for colorectal cancer, but may not be up to date with colorectal cancer screening. We sought to determine whether a one-time recommendation about needing colorectal cancer screening using patient navigation (PN) was better than just receiving the recommendation only.

Methods: Participants were FDRs of patients with Lynch syndrome-negative colorectal cancer from participating Ohio hospitals. FDRs from 259 families were randomized to a website intervention (528 individuals), which included a survey and personal colorectal cancer screening recommendation, while those from 254 families were randomized to the website plus telephonic PN intervention (515 individuals). Primary outcome was adherence to the personal screening recommendation (to get screened or not to get screened) received from the website. Secondary outcomes examined who benefited from adding PN.

Results: At the end of the 14-month follow-up, 78.6% of participants were adherent to their recommendation for colorectal cancer screening with adherence similar between arms (P = 0.14). Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared with the website intervention (OR: 2.98; 95% confidence interval, 1.68-5.28).

Conclusions: Addition of PN to a website intervention did not improve adherence to a colorectal cancer screening recommendation overall; however, the addition of PN was more effective in increasing adherence among FDRs who needed screening immediately.

Impact: These findings provide important information as to when the additional costs of PN are needed to assure colorectal cancer screening among those at high risk for colorectal cancer.

Trial registration: ClinicalTrials.gov NCT02112747.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

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Randomized Controlled Trial
. 2019 Dec 23;19(1):1247.
doi: 10.1186/s12885-019-6478-3.

AMAFRICA, a patient-navigator program for accompanying lymphoma patients during chemotherapy in Ivory Coast: a prospective randomized study

Affiliations
Randomized Controlled Trial

AMAFRICA, a patient-navigator program for accompanying lymphoma patients during chemotherapy in Ivory Coast: a prospective randomized study

K G Koffi et al. BMC Cancer. .

Abstract

Background: Previous studies have indicated that accompanying socially underserved cancer patients through Patient Navigator (PN) or PN-derived procedures improves therapy management and reassurance. At the Cancer Institute of Toulouse-Oncopole (France), we have implemented AMA (Ambulatory Medical Assistance), a PN-based procedure adapted for malignant lymphoma (ML) patients under therapy. We found that AMA improves adherence to chemotherapy and safety. In low-middle income countries (LMIC), refusal and abandonment were documented as major adverse factors for cancer therapy. We reasoned that AMA could improve clinical management of ML patients in LMIC.

Methods: This study was set up in the Abidjan University Medical Center (Ivory Coast) in collaboration with Toulouse. One hundred African patients were randomly assigned to either an AMA or control group. Main criteria of judgment were refusal and abandonment of CHOP or ABVD chemotherapy.

Results: We found that AMA was feasible and had significant impact on refusal and abandonment. However, only one third of patients completed their therapy in both groups. No differences were noted in terms of complete response rate (CR) (16% based on intent-to-treat) and median overall survival (OS) (6 months). The main reason for refusal and abandonment was limitation of financial resources.

Conclusion: Altogether, this study showed that PN may reduce refusal and abandonment of treatment. However, due to insufficient health care coverage, its ultimate impact on OS remains limited.

Keywords: AMAFRICA program; Malignant lymphoma.

Conflict of interest statement

The authors declare that they have no competing interests.

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Randomized Controlled Trial
. 2019 Dec 3;8(23):e014021.
doi: 10.1161/JAHA.119.014021. Epub 2019 Nov 30.

Changing Results-Engage and Activate to Enhance Wellness: A Randomized Clinical Trial to Improve Cardiovascular Risk Management

Affiliations
Randomized Controlled Trial

Changing Results-Engage and Activate to Enhance Wellness: A Randomized Clinical Trial to Improve Cardiovascular Risk Management

Esti Iturralde et al. J Am Heart Assoc. .

Abstract

Background Despite the success of current cardiovascular disease (CVD) management programs, many patients do not achieve optimal control of CVD-related risk factors. New strategies are needed to better activate and engage these patients. Methods and Results We conducted a parallel, 2-arm, randomized controlled trial, CREATE Wellness (Changing Results-Engage and Activate to Enhance Wellness) from February 2015 to September 2017 with 12-month follow-up to September 2018. Eligible participants had ≥1 uncontrolled CVD risk factors (hyperlipidemia, hypertension, or diabetes mellitus) for at least 2 years before study enrollment. The control group (n=315) received usual care within an existing CVD population-based disease management program. The intervention group (n=332) received usual care plus a group-based behavioral intervention focused on patient activation and engagement. Study outcomes included patient activation and patient-centered care processes (6 months) and healthcare system engagement, medication adherence, and control of CVD risk factors (12 months). Compared with the control group at follow-up, the intervention group had greater improvement in patient activation (adjusted mean difference=2.8, P=0.01), patient-centered care (adjusted mean difference=0.19, P=0.003), and 2 out of 3 measures of healthcare system engagement (eg, secure messages exchanged with a population health manager; adjusted incidence rate ratio=1.7, P=0.01). Intervention and control arms did not differ on improvement in 1-year CVD risk factor control. Conclusions Further work is needed to more effectively connect increased patient activation and engagement to downstream changes in risk factor control. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02302612.

Keywords: cardiovascular disease risk factors; disease management; patient‐centered care.

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Randomized Controlled Trial
. 2019 Dec:74:62-68.
doi: 10.1016/j.drugpo.2019.08.009. Epub 2019 Sep 16.

Taking opioids in times of crisis: Institutional oversight, chronic pain and suffering in an integrated healthcare delivery system in the U.S

Affiliations
Randomized Controlled Trial

Taking opioids in times of crisis: Institutional oversight, chronic pain and suffering in an integrated healthcare delivery system in the U.S

Inga Gruß et al. Int J Drug Policy. 2019 Dec.

Abstract

Background: Opioid treatment for chronic pain has garnered heightened public attention and political pressure to control a devastating public health crisis in the United States (U.S.). Resulting policy changes, together with ongoing public and political attention, have pushed health care systems and providers to lower doses or deprescribe and taper patients off opioids. However, little attention has been paid to the impact of such practice changes on patients who had relied on opioid treatment to manage their chronic pain. The aim of this article is to explore experiences with opioid-related care under aggressive tapering efforts and concomitant heightened monitoring and institutional oversight among patients with chronic pain in an integrated delivery system through in-depth interviews.

Methods: We interviewed 97 patients with chronic pain who were assigned to the usual care arm of the Pain Program for Active Coping and Training (PPACT) study. These patients had been prescribed opioids as part of their treatment regimens and taken opioids closely monitored by their health care providers. We followed the framework method for coding and analysing transcripts using NVivo 12.

Results: The experiences of these patients during this period of change can be understood through three interconnected themes: (1) many patients taking opioids experience debilitating physical side effects; (2) navigating opioid treatment contributes to significant emotional distress among many patients with chronic pain and; (3) the quality of patients' relationship with their primary care provider can be negatively affected by negotiations regarding long-term opioid treatment for chronic pain.

Conclusion: We highlight the importance of utilizing communication approaches that are patient-centered and include shared decision making during the tapering and/or deprescribing processes of opioids and ensuring alternative pain treatments are available to patients with chronic pain.

Keywords: Chronic pain; Institutional oversight; Integrated health care delivery system; Opioid treatment; Policy changes; Qualitative research.

Conflict of interest statement

Declaration of competing interest

None.

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Randomized Controlled Trial
. 2019 Dec;37(4):402-408.
doi: 10.1080/02813432.2019.1663581. Epub 2019 Sep 9.

Informing patients on planned consultation time - a randomised controlled intervention study of consultation time in primary care

Affiliations
Randomized Controlled Trial

Informing patients on planned consultation time - a randomised controlled intervention study of consultation time in primary care

Oskar Lindfors et al. Scand J Prim Health Care. 2019 Dec.

Abstract

Objective: To investigate whether patients' pre-consultation knowledge of the time frames for the consultation influences the actual consultation time and/or patient and physician related outcomes; satisfaction and enablement.Design: Randomised controlled blinded intervention study.Setting: Four strategically chosen Primary Health Care Centres (PHCC:s) in Kronoberg county in Sweden participated.Intervention: Pre-consultation information on planned consultation time. During one week in each PHCC consecutive patients were randomised to intervention group or control group, when booking an appointment with a physician.Subjects: Patients >18 years of age.Main outcome measures: Consultation time, patient satisfaction, patient enablement and physician satisfaction.Results: No significant difference in consultation time was found between the intervention group and control group. No differences were seen between intervention group and control group regarding any of the other measures. Stratified data showed significantly shorter consultation time for the intervention group in one of the PHCC:s and for employed physicians. Employed physicians also rated consultations as being easier and were more satisfied with their consultations compared to non-employed physicians.Conclusion: Information on the planned consultation time has a potential to decrease consultation time in certain settings. No negative side effects were found in this study. Key pointsPatients prepare before their consultation but to influence its contents and length is difficult.Informing patients on estimated consultation time can influence actual consultation time.Informing patients on planned consultation time has no adverse effects in this study.

Keywords: Mesh terms; appointments and schedule; general practice; patient centred care; patient satisfaction; physician patient relations; primary health care.

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Randomized Controlled Trial
. 2019 Dec 1;21(12):1785-1792.
doi: 10.1093/europace/euz209.

Integrated specialized atrial fibrillation clinics reduce all-cause mortality: post hoc analysis of a randomized clinical trial

Affiliations
Randomized Controlled Trial

Integrated specialized atrial fibrillation clinics reduce all-cause mortality: post hoc analysis of a randomized clinical trial

Jeroen M L Hendriks et al. Europace. .

Abstract

Aims: An integrated chronic care programme in terms of a specialized outpatient clinic for patients with atrial fibrillation (AF), has demonstrated improved clinical outcomes. The aim of this study is to assess all-cause mortality in patients in whom AF management was delivered through a specialized outpatient clinic offering an integrated chronic care programme.

Methods and results: Post hoc analysis of a Prospective Randomized Open Blinded Endpoint Clinical trial to assess all-cause mortality in AF patients. The study included 712 patients with newly diagnosed AF, who were referred for AF management to the outpatient service of a University hospital. In the specialized outpatient clinic (AF-Clinic), comprehensive, multidisciplinary, and patient-centred AF care was provided, i.e. nurse-driven, physician supervised AF treatment guided by software based on the latest guidelines. The control group received usual care by a cardiologist in the regular outpatient setting.After a mean follow-up of 22 months, all-cause mortality amounted 3.7% (13 patients) in the AF-Clinic arm and 8.1% (29 patients) in usual care [hazard ratio (HR) 0.44, 95% confidence interval (CI) 0.23-0.85; P = 0.014]. This included cardiovascular mortality in 4 AF-Clinic patients (1.1%) and 14 patients (3.9%) in usual care (HR 0.28; 95% CI 0.09-0.85; P = 0.025). Further, 9 patients (2.5%) died in the AF-Clinic arm due to a non-cardiovascular reason and 15 patients (4.2%) in the usual care arm (HR 0.59; 95% CI 0.26-1.34; P = 0.206).

Conclusion: An integrated specialized AF-Clinic reduces all-cause mortality compared with usual care. These findings provide compelling evidence that an integrated approach should be widely implemented in AF management.

Keywords: Atrial fibrillation; Integrated care; Mortality; Multidisciplinary teams; Nurse co-ordination.

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