Utilization of healthcare and prescription medicines after non-pharmacological interventions for depression - A 3-year register follow-up of an RCT in primary care

Abstract Objectives To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of COVID-19 in Primary Health Care. Trial design A randomized, two-armed (1:1), parallel, placebo-controlled, double-blind, clinical trial is being performed to test the following hypotheses: H0: homeopathic medicines = placebo (null hypothesis) vs. H1: homeopathic medicines ≠ placebo (alternative hypothesis) for mild cases of COVID-19 in Primary Care. Participants Setting: Primary Care of São Carlos – São Paulo – Brazil. One hundred participants aged 18 years or older, with Influenza-like symptoms and a positive RT-PCR for SARS-CoV-2. Willingness to give informed consent and to comply with the study procedures is also required. Exclusion criterium: severe acute respiratory syndrome. Intervention and comparator Homeopathy: 1 globule of Natrum muriaticum LM2 diluted in 20 mL of alcohol 30% and dispensed in a 30 ml bottle. Placebo: 20 mL of alcohol 30% dispensed in a 30 ml bottle. Posology: one drop taken orally every 4 hours (6 doses/day) while there is fever, cough, tiredness, or pain (headache, sore throat, muscle aches, chest pain, etc.) followed by one drop every 6 hours (4 doses/day) until the fourteenth day of use. The bottle of study medication should be submitted to 10 vigorous shakes (succussions) before each dose. Posology may be changed by telemedicine, with no break in blinding. Study medication should be maintained during home isolation. According to the Primary Care protocol, the home isolation period lasts until the 10th day after the appearance of the first symptom, or up to 72 hours without symptoms. Main outcomes The primary endpoint will be time to recovery, defined as the number of days elapsed before all COVID-19 Influenza-like symptoms are recorded as mild or absent during home isolation period. Secondary measures are recovery time for each COVID-19 symptom; score of the scale created for the study (COVID-Simile Scale); medicines used during follow-up; number of days of follow-up; number of visits to emergency services; number of hospitalizations; other symptoms and Adverse Events during home isolation period. Randomisation The study Statistician generated a block randomization list, using a 1:1 ratio of the two groups (denoted as A and B) and a web-based tool (http://www.random.org/lists). Blinding (masking) The clinical investigators, the statistician, the Primary Care teams, the study collaborators, and the participants will remain blinded from the identity of the two treatment groups until the end of the study. Numbers to be randomised (sample size) One hundred participants are planned to be randomized (1:1) to placebo (50) or homeopathy (50). Trial Status Protocol version/date May 21, 2020. Recruitment is ongoing. First participant was recruited/included on June 29,2020. Due to recruitment adaptations to Primary Care changes, the authors anticipate the trial will finish recruiting on April 10, 2021. Trial registration COVID-Simile Study was registered at the University Hospital Medical Information Network (UMIN - https://www.umin.ac.jp/ctr/index.htm) on June 1st, 2020, and the trial start date was June 15, 2020. Unique ID: UMIN000040602. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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The Seniors’ Community Hub: An Integrated Model of Care for the Identification and Management of Frailty in Primary Care

Geriatrics ◽

10.3390/geriatrics6010018 ◽

2021 ◽

Vol 6 (1) ◽

pp. 18

Author(s):

Marjan Abbasi ◽

Sheny Khera ◽

Julia Dabravolskaj ◽

Bernadette Chevalier ◽

Kelly Parker

Keyword(s):

Primary Care ◽

Gait Speed ◽

Family Physicians ◽

Community Dwelling ◽

Integrated Models ◽

Care Services ◽

Interprofessional Teamwork ◽

Team Working ◽

Centered Care

(1) Background: Integrated models of primary care deliver the comprehensive and preventative approach needed to identify and manage frailty in older people. Seniors’ Community Hub (SCH) was developed to deliver person-centered, evidence-informed, coordinated, and integrated care services to older community dwelling adults living with frailty. This paper aims to describe the SCH model, and to present patient-oriented results of the pilot. (2) Methods: SCH was piloted in an academic clinic with six family physicians. Eligible patients were community dwelling, 65 years of age and older, and considered to be at risk of frailty (eFI > 0.12). Health professionals within the clinic received training in geriatrics and interprofessional teamwork to form the SCH team working with family physicians, patients and caregivers. The SCH intervention consisted of a team-based multi-domain assessment with person-centered care planning and follow-up. Patient-oriented outcomes (EQ-5D-5L and EQ-VAS) and 4-metre gait speed were measured at initial visit and 12 months later. (3) Results: 88 patients were enrolled in the pilot from April 2016–December 2018. No statistically significant differences in EQ-5D-5L/VAS or the 4-metre gait speed were detected in 38 patients completing the 12-month assessment. (4) Conclusions: Future larger scale studies of longer duration are needed to demonstrate impacts of integrated models of primary care on patient-oriented outcomes for older adults living with frailty.

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The effect of COVID-19 pandemic and lockdown on consultation numbers, consultation reasons and performed services in primary care: results of a longitudinal observational study

BMC Family Practice ◽

10.1186/s12875-021-01471-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Ingmar Schäfer ◽

Heike Hansen ◽

Agata Menzel ◽

Marion Eisele ◽

Daniel Tajdar ◽

...

Keyword(s):

Primary Care ◽

Observational Study ◽

Rural Areas ◽

Longitudinal Observational Study ◽

Multivariable Analyses ◽

Gastrointestinal Complaints ◽

Urban And Rural Areas ◽

Quota Sampling ◽

Primary Care Practices

Abstract Objectives The aims of our study were to describe the effect of the COVID-19 pandemic and lockdown on primary care in Germany regarding the number of consultations, the prevalence of specific reasons for consultation presented by the patients, and the frequency of specific services performed by the GP. Methods We conducted a longitudinal observational study based on standardised GP interviews in a quota sampling design comparing the time before the COVID-19 pandemic (12 June 2015 to 27 April 2017) with the time during lockdown (21 April to 14 July 2020). The sample included GPs in urban and rural areas 120 km around Hamburg, Germany, and was stratified by region type and administrative districts. Differences in the consultation numbers were analysed by multivariate linear regressions in mixed models adjusted for random effects on the levels of the administrative districts and GP practices. Results One hundred ten GPs participated in the follow-up, corresponding to 52.1% of the baseline. Primary care practices in 32 of the 37 selected administrative districts (86.5%) could be represented in both assessments. At baseline, GPs reported 199.6 ± 96.9 consultations per week, which was significantly reduced during COVID-19 lockdown by 49.0% to 101.8 ± 67.6 consultations per week (p < 0.001). During lockdown, the frequency of five reasons for consultation (-43.0% to -31.5%) and eleven services (-56.6% to -33.5%) had significantly decreased. The multilevel, multivariable analyses showed an average reduction of 94.6 consultations per week (p < 0.001). Conclusions We observed a dramatic reduction of the number of consultations in primary care. This effect was independent of age, sex and specialty of the GP and independent of the practice location in urban or rural areas. Consultations for complaints like low back pain, gastrointestinal complaints, vertigo or fatigue and services like house calls/calls at nursing homes, wound treatments, pain therapy or screening examinations for the early detection of chronic diseases were particularly affected.

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An evaluation of the implementation of quality improvement (QI) in primary care dentistry: a multi-method approach

BMJ Open Quality ◽

10.1136/bmjoq-2019-000839 ◽

2021 ◽

Vol 10 (2) ◽

pp. e000839

Author(s):

Heather Cassie ◽

Vinay Mistry ◽

Laura Beaton ◽

Irene Black ◽

Janet E Clarkson ◽

...

Keyword(s):

Primary Care ◽

Quality Improvement ◽

Case Studies ◽

Quality Care ◽

Theoretical Domains Framework ◽

Team Members ◽

Knowledge And Skills ◽

Scottish Government ◽

The Impact

ObjectivesEnsuring that healthcare is patient-centred, safe and harm free is the cornerstone of the NHS. The Scottish Patient Safety Programme (SPSP) is a national initiative to support the provision of safe, high-quality care. SPSP promotes a coordinated approach to quality improvement (QI) in primary care by providing evidence-based methods, such as the Institute for Healthcare Improvement’s Breakthrough Series Collaborative methodology. These methods are relatively untested within dentistry. The aim of this study was to evaluate the impact to inform the development and implementation of improvement collaboratives as a means for QI in primary care dentistry.DesignA multimethod study underpinned by the Theoretical Domains Framework and the Kirkpatrick model. Quantitative data were collected using baseline and follow-up questionnaires, designed to explore beliefs and behaviours towards improving quality in practice. Qualitative data were gathered using interviews with dental team members and practice-based case studies.ResultsOne hundred and eleven dental team members completed the baseline questionnaire. Follow-up questionnaires were returned by 79 team members. Twelve practices, including two case studies, participated in evaluation interviews. Findings identified positive beliefs and increased knowledge and skills towards QI, as well as increased confidence about using QI methodologies in practice. Barriers included time, poor patient and team engagement, communication and leadership. Facilitators included team working, clear roles, strong leadership, training, peer support and visible benefits. Participants’ knowledge and skills were identified as an area for improvement.ConclusionsFindings demonstrate increased knowledge, skills and confidence in relation to QI methodology and highlight areas for improvement. This is an example of partnership working between the Scottish Government and NHSScotland towards a shared ambition to provide safe care to every patient. More work is required to evaluate the sustainability and transferability of improvement collaboratives as a means for QI in dentistry and wider primary care.

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Understanding the clinical reasoning processes involved in the management of multimorbidity in an ambulatory setting: study protocol of a stimulated recall research

BMC Medical Education ◽

10.1186/s12909-020-02459-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

M.-C. Audétat ◽

S. Cairo Notari ◽

J. Sader ◽

C. Ritz ◽

T. Fassier ◽

...

Keyword(s):

Primary Care ◽

Clinical Reasoning ◽

Primary Care Physicians ◽

Video Sequence ◽

Structured Interview ◽

Ambulatory Setting ◽

Structured Interviews ◽

Stimulated Recall ◽

Study Results

Abstract Background Primary care physicians are at the very heart of managing patients suffering from multimorbidity. However, several studies have highlighted that some physicians feel ill-equipped to manage these kinds of complex clinical situations. Few studies are available on the clinical reasoning processes at play during the long-term management and follow-up of patients suffering from multimorbidity. This study aims to contribute to a better understanding on how the clinical reasoning of primary care physicians is affected during follow-up consultations with these patients. Methods A qualitative research project based on semi-structured interviews with primary care physicians in an ambulatory setting will be carried out, using the video stimulated recall interview method. Participants will be filmed in their work environment during a standard consultation with a patient suffering from multimorbidity using a “button camera” (small camera) which will be pinned to their white coat. The recording will be used in a following semi-structured interview with physicians and the research team to instigate a stimulated recall. Stimulated recall is a research method that allows the investigation of cognitive processes by inviting participants to recall their concurrent thinking during an event when prompted by a video sequence recall. During this interview, participants will be prompted by different video sequence and asked to discuss them; the aim will be to encourage them to make their clinical reasoning processes explicit. Fifteen to twenty interviews are planned to reach data saturation. The interviews will be transcribed verbatim and data will be analysed according to a standard content analysis, using deductive and inductive approaches. Conclusion Study results will contribute to the scientific community’s overall understanding of clinical reasoning. This will subsequently allow future generation of primary care physicians to have access to more adequate trainings to manage patients suffering from multimorbidity in their practice. As a result, this will improve the quality of the patient’s care and treatments.

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Integrating Genomic Screening into Primary Care: Provider Experiences Caring for Latino Patients at a Community-Based Health Center

Journal of Primary Care & Community Health ◽

10.1177/21501327211000242 ◽

2021 ◽

Vol 12 ◽

pp. 215013272110002

Author(s):

Tarika Srinivasan ◽

Erica J. Sutton ◽

Annika T. Beck ◽

Idali Cuellar ◽

Valentina Hernandez ◽

...

Keyword(s):

Primary Care ◽

Health Care ◽

Patient Care ◽

Health Center ◽

Care Provider ◽

Primary Care Provider ◽

Genomic Sequencing ◽

Community Based ◽

Genomic Screening

Introduction: Minority communities have had limited access to advances in genomic medicine. Mayo Clinic and Mountain Park Health Center, a Federally Qualified Health Center in Phoenix, Arizona, partnered to assess the feasibility of offering genomic screening to Latino patients receiving care at a community-based health center. We examined primary care provider (PCP) experiences reporting genomic screening results and integrating those results into patient care. Methods: We conducted open-ended, semi-structured interviews with PCPs and other members of the health care team charged with supporting patients who received positive genomic screening results. Interviews were recorded, transcribed, and analyzed thematically. Results: Of the 500 patients who pursued genomic screening, 10 received results indicating a genetic variant that warranted clinical management. PCPs felt genomic screening was valuable to patients and their families, and that genomic research should strive to include underrepresented minorities. Providers identified multiple challenges integrating genomic sequencing into patient care, including difficulties maintaining patient contact over time; arranging follow-up medical care; and managing results in an environment with limited genetics expertise. Providers also reflected on the ethics of offering genomic sequencing to patients who may not be able to pursue diagnostic testing or follow-up care due to financial constraints. Conclusions: Our results highlight the potential benefits and challenges of bringing advances in precision medicine to community-based health centers serving under-resourced populations. By proactively considering patient support needs, and identifying financial assistance programs and patient-referral mechanisms to support patients who may need specialized medical care, PCPs and other health care providers can help to ensure that precision medicine lives up to its full potential as a tool for improving patient care.

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Evaluation of a multidisciplinary lipid clinic to improve the care of individuals with severe lipid conditions: a RE-AIM framework analysis

Implementation Science Communications ◽

10.1186/s43058-021-00135-8 ◽

2021 ◽

Vol 2 (1) ◽

Author(s):

Laney K. Jones ◽

Megan McMinn ◽

David Kann ◽

Michael Lesko ◽

Amy C. Sturm ◽

...

Keyword(s):

Primary Care ◽

Program Effectiveness ◽

Primary Care Providers ◽

Care Providers ◽

Lipid Levels ◽

Framework Analysis ◽

Lipid Clinic ◽

Adherence Counseling ◽

Clinically Significant

Abstract Background Individuals with complex dyslipidemia, or those with medication intolerance, are often difficult to manage in primary care. They require the additional attention, expertise, and adherence counseling that occurs in multidisciplinary lipid clinics (MDLCs). We conducted a program evaluation of the first year of a newly implemented MDLC utilizing the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework to provide empirical data not only on program effectiveness, but also on components important to local sustainability and future generalizability. Methods The purpose of the MDLC is to increase the uptake of guideline-based care for lipid conditions. Established in 2019, the MDLC provides care via a centralized clinic location within the healthcare system. Primary care providers and cardiologists were invited to refer individuals with lipid conditions. Using a pre/post-study design, we evaluated the implementation outcomes from the MDLC using the RE-AIM framework. Results In 2019, 420 referrals were made to the MDLC (reach). Referrals were made by 19% (148) of the 796 active cardiology and primary care providers, with an average of 35 patient referrals per month in 2019 (SD 12) (adoption). The MDLC saw 83 patients in 2019 (reach). Additionally, 50% (41/82) had at least one follow-up MDLC visit, and 12% (10/82) had two or more follow-up visits in 2019 (implementation). In patients seen by the MDLC, we found an improved diagnosis of specific lipid conditions (FH (familial hypercholesterolemia), hypertriglyceridemia, and dyslipidemia), increased prescribing of evidence-based therapies, high rates of medication prior authorization approvals, and significant reductions in lipid levels by lipid condition subgroup (effectiveness). Over time, the operations team decided to transition from in-person follow-up to telehealth appointments to increase capacity and sustain the clinic (maintenance). Conclusions Despite limited reach and adoption of the MDLC, we found a large intervention effect that included improved diagnosis, increased prescribing of guideline-recommended treatments, and clinically significant reduction of lipid levels. Attention to factors including solutions to decrease the large burden of unseen referrals, discussion of the appropriate number and duration of visits, and sustainability of the clinic model could aid in enhancing the success of the MDLC and improving outcomes for more patients throughout the system.

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Efficacy of Manual Therapy and Transcutaneous Electrical Nerve Stimulation in Cervical Mobility and Endurance in Subacute and Chronic Neck Pain: A Randomized Clinical Trial

Journal of Clinical Medicine ◽

10.3390/jcm10153245 ◽

2021 ◽

Vol 10 (15) ◽

pp. 3245

Author(s):

Belén Díaz-Pulido ◽

Yolanda Pérez-Martín ◽

Daniel Pecos-Martín ◽

Isabel Rodríguez-Costa ◽

Milagros Pérez-Muñoz ◽

...

Keyword(s):

Primary Care ◽

Neck Pain ◽

Manual Therapy ◽

Nerve Stimulation ◽

Transcutaneous Electrical Nerve Stimulation ◽

Sagittal Plane ◽

Chronic Neck Pain ◽

Post Intervention ◽

Electrical Nerve Stimulation

Neck pain is a frequent health problem. Manual therapy (MT) and transcutaneous electrical nerve stimulation (TENS) are recommended techniques for treatment of mechanical neck disorders (MND) in Spanish Public Primary Care Physiotherapy Services. The aim of this study was to compare the efficacy of MT versus TENS in active mobility and endurance in cervical subacute or chronic neck pain. Ninety patients with MND were randomly allocated to receive ten 30-min sessions of either MT or TENS, in a multi-centered study through 12 Primary Care Physiotherapy Units in the Madrid community. Active cervical range of motion (CD-ROM) and endurance (Palmer and Epler test) were evaluated pre- and post-intervention and at 6-month follow-up. A generalized linear model of repeated measures was constructed for the analysis of differences. Post-intervention MT yielded a significant improvement in active mobility and endurance in patients with subacute or chronic MND, and at 6-month follow-up the differences were only significant in endurance and in sagittal plane active mobility. In the TENS group, no significant improvement was detected. With regard to other variables, MT improved mobility and endurance more effectively than TENS at post-intervention and at 6-month follow-up in the sagittal plane. Only MT generated significant improvements in cervical mobility and endurance in the three movement planes.

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