Index by author
Plain Language Article Summaries
Ann Fam Med 20(3): 2022.
The Issue in Brief
Randomized Trials in Primary Care: Becoming Pragmatic
Miguel Marino and colleagues
Background Miguel Marino, Ph.D., and John Heintzman, MD, MPH, this edition’s editorialists, discuss various types of randomized clinical trials that incorporate pragmatic approaches to evidence generation. Pragmatic randomized control trials have benefits and limitations that researchers should consider when they design trials.
What This Study Found The authors cite three studies in the current edition of Annals of Family Medicine that demonstrate increasingly used approaches to construct trials that are pragmatic, but retain features and benefits of classic trial design. Those methods include a randomized trial that divided participants into intent-to-treat versus as-treated, which, when used together, can present a fuller picture of the study findings in proper context (Mitchell et al); cluster-randomizing, where participants are randomized by group, which can decrease bias and help make a trial more pragmatic (Orrego et al); and a stepped wedge cluster-randomized method, which randomizes clusters (i.e. groups) to a sequence, which determines when, and not if, they receive the intervention (Nguyen et al).
Implication
- Marino and Heintzman recommend that primary care researchers embrace pragmatic trials, which require careful thought in the protocol development stage, taking into account the various multilevel partners that will be involved in the study. “This careful thought will produce more rigorous and applicable evidence, will engage a greater proportion of our workforce in the creation of science, and will facilitate healthier patients and communities,” they write.
Carola Orrego and colleagues
Background Interventions that empower patients may improve health outcomes and quality of life
by encouraging them to seek a more active role in their own care. However, clinicians’
attitudes towards patient empowerment can serve as a barrier to these interventions.
Researchers from Spain conducted a study to evaluate the effect of a “virtual community
of practice intervention” on primary clinicians’ attitudes toward empowering patients
with chronic diseases.
Doctors and nurses at 63 primary care clinics were randomly assigned to either a control
group or the virtual community of practice intervention. The virtual community provided
guided educational modules and discussion boards for three thematic areas related
to patient empowerment: health literacy, self-management support, and shared decision-making.
Researchers used the Patient Provider Orientation Scale to assess participating clinicians’
beliefs regarding the patient-centeredness of care. Higher scores indicate a belief
that the provider is patient-centered, while lower scores indicate a belief that the
provider is doctor- or disease-centered. The scale can also be broken into two distinct
subscales: Sharing and Caring.
What This Study Found At 12-months follow-up, the researchers found no significant impact on the overall PPOS scores of clinicians who had participated in the intervention. However, those who had participated in the virtual community had slightly higher scores on the Sharing subscale of the PPOS. The intervention had no effect on the Caring subscale scores. Further, the intervention had no impact on patient-reported levels of self-activation.
Implication
- The researchers suggest that the interventions may need to be complemented with more comprehensive approaches, such as senior leadership support, integration into organizational functioning, and self-management support.
Camilla Aakjær Andersen and colleagues
Background While the use of point-of-care ultrasonography (POCUS) in the primary care setting may lead to faster and more precise diagnoses and referrals, overscreening can lead to unintended harms to patients, including over- or under-diagnosis and overtreatment. A new study published in Annals of Family Medicine examined general practitioners’(GP) understanding of appropriate ultrasound use versus how early adopters actually use it in their practices.
What This Study Found Researchers found that 24.5% of GPs interviewed for the study conducted POCUS for
exploratory purposes in practice, rather than for focused examinations. Additionally,
while all surveyed GPs indicated that they felt formalized POCUS training should be
a requirement, 75% of the GPs performed examinations outside of anatomic areas where
they had previously received training.
Implication
- These findings suggest that the use of POCUS by early adopters in primary care is widespread. It is not known if this puts patients at risk. The researchers argue that these findings indicate a need for evidence-based guidelines to support GPs in choosing which exams to perform and strategies for developing and maintaining scanning competency.
Evaluation of an Electronic Consultation Service for COVID-19 Care
Jatinderpreet Singh and colleagues
Background Researchers in Ontario, Canada, conducted a study to assess the impact of utilizing
an electronic consultation (eConsult) service to provide timely access to COVID-19
specialist advice for primary care practitioners. The study examined eConsult cases
submitted to a COVID-19 specialist group in order to assess usage patterns, impact
on response times and referrals, and the content of clinical questions being asked.
They analyzed 289 eConsults submitted to the Champlain BASE(™) and Ontario eConsult
services between March and September 2020.
Fifty-one eConsult requests were submitted to the Champlain BASE(™) and 238 to the
Ontario eConsult service. The median specialist response time was 0.6 days (range:
three minutes to 15 days) and the average time spent by specialists per eConsult was
16 minutes (range: five to 59 minutes). In 24% of cases, eConsults resulted in an
avoided face-to-face referral, saving patients and the health care system time and
money.
What This Study Found Five major themes were identified relating to clinical questions: (1) precautions for high-risk populations; (2) guidance on self isolation and return to work; (3) diagnostic clarification and/or need for COVID-19 testing; (4) guidance on personal protective equipment; and (5) management of chronic symptoms
Implication
- Researchers assert that their study demonstrates the significant potential of eConsults during a pandemic as the protocol was quickly implemented across Ontario and resulted in rapid and improved access to specialist care.
Antonio Calvo-Cebrián and colleagues
Background Researchers in Spain conducted a study to compare the diagnostic accuracy of lung ultrasounds (LUS) performed in the primary care setting to chest X-rays (CXR) performed by a radiologist when diagnosing community-acquired pneumonia (CAP). While previous research demonstrates that ultrasounds are a useful tool to diagnose pneumonia in the hospital setting, most studies have not addressed diagnosis in the primary care setting where patients often present with less severe symptoms.
What This Study Found Over a seven month period, physicians at 12 primary care clinics performed LUS, followed by CXR, on 82 patients with clinically suspected CAP. Researchers then compared each LUS finding with the corresponding CXR report. Their findings suggest that, for pneumonia cases detected by LUS, the test’s high specificity could mean it is safe for primary care physicians to directly prescribe antibiotics, thus reducing patients’ exposure to X-ray radiation and saving time and money.
Implication
- All study participants had performed ultrasound in other areas of medicine, including abdominal ultrasound, and were able to achieve a high level of diagnostic accuracy after receiving only five hours of LUS training. Because the test can typically be performed in 10 minutes or less, the authors posit that incorporating LUS into daily practice may be a time- and cost-saving measure for patients and physicians alike.
Paul Ronksley and colleagues
Background People with chronic kidney disease (CKD) require three- to eight-times higher levels of acute care than the general population for comorbidities such as hypertension, diabetes and cardiovascular disease. It is unclear how regular access to primary care influences subsequent acute care use. Researchers from the University of Calgary sought to determine if poor continuity of care is associated with higher rates of all-cause and potentially preventable acute care use, as well as sub-optimal prescribing of guideline-recommended medications.
What This Study Found The researchers found that hospital use increased among patients who experienced poorer continuity of care. Poor continuity also resulted in sub-optimal prescribing of a recommended statin. Researchers concluded that poor continuity of care is associated with increased health care use in general among those with CKD.
Implication
- They recommend the use of targeted strategies that strengthen patient-provider relationships and provide guidance to physicians about recommended prescribing.
Reducing Readmission of Hospitalized Patients With Depressive Symptoms: A Randomized Trial
Suzanne E. Mitchell and colleagues
Background New research published in the Annals of Family Medicine examined whether an enhanced 12-week post-discharge telehealth program would lead to reduced hospital readmission among patients who were hospitalized for a medical illness and tested positive for moderate to severe depressive symptoms while being cared for inpatient. Among patients hospitalized for acute conditions, comorbid depressive symptoms jeopardize a safe transition from hospital to home. Participants were randomized to either a nationally disseminated readmission reduction program, the Re-Engineered Discharge (Project RED) program, or to an enhanced version of the same discharge program (RED-D). This expanded version of Project RED offered patients the standard support services with additional telehealth support, including patient navigation, cognitive behavioral therapy, and self-management support over a 12-week period after being discharged from the hospital.
What This Study Found patients in the enhanced 12-week RED-D program were as likely to be rehospitalized as patients in the standard program. Secondary analyses suggest that implementation barriers, such as the perception of recently discharged patients that they did not need counseling (particularly when the reason for recommending counseling services was unrelated to the admission primary diagnosis) may have reduced the effect of the intervention. Patients who participated in at least three sessions of the RED-D intervention saw a greater reduction of 30-day readmission rates compared to those patients who participated in the standard RED group.
Implication
- Further work is needed to identify and address barriers to implementation of the RED-D program in order to realize the full potential of the enhanced discharge program.
Ann M. Nguyen and colleagues
Background The Stepped Wedge Cluster Randomized Trial is a research methodology that has been growing in popularity, particularly for pragmatic implementation and dissemination trials. SW-CRTs can have advantages over parallel cluster randomized trials with regards to statistical power. Clusters, such groups of physicians working together in a practice rather than individual physicians, are randomized to a sequence, which determines when – not if – they receive the intervention, which makes this design appealing and relevant for quality improvement and practice transformation initiatives. They also offer a pragmatic approach to providing the intervention to all practices.
What This Study Found Researchers interviewed investigators who conducted cluster randomized trials as part of the EvidenceNOW: Advancing Heart Health Initiative, one of the largest practice-improvement primary care studies funded by the Agency for Healthcare Research and Quality. All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages include: (1) incentivized recruitment, (2) staggered resource allocation and 3) statistical power. Challenges included: (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (5) Hawthorne effect (sites modifying their behavior when made aware that they are being observed), and (7) changes that may occur in primary care clinics over time not associated with an intervention implementation.
Implication
- Challenges experienced by EvidenceNOW grantees suggest that certain favorable, real-world conditions can increase the odds of a successful SW-CRT. Existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice—otherwise, funders and investigators should assess the feasibility and cost of data collection.
The Provincial Spread and Scale of the Ontario eConsult Service: Evaluation of the First 2 Years
Clare Liddy and colleagues
Background A new study in the Annals of Family Medicine examines usage data from a provincial electronic consultation (eConsult) service in Ontario, Canada, which facilitates rapid and secure communications between primary care physicians and subspecialists. The research team sought to analyze eConsult’s impact on primary care physicians’ access to subspecialty advice, health system costs, and whether there was a decreased need for in-person visits. They also identified barriers to access and uptake over a two-year period.
What This Study Found Study participants submitted 60,474 eConsult records during the study period. Uptake in eConsult usage increased significantly month over month, from 1,487 eConsults in July 2018 to 4,179 in June 2020. The median subspecialist response time was one day, with a billed median of 15 minutes per case, which resulted in a median cost of $50. Requesting physicians received advice for a new or additional course of action in 55% of cases, and received confirmation on their original course of action in 40%. In 51% of cases, a referral was avoided as a result of the eConsult.
Implication
- The researchers state these findings are comparable to the average subspecialist response time of other eConsult services across Canada, suggesting that eConsult is highly generalizable and can be scaled up without sacrificing effectiveness. The findings suggest that eConsult can also reduce unnecessary specialty referrals, saving the patient and health system time and money.
Elizabeth H. Golembiewski and colleagues
Background Rural residents in the U.S. face immense challenges to accessing health care services for chronic health conditions such as diabetes and cancer. These and other chronic conditions are not only more prevalent in rural communities compared to urban and suburban areas, but also are associated with higher rates of disease-attributable mortality. Researchers from the Mayo Clinic in Rochester, Minnesota, reviewed 62 studies involving 1,354 unique participants. The greatest proportion of studies (24.2%) was focused on the experience of patients with cancer, followed by behavioral health (16.1%); HIV (14.5%); and diabetes (12.9%).
What This Study Found Golembiewski et al identified four primary themes associated with the experience of accessing health care services in rural areas: (1) navigating the rural environment, (2) navigating the health care system, (3) financing chronic disease management, and (4) rural life (i.e., common elements of a distinct “rural” way of thinking and behaving).
Implication
- Important cultural, structural and individual factors influence the rural patient experience of health care access and utilization, and that their findings can inform policies and programs that improve access to care through culturally appropriate interventions.
Stephanie Davis and colleagues
Background In a special report, Australian researchers describe the national rollout of General
Practice Respiratory Clinics (GRPCs) at the onset of the COVID-19 pandemic. In March
2020, GPRCs were created in communities across Australia to divert individuals with
respiratory illness away from mainstream general practice into an environment specifically
designed to maximize infection prevention and control measures. This was also done
to protect health care providers, patients, and their immediate contacts. Additionally,
the clinics provided anonymized patient data for the Australian Government Department
of Health for weekly surveillance reports, as well as for state and Commonwealth public
health authorities and the Australian National COVID-19 Disease Surveillance plan.
The report describes the process for choosing GPRC sites. Additionally, it describes
a customized respiratory clinic data collection app, which works as a mini patient
record, capturing clinical symptoms, physical exam findings, diagnosis, management
and follow-up planning.
What This Study Found By September 2020, 150 GPRCs had opened across the country. GPRCs demonstrated the ability for rapid scale-up in response to COVID-19 cases in a specific area and could be integrated with other health and community services.
Implication
- This is the first time that this type of model has been used in Australia. It recognizes
and formalizes the key role of GPs in pandemic response, providing a level of integration
the researchers say is long overdue for primary care.
When Words Fail: Love's Rightful Place in Medicine
Marvin So
Background Medical student Marvin So writes an essay about an intimate connection he felt with a patient, which caused him to contemplate what he describes as the “transcendent, curious relationship entwining patients and clinicians,” and reflects on how such a relationship aligned with his own ideas about love and caregiving.
What This Study Found As a third-year medical student, he had expected to be frazzled by dealing with electronic health records administration, but was pleasantly surprised to find that, though his minutes with patients were brief, time and space stretched around him. Interacting with patients, noticing the most minute details: the rhythms of their breathing; asking them how they had slept and if they had eaten; and listening to their heartbeats through a stethoscope felt “a lot like love” to him. Expressing those words to a patient, So said he felt that perhaps he had crossed a line. However, in the moment of patient examination, the word “love” feels like the closest thing he has to the “right” word.
Implication
- According to So, there is a profound intimacy in a patient-provider relationship and
a responsibility to hold to account the power differences intrinsic to the roles of
“the sick” and “the healer.” “By choosing love, we affirm that the lives of our patients
are intrinsically, intimately bound together with our own. By choosing love, our daily
clinical practices manifest as the direct extension of a greater purpose, rather than
the constrained actions of an indifferent health care machine,” So writes.
Adrienne Feller Novick
Background Adrienne Feller Novick, a clinical social worker new to the field of geriatric psychiatry, writes an essay describing her journey toward building authentic rapport with patients, her greatest challenge as a new professional.
What This Study Found She was able to strengthen this valuable sense of rapport by finding a mentor who could spark a smile in an older person who had been admitted for psychiatric help. To her surprise, this lesson came from an unexpected person, an employee that was part of the facility’s maintenance team. “Carlos, in his blue maintenance uniform, made a profound therapeutic impact by taking a moment to observe people and connect with them,” she writes. “He explained that his grandmother raised him to be kind to everyone you meet and to treat people the way you want to be treated.”
Implication
- This was a simple and insightful reminder to Novick to provide the highest quality of patient care.
Housing For Health in the Veterans Affairs Greater Los Angeles Tent Community
Tiffany Owens and colleagues
Background Primary care clinicians who make up the Homeless Patient Aligned Care Team (part of the Veterans Administration Greater Los Angeles Healthcare System) initiated a program called the Care, Treatment and Rehabilitation Services. It was placed within a homeless encampment supported by the West Los Angeles VA health services and included on-site provision of 24/7 security, tent sites stability, three meals a day, unlimited water, hygiene stations, face masks, showers and housing placement services.
What This Study Found From June to August 2020, 110 veterans were admitted into the program, among which 64 were seen and treated by medical teams. All participants were tested for COVID-19 within 24 hours of admission,with monthly follow-up tests.
Implication
- The innovation of a multi-level approach to primary care provision within a federally run, low-barrier tent encampment is applicable to other programs working with populations experiencing homelessness. The team plans future medicine-oriented assessments and interventions.
Embedding Student Volunteer Affordable Care Act Navigators in a Primary Care Clinic
Shreyas Hallur and colleagues
Background Researchers from Duke University teamed with organizations in the Raleigh and Durham, North Carolina, areas to develop the Student Affordable Care Act Navigators program to help facilitate the enrollment of uninsured individuals while in the primary care setting.
What This Study Found In 2019, the ACA Navigators trained 19 students and embedded six volunteers in the clinic. In 2020, the consortium trained 15 students, including those who spoke Spanish.
Implication
- Considering that 28 states have provided federal funding to support ACA enrollment through navigator groups or consortia, health-focused student organizations could replicate this model by collaborating with local primary care clinics and federally funded navigator organizations.