Standardized Patient Education Research Articles

Study protocol of a prospective, interventional non-randomised trial investigating the impact of asthma education on specific disease understanding, health literacy and therapy outcome in childhood

IntroductionChildhood asthma is a highly prevalent chronic disease. A failure to implement patient education programmes may result in increased morbidity, despite the availability of distinct diagnostic and therapeutic approaches. Patients...

Improving patient education in hospitalized patients with chronic obstructive pulmonary disease: A quality improvement initiative using LEAN methodology.

Chronic obstructive pulmonary disease (COPD) is a costly chronic disease affecting more than 15 million Americans. The prevalence among US veterans is 3 times higher than the general population. The Veteran Health Administration developed a standardized, evidence-based COPD educational tool called Green Light to Go (GLTG) designed to educate patients on managing their COPD symptoms at home. Despite the availability of this resource, inpatient education on COPD self-management practices is highly variable across different medical teams. This quality improvement (QI) initiative sought to standardize inpatient COPD patient education using the GLTG tool. This initiative also assessed whether patients receiving standardized patient education during their index hospitalization had lower COPD 30-day readmission rates. The QI initiative followed the LEAN methodology and the A3 framework. The team performed rapid tests of change (plan-do-study-act cycles) to increase the percentage of veterans receiving COPD education. The interventions implemented for this QI initiative focused on clinical, patient, and system improvements. This initiative standardized COPD patient education and increased the percentage of veterans receiving (a) daily COPD education from 0% to 66%, (b) verbal COPD education on discharge from a baseline of 20% to 100%, (c) receipt of written educational material on discharge from 20% to 100%, and (d) the cohort all-cause 30-day readmission rate declined from 19.3% to 14.3%. Given the substantial economic burden of COPD readmissions on the health care system and patients, evidence-based educational interventions may potentially improve outcomes and reduce hospital readmissions in this veteran population.

Reducing Severe Maternal Morbidity for Birthing Persons with Severe Hypertension through a Statewide Quality Improvement Initiative

BackgroundHypertensive disorders of pregnancy are a leading preventable cause of severe maternal morbidity and maternal mortality worldwide. ObjectiveTo assess the improvement in hospital care processes and patient outcomes associated with hypertensive disorders of pregnancy after introduction of a statewide Severe Maternal Hypertension quality improvement initiative. Study DesignA prospective cohort design comparing outcomes before and after introduction of the Illinois Perinatal Quality Collaborative statewide hypertension quality improvement initiative among 108 hospitals across Illinois. Participating hospitals recorded data for all cases of new-onset severe hypertension (>160 systolic or >110 diastolic) during pregnancy through 6 weeks postpartum from May 2016 to December 2017. Introduction of the statewide quality improvement initiative included implementation of severe maternal hypertension protocols, standardized patient education and discharge planning, rapid access to medications and standardized treatment order sets, and provider and nurse education. The main outcome measure was the reduction of severe maternal morbidity for pregnant/postpartum patients with severe hypertension. Key process measures include time-to-treatment of severe hypertension, frequency of provider/nurse debriefs, appropriate patient education, and early postpartum follow up. ResultsData were reported for 8,073 cases of severe maternal hypertension. The frequency of patients with new-onset severe hypertension treated within 60 minutes increased from 41% baseline to 87% (p<0.001) at the end of the initiative. The initiative was associated with increased proportion of patients receiving preeclampsia education at discharge (41% to 89%, p<0.001), scheduling follow-up appointments within 10 days of discharge (68% to 83%, p<0.001), and having a care team debrief after severe hypertension was diagnosed (17% to 59%, p<0.001). Conversely, severe maternal morbidity was reduced from 11.5% baseline to 8.4% (p<0.002) at the end of the study period. Illinois hospitals were able to achieve time-to-treatment goal regardless of hospital characteristics including geography, birth volume, and patient mix. ConclusionsIntroduction of a statewide quality improvement effort was associated with improved time-to-treatment of severe hypertension, as well as increased frequency of provider/nurse debriefs, appropriate patient education, and early postpartum follow up scheduled at discharge, and reduced severe maternal morbidity.

Use of virtual reality in patient education program to reduce anxiety in upper gastrointestinal endoscopy: A randomized controlled trial.

Virtual reality (VR) provides an immersive image-viewing experience that has recently been expanding its use in clinical medicine. We aimed to examine a patient education program by VR to reduce anxiety in patients undergoing esophagogastroduodenoscopy (EGD). We conducted a randomized controlled trial and consecutively enrolled patients who had an indication for unsedated EGD with topical anesthesia. Patients were randomly assigned to use Oculus GO with three-dimensionally specific software content (a stand-alone VR headset) for patient education or standard patient education using oral information (the control group) before EGD. The primary outcome was the variation in anxiety scores before and after patient education programs. A total of 107 patients underwent EGD and received a VR (n = 58) and control (n = 49) patient education program. The mean anxiety score before starting the patient education program was 41.4 9.6 in the VR group and 41.9 7.7 in the control group. The mean anxiety score after the patient education program was 37.1 10.8 in the VR group and 38.9 8.07 in the control group (P-value = 0.354). The anxiety score in the VR group decreased more than in the control group but was not significant. The recall questionnaire scores were higher in the VR group (4.70.4) than the control group (3.91, P-value 0.001). A virtual reality-assisted patient education program before EGD did not significantly reduce anxiety but may provide more memory and understanding about the procedure to patients who underwent unsedated EGD.

The Role of Patient Engagement in Surgical Site Infection Reduction: A Process Improvement Project.

Surgical site infections (SSIs) are the second most common healthcare-associated infection, with prevention being a high-priority goal for all healthcare organizations. Although routine surveillance and standardized prevention protocols have long been used, patient engagement is an additional intervention that should be considered and may be beneficial in SSI prevention. To determine if the development of a standardized patient education discharge plan for management of a surgical site and/or surgical drain would contribute to a reduction in SSI rates in inpatients undergoing colorectal, plastic, or general surgery. A preintervention/postintervention design was used. Before intervention, patients and surgeons were surveyed regarding various discharge practices related to surgical incision/drain care. The intervention consisted of implementing a standardized discharge plan including standardized education and patient discharge kits. After implementation, patients were surveyed regarding discharge practices. Patient survey responses and SSI rates were compared between the preintervention and postintervention time frames. Rates of SSIs decreased across all three surgical specialties during the project period: colorectal SSIs decreased from 3.2% to 2.7%, plastics from 1.2% to 0.5%, and general from 0.86% to 0.33%. Improvements were also realized in patient survey responses to various aspects of surgical incision/drain care. Patient engagement may be an important strategy to integrate with SSI evidence-based care bundles. Active engagement of surgical patients perioperatively has the potential to improve the patient experience, which ultimately can result in improved healthcare outcomes for this population.

A Roadmap to Using Simulation-Enhanced Interprofessional Education to Incorporate Interprofessional Activities in Athletic Training Educational Programs

Context Interprofessional education and collaborative practice (IPECP) is a priority in health care. Collaborative care that includes clinicians across disciplines has been shown across health care to ensure quality patient outcomes. In athletic training, a team approach to clinical practice has been promoted for nearly a decade and continues to gain attention. Interprofessional education (IPE) is a core curricular content standard that requires programs to teach students to practice in collaboration with other health care professionals. Interprofessional education and collaborative practice necessitates students have opportunities to practice before being expected to demonstrate skills clinically. Background To effectively demonstrate IPECP, athletic trainers need exposure to and training in IPECP core competencies during education. Simulation-enhanced IPE (Sim-IPE) is one strategy to integrate these experiences. Between classroom learning and clinical practice, simulation provides an opportunity for students to apply knowledge in a realistic but low-stakes clinical environment. Objective This article will detail strategies to identify and develop Sim-IPE experiences that support achieving educational standards and prepare students for effective IPECP. Description Healthcare Simulation Standards of Best Practice™ and the Association of Standardized Patient Educators best practices were established to guide the design of quality Sim-IPE. This manuscript will provide a roadmap for these best practices, including conducting a needs assessment, coordinating event logistics, designing prebrief sessions, and selecting debrief models. Clinical Advantage(s) Students can gain valuable experience during Sim-IPE. Participation in Sim-IPE improves student understanding of the roles and responsibilities, communication techniques, and teamwork. These factors combine to achieve improved patient outcomes. Conclusion(s) Athletic training programs implementing Sim-IPE should use simulation best practices to provide quality IPECP opportunities.

Implementing Standardized Patient Education in Radiation Oncology.

Patient education empowers patients, improving their health status during and after cancer treatment (Howell et al., 2017). We hypothesize that standardizing healthcare provider delivery of educational materials (HPE) using an electronic medical record (EMR) will increase delivery to patients (pts). During the study period (9/2020 - 11/2022) 13,650 pts in a multi-centered single health system (HS) received HPE and were analyzed in a retrospective convenience sample frame. There were 16,769 education touchpoints from Radiation Oncology departments (RO) and 8,269 from Medical Oncology (MO) departments. Provision of HPE was standardized in RO during this era. Relationship of ethnicity, age, and sex/gender to receipt of HPE at single vs multiple time points across the HS was examined using association analysis. Within the combined sample taken from RO and MO departments in the HS the mean pt age was 64y (7 - >90); 71% of pts identified as white, 95.7% non-Hispanic, and 55% female. Across ethnicity, age, and sex/gender, increased HPE was provided in RO vs MO departments (p < 0.001). Distribution of HPE in RO was equal between male and female pts (73%), while distribution to female pts was higher than male in MO. (60% vs 57%, p < 0.001). Receipt of HPE at more than one time point was increased in RO across cancer types (Table 1). In RO, 73% of patients received education at more than one time point, compared to 58.7% in other departments (p < 0.001). Receipt of HPE at more than one time point was increased in RO for patients identifying as American Indian or Alaska Native (84% vs 0, p = 0.001, n = 28), Asian (73.4% vs 56%, p < 0.001, n = 824), and Black (75% vs 60%, p < 0.001, n = 4005). HPE was received at more than one time point in RO in 75.7% of patients age 7-39, 76.4% 40-64, 71.2% 65-79, and 67.6% in those 80 and above, compared to 62.0%, 63.2%, 56.3%, and 49.2%, respectively in MO departments (p = <0.01). Standardization of HPE within RO increased delivery to patients across gender, race/ethnicity, age, and cancer diagnosis, particularly regarding number of educational touchpoints for patients in underserved populations based on race and age. Our results suggest that widespread standardization of HPE is likely to improve distribution of education to all patient groups and should be systematically supported.

The development of practice standards for patient education in nurse-led clinics: a mixed-method study

IntroductionEducating patients and families about self-care is one of the important roles of nurses in Nurse-led clinics (NLCs). NLCs need standards for guiding the practice of nurses. A standard is an authoritative statement that sets out the legal and professional basis of nursing practice. This paper seeks to report the development of practice standards for patient and family education in NLCs.MethodsThis project used a Sequential-Exploratory mixed methods design. Before the study, we conducted a literature review to identify gaps. Directed content analysis was used in phase 1. The second phase involved two focus groups. The third phase involves two rounds of modified Delphi.ResultsTwenty-nine participants were interviewed, and 1816 preliminary codes were formed in phase 1. 95 standards were grouped into three main categories (structure, process, and outcome). In the first focus group, experts eliminate 32 standards. Experts eliminate 8 standards after the second stage of the focus group. After two rounds of Delphi, the final version of the standard consists of 46 standards (13 structure, 28 process and 5 outcome).ConclusionsNurses and institutions could benefit from practice standards for patient education in the NLCs, which consist of 46 statements in three domains, as a guide for clinical activities and a tool to gauge the quality of patient education in NLCs. The developed standards in this study can guide new and existing NLCs and help them evaluate ongoing activities. Providing patient education in NLCs based on standards can improve patients’ outcomes and promote their health.

The impact of a pharmacist intervention on post-discharge hypnotic drug discontinuation in geriatric inpatients: a before-after study

BackgroundChronic use of hypnotic agents is prevalent in older adults, who as a result are at increased risk for certain adverse events, such as day-time drowsiness and falls. Multiple strategies to discontinue hypnotics have been tested in geriatric patients, but evidence remains scarce. Hence, we aimed to investigate a multicomponent intervention to reduce hypnotic drug use in geriatric inpatients.MethodsA before-after study was performed on the acute geriatric wards of a teaching hospital. The before group (= control group) received usual care, while intervention patients (= intervention group) were exposed to a pharmacist-led deprescribing intervention, comprising education of health care personnel, access to standardized discontinuation regimens, patient education and support of transitional care. The primary outcome was hypnotic drug discontinuation at one month after discharge. Secondary outcomes among others were sleep quality and hypnotic use at one and two weeks after enrolment and at discharge. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) upon inclusion, two weeks after enrolment and one month after discharge. Determinants for the primary outcome were identified using regression analysis.ResultsA total of 173 patients were enrolled, with 70.5% of patients taking benzodiazepines. Average age was 85 years (interquartile range 81–88.5) and 28.3% were male. A higher discontinuation rate at one month after discharge was observed in favour of the intervention (37.7% vs. 21.9%, p = 0.02281). No difference in sleep quality was found between both groups (p = 0.719). The average sleep quality was 8.74 (95% confidence interval (CI): 7.98–9.49) and 8.57 (95% CI: 7.75–9.39) in the control and intervention groups respectively. Determinants for discontinuation at one month were: the intervention (odds ratio (OR) 2.36, 95% CI: 1.14–4.99), fall on admission (OR 2.05; 95% CI: 0.95–4.43), use of a z-drug (OR 0.54, 95% CI: 0.23–1.22), PSQI score on admission (OR 1.08, 95% CI: 0.97–1.19) and discontinuation prior to discharge (OR 4.71, 95% CI: 2.26–10.17).ConclusionsA pharmacist-led intervention in geriatric inpatients was associated with a reduction of hypnotic drug use one month after discharge, without any loss in sleep quality.Trial registrationClinicalTrials.gov Identifier: NCT05521971 (retrospectively registered on 29th of August 2022).

Clinical study PEPCA : The effect of standardized preoperative patient education for patient-controlled regional analgesia on postoperative pain

Patient-controlled analgesia (PCA) is awell-established form of postoperative pain management. One form of administration is patient-controlled regional analgesia (PCRA), where local anesthetics are administered via peripheral regional catheters; however, a prerequisite is that the patients are instructed on its use. Amultitude of sources recommend that these instructions are given before surgery as preoperative training on pain management procedures has been shown to significantly reduce patients' postoperative pain and increase their well-being. The aim was to assess the effect of guideline-assisted preoperative patient education for PCRA on postoperative pain in patients undergoing orthopedic surgery compared to unstructured postoperative standard instructions. Acontrolled study with two randomized samples and apostinterventional survey was conducted. Overall, 73patients with PCRA catheters for orthopedic surgery were enrolled in the study. The 37participants in the interventional group (IG) received guideline-based structured instructions on PCRA use as well as ahandout immediately before the surgical intervention. The 36patients in the control group (CG) received postoperative instructions in the anesthesia recovery room. Pain was documented according to the numerical rating scale (NRS) at 2h (t1), 6h (t2), and 24h (t3) after surgery. There were no statistically significant differences in the average pain scores between the two groups; however, there were lower mean pain scores in the IG at t1 and t3. Asignificant reduction of pain in the IG could not be shown. Further studies concerning this topic with larger samples and adapted points in time are recommended.

Postoperative Restrictive Opioid Protocols and Durable Changes in Opioid Prescribing and Chronic Opioid Use

Changes in postsurgical opioid prescribing practices may help reduce chronic opioid use in surgical patients. To investigate whether postsurgical acute pain across different surgical subspecialties can be managed effectively after hospital discharge with an opioid supply of 3 or fewer days and whether this reduction in prescribed opioids is associated with reduced new, persistent opioid use. In this prospective cohort study with a case-control design, a restrictive opioid prescription protocol (ROPP) specifying an opioid supply of 3 or fewer days after discharge from surgery along with standardized patient education was implemented across all surgical services at a tertiary-care comprehensive cancer center. Participants were all patients who underwent surgery from August 1, 2018, to July 31, 2019. Main outcomes were the rate of compliance with the ROPP in each surgical service, the mean number of prescription days and refill requests, type of opioid prescribed, and rate of conversion to chronic opioid use determined via a state-run opioid prescription program. Postsurgical complications were also measured. A total of 4068 patients (mean [SD] age, 61.0 [13.8] years; 2528 women [62.1%]) were included, with 2017 in the pre-ROPP group (August 1, 2018, to January 31, 2019) and 2051 in the post-ROPP group (February 1, 2019, to July 31, 2019). The rate of compliance with the protocol was 95%. After implementation of the ROPP, mean opioid prescription days decreased from a mean (SD) of 3.9 (4.5) days in the pre-ROPP group to 1.9 (3.6) days in the post-ROPP group (P < .001). The ROPP implementation led to a 45% decrease in prescribed opioids after surgery (mean [SD], 157.22 [338.06] mean morphine milligram equivalents [MME] before ROPP vs 83.54 [395.70] MME after ROPP; P < .001). Patients in the post-ROPP cohort requested fewer refills (367 of 2051 [17.9%] vs 422 of 2017 [20.9%] in the pre-ROPP cohort; P = .02). There was no statistically significant difference in surgical complications. The conversion rate to chronic opioid use decreased following ROPP implementation among both opioid-naive patients with cancer (11.3% [143 of 1267] to 4.5% [118 of 2645]; P < .001) and those without cancer (6.1% [19 of 310] to 2.7% [16 of 600]; P = .02). In this cohort study, prescribing an opioid supply of 3 or fewer days to surgical patients after hospital discharge was feasible for most patients, led to a significant decrease in the number of opioids prescribed after surgery, and was associated with a significantly decreased conversion to long-term opioid use without concomitant increases in refill requests or significant compromises in surgical recovery.

Enhancing Self-Management of Percutaneous Endoscopic Gastrostomy Tubes Through the Implementation of a Standardized Education and Assessment Pathway: A Quality Improvement Initiative.

Intraduodenal infusion of levodopa-carbidopa intestinal gel by percutaneous endoscopic gastrostomy tube with jejunal extension is a treatment option to reduce motor and nonmotor complications in patients with advanced Parkinson's disease when oral therapy no longer provides sufficient benefit. Medication management is of central focus; however, there was no standardized patient education on stoma-site care and tube maintenance, leading to the development of stoma-site complications. As a quality improvement (QI) initiative, a standardized education and assessment pathway was developed and implemented in an urban academic outpatient clinic to enhance patient self-management and reduce stoma-site complications. A retrospective chart review was conducted to establish baseline incidence of cutaneous stoma-site complications. QI interventions were implemented using a rapid-cycle improvement model. Routine stoma assessments by a nurse who specializes in wound, ostomy, and continence care were implemented at set points, and patient education on PEG tube care and maintenance was reinforced at each session. Results demonstrated a significant reduction in moderate-to-severe tube and stoma-site-related complication. Implementation of a similar standardized education and assessment pathway in patients with percutaneous endoscopic gastrostomy tubes may lead to a decrease in stoma-site-related complications and overall better patient self-management.

Effectiveness of manual therapy, computerised mobilisation plus home exercise, and home exercise only in treating work-related neck pain: study protocol for a randomised controlled trial

BackgroundWork-related neck pain (WRNP) is a leading cause of disability and absenteeism. Patients with neck pain often have neck muscle tenderness and decreased cervical mobility, which are sometimes combined with psychosocial issues, such as pain catastrophising, thereby reducing their work ability. Whilst multidisciplinary treatments, including pharmacological interventions, manual therapy and specific neck exercises, have produced positive outcomes, effective personalised treatment modalities are still needed. Furthermore, manual therapies using the hands can bring fatigue to therapist. Occiflex is a computerised device that can provide personalised segmental joint mobilisation based on symptoms and injury of the patient and then provide a medium range of joint activities to improve range of cervical motion. This study aims to compare the effect of computerised mobilisation performed with Occiflex with that of traditional manual therapy on WRNP.MethodsWe will conduct a prospective randomised controlled trial including 150 patients with WRNP. These patients will be randomly assigned to one of three groups: (i) home exercise (TE), (ii) home exercise plus Occiflex therapy and (iii) home exercise plus manual therapy delivered by a physical therapist. Ten treatment sessions will be performed in four weeks. During the trial, these patients will receive only the assigned treatment and the standard patient education and will be asked not to use any analgesics unless strictly necessary. Assessments by trained evaluators will occur at baseline, week 4 and week 12. The primary outcome measures will include visual analogue scale (VAS) for pain and neck disability index (NDI) at each time point. Secondary outcome measures will include cervical range of motion (CROM), pressure pain threshold (PPT), global perceived effect (GPE) and sick leave. Group by time differences will be analysed using linear mixed models with repeated measures.DiscussionThis protocol describes the methods for a randomised controlled trial to compare the effectiveness of computerised versus manual mobilisation techniques in treating WRNP. The results will provide an alternative method (Occiflex) that is possibly effective for treating neck pain whilst minimising the manual work done by therapists.Trial registrationThe study protocol was retrospectively registered at http://www.chictr.org.cn (registration number: ChiCTR2100053076) on November 10, 2021.

A Novel Text Message Protocol to Improve Bowel Preparation for Outpatient Colonoscopies in Veterans.

The current gold standard for screening for colorectal cancer is colonoscopy, a procedure that depends on the quality of bowel preparation. In 2016, the Veterans Health Administration introduced Annie, a text message service to improve health care communication with patients. The Minneapolis Veterans Affairs Medical Center conducted a prospective, single center study to measure the impact of Annie text messaging on patient satisfaction and quality of bowel preparation for patients undergoing outpatient colonoscopy. Patients undergoing colonoscopy were divided into 2 groups. The control group received standardized patient education and a phone call prior to procedure. The intervention group, consisting of all patients who agreed to enroll, received a 6-day Annie text messaging protocol consisting of key bowel preparation steps that started 5 days prior to their scheduled procedure. Bowel preparation quality was measured using the Boston Bowel Preparation Scale (BBPS) score. During the study period, 688 veterans were scheduled for outpatient colonoscopy: 484 veterans were in the control group, 204 veterans were in the intervention group, and 126 were surveyed. Annie text messaging instructions were associated with a higher BBPS score (8.2) compared with usual care (7.8); P = .007 using independent t test, and P = .002 using parametric independent t test. Patients also reported satisfaction with the Annie text messaging service. There was a statistically significant improvement in the average BBPS score in veterans receiving Annie text messages compared with the routine care control group for outpatient colonoscopies.

Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial

BackgroundPlantar fasciopathy is the most common reason for complaints of plantar heel pain and one of the most prevalent musculoskeletal conditions with a reported lifetime incidence of 10%. The condition is normally considered self-limiting with persistent symptoms that often last for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. Heavy-slow resistance training and radiofrequency microtenotomy for the treatment of plantar fasciopathy have shown potentially positive effects on short- and long-term outcomes (> 3 months). However, the effect of heavy-slow resistance training compared with a radiofrequency microtenotomy treatment is currently unknown. This trial compares the efficacy of heavy-slow resistance training and radiofrequency microtenotomy treatment with supplemental standardized patient education and heel inserts in improving the Foot Health Status Questionnaire pain score after 6 months in patients with plantar fasciopathy.MethodsIn this randomized superiority trial, we will recruit 70 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of two groups: (1) heavy-slow resistance training, patient education and a heel insert (n = 35), and (2) radiofrequency microtenotomy treatment, patient education and a heel insert (n = 35). All participants will be followed for 1 year, with the 6-month follow-up considered the primary endpoint. The primary outcome is the Foot Health Status Questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a Global Perceived Effect scale, the physical activity level, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment.DiscussionBy comparing the two treatment options, we should be able to answer if radiofrequency microtenotomy compared with heavy-slow resistance training is superior in patients with plantar fasciopathy.Trial registrationClinicalTrials.gov NCT03854682. Prospectively registered on February 26, 2019.

Stress Management in Pre- and Postoperative Care Amongst Practitioners and Patients in Cardiac Catheterization Laboratory: A Study Protocol.

BackgroundAs the number of cardiac diseases continuously increases within the last years in modern society, so does cardiac treatment, especially cardiac catheterization. The procedure of a cardiac catheterization is challenging for both patients and practitioners. Several potential stressors of psychological or physical nature can occur during the procedure. The objective of the study is to develop and implement a stress management intervention for both practitioners and patients that aims to reduce the psychological and physical strain of a cardiac catheterization.MethodsThe clinical study (DRKS00026624) includes two randomized controlled intervention trials with parallel groups, for patients with elective cardiac catheterization and practitioners at the catheterization lab, in two clinic sites of the Ernst-von-Bergmann clinic network in Brandenburg, Germany. Both groups received different interventions for stress management. The intervention for patients comprises a psychoeducational video with different stress management technics and additional a standardized medical information about the cardiac catheterization examination. The control condition includes the in hospitals practiced medical patient education before the examination (usual care). Primary and secondary outcomes are measured by physiological parameters and validated questionnaires, the day before (M1) and after (M2) the cardiac catheterization and at a postal follow-up 6 months later (M3). It is expected that people with standardized information and psychoeducation show reduced complications during cardiac catheterization procedures, better pre- and post-operative wellbeing, regeneration, mood and lower stress levels over time. The intervention for practitioners includes a Mindfulness-based stress reduction program (MBSR) over 8 weeks supervised by an experienced MBSR practitioner directly at the clinic site and an operative guideline. It is expected that practitioners with intervention show improved perceived and chronic stress, occupational health, physical and mental function, higher effort-reward balance, regeneration and quality of life. Primary and secondary outcomes are measured by physiological parameters (heart rate variability, saliva cortisol) and validated questionnaires and will be assessed before (M1) and after (M2) the MBSR intervention and at a postal follow-up 6 months later (M3). Physiological biomarkers in practitioners will be assessed before (M1) and after intervention (M2) on two work days and a two days off. Intervention effects in both groups (practitioners and patients) will be evaluated separately using multivariate variance analysis.DiscussionThis study evaluates the effectiveness of two stress management intervention programs for patients and practitioners within cardiac catheter laboratory. Study will disclose strains during a cardiac catheterization affecting both patients and practitioners. For practitioners it may contribute to improved working conditions and occupational safety, preservation of earning capacity, avoidance of participation restrictions and loss of performance. In both groups less anxiety, stress and complications before and during the procedures can be expected. The study may add knowledge how to eliminate stressful exposures and to contribute to more (psychological) security, less output losses and exhaustion during work. The evolved stress management guidelines, training manuals and the standardized patient education should be transferred into clinical routines.

Development and evaluation of a patient education programme for children, adolescents, and young adults with differences of sex development (DSD) and their parents: study protocol of Empower-DSD

BackgroundDifferences in sexual development (DSD) are rare diseases, which affect the chromosomal, anatomical or gonadal sex differentiation. Although patient education is recommended as essential in a holistic care approach, standardised programmes are still lacking. The present protocol describes the aims, study design and methods of the Empower-DSD project, which developed an age-adapted multidisciplinary education programme to improve the diagnosis-specific knowledge, skills and empowerment of patients and their parents.MethodsThe new patient education programme was developed for children, adolescents and young adults with congenital adrenal hyperplasia, Turner syndrome, Klinefelter syndrome or XX-/or XY-DSD and their parents. The quantitative and qualitative evaluation methods include standardised questionnaires, semi-structured interviews, and participatory observation. The main outcomes (assessed three and six months after the end of the programme) are health-related quality of life, disease burden, coping, and diagnosis-specific knowledge. The qualitative evaluation examines individual expectations and perceptions of the programme. The results of the quantitative and qualitative evaluation will be triangulated.DiscussionThe study Empower-DSD was designed to reduce knowledge gaps regarding the feasibility, acceptance and effects of standardised patient education programmes for children and youth with DSD and their parents. A modular structured patient education programme with four generic and three diagnosis-specific modules based on the ModuS concept previously established for other chronic diseases was developed. The topics, learning objectives and recommended teaching methods are summarised in the structured curricula, one for each diagnosis and age group. At five study centres, 56 trainers were qualified for the implementation of the training programmes. A total of 336 subjects have been already enrolled in the study. The recruitment will go on until August 2022, the last follow-up survey is scheduled for February 2023. The results will help improve multidisciplinary and integrated care for children and youth with DSD and their families.Trial registrationGerman Clinical Trials Register, DRKS00023096. Registered 8 October 2020 – Retrospectively registered.

A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial.

BackgroundDiabetes self-management education and support (DSMES) is a crucial component of diabetes care associated with improved clinical, psychosocial, and behavioral outcomes. The American Association of Diabetes Care and Education Specialists, the American Diabetes Association, and the American Academy of Family Physicians all recommend DSMES yet accessing linguistically and culturally appropriate DSMES is challenging in rural areas. The Diabetes One-Day (D1D) program is an established DSMES group intervention that has not been adapted or evaluated in rural communities.ObjectiveThe specific aims of this paper are (1) to adapt the existing D1D program for use in rural communities, called rural D1D (R-D1D); and (2) to conduct a patient-level randomized controlled trial to examine the effects of R-D1D and standard patient education, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework.MethodsThis is a protocol for a pilot type II hybrid implementation-effectiveness trial of a culturally adapted virtual DSMES program for rural populations, R-D1D. We will use Boot Camp Translation, a process grounded in the principles of community-based participatory research, to adapt an existing DSMES program for rural populations, in both English and Spanish. Participants at 2 rural primary care clinics (4 cohorts of N=16 plus care partners, 2 in English and 2 in Spanish) will be randomized to the intervention or standard education control. The evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Patient-level effectiveness outcomes (hemoglobin A1c, diabetes distress, and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A1c test kit. Practice-level and patient-level acceptability and feasibility will be assessed using surveys and interviews.ResultsThis study is supported by the National Institute of Nursing. The study procedures were approved, and the adaptation processes have been completed. Recruitment and enrollment started in July 2021.ConclusionsTo our knowledge, this will be the first study to evaluate both effectiveness and implementation outcomes for virtually delivered DSMES, culturally adapted for rural populations. This research has implications for delivery to other rural locations where access to specialty diabetes care is limited.Trial RegistrationClinicalTrials.gov NCT04600622; https://clinicaltrials.gov/ct2/show/NCT04600622International Registered Report Identifier (IRRID)DERR1-10.2196/34255

Learning In 360 Degrees: The Use of Virtual Reality for Radiation Therapy Patient Education

Purpose: External beam radiation therapy (EBRT) is not well understood by the cancer patient population and this lack of understanding can increase anxiety around the procedure. Conventional written or verbal education may not provide patients with a clear picture of the complex technical aspects of EBRT treatment. Commercially available technologies such as Virtual Reality (VR) can immerse an individual in a 360degree virtual world and are increasingly being used to manage anxiety through exposure and education in various medical settings. The purpose of this study was to determine if the integration of a VR video depicting EBRT from the patient's point of view into conventional patient education decreases patient anxiety prior to treatment. Methods: The study population included patients having EBRT to the pelvis in a supine position. Participants were assigned to one of 3 study arms: Control, Early Intervention or Intervention. All participants completed the National Comprehensive Cancer Network's Distress Thermometer (DT) as a pre-intervention assessment of anxiety and received standard patient education. Participants in the Early Intervention and Intervention arms also watched the VR video. Early Intervention participants viewed the VR video 2 weeks prior to treatment at their CT planning appointment while Intervention participants viewed the VR video just prior to treatment on the day of their first treatment fraction appointment. All participants completed a post-intervention DT and a modified Cancer Treatment Survey (CaTS) on the first day of treatment after all education was completed. Descriptive statistics were calculated for all variables of interest. The primary endpoint of pre-post anxiety between groups was assessed using general linear mixed model for repeated measures. Results: 82 patients were approached to participate in this investigation, 61 consented and 4 withdrew. 19 participants were assigned to each of the 3 arms. Mean pre-intervention anxiety levels on the DT scale (0-10) were generally low and not significantly different between the three arms (Control X=2.4, SD=2.3; Early Intervention X=2.6, SD=2.0; Intervention X=2.1, SD=2.3). The difference between pre and post-intervention anxiety was not significant in the Control (p=0.92, SE=0.10) or the Early Intervention arms (p=0.69, SE=0.04). However, the difference between pre and post-intervention anxiety was statistically significant in the Intervention arm (p<0.01, SE=0.07) with post-intervention anxiety being lower (X=1.3, SD=1.4). Responses to Likert scale questions on the CaTS showed similar levels of satisfaction with education received in all arms. Conclusion: Participants in the Intervention arm reported significantly less anxiety on the first day of treatment following the VR video. This suggests VR is a valuable tool for reducing radiation treatment-related anxiety. However, timing is an important factor as the anxiety reducing effect was no longer observed when the VR video was viewed two weeks before the first radiation treatment.

The importance of shared meaning-making for sustainable knowledge translation and health literacy.

The aim of the present paper is to describe and discuss how recent theories about translation, bridging medical and humanistic understandings of knowledge translation, in the medical humanitiescan bring about a new understanding of health literacy in the context of patient education. We argue that knowledge translation must be understood as active engagement with contextual meaning, considering the understandings, interpretation, and expertise of both patient and health care provider (deconstruction of the distinction between biomedical and cultural knowledge). To illustrate our points, we will describe the case of Jim, a kidney transplant recipient who received standard patient education but lost the graft (the new kidney). If we apply Kristeva's view to this context, graft function is not merely biology but a complex biocultural fact. In this perspective, graft function is seen as a phenomenon that embraces translation between health as a biomedical phenomenon and healing as lived experience, and that opens for shared meaning-making processes between the patient and the health care provider. In Jim's case, this means that we need to rethink the approach to patient education in a way that encourages the patient's idiosyncratic way of thinking and experiencing, and to transform health information into a means for sustaining Jim's singular life - not biological life "in general." The patient education programme did not take into consideration the singularities of Jim's biographical temporality, with its changes in everyday life, priorities, attitudes, and values. Hence, we claim that health literacy should involve a simultaneous interrogation of the patients and the health professional's constructions of knowledge.