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Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial.

ABSTRACT: Beside traditional outcomes of safety and (cost-)effectiveness, the Institute of Medicine states patient-centeredness as an independent outcome indicator to evaluate the quality of healthcare. Providing patient-centered care is important because patients want to be heard for their ideas and concerns. Healthcare areas associated with high emotions and intensive treatment periods could especially benefit from patient-centered care. How care can become optimally improved in patient-centeredness is unknown. Therefore, we will conduct a study in the context of Dutch fertility care to determine the effects of a multifaceted approach on patient-centeredness, patients' quality of life (QoL) and levels of distress. Our aims are to investigate the effectiveness of a multifaceted approach and to identify determinants of a change in the level of patient-centeredness, patients' QoL and distress levels. This paper presents the study protocol.In a cluster-randomized trial in 32 Dutch fertility clinics the effects of a multifaceted approach will be determined on the level of patient-centeredness (Patient-centredness Questionnaire - Infertility), patients' QoL (FertiQoL) and levels of distress (SCREENIVF). The multifaceted approach includes audit and feedback, educational outreach visits and patient-mediated interventions. Potential determinants of a change in patient-centeredness, patients' QoL and levels of distress will be collected by an addendum to the patients' questionnaire and a professionals' questionnaire. The latter includes the Organizational Culture Assessment Instrument about the clinic's culture as a possible determinant of an increase in patient-centered care.The study is expected to yield important new evidence about the effects of a multifaceted approach on levels of patient-centeredness, patients' QoL and distress in fertility care. Furthermore, determinants associated with a change in these outcome measures will be studied. With knowledge of these results, patient-centered care and thus the quality of healthcare can be improved. Moreover, the results of this study could be useful for similar initiatives to improve the quality of care delivery. The results of this project are expected at the end of 2013.Clinicialtrials.gov NCT01481064.

SUBMITTER: Huppelschoten AG

PROVIDER: S-EPMC3489822 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial.

Huppelschoten Aleida G AG van Duijnhoven Noortje T L NT Hermens Rosella P M G RP Verhaak Chris C Kremer Jan A M JA Nelen Willianne L D M WL

Trials 20120924

<h4>Background</h4>Beside traditional outcomes of safety and (cost-)effectiveness, the Institute of Medicine states patient-centeredness as an independent outcome indicator to evaluate the quality of healthcare. Providing patient-centered care is important because patients want to be heard for their ideas and concerns. Healthcare areas associated with high emotions and intensive treatment periods could especially benefit from patient-centered care. How care can become optimally improved in patie ...[more]

PMID: 23006997

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Project description:PURPOSE:Although the relevance of interprofessional teamwork in the delivery of patient-centered care is well known, there is a lack of interventions for improving team interaction in the context of rehabilitation in Germany. The aim of the present study is to evaluate whether a specially developed team coaching concept (TCC) could improve both teamwork and patient-centeredness. METHOD:A multicenter, cluster-randomized controlled intervention study was conducted with both staff and patient questionnaires. Data was collected at ten German rehabilitation clinics (five clusters) of different indication fields before (t1) and after (t2) the intervention. Intervention clinics received the TCC, while control clinics did not receive any treatment. Staff questionnaires were used to measure internal participation and other aspects of teamwork, such as team organization, while patient questionnaires assessed patient-centeredness. A multivariate analysis of variance was applied for data analysis. RESULTS:In order to analyze the effect of TCC on internal participation and teamwork, 305 questionnaires were included for t1 and 213 for t2 in the staff survey. In the patient survey, 523 questionnaires were included for t1 and 545 for t2. The TCC improved team organization, willingness to accept responsibility and knowledge integration according to staff, with small effect sizes (univariate: ?2=.010-.017), whereas other parameters including internal participation, team leadership and cohesion did not improve due to the intervention. The patient survey did not show any improvements on the assessed dimensions. CONCLUSION:The TCC improved dimensions that were addressed directly by the approach and were linked to the clinics' needs, such as restructured team meetings and better exchange of information. The TCC can be used to improve team organization, willingness to accept responsibility, and knowledge integration in rehabilitation practice, but some further evaluation is needed to understand contextual factors and processes regarding the implementation of the intervention.

Project description:BackgroundUnwarranted variability in clinical practice is a challenging problem in practice today, leading to poor outcomes for patients and low-value care for providers, payers, and patients.ObjectiveIn this study, we introduced a novel tool, QualityIQ, and determined the extent to which it helps primary care physicians to align care decisions with the latest best practices included in the Merit-Based Incentive Payment System (MIPS).MethodsWe developed the fully automated QualityIQ patient simulation platform with real-time evidence-based feedback and gamified peer benchmarking. Each case included workup, diagnosis, and management questions with explicit evidence-based scoring criteria. We recruited practicing primary care physicians across the United States into the study via the web and conducted a cross-sectional study of clinical decisions among a national sample of primary care physicians, randomized to continuing medical education (CME) and non-CME study arms. Physicians "cared" for 8 weekly cases that covered typical primary care scenarios. We measured participation rates, changes in quality scores (including MIPS scores), self-reported practice change, and physician satisfaction with the tool. The primary outcomes for this study were evidence-based care scores within each case, adherence to MIPS measures, and variation in clinical decision-making among the primary care providers caring for the same patient.ResultsWe found strong, scalable engagement with the tool, with 75% of participants (61 non-CME and 59 CME) completing at least 6 of 8 total cases. We saw significant improvement in evidence-based clinical decisions across multiple conditions, such as diabetes (+8.3%, P<.001) and osteoarthritis (+7.6%, P=.003) and with MIPS-related quality measures, such as diabetes eye examinations (+22%, P<.001), depression screening (+11%, P<.001), and asthma medications (+33%, P<.001). Although the CME availability did not increase enrollment in the study, participants who were offered CME credits were more likely to complete at least 6 of the 8 cases.ConclusionsAlthough CME availability did not prove to be important, the short, clinically detailed case simulations with real-time feedback and gamified peer benchmarking did lead to significant improvements in evidence-based care decisions among all practicing physicians.Trial registrationClinicalTrials.gov NCT03800901; https://clinicaltrials.gov/ct2/show/NCT03800901.

Project description:Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice.The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland. A total of 110 patients are being recruited and randomized to TBC (TBC: N?=?55) or usual care group (UC: N?=?55). Patients allocated to the TBC group receive the TBC intervention conducted by an interprofessional team, involving an ambulatory clinic nurse, a community pharmacist and a physician. A nurse and a community pharmacist meet patients every 6 weeks to measure BP, to assess lifestyle, to estimate medication adherence, and to provide education to the patient about disease, treatment and lifestyle. After each visit, the nurse and pharmacist write a summary report with recommendations related to medication adherence, lifestyle, and changes in therapy. The physician then adjusts antihypertensive therapy accordingly. Patients in the UC group receive usual routine care without sessions with a nurse and a pharmacist. The primary outcome is the difference in daytime ambulatory BP between TBC and UC patients at 6-month of follow-up. Secondary outcomes include patients' and healthcare professionals' satisfaction with the TBC intervention and BP control at 12 months (6 months after the end of the intervention).This ongoing study aims to evaluate the effect of a newly developed team-based care intervention engaging different healthcare professionals on BP control in a primary care setting in Switzerland. The results will inform policymakers on implementable strategies for routine clinical practice.ClinicalTrials.gov registration: NCT02511093 . Retrospectively registered on 28 July 2015.

Project description:BackgroundMore than half of the unaccompanied young refugees (UYRs) resettled in Europe report elevated levels of posttraumatic stress symptoms (PTSS) and comorbid symptoms. Earlier studies have highlighted the effectiveness of the trauma-focused preventive group intervention "Mein Weg" (English "My Way"), and the feasibility of trauma-focused cognitive behavioral therapy (TF-CBT) for UYRs. Both interventions are deemed to be empirically supported treatments (ESTs). However, UYRs seldom receive ESTs or, in fact, any treatment at all. In view of the high need and the limited treatment resources available, a stepped-care approach is indicated but has not been evaluated so far. The purpose of this trial is to compare the stepped-care approach BETTER CARE with usual care enhanced with screening and indication (usual care+).MethodsIn a cluster randomized controlled trial involving N = 540 UYRs living in up to N = 54 child and youth welfare service (CYWS) facilities, BETTER CARE will be compared with usual care+. We will randomize clusters comprising a CYWS facility with at least one eligible psychotherapist. BETTER CARE consists of step (1) screening and indication and either step (2) preventive trauma-focused group intervention "Mein Weg" delivered by trained CYWS staff or step (3) TF-CBT delivered by trained community therapists and supported by trained translators if necessary. Participants will be assessed 6 and 12 months after randomization. The primary outcome is the severity of PTSS after 12 months. Secondary outcomes are depressive and anxiety symptoms, quality of life, and proxy reported PTSS. Furthermore, drug use, health costs, benefits, and long-term effects on integration/acculturation will be assessed.DiscussionThe trial will directly integrate a stepped-care approach into existing structures of the German child welfare and (mental) health system. It could, therefore, serve as a blueprint for how to implement ESTs for UYRs. If successful, screening, prevention, and intervention will be sustainably implemented in CYWS in southern Germany.Trial registrationGerman Clinical Trials Register DRKS00017453 . Registered on 11 December 2019.

Project description:BackgroundAlthough the postpartum period poses substantial risks and can result in significant maternal morbidity and mortality, postpartum care of the mother receives much less attention in transitional countries.ObjectiveWe describe the protocol for a randomized controlled trial to implement and evaluate a postpartum care delivery model titled Focused-PPC (Focused Postpartum Care).MethodsFocused-PPC is an integrated group postpartum care model that meets the clinical care, education, and support needs of mothers up to 1 year after birth. The Focused-PPC intervention is a parallel randomized controlled trial with a total of 192 postpartum women at 4 health centers in Tamale, Ghana. Participants will be randomized into 1 of 2 trial arms at a 1:1 allocation ratio: (1) the control arm, which receives the standard postnatal care currently delivered in health facilities, or (2) the intervention arm, which receives the Focused-PPC model of care. Women enrolled in the intervention arm will receive postpartum clinical assessments and education for the first 6 weeks and will continue to receive education, measures of vital signs, and peer support for 12 months post partum during child welfare visits. Led by trained midwives, each postpartum group in the intervention arm will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year post partum, following the Ghana Health Service postnatal care schedule.ResultsThe Focused-PPC guide, data collection tools, and audiovisual education materials were successfully developed and translated into the local language. We have enrolled and conducted baseline surveys for 192 women (sample size met) in the Focused-PPC trial who have been randomized into intervention and control arms. We have established a total of 12 Focused-PPC groups in the intervention arm, 3 groups from each site, all of which have sessions underway.ConclusionsFocused-PPC has the potential to change the postpartum care delivery model in Ghana and other countries in sub-Saharan Africa and beyond.Trial registrationClinicalTrials.gov NCT05280951; https://clinicaltrials.gov/study/NCT05280951.International registered report identifier (irrid)DERR1-10.2196/47519.

Project description:Hospital malnutrition is an underestimated problem and as many as half of malnourished patients do not receive appropriate treatment. In order to extend the management of malnutrition in health care facilities, multidisciplinary teams focusing on clinical nutrition were established in France. The establishment of such teams within hospital facilities remains nonetheless difficult. We have consequently developed a multifaceted intervention coordinated by a Nutritional Support Team (NST). Our study aims to evaluate the impact of this multifaceted intervention coordinated by a NST, in adherence to recommended practices for the care of malnourished children, among health care workers of a paediatric university hospital.We carried out 1) a six-month observational phase focusing on the medical care procedures relative to malnourished children followed by 2) a cluster randomised controlled trial phase to evaluate the impact of a multidisciplinary nutrition team over an 18 month time frame.Based on power analyses and assuming a conservative intracluster correlation coefficient, 1289 children were needed to detect a 25% difference in rates between the two groups of the cluster trial.The implementation of our intervention was coordinated by the NST and had three major components: a) access to a computerised malnutrition screening system associated with an automatic alert system, b) an awareness campaign directed toward the health care workers and c) a leadership based strategy.Main outcomes included the number of daily weighings during hospitalisation, the investigation of malnutrition etiology and the management of malnutrition by a dietician and/or the NST.Due to the clustered nature of the data with children nested in departments, a generalized estimated equations approach will be used to analyse the impact of the multifaceted intervention on primary and secondary outcomes.Our results will provide an overall response regarding the effectiveness of our multifaceted intervention and we should be able to suggest an organization and mode of operation of NST.ClinicalTrials.gov: NCT01081587.

Project description:BackgroundMy Diabetes Care (MDC) is a multi-faceted intervention embedded within an established patient portal, My Health at Vanderbilt. MDC is designed to help patients better understand their diabetes health data and support self-care. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, provides literacy-level appropriate educational resources, and links to a diabetes online patient support community and diabetes news feeds.ObjectiveThis study aims to evaluate the effects of MDC on patient activation in adult patients with type 2 diabetes mellitus. Moreover, we plan to assess secondary outcomes, including system use and usability, and the effects of MDC on cognitive and behavioral outcomes (eg, self-care and self-efficacy).MethodsWe are conducting a 6-month, 2-arm, parallel-design, pragmatic pilot randomized controlled trial of the effect of MDC on patient activation. Adult patients with type 2 diabetes mellitus are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, are able to speak and read in English, are 21 years or older, and have an existing My Health at Vanderbilt account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long-term care facilities, patients with known cognitive deficits or severe visual impairment, and patients currently participating in any other diabetes-related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data, including the Patient Activation Measure (R) at baseline, 3 months, and 6 months. We will use mixed-effects regression models to estimate potentially time-varying intervention effects while adjusting for the baseline measure of the outcome. The mixed-effects model will use fixed effects for patient-level characteristics and random effects for health care provider variables (eg, primary care physicians).ResultsThis study is ongoing. Recruitment was closed in May 2020; 270 patients were randomized. Of those randomized, most (214/267, 80.1%) were non-Hispanic White, and 13.1% (35/267) were non-Hispanic Black, 43.7% (118/270) reported being 65 years or older, and 33.6% (90/268) reported limited health literacy. We obtained at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment.ConclusionsThis randomized controlled trial will be one of the first to evaluate a patient-facing diabetes digital health intervention delivered via a patient portal. By embedding MDC into Epic's MyChart platform with more than 127 million patient records, our intervention is directly integrated into routine care, highly scalable, and sustainable. Our findings and evolving patient portal functionality will inform the continued development of MDC to best meet users' needs and a larger trial focused on the impact of MDC on clinical end points.Trial registrationClinicalTrials.gov NCT03947333; https://clinicaltrials.gov/ct2/show/NCT03947333.International registered report identifier (irrid)DERR1-10.2196/25955.

Dataset Information

Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial.

Publications

Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial.

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