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Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol
Background
Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA.
Methods
We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics.
Discussion
This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences.
Trial registration
Clinicaltrials.gov
, NCT03985449. Registered 13 July 2019,
https://clinicaltrials.gov/ct2/show/NCT03985449
Journal Article
ACT made simple : an easy-to-read primer on acceptance and commitment therapy
\"Now fully-revised and updated, this second edition of ACT Made Simple includes new information and chapters on self-compassion, flexible perspective taking, working with trauma, and more. Why is it so hard to be happy? Why is life so difficult? Why do humans suffer so much? And what can we realistically do about it? No matter how rewarding your job, as a mental health professional, you may sometimes feel helpless in the face of these questions. You are also well aware of the challenges and frustrations that can present during therapy. If you're looking for ways to optimize your client sessions, consider joining the many thousands of therapists and life coaches worldwide who are learning acceptance and commitment therapy (ACT). With a focus on mindfulness, client values, and a commitment to change, ACT is proven-effective in treating depression, anxiety, stress, addictions, eating disorders, schizophrenia, borderline personality disorder (BPD), and myriad other psychological issues. It's also a revolutionary new way to view the human condition--packed full of exciting new tools, techniques, and strategies for promoting profound behavioral change. A practical primer, ideal for ACT newcomers and experienced ACT professionals alike, ACT Made Simple offers clear explanations of the six ACT processes and a set of real-world tips and solutions for rapidly and effectively implementing them in your practice. This book gives you everything you need to start using ACT with your clients for impressive results. Inside, you'll find: scripts, exercises, metaphors, and worksheets to use with your clients; a session-by-session guide to implementing ACT; transcripts from therapy sessions; guidance for creating your own therapeutic techniques and exercises; and practical tips to overcome \"therapy roadblocks.\" This book aims to take the complex theory and practice of ACT and make it accessible and enjoyable for therapists and clients\"-- Provided by publisher.
Book
Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II
Osteoporosis Choice, an encounter decision aid, can engage patients and clinicians in shared decision making about osteoporosis treatment. Its effectiveness compared to the routine provision to clinicians of the patient's estimated risk of fracture using the FRAX calculator is unknown.
Patient-level, randomized, three-arm trial enrolling women over 50 with osteopenia or osteoporosis eligible for treatment with bisphosphonates, where the use of Osteoporosis Choice was compared to FRAX only and to usual care to determine impact on patient knowledge, decisional conflict, involvement in the decision-making process, decision to start and adherence to bisphosphonates.
We enrolled 79 women in the three arms. Because FRAX estimation alone and usual care produced similar results, we grouped them for analysis. Compared to these, use of Osteoporosis Choice increased patient knowledge (median score 6 vs. 4, p = .01), improved understanding of fracture risk and risk reduction with bisphosphonates (p = .01 and p<.0001, respectively), had no effect on decision conflict, and increased patient engagement in the decision making process (OPTION scores 57% vs. 43%, p = .001). Encounters with the decision aid were 0.8 minutes longer (range: 33 minutes shorter to 3.0 minutes longer). There were twice as many patients receiving and filling prescriptions in the decision aid arm (83% vs. 40%, p = .07); medication adherence at 6 months was no different across arms.
Supporting both patients and clinicians during the clinical encounter with the Osteoporosis Choice decision aid efficiently improves treatment decision making when compared to usual care with or without clinical decision support with FRAX results.
clinical trials.gov NCT00949611.
Journal Article
Shared Treatment Decision Making Improves Adherence and Outcomes in Poorly Controlled Asthma
Abstract
Rationale
Poor adherence to asthma controller medications results in poor treatment outcomes.
Objectives
To compare controller medication adherence and clinical outcomes in 612 adults with poorly controlled asthma randomized to one of two different treatment decision-making models or to usual care.
Methods
In shared decision making (SDM), nonphysician clinicians and patients negotiated a treatment regimen that accommodated patient goals and preferences. In clinician decision making, treatment was prescribed without specifically eliciting patient goals/preferences. The otherwise identical intervention protocols both provided asthma education and involved two in-person and three brief phone encounters.
Measurements and Main Results
Refill adherence was measured using continuous medication acquisition (CMA) indices—the total days' supply acquired per year divided by 365 days. Cumulative controller medication dose was measured in beclomethasone canister equivalents. In follow-up Year 1, compared with usual care, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.46; P < 0.0001) and long-acting β-agonist adherence (CMA, 0.51 vs. 0.40; P = 0.0225); higher cumulative controller medication dose (canister equivalent, 10.9 vs. 5.2; P < 0.0001); significantly better clinical outcomes (asthma-related quality of life, health care use, rescue medication use, asthma control, and lung function). In Year 2, compared with usual care, SDM resulted in significantly lower rescue medication use, the sole clinical outcome available for that year. Compared with clinician decision making, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.59; P = 0.03) and long-acting β-agonist adherence (CMA, 0.51 vs. 0.41; P = 0.0143); higher cumulative controller dose (CMA, 10.9 vs. 9.1; P = 0.005); and quantitatively, but not significantly, better outcomes on all clinical measures.
Conclusions
Negotiating patients' treatment decisions significantly improves adherence to asthma pharmacotherapy and clinical outcomes.
Clinical trials registered with www.clinicaltrials.gov (NCT00217945 and NCT00149526).
Journal Article
Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care
Objective To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years.Design Three year follow-up of a multicentre cluster randomised controlled trial in primary care, with randomisation at practice level.Setting 207 general practices in 13 primary care sites in the United Kingdom.Participants 731 of the 824 participants included in the original trial were eligible for follow-up. Biomedical data were collected on 604 (82.6%) and questionnaire data on 513 (70.1%) participants.Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care.Main outcome measures The primary outcome was glycated haemoglobin (HbA1c) levels. The secondary outcomes were blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, emotional impact of diabetes, and drug use at three years.Results HbA1c levels at three years had decreased in both groups. After adjusting for baseline and cluster the difference was not significant (difference −0.02, 95% confidence interval −0.22 to 0.17). The groups did not differ for the other biomedical and lifestyle outcomes and drug use. The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years (P<0.01). Depression scores and quality of life did not differ at three years.Conclusion A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs. Trial registration Current Controlled Trials ISRCTN17844016.
Journal Article
Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention
ObjectiveTo evaluate the efficacy of the Patient Reporting and Action for a Safe Environment intervention.DesignA multicentre cluster randomised controlled trial.SettingClusters were 33 hospital wards within five hospitals in the UK.ParticipantsAll patients able to give informed consent were eligible to take part. Wards were allocated to the intervention or control condition.InterventionThe ward-level intervention comprised two tools: (1) a questionnaire that asked patients about factors contributing to safety (patient measure of safety (PMOS)) and (2) a proforma for patients to report both safety concerns and positive experiences (patient incident reporting tool). Feedback was considered in multidisciplinary action planning meetings.MeasurementsPrimary outcomes were routinely collected ward-level harm-free care (HFC) scores and patient-level feedback on safety (PMOS).ResultsIntervention uptake and retention of wards was 100% and patient participation was high (86%). We found no significant effect of the intervention on any outcomes at 6 or 12 months. However, for new harms (ie, those for which the wards were directly accountable) intervention wards did show greater, though non-significant, improvement compared with control wards. Analyses also indicated that improvements were largest for wards that showed the greatest compliance with the intervention.LimitationsAdherence to the intervention, particularly the implementation of action plans, was poor. Patient safety outcomes may represent too blunt a measure.ConclusionsPatients are willing to provide feedback about the safety of their care. However, we were unable to demonstrate any overall effect of this intervention on either measure of patient safety and therefore cannot recommend this intervention for wider uptake. Findings indicate promise for increasing HFC where wards implement ≥75% of the intervention components.Trial registration numberISRCTN07689702; pre-results.
Journal Article
The Impact of Health Literacy on Desire for Participation in Healthcare, Medical Visit Communication, and Patient Reported Outcomes among Patients with Hypertension
ABSTRACT
BACKGROUND
Low health literacy (HL) is associated with poor healthcare outcomes; mechanisms for these associations remain unclear.
OBJECTIVE
To elucidate how HL influences patients’ interest in participating in healthcare, medical visit communication, and patient reported visit outcomes.
DESIGN, SETTING, AND PATIENTS
Cross-sectional study of enrollment data from a randomized controlled trial of interventions to improve patient adherence to hypertension treatments. Participants were 41 primary care physicians and 275 of their patients. Prior to the enrollment visit, physicians received a minimal intervention or communication skills training and patients received a minimal intervention or a pre-visit coaching session. This resulted in four intervention groups (minimal patient/minimal physician; minimal patient/intensive physician; intensive patient/minimal physician; and intensive patient/intensive physician).
MEASUREMENTS
Rapid Estimate of Adult Literacy in Medicine; patients’ desire for involvement in decision making; communication behaviors; patient ratings of participatory decision making (PDM), trust, and satisfaction.
RESULTS
A lower percentage of patients with low versus adequate literacy had controlled blood pressure. Both groups were similarly interested in participating in medical decision making. Communication behaviors did not differ based on HL except for medical question asking by patients, which was lower among low literacy patients. This was particularly true in the intensive patient /intensive physician group (3.85 vs. 6.42 questions;
p
= 0.002). Overall, ratings of care didn’t differ based on HL; however, in analyses stratified by intervention assignment, patients with low literacy in minimal physician intervention groups reported significantly lower PDM scores than adequate literacy patients.
CONCLUSIONS
Patients with low and adequate literacy were similarly interested in participating in medical decision making. However, low literacy patients were less likely to experience PDM in their visits. Low literacy patients in the intensive physician intervention groups asked fewer medical questions. Patients with low literacy may be less able to respond to physicians’ use of patient-centered communication approaches than adequate literacy patients.
Journal Article
Enhanced Support For Shared Decision Making Reduced Costs Of Care For Patients With Preference-Sensitive Conditions
Shared decision making is an approach to care that seeks to fully inform patients about the risks and benefits of available treatments and engage them as participants in decisions about the treatments. Although recent federal and state policies pursue the expanded use of shared decision making as a way to improve care quality and patient experience, payers and providers want evidence that this emerging model of care is cost-effective. We examined data obtained from a yearlong randomized investigation. The study compared the effects on patients of receiving a usual level of support in making a medical treatment decision with the effects of receiving enhanced support, which included more contact with trained health coaches through telephone, mail, e-mail, and the Internet. We found that patients who received enhanced support had 5.3 percent lower overall medical costs than patients who received the usual level of support. The enhanced-support group had 12.5 percent fewer hospital admissions than the usual-support group, and 9.9 percent fewer preference-sensitive surgeries, including 20.9 percent fewer preference-sensitive heart surgeries. These findings indicate that support for shared decision making can generate savings. They also suggest that a \"remote\" model of support-combining telephonic coaching with decision aids, for example-may constitute a relatively low-cost and effective intervention that could reach broader populations without the need for the direct involvement of regular medical care team members. [PUBLICATION ABSTRACT]
Journal Article
Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial
Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known.
To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes.
Pragmatic cluster randomized trial.
A total of 1060 adults with type 2 diabetes in 22 primary care practices.
Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors).
Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models.
Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions.
Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order.
NCT03590041.
Journal Article