Safer Prescribing and Care for the Elderly (SPACE): Protocol of a Cluster Randomized Controlled Trial in Primary Care.
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SUBMITTER: Wallis KA
PROVIDER: S-EPMC5945992 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting.MethodsTOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination).ResultsPCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs).ConclusionsCDC-guideline adherence can be promoted and measured, and is not associated with worsening of outcomes for people with HIV receiving LTOT for CP. Future work would be needed to document scalability of these results and to determine whether CDC-guideline adherence results in a positive effect on public health. Trial registration https://clinicaltrials.gov/ct2/show/NCT03669939 . Registration date: 9/13/2018.
| S-EPMC9108346 | biostudies-literature
Project description:Routine assessment of women's pregnancy intentions and contraceptive use-a so-called contraceptive vital sign-may help primary care physicians identify patients who need preconception or contraceptive counseling and be of particular benefit when teratogenic medications are prescribed.We conducted a cluster-randomized controlled trial to evaluate the effect of a contraceptive vital sign on primary care documentation of contraceptive use and change in primary care physicians' provision of family planning services. Academic internists in the intervention group (n = 26) were provided with information on their female patients' pregnancy intentions and contraceptive use immediately before visits; internists in the control group (n = 27) received only standard intake information. Data were abstracted from the electronic health record for 5,371 visits by 2,304 women aged 18 to 50 years.Documentation of contraception increased from baseline, from 23% to 57% in the intervention group, but remained 28% in the control group, a change of +77.4 (95% confidence interval [CI], 70.7 to 84.1) adjusted percentage points in the former vs +3.1 (95% CI, 1.2 to 5.0) in the latter (P <.001). For visits involving a teratogenic prescription, documentation increased from 14% to 48% in the intervention group and decreased from 29% to 26% in the control group, a change of +61.5 (95% CI, 35.8 to 87.1) adjusted percentage points in the former vs -0.3 (95% CI, -4.3 to 3.6) in the latter (P <.001). Provision of new family planning services increased only minimally with this intervention, however. When women with documented nonuse of contraception were prescribed potential teratogens, only 7% were provided family planning services.A contraceptive vital sign improves documentation of contraceptive use; however, ongoing efforts are needed to improve provision of preconception and contraceptive services.
| S-EPMC3495925 | biostudies-literature
Project description:BACKGROUND:Asthma is the most common chronic condition in children. For many, the disease is inadequately controlled, which can burden the lives of children and their families as well as the health care system. Improved use of the best available scientific evidence by primary care practitioners could reduce the need for hospital care and improve quality of life and asthma control, thereby reducing overall costs to society and families. OBJECTIVE:The Primary Care Pathway for Childhood Asthma aims to improve the management of children with asthma by (1) providing primary care practitioners with an electronic guide (a clinical pathway) incorporated into the patient's electronic medical record, and (2) providing train-the-trainer education to chronic disease management health professionals to promote the provision of asthma education in primary care. METHODS:The research will utilize a pragmatic cluster-controlled design, quantitative and qualitative research methodologies, and economic evaluation to assess the implementation of a pathway and education intervention in primary care. The intervention will be analyzed for effectiveness, and if the results are positive, a strategy will be developed to implement delivery to all primary care practices in Alberta. RESULTS:The research has been successfully funded and ethics approvals have been obtained. Practice recruitment began fall 2015, and we expect all study-related activities to be concluded by March 2018. CONCLUSIONS:The proposed pathway and education intervention has the potential to improve pediatric asthma management in Alberta. The intervention is anticipated to result in better quality of care for equal or lesser cost. CLINICALTRIAL:ClinicalTrials.gov NCT02481037; https://clinicaltrials.gov/ct2/show/NCT02481037 (Archived by WebCite at http://www.webcitation.org/6fPIQ02Ma).
| S-EPMC4804104 | biostudies-literature
Project description:PurposeAlthough diabetes care guidelines recommend paying attention to oral health, the effect on daily practice has been limited, and patients with diabetes have yet to benefit. We investigated whether implementation of an oral care protocol for general practitioners (GPs [family physicians]) can improve patient-centered outcomes for patients with type 2 diabetes.MethodsTwenty-four GP offices were randomly assigned to the experimental or control group (12 offices each). In the experimental group, GPs and nurse practitioners implemented an oral care protocol. No extra attention was given to oral health in the control group. The primary outcome parameter was oral health-related quality of life (QoL) assessed with the 14-item Oral Health Impact Profile at baseline and 1 year later. Other outcomes were self-reported oral health complaints and general health-related QoL (36-item Short Form Health Survey).ResultsOf 764 patients with type 2 diabetes, 543 (71.1%) completed the 1-year follow-up. More patients reported improved oral health-related QoL in the experimental group (35.2%) compared to the control group (25.9%) (P = .046; P adj = .049). In a secondary post hoc analysis including GP offices with ≥60% patient follow-up (n = 18), improvement was 38.3% and 24.9%, respectively (P and P adj = .011). Improvement of self-reported oral health complaints did not differ between groups. The intervention had no effect on general health-related QoL, with the exception of the concept scale score for changes in health over time (P adj = .033).ConclusionsImplementation of an oral care protocol in primary diabetes care improved oral health-related QoL in patients with type 2 diabetes.
| S-EPMC8118494 | biostudies-literature
Project description:ObjectivesTo assess the effectiveness of a pharmacist-led systematic review of medications on: potentially inappropriate medications (PIM), health outcomes and costs.DesignProspective, open, controlled and cluster-randomized clinical trial.SettingSix primary care clinics from Balearic Islands.ParticipantsForty-two clusters (21 per group), and 549 patients aged ≥65 years and ≥5 chronic medications were included; of which 277 were allocated to Intervention Group (IG) and 272 to Control Group (CG). Patients were excluded if they were: institutionalized, temporarily displaced, routinely monitored under private healthcare, or home care.InterventionPIM detection by the pharmacist using a combination of explicit and implicit methods; and communication of the most appropriate therapeutic strategies to the physician.MeasurementsProportion of patients with PIM and mean number of PIM/patient (main outcomes); and morbidity, mortality, and costs (secondary outcomes) were assessed.Statistical planFollowing an intention-to-treat approach, quantitative and qualitative outcomes variables were compared by T-Student and Chi-square tests, respectively. Results were providing as difference in proportions for qualitative outcomes and difference in means for quantitative outcomes with respective 95% confidence intervals (95% CI).ResultsAfter intervention, proportion of patients with PIM decreased by 13.7% (95% CI: 9.3; 18.2) more in IG than CG. Mean number of PIM/patient and mean cost of PIM/patient decreased by 0.43 (95% CI: 0.32; 0.54) and 72.11€ (95% CI: 26.15; 118.06) more in IG than CG, respectively. However, no statistically significant differences were observed in morbidity, mortality or costs of healthcare resources.ConclusionsPIM detection and recommendations provided by pharmacist could contribute to reduce significantly PIM and drug expenditure; but without reaching statistically significant differences in morbidity, mortality, and healthcare resources costs.
| S-EPMC8424444 | biostudies-literature
Project description:BackgroundA gap exists between evidence and practice regarding the management of cardiovascular risk factors. This gap could be narrowed if systematically developed clinical practice guidelines were effectively implemented in clinical practice. We evaluated the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease.Methods and findingsWe conducted a cluster-randomized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practices in two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders linked to the medical record system. Pharmacists conducted the visits. Outcomes were measured for all eligible patients seen in the participating practices during 1 y before and after the intervention. The main outcomes were the proportions of (1) first-time prescriptions for hypertension where thiazides were prescribed, (2) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and (3) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals. The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug. Thiazides were prescribed to 17% of patients in the intervention group versus 11% in the control group (relative risk 1.94; 95% confidence interval 1.49-2.49, adjusted for baseline differences and clustering effect). Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.ConclusionsOur tailored intervention had a significant impact on prescribing of antihypertensive drugs, but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care.
| S-EPMC1472695 | biostudies-literature
Project description:IntroductionHigh-risk prescribing in primary care is common and causes considerable harm. Feedback interventions to improve care are attractive because they are relatively cheap to widely implement. There is good evidence that feedback has small to moderate effects, but the most recent Cochrane review called for more high-quality, large trials that explicitly test different forms of feedback.Methods and analysisThe study is a three-arm cluster-randomised trial with general practices being randomised and outcomes measured at patient level. 262 practices in three Scottish Health Board areas have been randomised (94% of all possible practices). The two active arms receive different forms of prescribing safety data feedback, with rates of high-risk prescribing compared with a 'usual care' arm. Sample size estimation used baseline data from participating practices. With 85 practices randomised to each arm, then there is 93% power to detect a 25% difference in the percentage of high-risk prescribing (from 6.1% to 4.5%) between the usual care arm and each intervention arm. The primary outcome is a composite of six high-risk prescribing measures (antipsychotic prescribing to people aged ≥75 years; non-steroidal anti-inflammatory drug (NSAID) prescribing to people aged ≥75 without gastroprotection; NSAID prescribing to people prescribed aspirin/clopidogrel without gastroprotection; NSAID prescribing to people prescribed an ACE inhibitor/angiotensin receptor blocker and a diuretic; NSAID prescription to people prescribed an oral anticoagulant without gastroprotection; aspirin/clopidogrel prescription to people prescribed an oral anticoagulant without gastroprotection). The primary analysis will use multilevel modelling to account for repeated measurement of outcomes in patients clustered within practices.Ethics and disseminationThe study was reviewed and approved by the NHS Tayside Committee on Medical Research Ethics B (11/ES/0001). The study will be disseminated via a final report to the funder with a publicly available research summary, and peer reviewed publications.Trial registrationClinicalTrials.gov, dossier number NCT01602705.
| S-EPMC3533102 | biostudies-literature
Project description:BackgroundElders living with polypharmacy may be taking medications that do not benefit them. Polypharmacy can be associated with elevated risks of poor health, reduced quality of life, high care costs, and persistently complex care needs. While many medications could be problematic, this project targets medications that should be deprescribed for most elders and for which guidelines and evidence-based deprescribing tools are available. These are termed potentially inappropriate prescriptions (PIPs) and are as follows: proton pump inhibitors, benzodiazepines, antipsychotics, and sulfonylureas. Implementation strategies for deprescribing PIPs in complex older patient populations are needed.MethodsThis will be a pragmatic cluster randomized controlled trial in community-based primary care practices across Canada. Eligible practices provide comprehensive primary care and have at least one physician that consents to participate. Community-dwelling patients aged 65 years and older with ten or more unique medication prescriptions in the past year will be included. The objective is to assess whether the intervention reduces targeted PIPs for these patients compared with usual care. The intervention, Structured Process Informed by Data, Evidence and Research (SPIDER), is a collaboration between quality improvement (QI) and research programs. Primary care teams will form interprofessional Learning Collaboratives and work with QI coaches to review electronic medical record data provided by their regional Practice Based Research Networks (PBRNs), identify areas of improvement, and develop and implement changes. The study will be tested for feasibility in three PBRNs (Toronto, Montreal, and Edmonton) using prospective single-arm mixed methods. Findings will then guide a pragmatic cluster randomized controlled trial in five PBRNs (Calgary, Winnipeg, Ottawa, Montreal, and Halifax). Seven practices per PBRN will be recruited for each arm. The analysis will be by intention to treat. Ten percent of patients who have at least one PIP at baseline will be randomly selected to participate in the assessment of patient experience and self-reported outcomes. Qualitative methods will be used to explore patient and physician experience and evaluate SPIDER's processes.ConclusionWe are testing SPIDER in a primary care population with complex care needs. This could provide a widely applicable model for care improvement.Trial registrationClinicaltrials.gov NCT03689049 ; registered September 28, 2018.
| S-EPMC6551894 | biostudies-literature
Project description:Young children are prone to low levels of physical activity in childcare. Researchers have identified that preschoolers tend to be more active outdoors than indoors, with higher activity levels occurring during the first 10 minutes of outdoor playtime. Additionally, interventions incorporating either staff training or the inclusion of play equipment have been effective at increasing children's activity in this setting. As such, the overarching objective of the Supporting Physical Activity in the Childcare Environment (SPACE) intervention is to improve the physical activity levels of preschoolers during childcare hours, utilizing a combination of the above components. The purpose of this manuscript is to provide a detailed account of the protocol, innovative methods, and evaluation plans used in the implementation of the SPACE study; in an effort to support the development of further research in this field.The SPACE study, a cluster randomized controlled trial, involves 22 childcare centres randomly allocated to either the experimental (n = 11) or the control (n = 11) group. Childcare centres receiving the intervention will adopt an 8-week physical activity intervention with the following components: 1. shorter, more frequent bouts of outdoor playtime (4 × 30 min periods rather than 2 × 60 min periods); 2. new portable play equipment (e.g., obstacle course, balls); and, 3. staff training (1 × 4 hr workshop). Actical accelerometers will be used to assess total physical activity with measurements taken at baseline (i.e., week 0), immediately post-intervention (i.e., week 8), and at 6- and 12-month follow-up. As secondary objectives, we aim to evaluate the effectiveness of the intervention on preschoolers': a) sedentary time; b) standardized body mass index scores (percentiles); c) health-related quality of life; and childcare providers' physical activity-related knowledge and self-efficacy to implement physical activity.The SPACE study aims to increase the low levels of physical activity observed within childcare centres. The findings of this work may be useful to policy makers and childcare providers to consider modifications to the current childcare curriculum and associated outdoor play time.ISRCTN70604107 (October 8, 2014).
| S-EPMC4739086 | biostudies-other
Project description:IntroductionMultimorbidity and polypharmacy are major risk factors for potentially inappropriate prescribing (eg, overprescribing and underprescribing), and systematic medication reviews are complex and time consuming. In this trial, the investigators aim to determine if a systematic software-based medication review improves medication appropriateness more than standard care in older, multimorbid patients with polypharmacy.Methods and analysisOptimising PharmacoTherapy In the multimorbid elderly in primary CAre is a cluster randomised controlled trial that will include outpatients from the Swiss primary care setting, aged ≥65 years with ≥three chronic medical conditions and concurrent use of ≥five chronic medications. Patients treated by the same general practitioner (GP) constitute a cluster, and clusters are randomised 1:1 to either a standard care sham intervention, in which the GP discusses with the patient if the medication list is complete, or a systematic medication review intervention based on the use of the 'Systematic Tool to Reduce Inappropriate Prescribing'-Assistant (STRIPA). STRIPA is a web-based clinical decision support system that helps customise medication reviews. It is based on the validated 'Screening Tool of Older Person's Prescriptions' (STOPP) and 'Screening Tool to Alert doctors to Right Treatment' (START) criteria to detect potentially inappropriate prescribing. The trial's follow-up period is 12 months. Outcomes will be assessed at baseline, 6 and 12 months. The primary endpoint is medication appropriateness, as measured jointly by the change in the Medication Appropriateness Index (MAI) and Assessment of Underutilisation (AOU). Secondary endpoints include the degree of polypharmacy, overprescribing and underprescribing, the number of falls and fractures, quality of life, the amount of formal and informal care received by patients, survival, patients' quality adjusted life years, patients' medical costs, cost-effectiveness of the intervention, percentage of recommendations accepted by GPs, percentage of recommendation rejected by GPs and patients' willingness to have medications deprescribed.Ethics and disseminationThe ethics committee of the canton of Bern in Switzerland approved the trial protocol. The results of this trial will be published in a peer-reviewed journal.Main fundingSwiss National Science Foundation, National Research Programme (NRP 74) 'Smarter Healthcare'.Trial registration numbersClinicaltrials.gov (NCT03724539), KOFAM (Swiss national portal) (SNCTP000003060), Universal Trial Number (U1111-1226-8013).
| S-EPMC6731954 | biostudies-literature