A non-randomised controlled pilot study of clinical pharmacist collaborative intervention for community dwelling patients with COPD.
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ABSTRACT:
SUBMITTER: Hunt V
PROVIDER: S-EPMC6180130 | biostudies-literature | 2018 Oct
REPOSITORIES: biostudies-literature
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A non-randomised controlled pilot study of clinical pharmacist collaborative intervention for community dwelling patients with COPD.
Hunt Vicki V Anderson Dave D Lowrie Richard R Montgomery Sardar Colette C Ballantyne Susan S Bryson Graeme G Kyle John J Hanlon Peter P
NPJ primary care respiratory medicine 20181010 1
UK, home-based patients with COPD receive specialist care from respiratory physicians, nurses, and general practitioners (GPs), but increasing complexity of therapeutic options and a GP/Nurse workforce crisis suggests merit in testing the role of home visits by a clinical pharmacist. We conducted a non-randomised intervention study with a contemporaneous comparator group, in Glasgow (Scotland). A clinical pharmacist (working closely with a consultant respiratory physician) visited patients with ...[more]
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Project description:BackgroundThe effects of dietary intervention in managing sarcopenic obesity are controversial, and behavior change techniques are lacking in previous studies which are important for the success of dietary intervention. This study aimed to evaluate the feasibility and preliminary effects of a dietary behaviour change (DBC) intervention on managing sarcopenic obesity among community-dwelling older people in the community.MethodsA two-armed, RCT was conducted. Sixty community-dwelling older adults (≥ 60 years old) with sarcopenic obesity were randomised into either the experimental group (n = 30), receiving a 15-week dietary intervention combined with behaviour change techniques guided by the Health Action Process Approach model, or the control group (n = 30), receiving regular health talks. Individual semi-structured interviews were conducted with 21 experimental group participants to determine the barriers and facilitators of dietary behaviour changes after the intervention.ResultsThe feasibility of the DBC intervention was confirmed by an acceptable recruitment rate (57.14%) and a good retention rate (83.33%). Compared with the control group, the experimental group significantly reduced their body weight (p = 0.027, d = 1.22) and improved their dietary quality (p < 0.001, d = 1.31). A positive improvement in handgrip strength (from 15.37 ± 1.08 kg to 18.21 ± 1.68 kg), waist circumference (from 99.28 ± 1.32 cm to 98.42 ± 1.39 cm), and gait speed (from 0.91 ± 0.02 m/s to 0.99 ± 0.03 m/s) was observed only in the experimental group. However, the skeletal muscle mass index in the experimental group decreased. The interview indicated that behaviour change techniques enhanced the partcipants' compliance with their dietary regimen, while cultural contextual factors (e.g., family dining style) led to some barriers.ConclusionThe DBC intervention could reduce body weight, and has positive trends in managing handgrip strength, gait speed, and waist circumference. Interestingly, the subtle difference between the two groups in the change of muscle mass index warrants futures investigation. This study demonstrated the potential for employing dietary behaviour change interventions in community healthcare.Trial registrationRegistered retrospectively on ClinicalTrailas.gov (31/12/2020, NCT04690985).
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Project description:BackgroundPharmacist-facilitated medicines review services have been postulated as a way to address current inequities in health outcomes between Māori and non-Māori. These interventions have been shown internationally to improve the appropriate use of medicines but remain underutilised in Aotearoa New Zealand (NZ). By reviewing the literature and engaging with key stakeholders, we developed an intervention, which included collaborative goal-setting, education and medicines optimisation, for testing in a feasibility study.ObjectiveTo determine the feasibility (recruitment, intervention delivery, and data collection methods) of a pharmacist-facilitated medicines review intervention for Māori older adults, and proposed intervention outcomes.MethodsThis study was reported in accordance with the CONSORT 2010 statement: extension to randomised controlled pilot and feasibility trials and the Consolidated criteria for strengthening reporting of health research involving indigenous peoples: the CONSIDER statement. Participant eligibility criteria were: Māori; aged 55-plus; community-dwelling; enrolled in a general practice in Waitematā District Health Board (Auckland, NZ). Consented participants engaged in a medicines education component (participant and pharmacist) and an optional medicines optimisation component (participant, pharmacist and prescriber). Outcomes measures included: the feasibility of data collection tools and methods, time taken to conduct the intervention and research processes; medicines knowledge, medicines appropriateness and quality of life (QoL); pharmacist recommendations and prescriber acceptance rate.ResultsSeventeen consented participants took part in the intervention from December 2019-March 2020 with the majority (n = 12) recruited through general practice mail-outs. Data collection was feasible using the predetermined outcome measure tools and was complete for all patient participants. Pharmacist intervention delivery was feasible. A mean of 9.5 recommendations were made per participant with a prescriber acceptance rate of 95%. These included non-medicine-related recommendations.ConclusionThe feasibility testing of pharmacist-facilitated medicines review intervention developed for (and with) community-dwelling Māori older adults allows for intervention refinement and can be utilised for further studies relating to pharmacist services in primary care.
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Project description:BackgroundGait impairment limiting mobility and restricting activities is common after stroke. Auditory rhythmical cueing (ARC) uses a metronome beat delivered during exercise to train stepping and early work reports gait improvements. This study aimed to establish the feasibility of a full scale multicentre randomised controlled trial to evaluate an ARC gait and balance training programme for use by stroke survivors in the home and outdoors.MethodsA parallel-group observer-blind pilot randomised controlled trial was conducted. Adults within 2 years of stroke with a gait-related mobility impairment were recruited from four NHS stroke services and randomised to an ARC gait and balance training programme (intervention) or the training programme without ARC (control). Both programmes consisted of 3x30 min sessions per week for 6 weeks undertaken at home/nearby outdoor community. One session per week was supervised and the remainder self-managed. Gait and balance performance assessments were undertaken at baseline, 6 and 10 weeks. Key trial outcomes included recruitment and retention rates, programme adherence, assessment data completeness and safety.ResultsBetween November 2018 and February 2020, 59 participants were randomised (intervention n=30, control n=29), mean recruitment rate 4/month. At baseline, 6 weeks and 10 weeks, research assessments were conducted for 59/59 (100%), 47/59 (80%) and 42/59 (71%) participants, respectively. Missing assessments were largely due to discontinuation of data collection from mid-March 2020 because of the UK COVID-19 pandemic lockdown. The proportion of participants with complete data for each individual performance assessment ranged from 100% at baseline to 68% at 10 weeks. In the intervention group, 433/540 (80%) total programme exercise sessions were undertaken, in the control group, 390/522 (75%). Falls were reported by five participants in the intervention group, six in the control group. Three serious adverse events occurred, all unrelated to the study.ConclusionWe believe that a definitive multicentre RCT to evaluate the ARC gait and balance training programme is feasible. Recruitment, programme adherence and safety were all acceptable. Although we consider that the retention rate and assessment data completeness were not sufficient for a future trial, this was largely due to the UK COVID-19 pandemic lockdown.Trial registrationISRCTN, ISRCTN10874601 , Registered on 05/03/2018.
| S-EPMC9652598 | biostudies-literature
Project description:Feasibility studyObjectives:Refine a bespoke enhanced support intervention (ESI) (including self-help materials, intervention manual and training) for implementation by community pharmacy (CP) staff to people with sub-threshold depression and long-term conditions (LTCs) based upon evidence-supported interventions in primary careDevelop and refine study procedures (recruitment strategies and set up, screening, participant recruitment, assessment, suitability of outcome measures and data collection procedures) for testing in the pilot study phaseDesign: A case series/qualitative studySetting: UK community pharmacyPopulation: Adults with long-term health conditions who screen-positive for depression but who do not reach the threshold for DSM IV Moderate Depressive disorderIntervention: Enhanced support intervention (ESI) delivered by an appropriately trained community pharmacy team member involving four to six sessions over four months. ESI is a modified form of an intervention within the collaborative care framework for sub-threshold depression validated in previous studies in UK primary care which appears suitable for implementation in community settings.Sample size: 20-30 participantsOutcomes: Study implementation (recruitment and attrition rates), quality of data collection at baseline and 4 months and ESI adherence (number of contacts, DNA and drop out) as per objectives 1a/bQualitative evaluation: Semi-structured interviews with up to 10 participants and ESI facilitators and focus group(s) (range of pharmacy staff n =?8-10) will be conducted to explore the acceptability of the intervention and feasibility of the study, training and study procedures.External pilot studyObjectives:Quantify the flow of participants (eligibility, recruitment and follow-up rate)Evaluate proposed recruitment, assessment and outcome measure collection methodsExamine the delivery of the enhanced support intervention in a community pharmacy setting (intervention uptake, retention and dose) to inform process evaluationProcess evaluation, using semi-structured interviews with participants across a range of socio-economic settings, and pharmacy staff to explore the acceptability of the ESI within community pharmacy, elements of the intervention that were considered useful (or not) and appropriateness of study proceduresDesign: Pilot randomised controlled trial, including a prospective economic and qualitative evaluationSetting: As abovePopulation: As aboveIntervention: As above with adaptations post feasibility studyComparator: Usual careSample size: 100 participantsOutcomes: Data will be used to estimate recruitment, intervention delivery and study completion rates as per objectives 2a-d. Definitive estimates of the effectiveness of ESI will not be made.Primary outcome: Depression severity (Patient Health Questionnaire 9) at four months.Secondary outcomes: Patient acceptance, uptake and attrition. ICD10 depression status, anxiety (GAD 7), health-related quality of life (SF-12v2) and health-state utility (EQ5D 3L) will be measured at four months.Economic evaluation: The incremental cost per QALY will be calculated from both the NHS and societal perspective.Process evaluation: Using mixed methods, potential mediators/moderators of the intervention, the acceptability (to participants and pharmacy staff), barriers and facilitators to the use of ESI in community pharmacy, and impact on usual practice will be examined. Semi-structured interviews with approximately 30 study participants, 20 pharmacy staff and eight GPs near participating pharmacies will be conducted.Trial registrationISRCTN: ISRCTN11290592Protocol version number: Version 4.1 (dated 16th January 2018)Study Sponsor Tees Esk and Wear Valleys NHS Foundation Trust.
| S-EPMC6540405 | biostudies-literature
Project description:BackgroundSmall trials with short term follow up suggest pharmacists' interventions targeted at healthcare professionals can improve prescribing. In comparison with clinical guidance, contemporary statin prescribing is sub-optimal and achievement of cholesterol targets falls short of accepted standards, for patients with atherosclerotic vascular disease who are at highest absolute risk and who stand to obtain greatest benefit. We hypothesised that a pharmacist-led complex intervention delivered to doctors and nurses in primary care, would improve statin prescribing and achievement of cholesterol targets for incident and prevalent patients with vascular disease, beyond one year.MethodsWe allocated general practices to a 12-month Statin Outreach Support (SOS) intervention or usual care. SOS was delivered by one of 11 pharmacists who had received additional training. SOS comprised academic detailing and practical support to identify patients with vascular disease who were not prescribed a statin at optimal dose or did not have cholesterol at target, followed by individualised recommendations for changes to management. The primary outcome was the proportion of patients achieving cholesterol targets. Secondary outcomes were: the proportion of patients prescribed simvastatin 40 mg with target cholesterol achieved; cholesterol levels; prescribing of simvastatin 40 mg; prescribing of any statin and the proportion of patients with cholesterol tested. Outcomes were assessed after an average of 1.7 years (range 1.4-2.2 years), and practice level simvastatin 40 mg prescribing was assessed after 10 years.FindingsWe randomised 31 practices (72 General Practitioners (GPs), 40 nurses). Prior to randomisation a subset of eligible patients were identified to characterise practices; 40% had cholesterol levels below the target threshold. Improvements in data collection procedures allowed identification of all eligible patients (n = 7586) at follow up. Patients in practices allocated to SOS were significantly more likely to have cholesterol at target (69.5% vs 63.5%; OR 1.11, CI 1.00-1.23; p = 0.043) as a result of improved simvastatin prescribing. Subgroup analysis showed the primary outcome was achieved by prevalent but not incident patients. Statistically significant improvements occurred in all secondary outcomes for prevalent patients and all but one secondary outcome (the proportion of patients with cholesterol tested) for incident patients. SOS practices prescribed more simvastatin 40 mg than usual care practices, up to 10 years later.InterpretationThrough a combination of educational and organisational support, a general practice based pharmacist led collaborative intervention can improve statin prescribing and achievement of cholesterol targets in a high-risk primary care based population.Trial registrationInternational Standard Randomised Controlled Trials Register ISRCTN61233866.
| S-EPMC4236200 | biostudies-literature
Project description:Rates of common mental health problems are much higher in prison populations, but access to primary care mental health support falls short of community equivalence. Discontinuity of care on release is the norm and is further complicated by substance use and a range of social problems, e.g. homelessness. To address these problems, we worked with criminal justice, third sector social inclusion services, health services and people with lived experiences (peer researchers), to develop a complex collaborative care intervention aimed at supporting men with common mental health problems near to and following release from prison. This paper describes an external pilot trial to test the feasibility of a full randomised controlled trial.Eligible individuals with 4 to 16 weeks left to serve were screened to assess for common mental health problems. Participants were then randomised at a ratio of 2:1 allocation to ENGAGER plus standard care (intervention) or standard care alone (treatment as usual). Participants were followed up at 1 and 3 months' post release. Success criteria for this pilot trial were to meet the recruitment target sample size of 60 participants, to follow up at least 50% of participants at 3 months' post release from prison, and to deliver the ENGAGER intervention. Estimates of recruitment and retention rates and 95% confidence intervals (CIs) are reported. Descriptive analyses included summaries (percentages or means) for participant demographics, and baseline characteristics are reported.Recruitment target was met with 60 participants randomised in 9 months. The average retention rates were 73% at 1 month [95% CI 61 to 83] and 47% at 3 months follow-up [95% CI 35 to 59]. Ninety percent of participants allocated to the intervention successfully engaged with a practitioner before release and 70% engaged following release.This pilot confirms the feasibility of conducting a randomised trial for prison leavers with common mental health problems. Based on this pilot study and some minor changes to the trial design and intervention, a full two-centre randomised trial assessing the clinical and cost-effectiveness of the ENGAGER intervention is currently underway.
| S-EPMC5501110 | biostudies-other
Project description:OBJECTIVE:Limited evidence suggests integration of pharmacists into the general practice team could improve medicines management for patients, particularly those with multimorbidity and polypharmacy. This study aimed to develop and assess the feasibility of an intervention involving pharmacists, working within general practices, to optimise prescribing in Ireland. DESIGN:Non-randomised pilot study. SETTING:Primary care in Ireland. PARTICIPANTS:Four general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles. INTERVENTION:A pharmacist joined the practice team for 6?months (10?hours/week) and undertook medication reviews (face to face or chart based) for adult patients, provided prescribing advice, supported clinical audits and facilitated practice-based education. OUTCOME MEASURES:Anonymised practice-level medication (eg, medication changes) and cost data were collected. Patient-reported outcome measure (PROM) data were collected on a subset of older adults (aged ?65 years) with polypharmacy using patient questionnaires, before and 6?weeks after medication review by the pharmacist. RESULTS:Across four practices, 786 patients were identified as having 1521 prescribing issues by the pharmacists. Issues relating to deprescribing medications were addressed most often by the prescriber (59.8%), compared with cost-related issues (5.8%). Medication changes made during the study equated to approximately €57?000 in cost savings assuming they persisted for 12 months. Ninety-six patients aged ?65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up. There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life. CONCLUSIONS:This non-randomised pilot study demonstrated that an intervention involving pharmacists, working within general practices is feasible to implement and has potential to improve prescribing quality. This study provides rationale to conduct a randomised controlled trial to evaluate the clinical and cost-effectiveness of this intervention.
| S-EPMC7322285 | biostudies-literature
Project description:BACKGROUND:There has been an increasing interest in reablement in Norway recently and many municipalities have implemented this form of rehabilitation despite a lack of robust evidence of its effectiveness. The aim of this study was to investigate the effectiveness of reablement in home-dwelling older adults compared with usual care in relation to daily activities, physical functioning, and health-related quality of life. METHODS:This is a parallel-group randomised controlled trial conducted in a rural municipality in Norway. Sixty-one home-dwelling older adults with functional decline were randomised to an intervention group (n = 31) or a control group (n = 30). The intervention group received ten weeks of multicomponent home-based rehabilitation. The Canadian Occupational Performance Measure (COPM) was used to measure self-perceived activity performance and satisfaction with performance. In addition, physical capacity and health-related quality of life were measured. The participants were assessed at baseline and at 3- and 9-month follow-ups. RESULTS:There were significant improvements in mean scores favouring reablement in COPM performance at 3 months with a score of 1.5 points (p = 0.02), at 9 months 1.4 points (p = 0.03) and overall treatment 1.5 points (p = 0.01), and for COPM satisfaction at 9 months 1.4 points (p = 0.03) and overall treatment 1.2 points (p = 0.04). No significant group differences were found concerning COPM satisfaction at 3 months, physical capacity or health-related quality of life. CONCLUSION:A 10-week reablement program resulted in better activity performance and satisfaction with performance on a long-term basis, but not the other outcomes measured. TRIAL REGISTRATION:The trial was registered in ClinicalTrials.gov November 20, 2012, identifier NCT02043262 .
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Project description:BackgroundDigital interventions provided through smartphones or the internet that are guided by a coach have been proposed as promising solutions to support the self-management of chronic conditions. However, digital intervention for poststroke self-management is limited; we developed the interactive Self-Management Augmented by Rehabilitation Technologies (iSMART) intervention to address this gap.ObjectiveThis study aimed to examine the feasibility and initial effects of the iSMART intervention to improve self-management self-efficacy in people with stroke.MethodsA parallel, 2-arm, nonblinded, randomized controlled trial of 12-week duration was conducted. A total of 24 participants with mild-to-moderate chronic stroke were randomized to receive either the iSMART intervention or a manual of stroke rehabilitation (attention control). iSMART was a coach-guided, technology-supported self-management intervention designed to support people managing chronic conditions and maintaining active participation in daily life after stroke. Feasibility measures included retention and engagement rates in the iSMART group. For both the iSMART intervention and active control groups, we used the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure to assess the feasibility, acceptability, and appropriateness, respectively. Health measures included the Participation Strategies Self-Efficacy Scale and the Patient-Reported Outcomes Measurement Information System's Self-Efficacy for Managing Chronic Conditions.ResultsThe retention rate was 82% (9/11), and the engagement (SMS text message response) rate was 78% for the iSMART group. Mean scores of the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure were 4.11 (SD 0.61), 4.44 (SD 0.73), and 4.36 (SD 0.70), respectively, which exceeded our benchmark (4 out of 5), suggesting high feasibility, acceptability, and appropriateness of iSMART. The iSMART group showed moderate-to-large effects in improving self-efficacy in managing emotions (r=0.494), symptoms (r=0.514), daily activities (r=0.593), and treatments and medications (r=0.870), but the control group showed negligible-to-small effects in decreasing self-efficacy in managing emotions (r=0.252), symptoms (r=0.262), daily activities (r=0.136), and treatments and medications (r=0.049). In addition, the iSMART group showed moderate-to-large effects of increasing the use of participation strategies for management in the home (r=0.554), work (r=0.633), community (r=0.673), and communication activities (r=0.476). In contrast, the control group showed small-to-large effects of decreasing the use of participation strategies for management in the home (r=0.567), work (r=0.342, community (r=0.215), and communication activities (r=0.379).ConclusionsOur findings support the idea that iSMART was feasible to improve poststroke self-management self-efficacy. Our results also support using a low-cost solution, such as SMS text messaging, to supplement traditional therapeutic patient education interventions. Further evaluation with a larger sample of participants is still needed.Trial registrationClinicalTrials.gov 202004137; https://clinicaltrials.gov/study/NCT04743037?id=202004137&rank=1.
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Project description:IntroductionWorldwide, demographic ageing is a major social, economic and health challenge. Despite the increase in life expectancy, elderly often live with multiple chronic conditions, exposing them to multiple medications. Concerns have been raised about the growing issue of inappropriate long-term usage of proton-pump inhibitors (PPI), which have been associated with adverse outcomes and increased healthcare costs. Deprescribing is a recommended intervention to reduce or withdraw medicines that might be causing harm or might no longer be of benefit. This protocol details a trial to assess the effectiveness and cost-effectiveness of a collaborative deprescribing intervention of PPI among community-dwelling elderly, involving community pharmacists and general practitioners.Methods and analysisA pragmatic, multicentre, two-arm, non-randomised controlled trial of a structured PPI collaborative deprescribing intervention in the primary care setting with a 6-month follow-up will be conducted. Patients must be 65 years old or older, live in the community and have been using PPI for more than 8 weeks. We hypothesize that the intervention will reduce the PPI usage in the intervention group compared to the control group. The primary outcome is the successful discontinuation or dose decrease of any PPI, defined as a statistically significant absolute 20% reduction in medication use between the intervention and control groups at 3- and 6-month follow-ups. An economic evaluation will be conducted alongside the trial. This study was approved by the Ethics Research Committee of Nova Medical School, NOVA University of Lisbon and by the Ethics Committee from the Local Health Unit Alto Minho, Portugal.DiscussionThis pragmatic trial will provide evidence on the effectiveness and cost-effectiveness of a patient-centred collaborative deprescribing intervention in the community setting in Portugal. It will also inform improvements for the development of future multi-faceted interventions that aim to optimise medication for the community-dwelling elderly.Clinical trial registrationISRCTN 49637686.
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