scholarly journals Deprescribing To Reduce Polypharmacy: Study Protocol For A Randomised Controlled Trial Assessing Deprescribing of Anticholinergic and Sedative Drugs In A Cohort of Frail Older People Living In The Community

2021 ◽  
Author(s):  
Ulrich Bergler ◽  
Nagham Ailabouni ◽  
John W. Pickering ◽  
Sarah Hilmer ◽  
Dee Mangin ◽  
...  
Keyword(s):  
New Zealand ◽  
Randomised Controlled Trial ◽  
Older People ◽  
General Practitioners ◽  
Residential Care ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Trial Registration ◽  
Sedative Drugs ◽  
Randomised Controlled

Abstract Background: Targeted deprescribing of anticholinergic and sedative medications in older people can improve their health outcomes. This trial will determine if pharmacist-led reviews lead to general practitioners deprescribing anticholinergic and sedative medications in older people living in the community. Methods and analysis: The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist was used to develop and report the protocol. The trial will involve three groups of older adults stratified by frailty (low, medium, and high). This will be a pragmatic two-arm randomised controlled trial to test general practitioner uptake of pharmacist recommendations to deprescribe anticholinergic and sedative medications that are causing adverse side effects in patients.Study population: Community dwelling frail adults, 65 years or older, living in the Canterbury region of New Zealand, seeking publicly funded home support services or admission to aged residential care and taking at least one anticholinergic or sedative medication regularly.Intervention: New Zealand registered pharmacists using peer-reviewed deprescribing guidelines will visit participants at home in the community, review their medications, and recommend to general practitioners’ anticholinergic and sedative medications that could be deprescribed. Total use of anticholinergic and sedative medications will be quantified using the Drug Burden index (DBI).Outcomes: The primary outcome will be the change in total DBI between baseline and six-months follow-up. Secondary outcomes will include entry into aged residential care, prolonged hospitalisation, and death.Data collection points: Data will be collected at the time of interRAI assessments (T0), at the time of the baseline review (T1), at 6 months following the baseline review (T2), and at the end of the study period, or end of study participation for participants admitted into aged residential care, or who died (T3).Ethics and dissemination: Ethics approval has been obtained from the Human, Disability and Ethics Committee. Ethical number (17CEN265).Trial registration: The trial was registered on 2 May 2018 with the Australian New Zealand Clinical Trials Registry: ACTRN12618000729224 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374924)

scholarly journals Deprescribing to reduce polypharmacy: study protocol for a randomised controlled trial assessing deprescribing of anticholinergic and sedative drugs in a cohort of frail older people living in the community

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ulrich Bergler ◽  
Nagham J. Ailabouni ◽  
John W. Pickering ◽  
Sarah N. Hilmer ◽  
Dee Mangin ◽  
...  
Keyword(s):  
New Zealand ◽  
General Practitioner ◽  
Older People ◽  
Residential Care ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Trial Registration ◽  
Home Support ◽  
Sedative Drugs ◽  
Randomised Controlled

Abstract Background Targeted deprescribing of anticholinergic and sedative medications in older people may improve their health outcomes. This trial will determine if pharmacist-led reviews lead to general practitioners deprescribing anticholinergic and sedative medications in older people living in the community. Methods and analysis The standard protocol items: Recommendations for Interventional Trials (SPIRIT) checklist was used to develop and report the protocol. The trial will involve older adults stratified by frailty (low, medium, and high). This will be a pragmatic two-arm randomized controlled trial to test general practitioner uptake of pharmacist recommendations to deprescribe anticholinergic and sedative medications that are causing adverse side effects in patients. Study population Community-dwelling frail adults, 65 years or older, living in the Canterbury region of New Zealand, seeking publicly funded home support services or admission to aged residential care and taking at least one anticholinergic or sedative medication regularly. Intervention New Zealand registered pharmacists using peer-reviewed deprescribing guidelines will visit participants at home in the community, review their medications, and recommend anticholinergic and sedative medications that could be deprescribed to the participant’s general practitioner. The total use of anticholinergic and sedative medications will be quantified using the Drug Burden Index (DBI). Outcomes The primary outcome will be the change in total DBI between baseline and 6-month follow-up. Secondary outcomes will include entry into aged residential care, prolonged hospitalization, and death. Data collection points Data will be collected at the time of interRAI assessments (T0), at the time of the baseline review (T1), at 6 months following the baseline review (T2), and at the end of the study period, or end of study participation for participants admitted into aged residential care, or who died (T3). Ethics and dissemination Ethical approval has been obtained from the Human, Disability and Ethics Committee: ethical number (17CEN265). Trial registration ClinicalTrials.gov ACTRN12618000729224. Registered on May 2, 2018, with the Australian New Zealand Clinical Trials Registry

scholarly journals Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e022205 ◽  
Author(s):  
Esther Williamson ◽  
Lesley Ward ◽  
Karan Vadher ◽  
Susan J Dutton ◽  
Ben Parker ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Best Practice ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Community Dwelling ◽  
Neurogenic Claudication ◽  
Randomised Controlled

IntroductionNeurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention.Methods and analysisThis is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by ‘intention to treat’. There is a parallel health economic evaluation and qualitative study.Ethics and disseminationEthical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website.Trial registration numberISRCTN12698674; Pre-results.

scholarly journals GP- and practice-related variation in ambulatory sensitive hospitalisations of older primary care patients

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Leah Palapar ◽  
Laura Wilkinson-Meyers ◽  
Thomas Lumley ◽  
Ngaire Kerse
Keyword(s):  
Primary Care ◽  
New Zealand ◽  
Older People ◽  
Home Visiting ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Trial Registration ◽  
Primary Care Redesign ◽  
Practice Level ◽  
Practice Characteristics

Abstract Background Reducing ambulatory sensitive hospitalisations (ASHs) is a strategy to control spending on hospital care and to improve quality of primary health care. This research investigated whether ASH rates in older people varied by GP and practice characteristics. Methods We identified ASHs from the national dataset of hospital events for 3755 community-dwelling participants aged 75+ enrolled in a cluster randomised controlled trial involving 60 randomly selected general practices in three regions in New Zealand. Poisson mixed models of 36-month ASH rates were fitted for the entire sample, for complex participants, and non-complex participants. We examined variation in ASH rates according to GP- and practice-level characteristics after adjusting for patient-level predictors of ASH. Results Lower rates of ASHs were observed in female GPs (IRR 0.83, CI 0.71 to 0.98). In non-complex participants, but not complex participants, practices in more deprived areas had lower ASH rates (4% lower per deprivation decile higher, IRR 0.96, CI 0.92 to 1.00), whereas main urban centre practices had higher rates (IRR 1.84, CI 1.15 to 2.96). Variance explained by these significant factors was small (0.4% of total variance for GP sex, 0.2% for deprivation, and 0.5% for area type). None of the modifiable practice-level characteristics such as home visiting and systematically contacting patients were significantly associated with ASH rates. Conclusions Only a few GP and non-modifiable practice characteristics were associated with variation in ASH rates in 60 New Zealand practices interested in a trial about care of older people. Where there were significant associations, the contribution to overall variance was minimal. It also remains unclear whether lower ASH rates in older people represents underservicing or less overuse of hospital services, particularly for the relatively well patient attending practices in less central, more disadvantaged communities. Thus, reducing ASHs through primary care redesign for older people should be approached carefully. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12609000648224.

scholarly journals A targeted promotional DVD fails to improve Māori and Pacific participation rates in the New Zealand bowel screening pilot: results from a pseudo-randomised controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Karen Bartholomew ◽  
Lifeng Zhou ◽  
Sue Crengle ◽  
Elizabeth Buswell ◽  
Anne Buckley ◽  
...  
Keyword(s):  
New Zealand ◽  
Randomised Controlled Trial ◽  
Positive Impact ◽  
Controlled Trial ◽  
Trial Registration ◽  
Reminder Letter ◽  
Pacific People ◽  
Screening Participation ◽  
Test Kit ◽  
Randomised Controlled

Abstract Background New Zealand’s Bowel Screening Pilot (BSP) used a mailed invitation to return a faecal immunochemical test. As a pilot it offered opportunities to test interventions for reducing ethnic inequities in colorectal cancer screening prior to nationwide programme introduction. Small media interventions (e.g. educational material and DVDs) have been used at both community and participant level to improve uptake. We tested whether a DVD originally produced to raise community awareness among the Māori population would have a positive impact on participation and reduce the proportion of incorrectly performed tests (spoiled kits) if mailed out with the usual reminder letter. Methods The study was a parallel groups pseudo-randomised controlled trial. Over 12 months, all Māori and Pacific ethnicity non-responders four weeks after being mailed the test kit were allocated on alternate weeks to be sent, or not, the DVD intervention with the usual reminder letter. The objective was to determine changes in participation and spoiled kit rates in each ethnic group, determined three months from the date the reminder letter was sent. Participants and those recording the outcomes (receipt of a spoiled or non-spoiled test kit) were blinded to group assignment. Results 2333 Māori and 2938 Pacific people participated (11 withdrew). Those who were sent the DVD (1029 Māori and 1359 Pacific) were less likely to participate in screening than those who were not (1304 Māori and 1579 Pacific). Screening participation was reduced by 12.3% (95% CI 9.1–15.5%) in Māori (13.6% versus 25.9%) and 8.3% (95% CI 5.8–10.8%) in Pacific (10.1% versus 18.4%). However, spoiled kit rates (first return) were significantly higher among those not sent the DVD (33.1% versus 12.4% in Māori and 42.1% versus 21.9% in Pacific). Conclusion The DVD sent with the reminder letter to BSP non-responders reduced screening participation to an extent that more than offset the lower rate of spoiled kits. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12612001259831. Registered 30 November 2013.

scholarly journals Promoting independence in frail older people: a randomised controlled trial of a restorative care service in New Zealand

2014 ◽  
Vol 43 (3) ◽  
pp. 418-424 ◽  
Author(s):  
H. E. J. Senior ◽  
M. Parsons ◽  
N. Kerse ◽  
M.-H. Chen ◽  
S. Jacobs ◽  
...  
Keyword(s):  
New Zealand ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Care Service ◽  
Controlled Trial ◽  
Frail Older People ◽  
Randomised Controlled

scholarly journals Impact of a “vegetables first” approach to complementary feeding on later intake and liking of vegetables in infants: a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jeanette P. Rapson ◽  
Pamela R. von Hurst ◽  
Marion M. Hetherington ◽  
Cathryn A. Conlon
Keyword(s):  
New Zealand ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Complementary Feeding ◽  
Iron Status ◽  
Controlled Trial ◽  
Fruit And Vegetables ◽  
Trial Registration ◽  
Randomised Control Trial ◽  
Randomised Controlled

Abstract Background Vegetables as first complementary foods for infants may programme taste preferences that lead to improved vegetable intake in children. Yet few studies have investigated the impact of a ”vegetables first” approach to complementary feeding, especially in New Zealand. The purpose of this randomised control trial is to investigate the effect of starting complementary feeding with vegetables only on infants’ later intake and liking of vegetables, compared to those starting with fruit and vegetables. Methods/design One-hundred and twenty mother-infant pairs living in Auckland, New Zealand, will be randomised to receive either vegetables only (intervention) or fruit and vegetables (control) for 28 days, starting from the first day of complementary feeding at around 4–6 months of age. Infants will be presented with a brassica (broccoli), followed by a green leafy vegetable (spinach) and sweet fruit (pear) at 9 months of age. The primary outcome measures of intake of each food will be assessed using a weighed food diary. Secondary outcome measures of overall intake, liking and wanting of vegetables will be assessed using a food frequency questionnaire, liking tool and video coding tool, respectively, at 9, 12, and 24 months of age. Infant growth and iron status will be assessed as part of health screening and monitoring at baseline, post intervention and 9 months of age. Other biological samples to be collected include infant stool samples, vitamin D (mother and infant), iron status (mother), and mothers’ diet. Discussion This randomised, controlled trial will be the first to our knowledge to investigate a “vegetables first” approach to complementary feeding on infants’ liking and intake of vegetables in New Zealand. Comparison against standard practice (fruit and vegetables as first foods) should complement other trials underway, such as the Baby’s First Bites and Nordic OTIS trial. Results may contribute to the evidence supporting complementary feeding guidelines in New Zealand and worldwide. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12619000737134. Registered on 16 May 2019.

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