Clinical and cost-effectiveness of the Managing Agitation and Raising Quality of Life (MARQUE) intervention for agitation in people with dementia in care homes: a single-blind, cluster-randomised controlled trial

Abstract Background Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their General Practitioner (GP) in the first instance, with conservative therapies recommended as initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care. Methods TRIUMPH is a 2-arm cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) General Practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and health care professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post-consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis. Discussion It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care therefore holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic cluster RCT will provide robust evidence in a primary care setting to inform future guidelines.

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Effects of a standard provision versus an autonomy supportive exercise referral programme on physical activity, quality of life and well-being indicators: a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/1479-5868-11-10 ◽

2014 ◽

Vol 11 (1) ◽

pp. 10 ◽

Cited By ~ 61

Author(s):

Joan L Duda ◽

Geoffrey C Williams ◽

Nikos Ntoumanis ◽

Amanda Daley ◽

Frank F Eves ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Well Being ◽

Cluster Randomised ◽

Randomised Controlled ◽

Exercise Referral

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Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017740 ◽

2018 ◽

Vol 8 (2) ◽

pp. e017740 ◽

Cited By ~ 17

Author(s):

Christiane Muth ◽

Lorenz Uhlmann ◽

Walter E Haefeli ◽

Justine Rochon ◽

Marjan van den Akker ◽

...

Keyword(s):

Quality Of Life ◽

General Practice ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectivesInvestigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice.DesignPragmatic, cluster randomised controlled trial with general practice as unit of randomisation.Setting72 general practices in Hesse, Germany.Participants505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study.InterventionsIntervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care.Outcome measuresThe primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months’ follow-up: quality of life, functioning, medication adherence, and so on.ResultsAt baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0–5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI −0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence).ConclusionsThe intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement.Trial registration numberISRCTN99526053. NCT01171339; Results.

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