Dataset Information

A cost utility analysis alongside a cluster-randomised trial evaluating a minor ailment service compared to usual care in community pharmacy

ABSTRACT:

Background

Minor ailments are “self-limiting conditions which may be diagnosed and managed without a medical intervention”. A cluster randomised controlled trial (cRCT) was designed to evaluate the clinical, humanistic and economic outcomes of a Minor Ailment Service (MAS) in community pharmacy (CP) compared with usual care (UC).

Methods

The cRCT was conducted for 6 months from December 2017. The pharmacist-patient intervention consisted of a standardised face-to-face consultation on a web-based program using co-developed protocols, pharmacists’ training, practice change facilitators and patients’ educational material. Patients requesting a non-prescription medication (direct product request) or presenting minor ailments received MAS or UC and were followed-up by telephone 10-days after the consultation. The primary economic outcomes were incremental cost-utility ratio (ICUR) of the service and health related quality of life (HRQoL). Total costs included health system, CPs and patient direct costs: health professionals’ consultation time, medication costs, pharmacists’ training costs, investment of the pharmacy and consultation costs within the 10 days following the initial consultation. The HRQoL was obtained using the EuroQoL 5D-5L at the time of the consultation and at 10-days follow up. A sensitivity analysis was carried out using bootstrapping. There were two sub-group analyses undertaken, for symptom presentation and direct product requests, to evaluate possible differences.

Results

A total of 808 patients (323 MAS and 485 UC) were recruited in 27 CPs with 42 pharmacists (20 MAS and 22 UC). 64.7% (n = 523) of patients responded to follow-up after their consultation in CP. MAS patients gained an additional 0.0003 QALYs (p = 0.053). When considering only MAS patients presenting with symptoms, the ICUR was 24,733€/QALY with a 47.4% probability of cost-effectiveness (willingness to pay of 25,000€/QALY). Although when considering patients presenting for a direct product request, MAS was the dominant strategy with a 93.69% probability of cost-effectiveness.

Conclusions

Expanding community pharmacists’ scope through MAS may benefit health systems. To be fully cost effective, MAS should not only include consultations arising from symptom presentation but also include an oversight of self-selected products by patients. MAS increase patient safety through the appropriate use of non-prescription medication and through the direct referral of patients to GP.

Trial registration

ISRCTN, ISRCTN17235323. Registered 07/05/2021 - Retrospectively registered

Supplementary Information

The online version contains supplementary material available at 10.1186/s12913-021-07188-4.

SUBMITTER: Amador-Fernandez N

PROVIDER: S-EPMC8605551 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundA cluster randomised controlled trial (cRCT) performed from July 2018 to March 2019 demonstrated the clinical impact of a community pharmacist delivered minor ailment service (MAS) compared with usual pharmacist care (UC). MAS consisted of a technology-based face-to-face consultation delivered by trained community pharmacists. The consultation was guided by clinical pathways for assessment and management, and communication systems, collaboratively agreed with general practitioners. MAS pharmacists were trained and provided monthly practice support by a practice change facilitator. The objective of this study was to assess the cost utility of MAS, compared to UC.MethodsParticipants recruited were adult patients with symptoms suggestive of a minor ailment condition, from community pharmacies located in Western Sydney. Patients received MAS (intervention) or UC (control) and were followed-up by telephone 14-days following consultation with the pharmacist. A cost utility analysis was conducted alongside the cRCT. Transition probabilities and costs were directly derived from cRCT study data. Utility values were not available from the cRCT, hence we relied on utility values reported in the published literature which were used to calculate quality adjusted life years (QALYs), using the area under the curve method. A decision tree model was used to capture the decision problem, considering a societal perspective and a 14-day time horizon. Deterministic and probabilistic sensitivity analyses assessed robustness and uncertainty of results, respectively.ResultsPatients (n = 894) were recruited from 30 pharmacies and 82% (n = 732) responded to follow-up. On average, MAS was more costly but also more effective (in terms of symptom resolution and QALY gains) compared to UC. MAS patients (n = 524) gained an additional 0.003 QALYs at an incremental cost of $7.14 (Australian dollars), compared to UC (n = 370) which resulted in an ICER of $2277 (95% CI $681.49-3811.22) per QALY.ConclusionEconomic findings suggest that implementation of MAS within the Australian context is cost effective.Trial registration Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

Project description:BackgroundCommunity pharmacies provide an appropriate setting to deliver minor ailment services (MASs). Many community pharmacy services have been developed previously without stakeholder involvement. As a result, implementation of services may fail to produce the expected impact. The aim of this research was to co-design and test the feasibility of an Australian MAS for minor ailment presentations.MethodsThis study used co-design methodology which included two phases: (1) a focus group with stakeholders to allow the conceptualization of the service and agreement on service elements; (2) a literature review of clinical guidelines and three working meetings with a team of editors and general practitioners for the development of treatment pathways. Following this, a study evaluating the feasibility of the co-designed service was undertaken. The qualitative part of the methodology associated with the feasibility study comprised semi-structured interviews with MAS pharmacists, observation and completion of a tool by change facilitators identifying barriers and facilitators to service delivery. Qualitative data obtained for all phases were analysed using thematic analysis.ResultsThe developed service included the following components: (i) an in-pharmacy consultation between the patient and pharmacist, (ii) treatment pathways accessible to pharmacists on the internet to guide consultations, (iii) existing digital communication systems used by general practice to exchange patient information, (iv) training, and (v) change facilitation. As a result of feasibility testing, twenty-six implementation factors were identified for practice change, with the main change being the simplification of the pharmacist-patient consultation and data collection processes.ConclusionsAn Australian MAS was generated as a result of co-design, while testing revealed that the co-designed service was feasible. As a result of integrating the views of multiple stakeholders, the designed MAS has been adapted to suit healthcare practices, which may increase the acceptance and impact of MAS when implemented into practice.

Project description:BackgroundSelf-perceived minor ailments might conceal other health conditions if patients are not appropriately assisted by health care professionals. The aim of the study was to evaluate the patient-related outcomes of a community pharmacy Minor Ailment Service (MAS) compared to usual pharmacist care (UC).MethodsA cluster randomised controlled trial was conducted over six months in community pharmacy in the province of Valencia (Spain). Patients seeking care or requesting a product for a minor ailments considered in the study (dermatological problems, gastrointestinal disturbance, pain and upper respiratory tract related symptoms) were included. The intervention consisted of a standardised pharmacist-patient consultation guided by a web-based program using co-developed management protocols and patients' educational material. Patients were followed up by phone ten days later. Primary clinical outcomes were appropriate medical referral and modification of direct product request. Secondary outcomes were symptom resolution and reconsultation rates.ResultsA total of 808 patients (323 MAS and 485 UC) were recruited in 27 pharmacies of 21 municipalities. Patients visiting MAS pharmacies had higher odds for being referred to a physician (OR = 2.343, CI95% = [1.146-4.792]) and higher reconsultation rates (OR = 1.833, CI95% = [1.151-2.919]) compared to UC. No significant differences between groups were observed for modification of direct product request and symptom resolution.ConclusionsThe use of management protocols through the MAS strengthened the identification of referral criteria such as red flags in patients suffering minor ailments. These patients with symptoms of minor ailments possibly due to more severe illness were to be referred and evaluated by physicians. Results reinforce that MAS increases safety for those patients consulting in community pharmacy for minor ailments.Trial registrationTrial registration number: ISRCTN17235323. Retrospectively registered 07/05/2021, https://www.isrctn.com/ISRCTN17235323.

Project description:Background: There is little experience in the economic evaluation of pharmacy/primary care collaborative health interventions using interprofessional technology-driven communication under real-world conditions. This study aimed to conduct cost-effectiveness and cost-utility analyses of a collaborative care intervention in hypertension and hyperlipidemia management between pharmacies and primary care versus usual (fragmented) care alongside a trial. Methods: An economic evaluation was conducted alongside a 6-month pragmatic quasi-experimental controlled trial. Data sources included primary care clinical software; pharmacy dispensing software; patient telephone surveys; and published literature. The target population was adult patients on hypertension and/or lipid-lowering medication. The perspective was societal. We collected patient-level data on resource use to estimate trial costs. Effect outcomes included blood pressure (BP) and quality-adjusted life years (QALYs). Bootstrapping was used to estimate uncertainty around the incremental cost-effectiveness and cost-utility ratios. Cost-effectiveness planes and acceptability curves were estimated. Results: The intervention was not shown to have reasonable levels of cost-effectiveness or cost-utility when compared to usual care as denoted by the levels of uncertainty expressed in wide confidence intervals. The probability of the intervention being cost-effective is 28% at the threshold of €20,000 per QALY gained and 57% at the threshold of €500 per mmHg systolic BP decrease. Conclusion: Considering the limitations of the trial which affected effectiveness and economic outcomes, our results are not generalizable for community pharmacy and primary care in Portugal. This research offers, however, valuable lessons on methods and strategies that can be used in future economic evaluations of collaborative public health interventions with the potential for reimbursement. Clinical trial registration: https://www.isrctn.com/ISRCTN13410498, identifier ISRCTN13410498.

Project description:INTRODUCTION:The management of minor conditions represents a significant burden for urgent and emergency care services and reduces the capacity to provide specialist care for higher acuity healthcare need. A pilot Digital Minor Illness Service (DMIRS) was commenced in the North East of England in December 2017 to feasibility test the NHS 111 referral to community pharmacy for patients presenting with minor conditions. OBJECTIVES:A formative evaluation of the service activity data and qualitative investigation of stakeholders involved in the service design, management, delivery and use, aims to present and investigate the service outcomes. METHOD:Routine service activity data was evaluated during Jan-Dec 2018 to investigate the demographics of patients included in the service; the presenting conditions; and how those referrals were managed by community pharmacies. Semi-structured interviews with NHS 111 call handlers, project team members, community pharmacists and patients were undertaken to investigate the design, management, implementation and delivery of the service. RESULTS:13,246 NHS 111 patient calls were referred to community pharmacy during the evaluative period. The most common presenting conditions were acute pain (n = 1144, 8.6%) and cough (n = 887, 6.7%). A large volume of complaints (47.1%, 6233) were resolved in community pharmacy. Stakeholders explained the structured approach to service design, organisation and implementation facilitated successful delivery and management. Patients reported positive experiences with accessing care via DMIRS. CONCLUSIONS:DMIRS demonstrated that patients could be referred to community pharmacy for the management of minor conditions, shifting a burden away from urgent and emergency care. The service data provides key information for further optimisation of service design, and stakeholder training and awareness. The service was acceptable and valued by patients. Evidence from the DMIRS pilot has been utilised to inform recent national healthcare policy and practice around the management of minor conditions within the urgent and emergency care setting.

Project description:OBJECTIVE:To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. DESIGN:A two-armed cluster randomised trial with occupational physicians (OPs) (n=62), clustered and randomised by region into an experimental and a control group, to conduct a health-economic investment appraisal. Online self-reported data were collected from employees at baseline, after 3, 6, 9 and 12 months. SETTING:Occupational health care in the Netherlands. PARTICIPANTS:Employees from small-sized and medium-sized companies (?18 years), sick-listed between 4 and 26 weeks with (symptoms of) common mental disorders visiting their OP. INTERVENTIONS:In the intervention group, employees (N=131) received an eHealth module aimed at changing cognitions regarding return to work, while OPs were supported by a decision aid for treatment and referral options. Employees in the control condition (N=89) received usual sickness guidance. OUTCOMES MEASURES:Net benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained. RESULTS:From the employer's perspective, the incremental net benefits were €3187 per employee over a single year, representing a return of investment of €11 per invested Euro, with a break-even point at 6 months. The economic case was also favourable from the employee's perspective, partly because of QALY health gains. The intervention was costing €234 per employee from a health service financier's perspective. The incremental net benefits from a social perspective were €4210. This amount dropped to €3559 in the sensitivity analysis trimming the 5% highest costs. CONCLUSIONS:The data suggest that the ECO intervention offers good value for money for virtually all stakeholders involved, because initial investments were more than recouped within a single year. The sometimes wide 95% CIs suggest that the costs and benefits are not always very precise estimates and real benefits could vary considerably. TRIAL REGISTRATION:NTR2108; Results.

Project description:BackgroundThe use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities.Methods and resultsThis study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects. There was no improvement in the Guideline Advantage score from baseline to 12 months in the control group (64.7% versus 63.1%, respectively; P=0.21). There was a statistically significant improvement in the intervention group from 63.3% at baseline to 67.8% at 12 months (P=0.02). The estimated benefit of the intervention was 5.0%±2.4% (95% confidence interval=-0.5% to 10.4%; P=0.07). Several criteria were significantly better for intervention subjects, including appropriate statin therapy (P<0.001), body mass index, screening (P<0.001), and alcohol screening (P<0.001). Only 13.7% of subjects with diabetes mellitus had hemoglobin A1c at goal at baseline, and this increased to 30.8% and 21.0% in the intervention and control group, respectively, at 12 months (P=0.10).ConclusionsThe centralized, remote pharmacist intervention was successfully implemented. The improvements in outcomes were modest, in part because of higher than expected baseline guideline adherence. Future studies of this model should focus on patients with uncontrolled conditions at high risk for cardiovascular events.Clinical trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT 01983813.