Dataset Information

'New Medicine Service': supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial.

ABSTRACT:

Objective

To examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks.

Methods

Pragmatic patient-level parallel randomised controlled trial in 46 English community pharmacies. 504 participants aged ≥14, identified in the pharmacy when presenting a prescription for a new medicine for predefined long-term conditions, randomised to receive NMS (n=251) or normal practice (n=253) (NMS intervention: 2 consultations 1 and 2 weeks after prescription presentation). Adherence assessed through patient self-report at 26-week follow-up. Intention-to-treat analysis employed. National Health Service (NHS) costs calculated. Disease-specific Markov models estimating impact of non-adherence combined with clinical trial data to calculate costs per extra quality-adjusted life-year (QALY; NHS England perspective).

Results

Unadjusted analysis: of 327 patients still taking the initial medicine, 97/170 (57.1%) and 103/157 (65.6%) (p=0.113) patients were adherent in normal practice and NMS arms, respectively. Adjusted intention-to-treat analysis: adherence OR 1.50 (95% CI 0.93 to 2.44, p=0.095), in favour of NMS. There was a non-significant reduction in 26-week NHS costs for NMS: -£104 (95% CI -£37 to £257, p=0.168) per patient. NMS generated a mean of 0.04 (95% CI -0.01 to 0.13) more QALYs per patient, with mean reduction in lifetime cost of -£113.9 (-1159.4, 683.7). The incremental cost-effectiveness ratio was -£2758/QALY (2.5% and 97.5%: -38 739.5, 34 024.2. NMS has an 89% probability of cost-effectiveness at a willingness to pay of £20 000 per QALY.

Conclusions

At 26-week follow-up, NMS was unable to demonstrate a statistically significant increase in adherence or reduction in NHS costs, which may be attributable to patient attrition from the study. Long-term economic evaluation suggested NMS may deliver better patient outcomes and reduced overall healthcare costs than normal practice, but uncertainty around this finding is high.

Trial registration number

NCT01635361, ISRCTN23560818, ISRCTN23560818, UKCRN12494.

SUBMITTER: Elliott RA

PROVIDER: S-EPMC7146933 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Publications

'New Medicine Service': supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial.

Elliott Rachel Ann RA Boyd Matthew J MJ Tanajewski Lukasz L Barber Nick N Gkountouras Georgios G Avery Anthony J AJ Mehta Rajnikant R Davies James E JE Salema Nde-Eshimuni NE Craig Christopher C Latif Asam A Waring Justin J Chuter Antony A

BMJ quality & safety 20191115 4

<h4>Objective</h4>To examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks.<h4>Methods</h4>Pragmatic patient-level parallel randomised controlled trial in 46 English community pharmacies. 504 participants aged ≥14, identified in the pharmacy when presenting a prescription for a new medicine for predefined long-term conditions, randomised to receive NMS (n=251) or normal practice (n=253) (NMS intervention: 2 consultations 1 and 2 weeks a ...[more]

PMID: 31732700

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Project description:BackgroundThe English community pharmacy New Medicine Service (NMS) significantly increases patient adherence to medicines, compared with normal practice. We examined the cost effectiveness of NMS compared with normal practice by combining adherence improvement and intervention costs with the effect of increased adherence on patient outcomes and healthcare costs.MethodsWe developed Markov models for diseases targeted by the NMS (hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma and antiplatelet regimens) to assess the impact of patients' non-adherence. Clinical event probability, treatment pathway, resource use and costs were extracted from literature and costing tariffs. Incremental costs and outcomes associated with each disease were incorporated additively into a composite probabilistic model and combined with adherence rates and intervention costs from the trial. Costs per extra quality-adjusted life-year (QALY) were calculated from the perspective of NHS England, using a lifetime horizon.ResultsNMS generated a mean of 0.05 (95% CI 0.00-0.13) more QALYs per patient, at a mean reduced cost of -£144 (95% CI -769 to 73). The NMS dominates normal practice with a probability of 0.78 [incremental cost-effectiveness ratio (ICER) -£3166 per QALY]. NMS has a 96.7% probability of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY. Sensitivity analysis demonstrated that targeting each disease with NMS has a probability over 0.90 of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY.ConclusionsOur study suggests that the NMS increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost.Trial registrationClinicalTrials.gov Trial reference number NCT01635361 ( http://clinicaltrials.gov/ct2/show/NCT01635361 ). Current Controlled trials: Trial reference number ISRCTN 23560818 ( http://www.controlled-trials.com/ISRCTN23560818/ ; DOI 10.1186/ISRCTN23560818 ). UK Clinical Research Network (UKCRN) study 12494 ( http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12494 ).FundingDepartment of Health Policy Research Programme.

Project description:BackgroundPreventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques.MethodsDesign: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.ParticipantsPWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers.InterventionsCentral randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32).OutcomesRCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5).ResultsThe pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised.ConclusionsWith improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible.Trial registrationISRCTN13076797 . Prospectively registered on 07/06/2016.

Project description:BACKGROUND:Mobile health (mHealth) apps have the potential to support patients' medication use and are therefore increasingly used. Apps with broad functionality are suggested to be more effective; however, not much is known about the actual use of different functionalities and the effective engagement. OBJECTIVE:The aim of this study was to explore the use and the effective engagement of adolescents (aged 12 to 18 years) with the Adolescent Adherence Patient Tool (ADAPT). METHODS:The ADAPT intervention consisted of an app for patients, which was connected to a management system for their pharmacist. The aim of the ADAPT intervention was to improve medication adherence and, therefore, the app contained multiple functionalities: questionnaires to monitor symptoms and adherence, medication reminders, short movies, pharmacist chat, and peer chat. For this study, data of the ADAPT study and a cluster randomized controlled trial were used. Adolescents with asthma had 6 months' access to the ADAPT intervention, and all app usage was securely registered in a log file. RESULTS:In total, 86 adolescents (mean age 15.0, SD 2.0 years) used the ADAPT app 17 times (range 1-113) per person. Females used the app more often than males (P=.01) and for a longer period of time (P=.03). On average, 3 different functionalities were used, and 13% of the adolescents used all functionalities of the app. The questionnaires to monitor symptoms and adherence were used by most adolescents. The total app use did not affect adherence; however, activity in the pharmacist chat positively affected medication adherence (P=.03), in particular, if patients sent messages to their pharmacist (P=.01). CONCLUSIONS:mHealth apps for adolescents with asthma should contain different functionalities to serve the diverging needs and preferences of individual patients. Suggested key functionalities to promote use and effectiveness in adolescents with asthma are questionnaires to monitor symptoms and a health care provider chat.

Project description:ImportanceOpioid tapering has been associated with negative consequences, such as increased overdoses and mental health needs. Tapering could also alter use of health care services and worsen care of comorbid conditions through disruption in primary care.ObjectiveTo evaluate tapering of stable long-term opioid therapy (LTOT) and subsequent health care service use and chronic condition care.Design, setting, and participantsA retrospective cohort study was conducted from January 1, 2008, to December 31, 2019. Data analysis was performed from July 9, 2020, to December 9, 2022. Data from the Optum Labs Data Warehouse, which contains deidentified retrospective administrative claims data and linked electronic health record data for commercial and Medicare Advantage enrollees, were used. Adults aged 18 years or older prescribed stable doses of LTOT at 50 morphine milligram equivalents or more per day during a 12-month baseline period were included, including subcohorts with hypertension or diabetes.ExposuresOpioid tapering, with 15% or more relative reduction in mean daily dose in 6 overlapping periods during 6 months.Main outcomes and measuresEmergency department visits, hospitalizations, primary care and specialist visits, antihypertensive or antiglycemic medication adherence, and blood pressure and hemoglobin A1c levels during up to 12 months' follow-up. Covariates included sociodemographic characteristics, comorbidities, health care use, and chronic condition control.ResultsAmong 113 604 patients (60 764 [53.5%] women; mean [SD] age, 58.1 [11.8] years) prescribed LTOT, 41 207 had hypertension and 23 335 had diabetes; in all cohorts, approximately half were women, and half were aged 50 to 65 years. In the overall cohort, tapering was associated with more emergency department visits (adjusted incidence rate ratio [aIRR], 1.19; 95% CI, 1.16-1.21) and hospitalizations (aIRR, 1.16; 95% CI, 1.12-1.20), with similar magnitude associations in the hypertension and diabetes subcohorts. Tapering was associated with fewer primary care visits in the overall cohort (aIRR, 0.95; 95% CI, 0.94-0.96) and hypertension subcohort (aIRR, 0.98; 95% CI, 0.97-0.99). For the hypertension or diabetes subcohorts, tapering was associated with reduced medication adherence (hypertension: aIRR, 0.60; 95% CI, 0.59-0.62; diabetes: aIRR, 0.69; 95% CI, 0.67-0.71) and small increases in diastolic blood pressure and hemoglobin A1c level.Conclusions and relevanceIn this cohort study of patients prescribed LTOT, opioid tapering was associated with more emergency department visits and hospitalizations, fewer primary care visits, and reduced antihypertensive and antidiabetic medication adherence. These outcomes may represent unintended negative consequences of opioid tapering for policy makers and clinicians to consider.

Project description:ObjectiveTo test a scalable health system intervention to improve long term adherence to secondary prevention treatments among patients who have had a recent myocardial infarction.DesignThree arm, pragmatic randomised controlled trial with blinded outcome assessment.SettingNine cardiac centres in Ontario, Canada.Participants2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry.InterventionsParticipants were randomised 1:1:1 to receive usual care, five mail-outs developed through a user centred design process, or mail-outs plus phone calls. The phone calls were delivered first by an interactive automated system to screen for non-adherence to treatment. Trained lay health workers followed up as necessary. Interventions were coordinated centrally but delivered from each patient's hospital site.Main outcome measuresCo-primary outcomes were completion of cardiac rehabilitation and adherence to recommended medication. Data were collected by blinded assessors through patient report and from administrative health databases at 12 months.Results2632 patients (mean age 66, 71% male) were randomised: 878 to the full intervention (mail plus phone calls), 878 to mail only, and 876 to usual care. Of the respondents, 174 (27%) of 643 in the usual care group, 200 (32%) of 628 in the mail only group, and 196 (37%) of 531 allocated to the full intervention completed cardiac rehabilitation (adjusted odds ratio 1.55, 95% confidence interval 1.18 to 2.03). In the mail plus phone group, 11.7%, 6.0%, 14.4%, 32.9%, and 35.0% reported adherence to 0, 1, 2, 3, and 4 drug classes after one year, respectively, in comparison with 12.5%, 6.8%, 13.6%, 30.2%, and 36.8% in the mail only group, and 12.2%, 8.4%, 13.1%, 30.3%, and 36.1% in the usual care group, respectively (mail only v usual care, odds ratio 0.98, 95% confidence interval 0.81 to 1.19; full intervention v usual care, 0.99, 0.82 to 1.20).ConclusionsScalable interventions delivered by mail plus phone can increase completion of cardiac rehabilitation after myocardial infarction but not adherence to medication. More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication.Trial registrationClinicalTrials.gov NCT02382731, registered 9 March 2015 before any patient enrolment.

Dataset Information

'New Medicine Service': supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial.

Objective

Methods

Results

Conclusions

Trial registration number

Publications

'New Medicine Service': supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial.

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