BMJ (Clinical research ed.) · 2020
Interventions supporting long term adherence and decreasing cardiovascular events after myocardial infarction (ISLAND): pragmatic randomised controlled trial.
СтатьяМногоцентровое исследованиеPragmatic Clinical TrialРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Ivers Noah M, Schwalm Jon-David, Bouck Zachary, McCready Tara, Taljaard Monica, Grace Sherry L, Cunningham Jennifer, Bosiak Beth, Presseau Justin, Witteman Holly O, Suskin Neville, Wijeysundera Harindra C, Atzema Clare, Bhatia R Sacha, Natarajan Madhu, Grimshaw Jeremy M
Аннотация
OBJECTIVE: To test a scalable health system intervention to improve long term adherence to secondary prevention treatments among patients who have had a recent myocardial infarction.
DESIGN: Three arm, pragmatic randomised controlled trial with blinded outcome assessment.
SETTING: Nine cardiac centres in Ontario, Canada.
PARTICIPANTS: 2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry.
INTERVENTIONS: Participants 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 MEASURES: Co-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.
RESULTS: 2632 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).
CONCLUSIONS: Scalable 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 REGISTRATION: ClinicalTrials.gov NCT02382731, registered 9 March 2015 before any patient enrolment.
DESIGN: Three arm, pragmatic randomised controlled trial with blinded outcome assessment.
SETTING: Nine cardiac centres in Ontario, Canada.
PARTICIPANTS: 2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry.
INTERVENTIONS: Participants 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 MEASURES: Co-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.
RESULTS: 2632 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).
CONCLUSIONS: Scalable 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 REGISTRATION: ClinicalTrials.gov NCT02382731, registered 9 March 2015 before any patient enrolment.
Предметные рубрики MeSH
Adrenergic beta-AntagonistsAgedAngiotensin-Converting Enzyme InhibitorsCardiac RehabilitationCoronary Artery DiseaseFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedMyocardial InfarctionOntarioPatient DropoutsPatient Education as TopicPlatelet Aggregation InhibitorsPostal ServiceQuality of LifeReminder SystemsSecondary PreventionTelephoneTime FactorsTreatment OutcomeDrug Monitoring