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Implementation of a new guideline in cardiovascular secondary preventive care: subanalysis of a randomized controlled trial
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine. (Research Unit Östersund)
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine. (Research Unit Östersund)
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine. (Research Unit Östersund)
2016 (English)In: BMC Cardiovascular Disorders, ISSN 1471-2261, E-ISSN 1471-2261, Vol. 16, article id 77Article in journal (Refereed) Published
Abstract [en]

Background

Cardiovascular secondary preventive recommendations are often not reached. We investigated whether a nurse-led telephone-based follow-up could improve the implementation of a new guideline within a year after its release.

Methods

In February 2013, a new secondary preventive guideline for diabetic patients was released in the county of Jämtland, Sweden. It included a changed of the low-density lipoprotein cholesterol (LDL-C) target value from <2.5 mmol/L to <1.8 mmol/L. In the Nurse-Based Age-Independent Intervention to Limit Evolution of Disease (NAILED) trial, patients with an acute coronary syndrome, stroke, or transient ischemic attack were randomized to secondary preventive care with nurse-based telephone follow-up (intervention) or usual care (control). Patient data were obtained from the NAILED trial to study the implementation of the new LDL-C guideline by comparing telephone follow-up with usual care. The Mann–Whitney U-test was used for continuous variables, and Person’s χ 2 test was used for categorical variables to assess between-group differences.

Results

Out of the 1267 patients that entered the study period, 101 intervention and 100 control patients with diabetes fulfilled the inclusion criteria and completed the study period. Before the guideline change, 96 % of the intervention patients and 70 % of the control patients reached the target LDL-C value (p < 0.001). After the guideline change, the corresponding respective proportions were 65 % and 36 % (p < 0.001). The main reason that intervention patients did not achieve the target LDL-C value was that they received full-dose treatment; for control patients, the main reason was that medication was not adjusted, for an unknown reason.

Conclusions

One year after a change in the cardiovascular secondary preventive guideline, nurse-based telephone follow-up performed better than usual care to implement the new recommendation.

Place, publisher, year, edition, pages
2016. Vol. 16, article id 77
Keywords [en]
Acute coronary syndrome, Cardiovascular disease, Myocardial infarction, Randomized controlled trial, Secondary prevention, Stroke, Transient ischemic attack
National Category
Cardiac and Cardiovascular Systems
Research subject
Medicine, cardiovascular disease
Identifiers
URN: urn:nbn:se:umu:diva-109782DOI: 10.1186/s12872-016-0252-0ISI: 000375098300001OAI: oai:DiVA.org:umu-109782DiVA, id: diva2:859169
Note

Originally included in thesis in manuscript form

Available from: 2015-10-06 Created: 2015-10-06 Last updated: 2019-04-26Bibliographically approved
In thesis
1. Cardiovascular disease and diabetes or renal insufficiency: the risk of ischemic stroke and risk factor intervention
Open this publication in new window or tab >>Cardiovascular disease and diabetes or renal insufficiency: the risk of ischemic stroke and risk factor intervention
2015 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background

In patients with diabetes mellitus (DM) or chronic kidney disease (CKD), established cardiovascular disease (CVD) is associated with an increased risk of recurrent events and poor outcome. Ischemic stroke after an acute myocardial infarction (AMI) is a devastating event that carries high risks of decreased patient independence and death. Among patients with DM or CKD, the risk of an ischemic stroke within a year following an AMI is not known. Improved risk factor control is required to reduce the likelihood of CVD recurrence. Guidelines recommend target lipid profile and blood pressure values; however, data show that these targets are often not met. Therefore, there remains an urgent need for improved cardiovascular secondary preventive follow- up.

Aims

The aims of the present studies were to define trends in the incidence and predictors of ischemic stroke after an AMI in patients with DM or CKD. Furthermore to assess whether secondary preventive follow-up with nurse-based telephone follow-up including medication titration after CVD improves risk factor values in patients with DM or CKD and to investigate if this method performs better than usual care to implement a new treatment guideline in diabetic patients.

Methods

To assess the risk of post-AMI ischemic stroke, patient data were obtained from the Swedish Register of Information and Knowledge about Swedish Heart Intensive Care Admissions (RIKS-HIA). In separate studies, we compared a total of 173 233 AMI patients with and without DM, and 118 434 AMI patients with and without CKD.

Within the nurse-based age-independent intervention to limit evolution of disease (NAILED) trial, we investigated a nurse-based cardiovascular secondary preventive follow-up protocol. Patients with acute coronary syndrome, stroke, or transient ischemic attack were randomized to receive either nurse-based telephone follow-up (intervention) or usual care (control). Low-density lipoprotein (LDL-C) levels and blood pressure (BP) were measured at 1 month (baseline) and 12 months post- discharge. Intervention patients with above-target baseline values received medication titration to achieve treatment goals, while the measurements for control patients were forwarded to their general practitioners for assessment. We calculated the changes in LDL-C level and BP between baseline and 12 months post-discharge, and compared 

these changes between 225 intervention patients and 215 control patients with concurrent DM or CKD. During the course of the NAILED trial, new secondary preventive guidelines for DM patients were released, including a new LDL-C target value. To assess adherence to the new guidelines within the NAILED trial, we compared LDL-C levels in the 101 intervention patients and 100 control patients with DM.

Results

Ischemic stroke after AMI

The rates of ischemic stroke within one-year after admission for an AMI decreased over time, from 7.1% in 1998–2000 to 4.7% in 2007–2008 among DM patients, and from 4.2% to 3.7% during the same time periods for non-diabetic patients. Lower stroke risk was associated with percutaneous coronary intervention (PCI) and initiation of secondary preventive treatments in-hospital.

In-hospital ischemic stroke occurred in 2.3% of CKD patients and 1.2% of non-CKD patients, with no change in these incidences over time. The rates of one-year post- discharge ischemic stroke decreased between 2003–2004 and 2009–2010 from 4.1% to 2.5% among CKD patients, and from 2.0% to 1.3% among non-CKD patients. Lower rates of post-discharge stroke were associated with PCI and statins.

Cardiovascular secondary preventive follow-up

Among DM and CKD patients with above-target baseline values in the NAILED trial, the median LDL-C value at 12 months was 2.2 versus 3.0 mmol/L (p<0.001) and median systolic BP was 140 versus 145 mmHg (p=0.26) for intervention and control patients, respectively.

Before the guideline change, 96% of the intervention and 70% of the control patients reached the target LDL-C value (p<0.001). After the guideline change, the corresponding respective proportions were 65% and 36% (p<0.001).

Conclusion

Ischemic stroke is a fairly common post-AMI complication among patients with DM and CKD. This risk of stroke has decreased during recent years, possibly due to the increased use of evidence-based therapies. Compared with usual care, cardiovascular secondary prevention including nurse-based telephone follow-up improved LDL-C values at 12 months after discharge in patients with DM or CVD, and led to more efficient implementation of new secondary preventive guidelines. 

Place, publisher, year, edition, pages
Umeå: Umeå Universitet, 2015. p. 55
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 1743
Keywords
cardiovascular disease, secondary prevention, diabetes mellitus, chronic kidney disease, acute coronary syndrome, stroke, randomized control trial
National Category
Cardiac and Cardiovascular Systems
Research subject
Medicine, cardiovascular disease
Identifiers
urn:nbn:se:umu:diva-109785 (URN)978-91-7601-320-5 (ISBN)
Public defence
2015-11-06, Hörsalen, Östersunds sjukhus, Östersund, 09:00 (Swedish)
Opponent
Supervisors
Available from: 2015-10-16 Created: 2015-10-06 Last updated: 2018-06-07Bibliographically approved
2. On secondary prevention after acute coronary syndrome: -what, when, and who
Open this publication in new window or tab >>On secondary prevention after acute coronary syndrome: -what, when, and who
2019 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background

Cardiovascular disease, of which coronary heart disease constitutes the lion’s share, is the leading cause of premature morbidity and mortality worldwide. Management of the condition has evolved rapidly in recent decades, and mortality has more than halved in the western world. Because of intense research, solid evidence supports effective and inexpensive means of preventing disease progression. However, secondary prevention still yields disappointingly low success in meeting guideline-recommended risk factor targets. It is therefore vital to develop more effective risk factor management.

Aims

We aimed to assess the feasibility of a nurse-led, telephone-based, secondary preventive intervention in an unselected population with acute coronary syndrome (ACS). Furthermore, we sought to evaluate the flexibility of the intervention to adapt to a change in guidelines. We also aimed to evaluate whether the intervention was more effective than usual care at improving risk factor levels for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) 12 months after discharge. Finally, we aimed to measure whether the intervention improved long-term adherence to statins.

Methods

All papers are based on the Nurse-based Age-independent Intervention to Limit Evolution of Disease after ACS (NAILED-ACS) trial. The NAILED trail has two arms, one after stroke/transient ischemic attack (NAILED-Stroke) and one after ACS (NAILED-ACS). All studies are based on NAILED-ACS aside from study II which includes both arms. The trial was an open, 1:1 randomized, controlled, parallel group trial that compared nurse-led telephone follow-up with medical titration (intervention) to a control group with follow-up by a general practitioner (control). All patients admitted to Östersund Hospital for ACS during 2010–2014 were eligible if available for preventive management by telephone. A baseline assessment was made at 1 month after discharge and thereafter every 12 months for at least 3 years. 

Feasibility was assessed among patients admitted until 31 January 2013, and predictors of exclusion and non-participation were identified. The performance of the intervention in implementing a guideline change was evaluated in patients with diabetes with both ACS and stroke as inclusion events after a change in LDLC target from <2.5 mmol/L to <1.8 mmol/L. LDL-C levels were compared between intervention and control patients before and after the guideline changed. Reasons for not reaching the target level were recorded. The outcomes of the intervention on BP and LDL-C were studied in patients admitted until 31 December 2013. We measured proportions reaching targets and levels of LDL-C and BP during the first 12 months of follow-up, with comparisons between the intervention and control groups. Adherence to statin treatment was measured in the entire study cohort, with at least 36 months of follow-up, with classification of reasons and analysis of predictors for both a first and a permanent discontinuation.

Results

Of 907 screened patients with ACS in the first study, 72.9% were included, and 11% declined participation. Among the 16.1% who were excluded, the predominant reasons were participation in other trial, dementia, and advanced disease. Non-included patients were significantly older, with more comorbidities, decreased functional capability, and lower level of education compared to included. Excluded and declining patients also had a reduced oneyear survival in comparison with included.

Before the guideline changed, 96% of the 101 patients in the intervention group reached LDL-C <2.5 mmol/L compared to 70% of the 100 control patients (p<0.001). One year after target reduction to <1.8 mmol/L, the same proportions were 65% and 36%, respectively (p<0.001). The predominant reason for nonattainment of target in the intervention group was full-dose treatment; for the control group, it was that no medication adjustment was made. After medical titration, at 1 month (baseline), 94.1% in the intervention group achieved target for LDL-C (<2.5 mmol/L) compared to 68.4% in the control group. Mean LDL-C was 0.38 mmol/L lower in the intervention group (p<0.05 for both). At the 12-month assessment, 77.7% of the intervention group attained the LDL-C target compared to 63.2% of the control group, and mean LDL-C was 0.3 mmol/L lower among intervention patients (p<0.05 for both). In the intervention group, 91.9% achieved targets for systolic BP and 96.2% for diastolic BP after baseline titration compared to 65.6% and 82.0%, respectively, in the control group (p<0.05 for both). At 12 months, 68.9% in the intervention group reached the target for systolic BP and 88.1% for diastolic BP, compared to 63.7% and 82.8%, respectively, in the control group (p=0.125 and <0.05). Mean systolic BP was 7 mmHg lower and mean diastolic BP 4 mmHg lower in the intervention group after 1-month titration compared to controls. At 12 months, the mean systolic BP was 1.5 mmHg lower and mean diastolic BP 2.1 mmHg lower in the intervention group.

In our assessment of adherence to statin treatment, 89.3% in the intervention group and 81.7% in the control group were adherent to treatment during a mean follow-up of 3.9 years (p<0.001). In the intervention group, 27.8% discontinued at least once during the period, compared to 20.8% in the control group (p<0.05). The main reason for a first discontinuation was avoidable in both groups: sideeffects without a compelling association with treatment. The main reason for permanent discontinuation was predominantly non-avoidable in the intervention group (advanced disease and dementia) but avoidable in the control group (sideeffects without a compelling association with treatment). Predictors for increased risk for discontinuation were female sex, and for a first event, inclusion in the intervention group. Predictors for reduced risk of non-adherence were ST elevation myocardial infarction as an including event, and for permanent discontinuation, inclusion in the intervention group.

Conclusion

A nurse-led telephone-based method for secondary prevention can encompass a large proportion of an ordinary ACS cohort. Compared to usual care, it is more adaptable to changes in treatment guidelines and leads to better achievement of major risk factor targets as well as improved medication adherence.

Abstract [sv]

Enkel sammanfattning på svenska

Hjärt-kärlsjukdomar är idag den största orsaken till nedsättning av livskvalitet och förtidig död i världen. Detta till trots att utveckling av behandling och förbättringar i livsstilsrelaterade faktorer har halverat dödligheten under de senaste decennierna i västvärlden.

Hjärtkärlsjukdom utvecklas ur åderförkalkning, som är en inflammatorisk process i kroppens pulsådror med en inlagring av blodfetter och efterföljande förkalkning. Detta leder till plackbildning i kärlväggen som sedan helt eller delvis kan täppa till blodflödet och då ge upphov till hjärtmuskelcelldöd (hjärtinfarkt).Den akuta behandlingen av hjärtinfarkt går ut på att med mediciner minska belastningen på hjärtat samt att återställa blodflödet. Detta görs idag oftast med ballongsprängning och inläggande av ”stent” (PCI) eller kranskärls bypassoperation (CABG). För att undvika nya förträngningar är det därefter avyttersta vikt att begränsa åderförkalkningsprocessen genom att behandla de riskfaktorer som driver densamma, så kallad sekundär prevention. Detta görs genom livsstilsförändringar i form av rökstopp, kostomläggning och ökad motion tillsammans med att med mediciner behandla kända risker som högt blodtryckoch blodfettsrubbning. Tyvärr visar alla studier att en stor andel inte uppnår de målnivåer för de mest allvarliga riskfaktorerna som visats minska risken för ny hjärtinfarkt och död. I den här avhandlingen undersöker vi om en sjuksköterskeledd uppföljning via telefon kan förbättra den sekundärpreventiva behandlingen efter hjärtinfarkt.

Syfte

Vi vill specifikt undersöka om en sjuksköterskeledd telefonbaserad uppföljning efter hjärtinfarkt med individuell medicinjustering:

• Är tillämpbar i den normala patientgruppen med hjärtinfarkt.

• Är i jämförelse med dagens vård mer följsam till vetenskaplig utveckling.

• Uppnår bättre resultat under de första 12 månaderna än sedvanliguppföljning avseende behandling av blodfettsrubbning (LDL kolesterol)samt blodtryck.

• Ökar följsamheten till statiner, den vanligaste behandlingen avblodfettsrubbning.

Metod

Avhandlingen baseras på den randomiserad kontrollerade studien NAILED (Nurse-based Age independent Intervention to Limit evolution of Disease) som har två armar: en med akut koronart syndrom (hjärtinfarkt och instabil kärlkramp) samt en med stroke och TIA (transient ischemisk attack). Alla ingående delarbeten förutom studie II fokuserar på patienter med akut koronart syndrom

NAILED-ACS

Alla patienter som lades in på Östersunds sjukhus i Jämtland mellan 2010–2014 för hjärtinfarkt eller instabil kärlkramp beroende av åderförkalkning utvärderades för deltagande. Kriterier för att inte kunna deltaga var oförmåga att följa studiedesignen eller deltagande i annan klinisk studie. Efter utvärdering och godkänt deltagande lottades patienter till en interventionsgrupp eller enkontrollgrupp. Alla patienter oavsett grupptilldelning fick en månad efter utskrivning mäta blodtryck och blodfetter på sin närmaste Hälsocentral. Därefter blev de uppringda av en studiesköterska. Vid samtalet intervjuades patienterna avseende symptom från hjärtat, livsstilsrelaterade faktorer samt följsamhet till behandling och eventuella biverkning av läkemedel. En dylik bedömning med föregående mätning av blodtryck och blodfetter skedde därefter årligen tills minst 3 år efter händelsen eller studiens slut.

Intervention

I interventionsgruppen skedde utefter behov efter svar på mätvärdena en medicinjustering för att uppnå målvärden på blodtryck (<140/90 mmHg) samtLDL-kolesterol (<2,5mmol/L). Justeringen utvärderades efter 4 veckor med nya mätningar och om fortsatt behov upprepades denna rutin tills målvärde uppnåttseller en bedömning om att målet var ouppnåeligt. Patienterna fick även råd om livsstilsförändringar.

Kontroll

I kontrollgruppen skedde ingen justering eller rådgivning, och resultaten av mätningarna skickades till patientens ordinarie vårdcentral och eventuell vidarejustering sköttes därifrån enligt gällande rutin.

Studie I

I den första studien undersökte vi hur stor andel av patientgruppen som kunde och ville delta i studieupplägget. Vi undersökte vilka faktorer som bidrog tilldeltagande eller icke-deltagande.

Studie II

Under 2013 genomförde primärvården i länet en justering av målvärdet för LDLkolesterol hos diabetiker från <2,5 mmol/L till <1,8 mmol/L för att följanationella riktlinjer. Vi antog samma målvärde i studien, och undersökte vad som hände med behandlingen i de två grupperna under det följande året. I dennastudie inkluderade vi patienter med både akut koronart syndrom och stroke/TIA.

Studie III

Vi undersökte resultatet av interventionen i jämförelse med kontrollgruppen med avseende på LDL-kolesterol och blodtryck under det första årets uppföljning.

Studie IV

I fjärde studien undersökte vi andelen som avslutat behandling med statiner under minst 3 år av uppföljning. Vi tog reda på orsaker till avslut och vilkaindividfaktorer som ökar risken för avslut av behandling.

Resultat

Av 907 bedömda patienter kunde 72,9% inkluderas, 11% avstod deltagande och 16,1% exkluderades. Den vanligaste orsaken till exklusion var deltagande i annanstudie följt av demens eller annan svår sjuklighet. Icke-deltagande patienter (exkluderade och de som avstod) var i allmänhet äldre, med mer samsjuklighetsamt lägre utbildningsnivå jämfört med deltagande patienter. Detta avspeglades även i en ökad risk för död i gruppen av icke-inkluderade patienter.

Före förändringen av riktlinjerna för LDL-kolesterol uppnådde 96% av de 101 diabetikerna i interventionsgruppen målnivån på <2,5 mmol/L. Samma andel ikontrollgruppen var 70% av 100 patienter. Ett år efter målnivåjustering till <1,8 mmol/L uppnådde 65% av diabetikerna i interventionsgruppen och 36% ikontrollgruppen den nya målnivån. Den vanligaste orsaken till att inte uppnå den nya målnivån var i interventionsgruppen fulldos behandling och ikontrollgruppen att ingen läkemedelsjustering hade utförts.

Efter den medicinska justeringen 1 månad efter utskrivning uppnådde 94,1% iinterventionsgruppen målvärdet för LDL-kolesterol (<2,5 mmol/L), jämfört med 68,4% i kontrollgruppen. Vid 12-månaderskontrollen uppnådde 77,7% iinterventionsgruppen samma målvärde jämfört med 63,2% i kontrollgruppen. Vid 1 månadskontrollen var LDL-kolesterol i medel 0,38 mmol/L lägre i interventionsgruppen och vid 12 månaders kontrollen 0,3 mmol/L lägre jämfört med kontroller. Gällande blodtryck efter justeringen vid 1 månad uppnådde iinterventionsgruppen 91,9% målvärdet för systoliskt blodtryck och 96,2% målvärdet för diastoliskt blodtryck jämfört med kontrollgruppen där 65,6%uppnådde målet för systoliskt samt 82,0% för diastoliskt blodtryck. Vid 12-månaderskontrollen uppnådde i interventionsgruppen 68,9% målvärdet försystoliskt och 88,1% för diastoliskt blodtryck. Motsvarande uppfyllelse i kontrollgruppen var 63,7% för systoliskt och 82,8% för diastoliskt blodtryck.Medelblodtryck var efter medicinjustering vid 1 månad 7 mmHg systoliskt och 4 mmHg diastoliskt lägre i interventionsgruppen jämfört med kontrollgruppen.Vid 12 månader var medelblodtrycket i interventionsgruppen lägre jämfört med kontroller med 1,5 mmHg systoliskt och 2,1 mmHg diastoliskt.

Vid bedömning av följsamhet till statinbehandling var 89,3% i interventionsgruppen och 81,7% i kontrollgruppen följsamma efter i medel 3,9års uppföljning. I interventionsgruppen avslutade 27,8% sin behandling någon gång under studietiden och motsvarande siffra i kontrollgruppen 20,8%. Denvanligaste anledningen till ett första avslut var i bägge grupperna undvikbar (biverkan utan tydlig relation till medicinering). Den vanligaste anledningen tillett permanent avslut var i interventionsgruppen oundvikbar (avancerad sjukdom inklusive demens) och i kontrollgruppen fortsatt undvikbar (biverkan utanrelation till medicinering). Kvinnor löpte en ökad risk för behandlingsavslut och s.k. ST-höjningsinfarkt vid vårdtillfället minskade risken. Att vara deltagare iinterventionsgruppen ökade risken för ett första behandlingsavslut men minskade risken för att permanent avslut.

Slutsatser

En sköterskeledd telefonbaserad metod för sekundär prevention efter akut koronart syndrom kan innefatta en stor andel av en normalhjärtinfarktspopulation. Jämfört med nuvarande rutin leder metoden till ökad följsamhet vid förändringar i rutiner samt bättre måluppfyllelse av de viktigasteriskfaktorerna högt blodtryck och blodfettsrubbning. Metoden leder även till ökad följsamhet till statinbehandling och minskad risk för undvikbara avslut av densamma.

Place, publisher, year, edition, pages
Umeå: Umeå universitet, 2019. p. 64
Series
Umeå University medical dissertations, ISSN 0346-6612
Series
2026
Keywords
Cardiovascular disease, acute coronary syndrome, secondary prevention, nurse-led, statins, randomized controlled trial.
National Category
Cardiac and Cardiovascular Systems
Research subject
Cardiology
Identifiers
urn:nbn:se:umu:diva-158414 (URN)978-91-7855-046-3 (ISBN)
Public defence
2019-05-24, Hörsalen Snäckan, Östersunds Sjukhus, Östersund, 09:30 (Swedish)
Opponent
Supervisors
Projects
NAILED
Available from: 2019-05-03 Created: 2019-04-26 Last updated: 2019-05-06Bibliographically approved

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