NCT00509717

Brief Summary

The purpose of this study is to determine the effectiveness of maximal support of community pharmacies to implement a pharmaceutical care model for improving underprescription and treatment persistence regarding lipid-lowering medication in patients with cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 10, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

February 28, 2007

Last Update Submit

July 9, 2008

Conditions

Keywords

quality of health careprescriptions, druganticholesteremic agentscommunity pharmacy services

Outcome Measures

Primary Outcomes (1)

  • The percentage of selected (=undertreated) patients receiving at least one prescription for lipid-lowering medication.

    six months after the general practitioner received the list with selected patients

Secondary Outcomes (1)

  • Differences in prescribing for age categories and co-medication.

    six months

Study Arms (2)

experimental

EXPERIMENTAL
Other: intensive implementation programme

control

ACTIVE COMPARATOR
Other: control

Interventions

educational manual; interactive educational meeting tailored to individual needs; reminders and feedback by 3 newsletters and at least 3 telephone calls.

experimental
controlOTHER

educational manual

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pharmacies: resident in the south of the Netherlands
  • patients: with antiplatelet therapy and without lipid-lowering medication

You may not qualify if:

  • terminal disease
  • severe mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC St Radboud, Scientific Institute for Quality of Healthcare

Nijmegen, NL, 6500 HB, Netherlands

Location

Related Publications (10)

  • Mantel-Teeuwisse AK, Verschuren WM, Klungel OH, de Boer A, Kromhout D. Recent trends in (under)treatment of hypercholesterolaemia in the Netherlands. Br J Clin Pharmacol. 2004 Sep;58(3):310-6. doi: 10.1111/j.1365-2125.2004.02152.x.

    PMID: 15327591BACKGROUND
  • Blenkinsopp A, Anderson C, Armstrong M. Systematic review of the effectiveness of community pharmacy-based interventions to reduce risk behaviours and risk factors for coronary heart disease. J Public Health Med. 2003 Jun;25(2):144-53. doi: 10.1093/pubmed/fdg030.

    PMID: 12848404BACKGROUND
  • Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, Whitty P, Eccles MP, Matowe L, Shirran L, Wensing M, Dijkstra R, Donaldson C. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004 Feb;8(6):iii-iv, 1-72. doi: 10.3310/hta8060.

    PMID: 14960256BACKGROUND
  • Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22. doi: 10.1016/S0140-6736(02)09327-3.

    PMID: 12114036BACKGROUND
  • Gaw A. The care gap: underuse of statin therapy in the elderly. Int J Clin Pract. 2004 Aug;58(8):777-85. doi: 10.1111/j.1368-5031.2004.00300.x.

    PMID: 15372851BACKGROUND
  • Teeling M, Bennett K, Feely J. The influence of guidelines on the use of statins: analysis of prescribing trends 1998-2002. Br J Clin Pharmacol. 2005 Feb;59(2):227-32. doi: 10.1111/j.1365-2125.2004.02256.x.

    PMID: 15676046BACKGROUND
  • van Wyk JT, Picelli G, Dieleman JP, Mozaffari E, Kramarz P, van Wijk MA, van der Lei J, Sturkenboom MC. Management of hypertension and hypercholesterolaemia in primary care in The Netherlands. Curr Med Res Opin. 2005 Jun;21(6):839-48. doi: 10.1185/030079905X46368.

    PMID: 15969884BACKGROUND
  • Nederlands Huisartsen Genootschap (NHG). NHG-standaard Cardiovasculair Risicomanagement. 2006 Jan.

    BACKGROUND
  • Stuurman-Bieze AG, de Boer WO, Kokenberg ME, Hugtenburg JG, de Jong-van den Berg LT, Tromp TF. Complex pharmaceutical care intervention in pulmonary care: part A. The process and pharmacists' professional satisfaction. Pharm World Sci. 2005 Oct;27(5):376-84. doi: 10.1007/s11096-005-7112-9.

    PMID: 16341744BACKGROUND
  • Van de Steeg-van Gompel CH, Wensing M, De Smet PA. Implementation of patient education at first and second dispensing of statins in Dutch community pharmacies: the sequel of a cluster randomized trial. BMC Health Serv Res. 2011 Nov 16;11:313. doi: 10.1186/1472-6963-11-313.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Peter G. de Smet, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR
  • Michel Wensing, PhD

    Scientific Institute for Quality of Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2007

First Posted

July 31, 2007

Study Start

October 1, 2006

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

July 10, 2008

Record last verified: 2008-07

Locations