NCT01152151

Brief Summary

The aim of this project is to evaluate the efficacy of electronic reminder letters versus postal reminder letters on general practices adherence to clinical quality guidelines regarding Point Of Care Testing (POCT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 22, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 30, 2014

Status Verified

June 1, 2010

Enrollment Period

9 months

First QC Date

June 22, 2010

Last Update Submit

July 29, 2014

Conditions

Keywords

Heading Health Plan ImplementationGeneral PracticePoint of care testingeducation

Outcome Measures

Primary Outcomes (1)

  • Total number of split tests performed in study period.

    Total number of split tests performed in study period.

    January - April 2011

Secondary Outcomes (2)

  • Proportion of practices with a high quality of tests defined as 75% of the performed split tests for INR within the accepted interval according to the CGPL quality guidelines1 in study period.

    January - April 2011

  • Proportion of practices conducting split tests in study period.

    January - April 2011

Study Arms (2)

Postal reminders

ACTIVE COMPARATOR

Postal reminders

Device: Postal reminder lettersDevice: Reminder letters

Electronic reminders

ACTIVE COMPARATOR

Electronic reminders

Device: Electronic reminder lettersDevice: Reminder letters

Interventions

Postal reminder letters if adherence is not obtained (up to four)

Also known as: POST
Postal reminders

Electronic reminder letters if adherence is not obtained (up to four)

Also known as: ELECTRONIC
Electronic reminders

up to four reminder letters in september - december 2010

Also known as: POCIP study
Electronic remindersPostal reminders

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All GPs using at least 5 INR POCT analysis during baseline period (january-april 2010)

You may not qualify if:

  • GPs stopping during study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit of General Practice

Copenhagen, Capital, 1014, Denmark

Location

Related Publications (2)

  • Siersma V, Kousgaard MB, Reventlow S, Ertmann R, Felding P, Waldorff FB. The effectiveness of computer reminders versus postal reminders for improving quality assessment for point-of-care testing in primary care: a randomized controlled trial. J Eval Clin Pract. 2015 Feb;21(1):13-20. doi: 10.1111/jep.12210. Epub 2014 Jun 21.

  • Waldorff FB, Siersma V, Ertmann R, Kousgaard MB, Nielsen AS, Felding P, Mosbaek N, Hjortso E, Reventlow S. The efficacy of computer reminders on external quality assessment for point-of-care testing in Danish general practice: rationale and methodology for two randomized trials. Implement Sci. 2011 Jul 23;6:79. doi: 10.1186/1748-5908-6-79.

Study Officials

  • Frans B Waldorff, PhD

    Research Unit of General Practice

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 22, 2010

First Posted

June 29, 2010

Study Start

August 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 30, 2014

Record last verified: 2010-06

Locations