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CompletedNCT01152151POCIPUpdated Jul 30, 2014

Point Of Care Testing In Danish General Practice

An interventional study of Postal reminder letters and Electronic reminder letters in Point-of-Care Testing, sponsored by Research Unit Of General Practice, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-30.

Sponsored by Research Unit Of General Practice, Copenhagen · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
213
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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).

Read the detailed description

Background Point-of-care testing (POCT) is increasingly being used in general practice to assist GPs in their management of patients with diseases. An accredited external quality assessment (EQA) program and internal quality control system is recommended. In the Copenhagen area external as well as internal quality control has been enforced by annual outreach consultant visits and by split sample EQA procedures, where POCT results have been compared with central laboratory results. However, the adherence to quality guidelines has been seen to be less than anticipated among GPs in the Copenhagen municipality and in the former county of Copenhagen.

Dissemination of guidelines alone rarely brings about improvements in clinical practice and even an multifaceted implementation of guidelines may not change clinical practice. Multiple strategies for implementing guidelines appear to be more effective than single ones 5;6. However, well-designed empirical research looking into various implementation strategies is still needed in this area.

E-mails have successfully been used in several studies to promote health behaviour change in risk populations and our hypothesis is that electronic reminder letters (send to the GPs electronic patient records) is an efficient and inexpensive way to influence the behaviour of GP's.

Due to the low adherence, the Copenhagen General Practitioners' Laboratory (CGPL) plans to introduce electronic reminder letters (alongside the standard implementation procedures) during 2010 in order to increase adherence to the quality guideline.

The aims of this study are:

To evaluate the effect of electronic reminder letters versus postal reminder letters on general practices adherence to clinical quality guidelines regarding POCT.

Participants All practices conducting POCT INR (Approximately 240 practices). Practices are allocated to usual CGPL quality guideline activities and postal reminder letters (postal reminder group) and usual CGPL implementation activities in addition to electronic reminder letters (electronic reminder group).

Data collection Data on performed split test EQA procedures is retrieved from CGPL database. These data do not contain any patient related data because all split test EQA are conducted by a constructed identification code. Process indicators (sent reminder letters) are also obtained from CGPL. The Capital Region databases provide information on the participating practices and corresponding GPs.

Data from The Capital Region Information regarding: Sex, age, year of graduation from university, working address, type of practice, patient listed to practice and use the following tests: Hemoglobin, glucose, INR; CRP, HbA1C were retrospectively collected 4 months before the start of the trial (tentative in order to establish a baseline). Every month in the rest of the study period the investigators receive data from the Capital Region regarding practices in the study areas and identify practices having used Hemoglobin or blood glucose as a POCT. These data will be compared with the CGPL database every month and those practices that have not done a split sample EQA will receive electronic reminder letters during the following 4 months.

Randomization:

Practices are stratified by area and type of organization by means of SAS (Proc PLAN) by an independent organization.

Outcome:

Primary outcome:

  1. Total number of split tests performed in study period (three periods).

    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.
  3. Proportion of practices conducting split tests in study period.

Power calculation:

The investigators use a 50% adherence estimate based on CGPL data from 2007 in order to ascertain the power of the study. Given a MEREDIF at 25% and a power of 90% it is estimated that 160 practices are to be included in this study.

Statistics:

Differences in the outcomes between allocation groups at baseline, intervention and outcome period are tested by means of chi-square tests (outcomes 2 and 3) and t-tests (outcome 1).

In order to investigate the development of adherence relative to the intervention the investigators will for the three periods use logistic (outcome 2 and 3) and linear (outcome 1) regression where the investigators use GEE methods to account for the repeated measurements.

To identify predictors for adhering to guidelines adjusted odds ratios for the practice characteristics are estimated in multivariate logistic (outcomes 2 and 3) and linear (outcome 1) regression analysis on the outcomes at baseline.

All statistical analyses are performed using SAS, version 9.2 (SAS Institute Inc, Cary, NC).

Intervention Standard implementation The standard implementation of EQA consists of invited meetings and an annual facilitator visit in each practice. As part of the planned implementation strategy GPs were invited to meetings, received written material from the CGPL. At start each practice received written information from KPLL emphasizing the need of adhering to the EQA.

Postal reminder letters

In this group, postal reminder letters are sent to practices not adhering to the guideline recommendations of split testing within 30 days; i.e. a reminder letter is send when the CGPL database registers that the last split test or last reminder letter was 31 days ago. Thus, practices may receive up to four postal reminder letters:

Electronic reminder letters

In this group, electronic reminder letters are sent to practices not adhering to the guideline recommendations of split testing within 30 days; i.e. a reminder letter is send when the CGPL database registers that the last split test or last reminder letter was 31 days ago. Thus, practices may receive up to four electronic reminder letters:

Time table Substudy A

Jan - Apr 2010 Sep - Dec 2010 Jan - Apr 2011 Baseline Intervention Outcome

02

Conditions studied

  • Point-of-Care Testing

Keywords

  • Heading Health Plan Implementation
  • General Practice
  • Point of care testing
  • education
03

In context

Lead sponsor

Research Unit Of General Practice, Copenhagen is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • GPs stopping during study period.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
213 participants (actual)

Study arms

  • Active comparator
    Postal reminders

    Postal reminders

    Device: Postal reminder letters · Device: Reminder letters

  • Active comparator
    Electronic reminders

    Electronic reminders

    Device: Electronic reminder letters · Device: Reminder letters

Interventions

  • DevicePostal reminder letters

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

    Also known as: POST

  • DeviceElectronic reminder letters

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

    Also known as: ELECTRONIC

  • DeviceReminder letters

    up to four reminder letters in september - december 2010

    Also known as: POCIP study

06

What researchers measure

Primary outcomes

  1. Total number of split tests performed in study period.

    Total number of split tests performed in study period.

    Time frame: January - April 2011

Secondary outcomes

  1. 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.

    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.

    Time frame: January - April 2011

  2. Proportion of practices conducting split tests in study period.

    Proportion of practices conducting split tests in study period.

    Time frame: January - April 2011

07

Study locations

1 site
  • Research Unit of General Practice
    Copenhagen, Capital 1014, Denmark
08

References and documents

Publications

  • 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. PubMed 24953533 ↗
  • 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. PubMed 21781338 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2010, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2010
First posted
Jun 29, 2010
Start
Aug 2010
Primary completionActual
May 2011
CompletionActual
May 2011
Last update
Jul 30, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01152151
Lead sponsor
Research Unit Of General Practice, Copenhagen
Collaborators
University of Copenhagen, The Copenhagen General Practice Laboratorium, Centre for Quality Development and CME for GP's in the Capital Region, Region Capital Denmark
First posted
Jun 29, 2010
Start date
Aug 2010
Primary completion
May 2011
Completion
May 2011
Last update
Jul 30, 2014

Study contacts

Frans B Waldorff, PhD
principal investigator · Research Unit of General Practice

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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