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Point-of-Care TestingPOCIPNCT01152151

Point Of Care Testing In Danish General Practice

A study testing Postal reminder letters, Electronic reminder letters and Reminder letters in people with Point-of-Care Testing, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Point-of-Care Testing
What is being tested?
Postal reminder letters, Electronic reminder letters and Reminder letters
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
1 siteDenmark
Study dates
Aug 2010to May 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • GPs stopping during study period.

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Research Unit of General Practice

    Copenhagen, Capital, 1014

Other trials in Denmark

About this study

Official title: Point-Of-Care Testing In Danish General Practice: A Randomised Controlled Trial

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

Being tested
Postal reminder letters, Electronic reminder letters, Reminder letters
Keywords
Heading Health Plan Implementation, General Practice, Point of care testing, education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postal reminder lettersDevice

    Also called POST

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

  • Electronic reminder lettersDevice

    Also called ELECTRONIC

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

  • Reminder lettersDevice

    Also called POCIP study

    up to four reminder letters in september - december 2010

Study groups in NCT01152151
Study groupRoleWhat they receive
Postal remindersActive comparatorPostal reminders
Receives: Device: Postal reminder letters; Device: Reminder letters
Electronic remindersActive comparatorElectronic reminders
Receives: Device: Electronic reminder letters; Device: Reminder letters

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Total number of split tests performed in study period.

    Measured: January - April 2011

Secondary outcomes (2)
  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.

    Measured: January - April 2011

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

    Proportion of practices conducting split tests in study period.

    Measured: January - April 2011

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01152151
Sponsor's protocol ID
GP00990001
Acronym
POCIP
Status last verified
Jun 2010
First submitted
22 Jun 2010
Last updated
30 Jul 2014
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Postal reminder letters, Electronic reminder letters and Reminder letters in people with Point-of-Care Testing, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total number of split tests performed in study period. (time frame: January - April 2011). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01152151, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.

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