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Point Of Care Testing In Danish General Practice (POCIP)

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ClinicalTrials.gov Identifier: NCT01152151
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : July 30, 2014
Sponsor:
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
Information provided by:
Research Unit Of General Practice, Copenhagen

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).

Condition or disease Intervention/treatment Phase
Point-of-Care Testing Device: Postal reminder letters Device: Electronic reminder letters Device: Reminder letters Not Applicable

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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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Point-Of-Care Testing In Danish General Practice: A Randomised Controlled Trial
Study Start Date : August 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Active Comparator: Postal reminders
Postal reminders
Device: Postal reminder letters
Postal reminder letters if adherence is not obtained (up to four)
Other Name: POST

Device: Reminder letters
up to four reminder letters in september - december 2010
Other Name: POCIP study

Active Comparator: Electronic reminders
Electronic reminders
Device: Electronic reminder letters
Electronic reminder letters if adherence is not obtained (up to four)
Other Name: ELECTRONIC

Device: Reminder letters
up to four reminder letters in september - december 2010
Other Name: POCIP study




Primary Outcome Measures :
  1. Total number of split tests performed in study period. [ Time Frame: January - April 2011 ]
    Total number of split tests performed in study period.


Secondary Outcome Measures :
  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. [ Time Frame: January - April 2011 ]
    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.

  2. Proportion of practices conducting split tests in study period. [ Time Frame: January - April 2011 ]
    Proportion of practices conducting split tests in study period.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • GPs stopping during study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152151


Locations
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Denmark
Research Unit of General Practice
Copenhagen, Capital, Denmark, 1014
Sponsors and Collaborators
Research Unit Of General Practice, Copenhagen
University of Copenhagen
The Copenhagen General Practice Laboratorium
Centre for Quality Development and CME for GP's in the Capital Region
Region Capital Denmark
Investigators
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Principal Investigator: Frans B Waldorff, PhD Research Unit of General Practice

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GP, Associate Research Professor Frans Boch Waldorff, The Research Unit for General Practice, Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT01152151     History of Changes
Other Study ID Numbers: GP00990001
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: June 2010

Keywords provided by Research Unit Of General Practice, Copenhagen:
Heading Health Plan Implementation
General Practice
Point of care testing
education