Point Of Care Testing In Danish General Practice
Condition: Point-of-Care Testing
Study type: Interventional

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).
    

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
    

Intervention name(s): Postal reminder letters; Electronic reminder letters; Reminder letters
Intervention type(s): Device; Device; Device
Intervention description(s): Postal reminder letters if adherence is not obtained (up to four); Electronic reminder letters if adherence is not obtained (up to four); up to four reminder letters in september - december 2010
Other intervention name(s): POST; ELECTRONIC; POCIP study
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Heading Health Plan Implementation; General Practice; Point of care testing; education