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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

Tracking Information
First Submitted Date  ICMJE June 22, 2010
First Posted Date  ICMJE June 29, 2010
Last Update Posted Date July 30, 2014
Study Start Date  ICMJE August 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2010)
Total number of split tests performed in study period. [ Time Frame: January - April 2011 ]
Total number of split tests performed in study period.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01152151 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2010)
  • 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.
  • Proportion of practices conducting split tests in study period. [ Time Frame: January - April 2011 ]
    Proportion of practices conducting split tests in study period.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Point Of Care Testing In Danish General Practice
Official Title  ICMJE Point-Of-Care Testing In Danish General Practice: A Randomised Controlled Trial
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).
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Point-of-Care Testing
Intervention  ICMJE
  • Device: Postal reminder letters
    Postal reminder letters if adherence is not obtained (up to four)
    Other Name: POST
  • 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
Study Arms  ICMJE
  • Active Comparator: Postal reminders
    Postal reminders
    Interventions:
    • Device: Postal reminder letters
    • Device: Reminder letters
  • Active Comparator: Electronic reminders
    Electronic reminders
    Interventions:
    • Device: Electronic reminder letters
    • Device: Reminder letters
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2014)
213
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2010)
240
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • GPs stopping during study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01152151
Other Study ID Numbers  ICMJE GP00990001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GP, Associate Research Professor Frans Boch Waldorff, The Research Unit for General Practice, Copenhagen, Denmark
Study Sponsor  ICMJE Research Unit Of General Practice, Copenhagen
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Frans B Waldorff, PhD Research Unit of General Practice
PRS Account Research Unit Of General Practice, Copenhagen
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP