Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01152151 |
| Other study ID # |
GP00990001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 22, 2010 |
| Last updated |
July 29, 2014 |
| Start date |
August 2010 |
| Est. completion date |
May 2011 |
Study information
| Verified date |
June 2010 |
| Source |
Research Unit Of General Practice, Copenhagen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: Danish Dataprotection Agency |
| Study type |
Interventional
|
Clinical 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).
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
