Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01152177 |
| Other study ID # |
GP009900012 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 23, 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
none on general practices adherence to clinical quality guidelines regarding Point Of Care
Testing (POCT). The investigators hypothesize, that electronic reminder letters may increase
adherence.
Description:
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 recommended1. 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 practice2 and
even an multifaceted implementation of guidelines may not change clinical practice 3;4.
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 7.
E-mails have successfully been used in several studies to promote health behaviour change in
risk populations 8;9 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 on general practices adherence to
clinical quality guidelines regarding POCT.
To evaluate the legacy effect of a potential effect of reminder letters (i.e. the impact of
the intervention after it has stopped).
Participants Included in the study are all, approximately 320, GP practices conducting POCT
at least four POCT (either haemoglobin or glucose) during a 4 month before study period and
not conducting INR analysis (defined as four or less tests during 4 four months period).
These practices were identified in the GP database of the Capital area and by the CGPL.
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. KvEAP and 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 6
months before the start of the trial (tentative in order to establish a baseline). Each
month in the remainder 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 6 months.
Randomization:
Practices are stratified by area and type of organization by means of SAS (Proc PLAN) by an
independent organization. Practices are allocated to usual CGPL quality guideline activities
(control group) and usual CGPL implementation activities in addition to electronic reminder
letters (intervention group).
Outcome:
Primary outcome:
1. Total number of split tests performed in study period for Hemoglobin and Glucose.
Secondary outcomes:
2. Proportion of practices with a high quality of tests defined as 75% of the performed
split tests for Hemoglobin and Glucose within the accepted interval according following
the CGPL quality guidelines1 in study period.
3. Proportion of practices conducting split tests for Hemoglobin and Glucose in study
period.
Power calculation:
The investigators use a 10% adherence estimate based on CGPL data from 2007 in order to
ascertain the power of the study. Given a MEREDIF at 15% and a power of 90% it is estimated
that 274 practices are to be included in this study.
Statistics:
Differences in the outcomes between allocation groups at baseline and at 6 months follow-up
are tested by means of chi-square tests (outcomes 2 and 3) and t-tests (outcome 1).
In order to test the development of adherence relative to the intervention the investigators
will in the 3 data collection points 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.
Electronic reminder letters
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, all practices may receive up to 4 electronic reminder letters in each period:
After the 4 months a cross-over will be applied, so that the practices allocated to the
control group receive electronic prompting while prompting ceases in the intervention group.
This further follow-up acts to investigate the legacy effect of the intervention. The main
hypothesis is that the first 4 months of intervention also shows some effect 4 months beyond
the intervention period.
