Point-of-Care TestingPOCIPNCT01152151
Point Of Care Testing In Danish General Practice
A study testing Postal reminder letters, Electronic reminder letters and Reminder letters in people with Point-of-Care Testing, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Point-of-Care Testing
- What is being tested?
- Postal reminder letters, Electronic reminder letters and Reminder letters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All GPs using at least 5 INR POCT analysis during baseline period (january-april 2010)
Who cannot join
- GPs stopping during study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point-Of-Care Testing In Danish General Practice: A Randomised Controlled Trial
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).
Read the 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:
- Total number of split tests performed in study period (three periods). Secondary outcomes:
- 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.
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
- Conditions
- Point-of-Care Testing
- Being tested
- Postal reminder letters, Electronic reminder letters, Reminder letters
- Keywords
- Heading Health Plan Implementation, General Practice, Point of care testing, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postal reminder lettersDevice
Also called POST
Postal reminder letters if adherence is not obtained (up to four)
Electronic reminder lettersDevice
Also called ELECTRONIC
Electronic reminder letters if adherence is not obtained (up to four)
Reminder lettersDevice
Also called POCIP study
up to four reminder letters in september - december 2010
| Study group | Role | What they receive |
|---|---|---|
| Postal reminders | Active comparator | Postal reminders Receives: Device: Postal reminder letters; Device: Reminder letters |
| Electronic reminders | Active comparator | Electronic reminders Receives: Device: Electronic reminder letters; Device: Reminder letters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of split tests performed in study period.
Total number of split tests performed in study period.
Measured: January - April 2011
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.
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.
Measured: January - April 2011
Proportion of practices conducting split tests in study period.
Proportion of practices conducting split tests in study period.
Measured: January - April 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Point-of-Care TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Unit Of General Practice, Copenhagen
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Frans B Waldorff, PhD, Principal investigator, Research Unit of General Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152151
- Sponsor's protocol ID
- GP00990001
- Acronym
- POCIP
- Status last verified
- Jun 2010
- First submitted
- 22 Jun 2010
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Siersma V, Kousgaard MB, Reventlow S, Ertmann R, Felding P, Waldorff FB. The effectiveness of computer reminders versus postal reminders for improving quality assessment for point-of-care testing in primary care: a randomized controlled trial. J Eval Clin Pract. 2015 Feb;21(1):13-20. doi: 10.1111/jep.12210. Epub 2014 Jun 21.
PubMed 24953533Waldorff FB, Siersma V, Ertmann R, Kousgaard MB, Nielsen AS, Felding P, Mosbaek N, Hjortso E, Reventlow S. The efficacy of computer reminders on external quality assessment for point-of-care testing in Danish general practice: rationale and methodology for two randomized trials. Implement Sci. 2011 Jul 23;6:79. doi: 10.1186/1748-5908-6-79.
PubMed 21781338
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-Of-Care Testing In Danish General Practice: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01152151
- Acronym / sponsor ID
- POCIP / GP00990001
- Conditions
- Point-of-Care Testing
- Keywords
- Heading Health Plan Implementation, General Practice, Point of care testing, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Research Unit Of General Practice, CopenhagenUniversity, hospital or other
- 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
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Total number of split tests performed in study period (three periods). Secondary outcomes:
- 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postal reminders | Active comparator | Device: Postal reminder letters, Device: Reminder lettersPostal reminders |
| Electronic reminders | Active comparator | Device: Electronic reminder letters, Device: Reminder lettersElectronic reminders |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All GPs using at least 5 INR POCT analysis during baseline period (january-april 2010)
Key exclusion criteria (1 listed)
- GPs stopping during study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postal reminder lettersAlso: POSTPostal reminder letters if adherence is not obtained (up to four) | Device | Postal reminders |
| Electronic reminder lettersAlso: ELECTRONICElectronic reminder letters if adherence is not obtained (up to four) | Device | Electronic reminders |
| Reminder lettersAlso: POCIP studyup to four reminder letters in september - december 2010 | Device | Electronic reminders, Postal reminders |
Primary outcome
Total number of split tests performed in study period.
Time frame: January - April 2011
Total number of split tests performed in study period.
2 secondary outcomes
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 conducting split tests in study period.
Time frame: January - April 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
- Derived from this study: PubMed 24953533Siersma V, Kousgaard MB, Reventlow S, Ertmann R, Felding P, Waldorff FB. The effectiveness of computer reminders versus postal reminders for improving quality assessment for point-of-care testing in primary care: a randomized controlled trial. J Eval Clin Pract. 2015 Feb;21(1):13-20. doi: 10.1111/jep.12210. Epub 2014 Jun 21.
- Derived from this study: PubMed 21781338Waldorff FB, Siersma V, Ertmann R, Kousgaard MB, Nielsen AS, Felding P, Mosbaek N, Hjortso E, Reventlow S. The efficacy of computer reminders on external quality assessment for point-of-care testing in Danish general practice: rationale and methodology for two randomized trials. Implement Sci. 2011 Jul 23;6:79. doi: 10.1186/1748-5908-6-79.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans B Waldorff, PhD principal investigator
Research Unit of General Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postal reminder letters, Electronic reminder letters and Reminder letters in people with Point-of-Care Testing, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of split tests performed in study period. (time frame: January - April 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01152151, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.