Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-30 @ 8:50 PM
Study NCT ID:
NCT01152151
Status:
COMPLETED
Last Update Posted:
2014-07-30
First Post:
2010-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point Of Care Testing In Danish General Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-29', 'studyFirstSubmitDate': '2010-06-22', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of split tests performed in study period.', 'timeFrame': 'January - April 2011', 'description': 'Total number of split tests performed in study period.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'January - April 2011', 'description': '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.'}, {'measure': 'Proportion of practices conducting split tests in study period.', 'timeFrame': 'January - April 2011', 'description': 'Proportion of practices conducting split tests in study period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heading Health Plan Implementation', 'General Practice', 'Point of care testing', 'education'], 'conditions': ['Point-of-Care Testing']}, 'referencesModule': {'references': [{'pmid': '24953533', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '21781338', 'type': 'DERIVED', 'citation': 'Waldorff 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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nDissemination 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.\n\nE-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.\n\nDue 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.\n\nThe aims of this study are:\n\nTo evaluate the effect of electronic reminder letters versus postal reminder letters on general practices adherence to clinical quality guidelines regarding POCT.\n\nParticipants 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).\n\nData 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.\n\nData 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.\n\nRandomization:\n\nPractices are stratified by area and type of organization by means of SAS (Proc PLAN) by an independent organization.\n\nOutcome:\n\nPrimary outcome:\n\n1. Total number of split tests performed in study period (three periods).\n\n Secondary outcomes:\n2. 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.\n3. Proportion of practices conducting split tests in study period.\n\nPower calculation:\n\nThe 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.\n\nStatistics:\n\nDifferences 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).\n\nIn 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.\n\nTo 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.\n\nAll statistical analyses are performed using SAS, version 9.2 (SAS Institute Inc, Cary, NC).\n\nIntervention 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.\n\nPostal reminder letters\n\nIn 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:\n\nElectronic reminder letters\n\nIn 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:\n\nTime table Substudy A\n\nJan - Apr 2010 Sep - Dec 2010 Jan - Apr 2011 Baseline Intervention Outcome"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All GPs using at least 5 INR POCT analysis during baseline period (january-april 2010)\n\nExclusion Criteria:\n\n* GPs stopping during study period.'}, 'identificationModule': {'nctId': 'NCT01152151', 'acronym': 'POCIP', 'briefTitle': 'Point Of Care Testing In Danish General Practice', 'organization': {'class': 'OTHER', 'fullName': 'Research Unit Of General Practice, Copenhagen'}, 'officialTitle': 'Point-Of-Care Testing In Danish General Practice: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'GP00990001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Postal reminders', 'description': 'Postal reminders', 'interventionNames': ['Device: Postal reminder letters', 'Device: Reminder letters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electronic reminders', 'description': 'Electronic reminders', 'interventionNames': ['Device: Electronic reminder letters', 'Device: Reminder letters']}], 'interventions': [{'name': 'Postal reminder letters', 'type': 'DEVICE', 'otherNames': ['POST'], 'description': 'Postal reminder letters if adherence is not obtained (up to four)', 'armGroupLabels': ['Postal reminders']}, {'name': 'Electronic reminder letters', 'type': 'DEVICE', 'otherNames': ['ELECTRONIC'], 'description': 'Electronic reminder letters if adherence is not obtained (up to four)', 'armGroupLabels': ['Electronic reminders']}, {'name': 'Reminder letters', 'type': 'DEVICE', 'otherNames': ['POCIP study'], 'description': 'up to four reminder letters in september - december 2010', 'armGroupLabels': ['Electronic reminders', 'Postal reminders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1014', 'city': 'Copenhagen', 'state': 'Capital', 'country': 'Denmark', 'facility': 'Research Unit of General Practice', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Frans B Waldorff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Unit of General Practice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Unit Of General Practice, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'The Copenhagen General Practice Laboratorium', 'class': 'UNKNOWN'}, {'name': "Centre for Quality Development and CME for GP's in the Capital Region", 'class': 'UNKNOWN'}, {'name': 'Region Capital Denmark', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'GP, Associate Research Professor Frans Boch Waldorff', 'oldOrganization': 'The Research Unit for General Practice, Copenhagen, Denmark'}}}}