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Table 1 Consort checklist[27]

From: Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial

Item Standard Checklist item  
Title Identification of study as randomised Implementation strategies of internet-based asthma self-management support in usual care. Study protocol of the IMPASSE study - a cluster randomized trial
Trial design Description of the trial design (e.g., parallel, cluster, non-inferiority) Cluster-randomized trial with a cluster pre-randomization design.
Methods
Participants Eligibility criteria for participants and the settings where the data were collected Eligibility criteria for general practices:
   Location within the Leiden - the Hague region. General practitioner/practice nurse that is willing and available to support patients in internet-based self-management.
   Patient eligibility criteria: Age 18 to 50 years; a doctor diagnosis of asthma; prescription of inhaled corticosteroids and/or montelukast ≥ three months within 12 months prior to enrolment; internet access; ability to understand written and oral Dutch instructions. Patient exclusion criteria: Severe co-morbidities, daily or alternate day oral corticosteroid therapy for ≥1 month prior to entering the study and being primarily under treatment by a respiratory physician.
   Data will be collected in a research module of the internet-based self-management support program (PatientCoach.nl) using web-based questionnaires (SurveyGizmo, Boulder, Colorado).
Interventions Interventions intended for each group Internet-Based Self-Management (IBSM) support program :
   PatientCoach.nl consists of both a generic web-based system and an instruction visit for patients. PatientCoach includes modules for self-monitoring (asthma control and lung function), a treatment plan (medication,), motivational feedback, e-consultation, personalized information (i.e., inhalation technique), reminders and forums for patients and professionals. PatientCoach has been developed by the LUMC. Patient Coach will be integrated in the general practice information system. Additionally PatientCoach contains a research module which consists of electronic versions of questionnaires.
   General practice level
   The implementation strategies for internet-based self-management support are primarily targeted general practices:
   1. Minimum strategy (MS): dissemination of the IBSM program.
   2. Intermediate strategy (IS): MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals).
   3. Extended strategy (ES): IS + additional training and ongoing support for professionals.
   All general practices will be asked to invite at least 10 patients to participate in PatientCoach. Follow-up duration at general practice level is one year.
   Patient level:
   Instruction visit on how to use PatientCoach, particularly focusing the essential self-management skills in asthma (i.e., monitoring, inhalation technique). Patients will be instructed to monitor their level of asthma control at least once per month, preferably once weekly using the Asthma Control Questionnaire. General practices themselves can decide whether the practice nurse and/or general practitioner guide patients in using PatientCoach. Follow-up per patient is six months. However, patients will have the possibility to continue using PatientCoach.nl after this period.
Objective Specific objective or hypothesis The objectives of this study are to investigate the effectiveness and cost- effectiveness of a Minimum strategy, as compared to an Intermediate strategy and an Extended strategy in a three arm cluster-randomized trial. Since these different implementation strategies have a sequence of effects, the evaluation is aimed to assess to what extent: 1. practices participate in IBSM (practice level); 2. IBSM improves asthma related quality of life (patient level); 3. patients participate in IBSM (patient level); and 4. The various implementation strategies are cost-effective (societal/organisational level)
Outcome Clearly defined primary outcome for this report Primary outcome measures are a) the proportion of referred patients that participate in IBSM (general practice (cluster) and patient level) and b) the proportion of patients that have clinically relevant improvement in the asthma-related quality of life as measured by the Asthma Quality of Life Questionnaire[30].Patient usage of IBSM is defined as two out of three months ACQ-monitoring compliance.
Randomisation How participants were allocated to interventions As the implementation strategies (interventions) are primarily targeted at general practices, randomisation will occur at practice level.
   General practices (i.e., 2,300 patients per ‘standard practice’) are the unit of randomisation. Prior to informed consent all general practices in the Leiden-the Hague region will be allocated to one of the three strategies (1:1:1 ratio). General practices receive a letter with information on the allocated strategy and an invitation to participate in the project.
   Randomization will be conducted by Jacob Sont using a computer-generated, permuted-block scheme. Practices will be stratified according the following characteristics: postal code (area) and practice size (practices with < 4 general practitioners are defined as a small practice, practices with ≥4 general practitioners as a large practice.
   General practices will be enrolled by Moira Bakker, Johanna van Gaalen and Jiska Snoeck-Stroband. Patients will be enrolled by general practices.
Blinding (masking) Whether or not participants, care givers, and those assessing the outcomes were blinded to group assignment All general practices and patients are blinded to group allocation. Researchers are not blinded for group allocation.
Results
Numbers randomized Number of participants randomized to each group For all three strategies, 12 general practices (clusters) will be recruited, involving 10 patients per practice to be invited for using PatientCoach per general practice.
Recruitment Trial status Recruitment of patients is ongoing
Numbers analysed Number of participants analysed in each group Not applicable.
Outcome For the primary outcome, a result for each group and the estimated effect size and its precision Not applicable.
Harms Important adverse events or side effects Not applicable.
Conclusions General interpretation of the results This study provides insight in the amount of support that is required by general practices for cost-effective implementation of IBSM. Additionally, design and results can be beneficial for implementation of other self-management initiatives in clinical practice.
Trial registration Registration number and name of trial register the Netherlands National Trial Register NTR2970
Funding Source of funding This study is supported by grants from: - The Netherlands Organisation for Health Research and Development (ZON-MW 80-82315-97-10004) - The Netherlands Asthma Foundation (NAF 3.4.09.011) - Funding for this publication was obtained from the Netherlands Organisation for Scientific Research (NWO) Incentive fund Open Access publications - - Hand-held electronic lung function meters for patients (PikO-1, Ferraris Respiratory, Hertford, United Kingdom) were provided by GlaxoSmithKline (GSK), Zeist, the Netherlands