ADLIFE SOP outline (headings and subheadings)
|
|
Approvals Local ethical committee approval Local ICT and data security approval Clear agreements with local ICT department on interfaces with the ADLIFE platform, hosting data, keeping data for ADLIFE patients identifiable and trackable Governance approval Data Protection Impact assessment (DPIA) Data Processing Agreement (DPA) Management Appoint a pilot site manager Appoint a pilot site team Define pilot site team members roles and responsibilities (the same person may have multiple roles) Clinical lead Nurse lead ICT lead Training lead Research lead Communication lead List of tasks to be performed prior to site implementation with milestones/deadlines ICT related activities – list and define Infrastructure design and implementation System installation, support and maintenance System testing Data management, integration and data extracts Business continuity and disaster recovery System security and user access Translation of stakeholder pre-pilot interview guidelines Preparations for the recruitment of professionals Translation of platforms, guidelines, questionnaires etc. Preparation of data base of potential patients for intervention and control group Preparation of material for recruitment of professionals Preparation of information materials for recruitment of patients Preparation of training materials (manuals, slides, videos) for professionals and patients Set up a “help desk” for supporting both professionals and patients/carers both for ICT-related and process-related issues. Appoint the people, define what they will do, how they can be contacted Other tasks Change management prepare internal information and communication materials about the project Meet with upper-level management people to provide updates on the project. Identify support need from them and ask for it Meet with key stakeholders Implementation of the pilot Recruitment of professionals Training of professionals Providing professionals with their list of patients that meet inclusion criteria Selection of patients to be approached Define patient recruitment process for your site Training of patients and carers |
Study operation Document electronic systems – informing MDT staff about how the ICT systems will work and how they will use them Initial visit protocol – specify the process for scheduling clinical appointments for study patients Follow-up protocol – specify the process for scheduling follow-up visits, and Patient self-management and empowerment – how will this work, what devices if any will be used, how patients will be able to upload readings directly from personal sensor devices, e.g. blood pressure readings or if they are using regular devices, how will they enter the measures manually, complete questionnaires, report symptoms Handling of patient queries Clear contact points and guidance for enquiries about; The research project Use of the PEP Self-management and wellness queries Potentially serious health concerns Documenting interactions with patients Dealing with issues If the system is not available, based on SLA, the webpage should provide a suitable message and contact details Agree on how participants get notified Agree on how issue gets resolved Multi-disciplinary team interactions (define how this will work in your site. Will their interactions be by telephone, videoconference, email, instant messaging, messaging using the PCPMP?). In all instances, how will interactions or the results of the interactions be documented? Withdrawal from the study Withdrawal from the study–health Centers/Organizations Withdrawal from the study – MDT members Withdrawal from the study – Patients Conducting the pilot study evaluation |
Source(s): Authors’ own work