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STEP-BY-STEP PROCESS FOR RAI-AC RELIABILITY TRIAL PARTICIPANTS. Academic Unit in Geriatric Medicine The University of Queensland School of Medicine Princess Alexandra Hospital. METHODOLOGY. Assessors
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STEP-BY-STEP PROCESS FOR RAI-AC RELIABILITY TRIAL PARTICIPANTS Academic Unit in Geriatric Medicine The University of Queensland School of Medicine Princess Alexandra Hospital
METHODOLOGY • Assessors • Select/Train 2 Assessors. Designate as Assessor 1 and Assessor 2. The protocol stipulates a minimum standard of training, of several hours duration. • Ethics approval • If such assessments are not normal practice at your institution, ethics approval may be required. The University of Queensland has given ethics approval for the entire trial. Please advise us if you require a copy of the approval documentation. • A Patient Information Sheet and a Consent Form (Appendix 1) (both requirements of the UQ Ethics Committee) are enclosed as part of the Protocol Pack for Participants). Amend as required for your site.
SAMPLE SELECTION -1 • Cases: • patients aged 70+, • expected LOS at least 48 hours, • from acute (general or geriatric) medicine or orthopaedic wards. (Either or both) • Random or sequential selection, depending on admission rates • – assessment, incl. consent, will take 1 to 2 hours. • An assessor could probably do 4-5 cases in any one day. • If admission rates are higher - allowing for, say, 70% consent rate – then use random sampling (e.g. if admission rates are twice daily number required, generate a random list of 1s and 2s and use to select one of every two presenting cases). If admission rates are less than, say, 7 cases per day you may choose to select all patients admitted/consenting on Monday-Thursday during the study period – allowing for refusals.
SAMPLE SELECTION -2 • Cases can be recruited from Geriatric Consulting Services. Patients are pre-selected for referral to these Services. While not precluding participation, patient’s status must be assessed for their first 24 hours in acute care. If referral to Consulting Service occurs at admission, this would be acceptable. • Patients who spend several days in ED before admission to acute care would not be eligible for inclusion in the Trial.
IDENTIFICATION CODES • Each Trial site has been allocated an ID Code, as follows: • Australia – Prof. Len Gray 1 • Australia – Dr Michael Brignell 2 • Canada – Prof. John Hirdes 3 • Finland – Dr Harriet Finne-Soveri 4 • Iceland – A/Prof. Palmi Jonsson 5 • Italy – Prof. Roberto Bernabei 6 • Mexico – Dr Luis Miguel Gutierrez r 7 • Norway – Dr Anette Hylen Ranhoff 8 • Spain – Dr Sergio Arino Blasco 9 • USA – Prof. John Morris 10 • Australia – Dr Peter Hunter 11
CODING ASSESSMENT FORMS • Code first 20 forms with your ID Code, then a consecutive number from 01-20, e.g. for Australia (UQ) the coding would be 101 – 120. These are the forms used by the two Assessors (i.e. 10 each) for the “general cases”, • Code next 15 forms with ID Code, then a consecutive number from 21-35, followed by the letter A. For Australia (UQ) the coding would be 121A – 135A. These are the forms used by Assessor 1 for the reliability testing; • Code next 15 forms with ID Code, then a consecutive number from 21-35 followed by the letter B. For Australia (UQ) the coding would be 121B – 135B. These are the forms used by Assessor 2 for the reliability testing; • Code next 15 forms with ID Code, then a consecutive number from 36 - 50, followed by the letter A. For Australia (UQ) the coding would be 136A – 150A. These are the forms used by Assessor 1 for the validity testing; • Code both the MMSE and the BAI forms with ID Code, then consecutive number from 36 - 50 followed by the letter B. For Australia (UQ) the coding would be 136B – 150B. These forms are used by Assessor 2 for validity testing (i.e. there should be an MMSE form coded 136B and a Barthel ADL Index form coded 136B, etc.)
ASSESSMENT - 1 • Both Assessors will conduct an assessment on two “practice” patients and then meet with Site Coordinator for First Debriefing. Assessors will then commence Trial assessments. • Record each assessment on the Case Assignment/Packing Form. • Assessor 1 conducts first assessment on 40 of the 50 selected cases, using the RAI-AC 1.09, 24-48 hrs after admission for medical treatment or 72-96 hrs after surgery for orthopaedic patients undergoing surgery. If assessment cannot be done in the 24-48 hr period and it is done (e.g.) 48-72 hrs post-admission, data required is still the patient’s status during first 24 hrs post-admission. • The assessment will collect data on patient status in the pre-morbid period (i.e. for the 3 days prior to the event that precipitated the current hospital admission) and in the first 24 hrs following admission. The first 10 cases of Assessor 1 will be “general” cases, i.e. not for reliability or validity comparison. They require only 1 assessment.
ASSESSMENT - 2 • Assessor 2 will conduct an assessment on the 10/50 cases not assessed by Assessor 1 - as for Assessor 1, these 10 cases will be “general” cases, i.e. not for reliability or validity comparison. They require only 1 assessment. • For cases 11-25 of Assessor 1, Assessor 2 will repeat the RAI-AC assessment within 4 hrs of first assessment, if possible, but no later than 24 hours after the first assessment. This will test for inter-rater reliability. There should be no discussion or exchange of findings between Assessor 1 and Assessor 2 before the second assessment is completed. • For cases 26-40 of Assessor 1, Assessor 2 will administer the Barthel ADL Index and the MMSE, again within 4 hours of the first assessment, if possible, but no later than 24 hours after the first assessment. This will test for validity.
DATA ENTRY/ANALYSIS • At the end of each week, each Site Coordinator will sign off on each assessment completed during that week. Assessment forms will then be returned to the Senior Investigator (unless that is the same person). • Negotiations are underway to provide software that will be available to Trial participants at no charge. Alternatively, the data will be entered at the University of Queensland.
RETURN OF FORMS • At the end of each week, each Assessor will return completed assessment forms and a copy of the Case Assignment/ Packing Form (with a running record of assessments completed, and page 1 of the Case Assignment/Packing Form completed) to the Site Coordinator. At the end of Week 1, each Assessor will also return a completed Hospital and Assessor Description form (Appendix 6) to the Site Coordinator. • When all 50 cases have been completed, the Assessors will meet with the Site Coordinator to complete the Final Briefing.