Contributions to the literature
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Our paper will determine the impact of telemedication review at high iatrogenic risk on unplanned hospital admission in addition to health-related quality of life, behavioral disturbances, frequency of falls, potentially inappropriate medications and convenience of drug administration for nursing staff
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We will provide insight into the impact of tele-expertise in terms of health economics with a cost effectiveness study.
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Ultimately, we will attempt to determine which organizational and psychosocial factors are likely to facilitate or on the contrary to hamper telemedication review development and acceptability
Background
Methods
Study design
Recruitment and randomization
Timepoint | Study Period | |||
---|---|---|---|---|
Enrolment | Inital assessment | Follow-up at 3 months | Follow-up at 6 months | |
Enrolment | ||||
Eligibility screen | X | |||
Information to patients/careviger | X | |||
Collection of consent | X | |||
Date of the visits | X | X | X | X |
Assessments | ||||
Primary outcome: | ||||
Unplanned Hospitalizations | X | |||
Secondary outcomes: | ||||
Unplanned Hospitalizations | X | |||
Behavioral disorders (NPI) | X | X | X | |
Quality of life (EQ-5D-3 L) | X | X | X | |
Number of falls | X | X | X | |
Number of patients with at least 1 potentially inappropriate prescription | X | X | X | |
Nursing staff satisfaction | X | X | ||
Characteristics of patients whose GP have taken account of TMR recommendations | X | X | ||
GP’ adherence rate to therapeutic recommendations | X | X | ||
Cost-effectiveness ratio of TMR | X | |||
Factors facilitating or hampering GPs’ adherence rate | X | X | X | |
Characteristics | ||||
Sociodemographic data (age, gender) | X | X | ||
MMSE | X | |||
Comorbidities | X | X | X | |
Pharmaceutical therapeutics | X | X | X | |
Blood test | X | X | X | |
Trivalle’s score | X |
Inclusion criteria
Exclusion criteria
Ethical and legal considerations
Sample size
Groups
Experimental group
- medication reconciliation to have an exhaustive list of all medications taken by the patient (including prescription and non-prescription medication);
- inclusion of the most recent results from laboratory tests (blood sodium, potassium and creatinine levels) and clinical data (blood pressure, weight);
- knowledge of patient history, active comorbidity and geriatric syndromes.
Control group: standard care management
Study aims
Primary endpoint
Secondary endpoints
- Number of unplanned hospital admissions at 6 months post-randomization.
- Quality of life (QoL) of nursing home residents will be evaluated by the validated french version of EuroQol five-dimension three-level (EQ-5D-3 L) generic quality-of-life questionnaire [26, 27]. The questionnaire consists of two parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3 L descriptive system comprises five dimensions as follows: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement for each of the five dimensions. Each response generates a 1-digit number that represents the level selected for that dimension. The EQ VAS records self-rated patient health on a vertical visual analogue scale where the endpoints are labelled ‘best imaginable health state’ and ‘worst imaginable health state’. The EQ-5D-3 L questionnaire will be administered at the inclusion, at 3- and 6-month follow-up.
- Incidence of behavioral disturbances will be assessed by the validated french version of Neuropsychiatric Inventory (NPI) questionnaire at the inclusion, at 3- and 6-month follow-up [28]. NPI scoring is based on interviews with main caregivers. The NPI assesses the frequency (4-point scale) and severity (3-point scale) of 10 neuropsychiatric disturbances (delusions, hallucinations, agitation, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, and aberrant motor behavior), and a score from 0 to 12 is obtained for each scale by multiplying frequency by severity. The total NPI score is the sum of the subscale scores.
- The number of falls at 3- and 6-months post-randomization.
- The proportion of residents who will have been subjected to at least 1 potentially inappropriate prescription at the inclusion, 3 and 6 months. STOPP and START tool will be used for explicit criteria (French version 2). The implicit approach includes all available medical data, potential self-medication, and questions from the Medication Appropriateness Index [29].
- Nursing staff satisfaction with methods of medication administration to residents, number of oral medications dispensed, choice of galenic formulation, time spent on drug administration, and treatment dispensed to a patient consistent with that patient’s state of health. Satisfaction will be evaluated using 5-point Likert scales at the inclusion and at 3 months.
- Description of therapeutic recommendations which will have been proposed and GP’ adherence rate of its at 3- and 6-months.
- Characteristics of patients whose GP have taken account of TMR recommendations.
- Cost-effectiveness ratio of TMR versus standard care at 6-month follow-up (see details in Health Economic Analysis section below).
- The present study will also attempt to determine which organizational and psychosocial factors are likely to facilitate or on the contrary to hamper TMR development and acceptability (see details in Evaluation of Acceptability/Satisfaction section below).