Effect of Telemedecine on Post -Trauma Pain Medication Adherence .

Study Overview
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Brief Summary
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The impact of telemonitoring on patients' adherence to post trauma pain treatment , their satisfaction and pain relief after discharge from the ED.

Detailed Description
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This is a prospective, multicenter, randomized trial . Participants are recruited from the emergency departement of Fattouma Bourguiba Monastir. This study is a seven day three-arm parallel group trial . Participants inculded are aged more than 16 years old who presented to the ED for minor trauma and discharged with analgesic treatment. They are randomized to one of two trial TM intervention groups (SMS and TM) or usual care group (control) in a 1 :1 :1 allocation ratio. For all inculded patients, demographic characteristics were collected as well as clinical examination findings. The interventional care provided at the ED was mentioned. At ED discharge the pain Visual Analogue Scale (VAS) was evaluated and the analgesic treatment prescribed was noted.

Official Title
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Effect of Telemedecine on Post-trauma Pain Medication Adherence After Discharge From Emergency Departement

Conditions
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Post-traumatic Pain

Intervention / Treatment
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* Other: SMS reminding
* Other: telemonitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >16 years old with minor trauma and discharged with an analgesic treatment. Included patients should have regular access to a mobile phone ,were able to interact with SMS or could do so with help of a relative. Patients who accepted to participate to the study. No contraindication to analgesic medication Exclusion Criteria: Swallowing disorder or inability to swallow. Unsuitable for follow-up.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Included patients were randomized to one of the 3 groups: Usual care (control) group Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period. SMS group Or short message service (SMS) group: patients received SMS at day 2 every day to remind them to take their treatment . Telemonitoring group: Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed according to an algorithm: At each call (day 2 and day 4), the VAS was assessed. If VAS ≥ 3 we looked for a medication discontinuation, inadequate dose or change of the prescribed treatment and the patient was instructed to take action accordingly . If the problem is related to side effects, the analgesic treatment was changed or associated to another analgesic
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard group<br>Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period. | Other: telemonitoring<br>* Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed.<br>|
| Active Comparator: SMS group<br>patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment . | Other: SMS reminding<br>* patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .<br>|
| Active Comparator: telemonitoring group<br>Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed. | Other: telemonitoring<br>* Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale after 7 days of follow-up | Patient's adherence to analgesics treatment which was assessed by calling patients or by sending SMS in day 2, day 4,and day 7 in SMS group and the telemonitoring group respectively. | at seven day after ED discharge . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert scale | Patients' satisfaction which was assessed through likert scale. minimum=1(strongly disagree) , maximum=5 (strongly agree) | at seven day post ED discharge . | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedecine, Adherence, post- traumatic pain