Clinical trial NCT05149417: Effect of Telemedecine on Post -Trauma Pain Medication Adherence .
Official title: Effect of Telemedecine on Post-trauma Pain Medication Adherence After Discharge From Emergency Departement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Pain
Keywords: Telemedecine
Adherence
post- traumatic pain
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 1350
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Included patients were randomized to one of the 3 groups:

1. Usual care (control) group Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period.
2. SMS group Or short message service (SMS) group: patients received SMS at day 2 every day to remind them to take their treatment .
3. 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
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analog scale after 7 days of follow-up
timeFrame: at seven day after ED discharge .
Secondary outcomes:
measure: Likert scale
timeFrame: at seven day post ED discharge .
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba Monastir University Hospital Center
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital of Monastir
Study officials:
References: