Effect of Telemedecine on Post -Trauma Pain Medication Adherence .

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-21

Study Completion Date

2022-07-31

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.

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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.

Conditions

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Post-traumatic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard group

Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period.

Group Type PLACEBO_COMPARATOR

telemonitoring

Intervention Type OTHER

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.

SMS group

patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .

Group Type ACTIVE_COMPARATOR

SMS reminding

Intervention Type OTHER

patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge 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.

Group Type ACTIVE_COMPARATOR

telemonitoring

Intervention Type OTHER

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.

Interventions

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SMS reminding

patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .

Intervention Type OTHER

telemonitoring

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.

Intervention Type OTHER

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