A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery
A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Introduction: Enhanced Recovery Programs (ERP) in colorectal surgery reduce postoperative morbidity and shorten length of hospital stay with no increase in readmission rates. However, poor adherence to ERP elements remains a challenge. Recent studies suggest that the use of mobile device applications has the potential to improve patient compliance with treatment guidelines. We recently developed and pilot tested a mobile app to support an ERP for colorectal surgery which collects patient-reported recovery information and engages patients as stakeholders in their recovery process. The overall aim of this study is to estimate the extent to which the use of this mobile device app impacts adherence to postoperative ERP elements in comparison to standard preoperative education.
Methods. The proposal is for a two-group, assessor-blind, randomized trial including adult patients with colorectal diseases planned for surgical resection.
Participants will be randomly assigned into one of two groups:
- usual perioperative education and audit, or
- a mobile device application for postoperative education and self-audit.
The intervention will be delivered through a tablet present at the bedside with an application which links education, recovery planning, and daily self-assessment to a plan of care. It educates patients about daily recovery milestones and track their adherence. The primary outcome will be patient adherence to postoperative enhanced recovery elements. Other targeted outcomes include self-reported recovery, satisfaction and patient activation. According to an a priori power analysis, a sample of 104 patients (52 per group) is targeted for this trial.
Significance: This study will contribute evidence regarding the use of mobile device technology for education and the direct involvement of patients as stakeholders in postoperative recovery.
The study findings have the potential to increase patient engagement in the care pathway, which has the potential to increase compliance to pathway elements and improve postoperative outcomes.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Quebec
-
Montréal, Quebec, Kanada, h3g1a4
- Montreal General Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- elective laparoscopic colorectal resection.
- Proficient in english or french
Exclusion Criteria:
- intellectual disabilities
- major simultaneous procedures
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Sham Comparator: control
Patients receive an ipad with no app.
|
Patient receive an ipad with no application.
|
|
Experimentell: Mobile application no stoma
Patients who did not receive a stoma receive an ipad containing the app and are instructed how to use it.
|
A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway.
Contains information, guidelines, questionnaires and feedback
|
|
Experimentell: Mobile application stoma
Patients who receive a stoma receive an ipad containing the app and are instructed how to use it.
|
A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway.
Contains information, guidelines, questionnaires and feedback
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.
Tidsram: postoperative day 2
|
Questionnaire including 5 pathway interventions that involve patient participation during the first 48 hours after surgery (mobilization, gum chewing, consumption of oral liquids, breathing exercises, nutritional supplement).
|
postoperative day 2
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Length of stay
Tidsram: one month
|
Number of days spent in the hospital after surgery
|
one month
|
|
Complications
Tidsram: one month
|
Comprehensive complication index (CCI)
|
one month
|
|
Successful Recovery
Tidsram: postoperative day 4
|
Discharge by postoperative day 4 with no complications.
|
postoperative day 4
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- McgillGensurgAPPRCT
Plan för individuella deltagardata (IPD)
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