RAPP- Systematic E-assessment of Postoperative Recovery in Patients Undergoing Day Surgery

NCT ID: NCT02492191

Last Updated: 2016-09-27

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

1046 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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Introduction Day surgery is a well-established practice in many European countries, but only limited information is available regarding postoperative recovery at home though there is a current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is also a need for improvement of modern technology in assessing patient related outcomes such as native software applications. This article describes the RAPP study protocol, a mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing day surgery is cost effective and improves postoperative recovery, health and quality of life.

Methods and analysis This study is a mixed-methods study design that includes a multicenter, two-group, parallel, single-blind randomized controlled trial (RCT) and qualitative interview studies. One thousand patients \>17 years of age who are undergoing day surgery will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR) or to standard care (i.e. no follow up). The primary aim is cost effectiveness. Secondary aims are improvements on postoperative recovery, health-related quality of life (QoL) and overall health; (b) to determine whether differences in health literacy have a substantial and distinct effect on postoperative recovery, health, and QoL; and (c) to describe day-care patient and staff experiences with a systematic e-assessment follow-up after day surgery.The primary will be measured at 2 weeks postoperatively and secondary outcomes b) at 1 and 2 weeks and c) at 1 and 4 months.

Detailed Description

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Conditions

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Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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RAPP, e- assessed follow-up

A mobile application (app) is installed on each patient's own smartphone. The app includes the Swedish web version of the QoR (SwQoR). After a patient is discharged from the day-surgery department, the patients in the intervention group will answer the RAPP daily for 14 days. His or her smartphone will initiate the postoperative recovery measurements daily through a "push" function. Each question will appear separately on the mobile phone screen and will disappear from the screen immediately after a response is given. The app also contains a question asking if the patient wants to be contacted by a nurse, which they will answer with a YES or NO. If YES, a nurse at the day surgery department will contact the patient and offer further information and assistance. The number of contacts and the reasons for contact requests will be documented.

Group Type ACTIVE_COMPARATOR

Smartphone app Recovery Assessment by Phone Points (RAPP)

Intervention Type DEVICE

An e-assessed follow-up of day surgery patients postoperative recovery measured via smartphone app

Control

The control group will receive standard care; i.e., no follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smartphone app Recovery Assessment by Phone Points (RAPP)

An e-assessed follow-up of day surgery patients postoperative recovery measured via smartphone app

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Understand the Swedish language in speech and writing, have an Android or iPhone OS smartphone, and give their informed consent to participate

Exclusion Criteria

* Undergoing abortion, if their journal entries indicate alcohol and/or drug abuse or memory impairment, if they are participating in another clinical trial or suffering from visual impairment. .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Ulrica Nilsson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrica Nilsson, Prof

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine and Health, Örebro University, Sweden

Locations

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Örebro university hospital, Day surgery department

Örebro, , Sweden

Site Status

Countries

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Sweden

References

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Nilsson U, Jaensson M, Dahlberg K, Odencrants S, Gronlund A, Hagberg L, Eriksson M. RAPP, a systematic e-assessment of postoperative recovery in patients undergoing day surgery: study protocol for a mixed-methods study design including a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies. BMJ Open. 2016 Jan 13;6(1):e009901. doi: 10.1136/bmjopen-2015-009901.

Reference Type BACKGROUND
PMID: 26769788 (View on PubMed)

Jaensson M, Dahlberg K, Eriksson M, Gronlund A, Nilsson U. The Development of the Recovery Assessments by Phone Points (RAPP): A Mobile Phone App for Postoperative Recovery Monitoring and Assessment. JMIR Mhealth Uhealth. 2015 Sep 11;3(3):e86. doi: 10.2196/mhealth.4649.

Reference Type BACKGROUND
PMID: 26362403 (View on PubMed)

Nilsson U, Dahlberg K, Jaensson M. Swedish Web Version of the Quality of Recovery Scale Adapted for Patients Undergoing Local Anesthesia and Peripheral Nerve Blockade (SwQoR-LA): Prospective Psychometric Evaluation Study. JMIR Perioper Med. 2021 Jan 15;4(1):e23090. doi: 10.2196/23090.

Reference Type DERIVED
PMID: 33448932 (View on PubMed)

Jaensson M, Dahlberg K, Nilsson U. Sex Similarities in Postoperative Recovery and Health Care Contacts Within 14 Days With mHealth Follow-Up: Secondary Analysis of a Randomized Controlled Trial. JMIR Perioper Med. 2018 Mar 26;1(1):e2. doi: 10.2196/periop.9874.

Reference Type DERIVED
PMID: 33401367 (View on PubMed)

Halleberg Nyman M, Nilsson U, Dahlberg K, Jaensson M. Association Between Functional Health Literacy and Postoperative Recovery, Health Care Contacts, and Health-Related Quality of Life Among Patients Undergoing Day Surgery: Secondary Analysis of a Randomized Clinical Trial. JAMA Surg. 2018 Aug 1;153(8):738-745. doi: 10.1001/jamasurg.2018.0672.

Reference Type DERIVED
PMID: 29710226 (View on PubMed)

Dahlberg K, Philipsson A, Hagberg L, Jaensson M, Halleberg-Nyman M, Nilsson U. Cost-effectiveness of a systematic e-assessed follow-up of postoperative recovery after day surgery: a multicentre randomized trial. Br J Anaesth. 2017 Nov 1;119(5):1039-1046. doi: 10.1093/bja/aex332.

Reference Type DERIVED
PMID: 29077819 (View on PubMed)

Jaensson M, Dahlberg K, Eriksson M, Nilsson U. Evaluation of postoperative recovery in day surgery patients using a mobile phone application: a multicentre randomized trial. Br J Anaesth. 2017 Nov 1;119(5):1030-1038. doi: 10.1093/bja/aex331.

Reference Type DERIVED
PMID: 29077818 (View on PubMed)

Other Identifiers

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2014-4765

Identifier Type: -

Identifier Source: org_study_id

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