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

NCT02492191 | Completed

• 1 other identifier: 2014-4765
• Study Type: interventional
• Target: 1,046
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications

Keywords

Smart Phones; Ambulatory Care; Outcome and Process Assessment

Outcome Measures

Primary Outcomes (1)

• Cost effectiveness

  The analysis of cost effectiveness will consider the costs associated with the follow-up, gained QALYs from SF-6D. The SF-6D provides a means for using the SF-36 by estimating a preference-based single-index measure for health from these data using general population values. This analysis will be complemented with information regarding the individuals' willingness to pay for the follow-up, number of healthcare contacts, and duration and degree of sick leave.

  14 days postoperatively

Secondary Outcomes (6)

• Postoperative recovery

  7 and 14 days postoperatively

• Quality of Life (QoL)

  Preoperatively(baseline) and 14 days postoperatively

• Overall health

  Preoperatively(baseline) and 14 days postoperatively

• Health literacy

  14 days postoperatively

• Patient experience of the intervention

  1 month postopertively

Study Arms (2)

RAPP, e- assessed follow-up

ACTIVE COMPARATOR

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.

Device: Smartphone app Recovery Assessment by Phone Points (RAPP)

Control

NO INTERVENTION

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

Interventions

Smartphone app Recovery Assessment by Phone Points (RAPP) DEVICE

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

RAPP, e- assessed follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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. .

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Örebro university hospital, Day surgery department

Örebro, 70185, Sweden

Location

Related Publications (7)

• 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.

  PMID: 26769788 BACKGROUND

• 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.

  PMID: 26362403 BACKGROUND

• 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.

  PMID: 33448932 DERIVED

• 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.

  PMID: 33401367 DERIVED

• 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.

  PMID: 29710226 DERIVED

• 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.

  PMID: 29077819 DERIVED

• 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.

  PMID: 29077818 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrica Nilsson, Prof

  Faculty of Medicine and Health, Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2015
• First Posted: July 8, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)