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

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Smartphone app Recovery Assessment by Phone Points (RAPP)
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Complications focused on measuring Smart Phones, Ambulatory Care, Outcome and Process Assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. .

Sites / Locations

  • Örebro university hospital, Day surgery department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

RAPP, e- assessed follow-up

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative recovery
All participants will evaluate their postoperative recovery using the SwQoR. Participants in the intervention group will answer by using the smartphone app, and those in the control group will use a conventional paper-based questionnaire.
Quality of Life (QoL)
QoL will be assessed with the SF-36
Overall health
Overall health will be measured by the EQ visual analog scale (EQ-VAS). This scale consists of a vertically graduated scale with endpoints (anchors) of 0 indicating worst imaginable health state and 100 indicating best imaginable health state
Health literacy
To measure health literacy (i.e., the equality perspective), we will use the Japanese Communicative and Critical Health Literacy scale (C&CHL scale), which includes items covering the major aspects of communicative and critical health literacy. The C&CHL scale has been translated into Swedish and demonstrated to be understandable, stable over time, and equivalent to the Japanese C&CHL scale in terms of language and content
Patient experience of the intervention
Following the RCT, inductive qualitative research will be conducted to explore the perceptions, views, experiences, and expectations of the participants from the intervention group. Data will be collected based on 20 semistructured interviews. A purposeful sampling will be conducted. Patients who wished to be contacted by a nurse via the RAPP during the intervention period will be selected, with variation regarding age and gender. The aim of this study is to explore the participants' experience of postoperative recovery and how using the RAPP for postoperative follow-up influenced this recovery. Further questions will be asked regarding the participants' experience of being contacted by a nurse; in addition, descriptions and eventual expectations about the help that was received will also be solicited. All interviews will be recorded and transcribed verbatim.
Staff experience of the implementation
As part of this RCT, we will also describe the staffs' experience of using a systematic postoperative follow-up tool and their willingness to pay for the follow-up service. We plan to make the data from the patients' daily postoperative recovery measurements available to the staff at the day-surgery departments and to record the experiences and opinions of the clinicians. The study design will be qualitative and will use focus-group interviews. One to two focus-group interviews with 5-8 participants each will be conducted at each hospital, depending on the size of the day-surgery department. Staff from the day-surgery department (nurses, surgeons, and anesthesiologists) will be asked to participate in the interviews. All interviews will be recorded and transcribed verbatim.

Full Information

First Posted
July 5, 2015
Last Updated
September 26, 2016
Sponsor
Örebro University, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02492191
Brief Title
RAPP- Systematic E-assessment of Postoperative Recovery in Patients Undergoing Day Surgery
Acronym
RAPP
Official Title
RAPP- Systematic E-assessment of Postoperative Recovery in Patients Undergoing Day Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro University, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Smart Phones, Ambulatory Care, Outcome and Process Assessment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1046 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAPP, e- assessed follow-up
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive standard care; i.e., no follow-up
Intervention Type
Device
Intervention Name(s)
Smartphone app Recovery Assessment by Phone Points (RAPP)
Intervention Description
An e-assessed follow-up of day surgery patients postoperative recovery measured via smartphone app
Primary Outcome Measure Information:
Title
Cost effectiveness
Description
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.
Time Frame
14 days postoperatively
Secondary Outcome Measure Information:
Title
Postoperative recovery
Description
All participants will evaluate their postoperative recovery using the SwQoR. Participants in the intervention group will answer by using the smartphone app, and those in the control group will use a conventional paper-based questionnaire.
Time Frame
7 and 14 days postoperatively
Title
Quality of Life (QoL)
Description
QoL will be assessed with the SF-36
Time Frame
Preoperatively(baseline) and 14 days postoperatively
Title
Overall health
Description
Overall health will be measured by the EQ visual analog scale (EQ-VAS). This scale consists of a vertically graduated scale with endpoints (anchors) of 0 indicating worst imaginable health state and 100 indicating best imaginable health state
Time Frame
Preoperatively(baseline) and 14 days postoperatively
Title
Health literacy
Description
To measure health literacy (i.e., the equality perspective), we will use the Japanese Communicative and Critical Health Literacy scale (C&CHL scale), which includes items covering the major aspects of communicative and critical health literacy. The C&CHL scale has been translated into Swedish and demonstrated to be understandable, stable over time, and equivalent to the Japanese C&CHL scale in terms of language and content
Time Frame
14 days postoperatively
Title
Patient experience of the intervention
Description
Following the RCT, inductive qualitative research will be conducted to explore the perceptions, views, experiences, and expectations of the participants from the intervention group. Data will be collected based on 20 semistructured interviews. A purposeful sampling will be conducted. Patients who wished to be contacted by a nurse via the RAPP during the intervention period will be selected, with variation regarding age and gender. The aim of this study is to explore the participants' experience of postoperative recovery and how using the RAPP for postoperative follow-up influenced this recovery. Further questions will be asked regarding the participants' experience of being contacted by a nurse; in addition, descriptions and eventual expectations about the help that was received will also be solicited. All interviews will be recorded and transcribed verbatim.
Time Frame
1 month postopertively
Title
Staff experience of the implementation
Description
As part of this RCT, we will also describe the staffs' experience of using a systematic postoperative follow-up tool and their willingness to pay for the follow-up service. We plan to make the data from the patients' daily postoperative recovery measurements available to the staff at the day-surgery departments and to record the experiences and opinions of the clinicians. The study design will be qualitative and will use focus-group interviews. One to two focus-group interviews with 5-8 participants each will be conducted at each hospital, depending on the size of the day-surgery department. Staff from the day-surgery department (nurses, surgeons, and anesthesiologists) will be asked to participate in the interviews. All interviews will be recorded and transcribed verbatim.
Time Frame
4 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrica Nilsson, Prof
Organizational Affiliation
Faculty of Medicine and Health, Örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Örebro university hospital, Day surgery department
City
Örebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26769788
Citation
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.
Results Reference
background
PubMed Identifier
26362403
Citation
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.
Results Reference
background
PubMed Identifier
33448932
Citation
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.
Results Reference
derived
PubMed Identifier
29710226
Citation
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.
Results Reference
derived
PubMed Identifier
33401367
Citation
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.
Results Reference
derived
PubMed Identifier
29077819
Citation
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.
Results Reference
derived
PubMed Identifier
29077818
Citation
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.
Results Reference
derived

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

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