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Postoperative ComplicationsRAPPNCT02492191

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

A study testing Smartphone app Recovery Assessment by Phone Points (RAPP) in people with Postoperative Complications, run by Örebro University, Sweden at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Complications
What is being tested?
Smartphone app Recovery Assessment by Phone Points (RAPP)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,046 participants
Where
1 siteSweden
Study dates
Oct 2015to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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. .

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Örebro university hospital, Day surgery department

    Örebro, 70185

Other trials in Sweden

About this study

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.

Being tested
Smartphone app Recovery Assessment by Phone Points (RAPP)
Keywords
Smart Phones, Ambulatory Care, Outcome and Process Assessment
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT02492191
Study groupRoleWhat they receive
RAPP, e- assessed follow-upActive comparatorA 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.
Receives: Device: Smartphone app Recovery Assessment by Phone Points (RAPP)
ControlNo interventionThe control group will receive standard care; i.e., no follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 14 days postoperatively

Secondary outcomes (6)

  1. 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.

    Measured: 7 and 14 days postoperatively

  2. Quality of Life (QoL)

    QoL will be assessed with the SF-36

    Measured: Preoperatively(baseline) and 14 days postoperatively

  3. 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

    Measured: Preoperatively(baseline) and 14 days postoperatively

  4. 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

    Measured: 14 days postoperatively

  5. 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.

    Measured: 1 month postopertively

  6. 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.

    Measured: 4 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
1,046 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02492191
Sponsor's protocol ID
2014-4765
Acronym
RAPP
Status last verified
Sep 2016
First submitted
5 Jul 2015
Last updated
27 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26769788

  • 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.

    PubMed 26362403

  • 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.

    PubMed 33448932

  • 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.

    PubMed 33401367

  • 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.

    PubMed 29710226

  • 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.

    PubMed 29077819

  • 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.

    PubMed 29077818

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone app Recovery Assessment by Phone Points (RAPP) in people with Postoperative Complications, run by Örebro University, Sweden at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost effectiveness (time frame: 14 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02492191, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.

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