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

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ClinicalTrials.gov Identifier: NCT02492191
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Ulrica Nilsson, Örebro University, Sweden

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.


Condition or disease Intervention/treatment Phase
Postoperative Complications Device: Smartphone app Recovery Assessment by Phone Points (RAPP) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1046 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: RAPP- Systematic E-assessment of Postoperative Recovery in Patients Undergoing Day Surgery
Study Start Date : October 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: Smartphone app Recovery Assessment by Phone Points (RAPP)
An e-assessed follow-up of day surgery patients postoperative recovery measured via smartphone app

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



Primary Outcome Measures :
  1. Cost effectiveness [ Time Frame: 14 days postoperatively ]
    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 :
  1. Postoperative recovery [ Time Frame: 7 and 14 days postoperatively ]
    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.

  2. Quality of Life (QoL) [ Time Frame: Preoperatively(baseline) and 14 days postoperatively ]
    QoL will be assessed with the SF-36

  3. Overall health [ Time Frame: Preoperatively(baseline) and 14 days postoperatively ]
    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

  4. Health literacy [ Time Frame: 14 days postoperatively ]
    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

  5. Patient experience of the intervention [ Time Frame: 1 month postopertively ]
    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.

  6. Staff experience of the implementation [ Time Frame: 4 months postoperatively ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492191


Locations
Sweden
Örebro university hospital, Day surgery department
Örebro, Sweden, 70185
Sponsors and Collaborators
Örebro University, Sweden
Investigators
Principal Investigator: Ulrica Nilsson, Prof Faculty of Medicine and Health, Örebro University, Sweden

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrica Nilsson, Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT02492191     History of Changes
Other Study ID Numbers: 2014-4765
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ulrica Nilsson, Örebro University, Sweden:
Smart Phones
Ambulatory Care
Outcome and Process Assessment

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes