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

Postoperative Complications Clinical Trial

— RAPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492191
• Other study ID #: 2014-4765
• Status: Completed
• Phase: N/A
• First received: July 5, 2015
• Last updated: September 26, 2016
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1046
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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. .

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Device:
• Smartphone app Recovery Assessment by Phone Points (RAPP)
An e-assessed follow-up of day surgery patients postoperative recovery measured via smartphone app

Locations

Country	Name	City	State
Sweden	Örebro university hospital, Day surgery department	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Jaensson M, Dahlberg K, Eriksson M, Grönlund Å, 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. — View Citation

Nilsson U, Jaensson M, Dahlberg K, Odencrants S, Grönlund Å, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	7 and 14 days postoperatively	Yes
Secondary	Quality of Life (QoL)	QoL will be assessed with the SF-36	Preoperatively(baseline) and 14 days postoperatively	No
Secondary	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	Preoperatively(baseline) and 14 days postoperatively	No
Secondary	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	14 days postoperatively	No
Secondary	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.	1 month postopertively	No
Secondary	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.	4 months postoperatively	No

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