The "Seamless" Patient:From Preoperative Preparation to Postoperative Rehabilitation

The "Seamless" Patient: From Preoperative Preparation to Postoperative Rehabilitation

The "seamless" patient: from preoperative preparation to postoperative rehabilitation.

The effects of digital services for perioperative care of patients undergoing cardiac surgery will be investigated

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: pre rehabilitation

Detailed Description

Intervention by randomization in: G1. "Standard of care" Previous postal call-in without additional communication or special follow-up G2: Intensified patient education via classical communication channels as well as provision of information material for outpatient, preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and telephone postoperative communication (postoperative for Patient-Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROM) analysis) with the surgical center. G3: Intensified education on new media (mobile app) with outpatient preoperative rehabilitation (respiratory training, exercise therapy). Creation of an individualized rehabilitation plan and postoperative, two-way communication via mobileapp.

This project combines the establishment of outpatient pre-rehabilitation with the additional benefit of interrogating patient-reported outcome (PROs) with individualized rehabilitation. Through the improved exchange of information and the resulting more intensive care of patients alone, we hope not only to improve the quality of life, but also to reduce postoperative mortality and morbidity. The use of new techniques with the establishment of a mobile-based app should provide a decisive advantage in the effectiveness of the measures in this regard. The integration of secure, direct, and always-available communication channels will both improve the flow of information and enhance patients' sense of security in an increasingly fast-moving healthcare system.

Hypotheses:

• The intervention in G2 "classic forms of communication" does not significantly improve the primary and secondary endpoints compared to the control group G1.
• The intervention in G3 "next level" communication via app leads to a significant improvement of the primary and secondary endpoints compared to control group G1.
• The rate of exercise performance (in the prehabilitation and rehabilitation phases; % of days) is significantly higher in the G3 "next level" communication via app group compared to the G2 "classical forms of communication" group.
• Intervention in G2 "classical forms of communication" and G3 "next level" communication via app leads to significant improvement in PREMs compared to control group G1.
• The questionaires: EQ-VAS, PROMIS-10 and HSSI are equally suitable for mapping the health status of patients* in the postoperative course.
• The feedback rate (completion of the query) on health status is significantly higher for the questionaires EQ-VAS compared to questionaire PROMIS-10, questionaire HSSI and questionaire MLHFQ.
• In patients* who develop postoperative pericardial tamponade, pneumonia, or surgical access wound complication (bleeding/Dressler syndrome, infection/sepsis, wound dehiscence/infection, mechanical instability), Questionaire EQ-VAS scores drop significantly before diagnosis. The questionaire EQ-VAS is therefore suitable as a non-specific postoperative parameter for triggering early further diagnostics.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bastian Schmack, PD; Phone Number: 0511-532-3452; Email: Schmack.bastian@mh-hannover.de
• Study Contact Backup: Name: Jasmin S Hanke, PD; Email: hanke.jasmin@mh-hannover.de

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • Recruiting
      • Medical School Hanover
      • Contact: Bastian Schmack, PD; Email: Schmack.Bastian@mh-hannover.de
      • Contact: Jasnin s Hanke, PD; Email: Hanke.Jasmin@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is capable of giving consent;
• planned, elective cardiac surgery (coronary bypass surgery and heart valve surgery incl. combination surgery). The planned surgery can be performed with or without a heart-lung machine.
• Minimally invasive procedures may also be explicitly included in the study.

Exclusion Criteria:

• Emergency care;
• congenital heart defects;
• age less than 18 years;
• patient unable to give consent;
• patient unable to perform simple physical training;
• high-risk surgery with a calculated Euroscore II of more than 8%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care"; Previous postal call-in without additional communication or special follow-up
Other: Intensified patient education; via classical communication channels as well as provision of information material for outpatient, preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and telephone postoperative communication (postoperative for Patient-Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROM) analysis) with the surgical center	Other: pre rehabilitation; preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and postoperative communication via telephone or app
Other: Intensified education on new media (mobile app); with outpatient preoperative rehabilitation (respiratory training, exercise therapy). Creation of an individualized rehabilitation plan and postoperative, two-way communication via mobileapp.	Other: pre rehabilitation; preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and postoperative communication via telephone or app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of patient via questionnaire	via questionnaire	6 month

Collaborators and Investigators

• Sponsor: Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 01VSF21036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No