Multifunctional Approach in Cardiac Surgery (TITANIC)

OsteopaThic, logopedIc and Psychological Assessment To Improve Outcome in pAtieNts undergoIng Cardiac Surgery: a Randomized Clinical Trial (TITANIC Trial)

Postoperative pain and swallowing disorders are complex, multifactorial phenomenon that frequently occur after cardiac surgery. Preoperative anxiety and the interaction between sex and other sociocultural factors may predict greater sensitivity to postoperative pain, whereas the epidemiology and course of swallowing disorders has not been systematically investigated, along with the interaction between dysphagia, post-operative pain and emotional stress. Cardiac rehabilitation is a multifunctional intervention which may address all these functional domains, improving patients' prognosis.

The aim of the present study is to demonstrate the superiority of a multifunctional approach (OMT, systematic swallowing screening and specific treatment according to good clinical practice associated with psychological counseling) compared to local clinical practice in the management of pain and swallowing disorders.

Study Overview

• Status: Completed
• Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
• Intervention / Treatment: Behavioral: Multifunctional rehabilitation treatment

Detailed Description

The TITANIC trial will provide evidence on whether a multifunctional intervention systematically implemented in the cardiac rehabilitation setting will improve the clinical course and prognosis of patients with recent cardiac surgery.

The design is a randomized clinical trial with parallel group design. Patients aged over 18 undergoing elective cardiac surgery and admitted to IRCCS Fondazione Don Gnocchi, Santa Maria Nascente, Milan, for cardiac rehabilitation will be randomized to standard post-acute treatments (cardiovascular training, monitoring and logopedic treatment only in case of swallowing dysfunction) compared with an experimental approach which consists of osteopathic manipulative treatment (OMT) treatments, swallowing screen protocol, psychological assessment and counseling.

This study may help in the identification of a new diagnostic-therapeutic pathway in cardiac surgery patients that allows a reduction in the use of analgesics and anti-inflammatories and increases the early detection of swallowing disorders. Furthermore, by allowing an integrated assessment of emotional needs, it can have a positive effect in reducing the need for post-operative clinical visits and assessments in the medium to long term, improving the patients' quality of life.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • IRCCS Fondazione Don Gnocchi, ONLUS

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria (all the following must be satisfied):

• patients with recent cardiac surgery (within one month)
• without swallowing disorders already identified before discharge
• with the presence of chest pain (NRS>2).

Exclusion Criteria:

• patients who are unable to sign informed consent.
• patients with already known psychological/psychiatric disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; The cases (active treatment) will be treated with an approach that includes osteopathic treatment for pain control (by the Osteopath Bruno Bordoni), systematic swallowing screening (Speech Therapist, Leone Stilo), psychological counseling (Psychologist, Eleonora Volpato, Giulia Novembre ). The duration of treatment will be that of hospitalization, on average about 3 weeks. The osteopathic treatment will last 5 sessions, while the counseling will have one session at the admission and one at the discharge and up to two sessions a week (variable according to individual needs); the swallowing screening will have one session at the admission and one at discharge and about two-three sessions a week (variable according to individual needs).	Behavioral: Multifunctional rehabilitation treatment; multidisciplinary approach with (OMT, psychological counseling, and therapists dedicated to swallowing disorders)
No Intervention: Controls; Controls will follow good clinical practice (in this case systematic screening from a swallowing point of view will not be applied, nor will osteopathic treatment and systematic psychological counseling be considered).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain release through the Brief Pain Inventory	To verify the effectiveness of the multifunctional rehabilitation approach in reducing pain assessed by the Brief Pain Inventory: likert scale with maximum pain intensity equal to 7-10.	Through study completion, an average of 4 weeks
Anxiety and depression control through the Hospital Anxiety and Depression Scale	To verify the effectiveness of the multifunctional rehabilitation approach in reducing anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), with maximum anxiety and depression equal to 15-21 points.	Through study completion, an average of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess functional swallowing disorders post-cardiac surgery (Mealtime Assessment Scale)	Epidemiological framework of the cardiac surgery population, in terms of presence/absence of swallowing disorders. MAS: points 0-36, with higher scores defining the worst outcome.	Through study completion, an average of 4 weeks
Anti-inflammatory drugs use (numbers of pills used)	Monitoring the use of anti-inflammatory drugs	Through study completion, an average of 4 weeks
LOS	Length of stay	Through study completion, an average of 4 weeks
Number of participants with persistent inflammatory status	The persistent inflammatory status will be described in terms of fever and PCR> 5 in at least two successive measurements 8 days apart)	Through study completion, an average of 4 weeks
Adherence to treatment	Monitoring of adherence to treatment using the 4-item Morisky, Green, and Levine Adherence Scale. With a sum of scores of 8, from 6 to <8 or <6, patients can be classified as having high, medium or low adherence to therapy, respectively.	Through study completion, an average of 4 weeks
Quality of life improvement through the EuroQol Visual Analogue Scale (EuroQoL-VAS) questionnaire	Consisting of two parts. The first explores 5 areas of interest: mobility, personal hygiene, social activities, pain and anxiety/depression. Each individual area has, in turn, three levels of severity (no problem, problem of some size, problem of extreme seriousness). The second section consists of a 20 cm visual analog scale (VAS) on which the patient indicates the best (score=0) or worst (score=100) possible state of health.	Through study completion, an average of 4 weeks
Cognitive impairment	Monitoring of cognitive abilities through the administration of the Montreal Cognitive Assessment Test (MOCA) scale, with a score more than 17,54 in the normal range. A raw and then corrected score: - less than 15.5 suggests the presence of a cognitive impairment; - between 15.5 and 17.54 assumes a borderline performance; - a score above 17.54 would show functioning within the normal range.	Through study completion, an average of 4 weeks
Quality of life improvement through the Short Form-12 (SF-12) questionnaire	Scores can be reported as Z-scores (difference from the population mean, measured in standard deviations). The population mean is 50 points. The population standard deviation is 10 points. Thus, each 10-point increase above or below 50 is one standard deviation from the mean.	Through study completion, an average of 4 weeks

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cardiac surgery; osteopathic manipulative treatment; cardiac rehabilitation; post-surgical pain; swallowing disorders; psychological counseling
• Other Study ID Numbers: 06_08/02/2023

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