Clinical trial NCT04462211: Constipation Bundle/Protocol and the Effect of Adherence in the Incidence of Constipation in Critically Ill Patients
Official title: Pilot Study of the Preparation and Implementation of a Constipation Bundle & Management Protocol and the Effect of Adherence in Reducing the Incidence of Constipation in Critically Ill Patients of a University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Critical Illness
Constipation Drug Induced
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Gastrointestinal abnormalities are present in more than 80% of critical patients, and their management has taken an important importance in intensive care unit (ICU), since it can largely determine the clinical outcome, costs and long-term prognosis in This group of patients. Only the constipation in the critical patient has been related to the failure of weaning of the mechanical ventilator, an increase in mechanical ventilation time, and with the increase of the stay in the ICU.

In general, most critical health conditions cause a decrease in the motility of the gastrointestinal tract that intrinsically can contribute to constipation. This is explained by the increase in pro-inflammatory cytokines, increased activity of the sympathetic system, the use of vasopressors, high and prolonged doses of opiates, among others, which can reduce gastric emptying and delay motility. These gastrointestinal abnormalities may be associated with an increase in intra-abdominal pressure, reduced nutritional intake, bacterial hyperproliferation in the digestive tract, intestinal mucosal injury and bacterial translocation through the injured and / or inflamed mucosa. In addition, patients who experience constipation often have gastroparesis and paresis of the ileum, conditions that hinder the progression of nutritional support enterally and worsen the patient's clinical picture.

In spite of being quite common in the ICU, the impact is not known in depth, which implies that these alterations are usually not prevented and on the other hand when treating their pharmacological and non-pharmacological management is highly variable because, for a On the other hand, staff turnover (intensivist physician) and on the other hand because there are no protocols that reduce these problems.

To provide comprehensive care in critical patient units, according to the best available evidence in order to reduce the variation in daily care, clinical guidelines and protocols are applied to manage the various specific problems that affect this group. of patients One way to address the complexity of these problems is through the implementation of care packages, which have taken relevance in the prevention of characteristic events of high mortality and morbidity. It is in this scenario, where the clinical pharmacist plays an important role in the development of protocols, packages and their compliance. The clinical pharmacist is dedicated to the review of the therapy of each patient, through pharmacological conciliation actions with the attending physician, actively participating in the daily round of the multidisciplinary team and at the same time developing "professional support activities" that include , reviews of adverse events associated with medications, education, auditing, research, development of guidelines and institutional protocols for the use of effective and safe medications, with the objective of reducing mortality and its associated costs, thus improving the quality of the Attention.

Given the importance of the problem, it is that this work proposes that the implementation and active dissemination of a constipation bundle/protocol guided by a clinical pharmacist ensures adherence to the strategy in the treatment team and a decrease in the incidence of constipation in the critical patient of the ICU of a university hospital. To fulfill this objective, a quasi-experimental study was designed in which the first stage will be diagnostic observational and a second part of the interventional type, in order to evaluate the effect of adherence to the bundle/protocol on the incidence of constipation in critically ill patients admitted to a ICU of a university hospital for a period of 6 months.

Detailed description: Stages of the study

The project will be carried out in 5 phases distributed in 3 continuous periods of time.

* Stage 1 - 2 month period (observational period).
* Collection of patient information for bundle/protocol development.
* Stage 2 - 3 month period.
* Protocol / bundle development according to evidence-based approach
* Active dissemination of bundle/protocol.
* Stage 3 - 1 month period (implementation and evaluation period)
* Protocol / bundle implementation.
* Collection of patient information, measurement of adherence and evaluation of the effect of the bundle/protocol.

Description of the Phases of the Study

Stage 1

• Collection of patient information for the elaboration of the bundle/protocol.

Information from patients hospitalized at the ICU will be collected through a data collection sheet, prospectively to quantify the local magnitude of the constipation and other alterations associated with the decrease in intestinal motility, interventions performed with their results and its consequences.

The data will be collected through a collection form, which will consist of 5 parts:

* Part I: Basic background record (Age, gender, anthropometric data, ICU service you enter, service from which it comes, chronic morbid history).
* Part II: Registration of factors in the patient that may be related to the presence of gastrointestinal motility disorders, as a risk or protective factor during the stay in ICU (type of mechanical ventilation, use of norepinephrine, medicines used in sedoanalgesia, degree of sedation according to SAS scale)
* Part III: Characterization of the nutrition administered to the patient during the stay in ICU (what type of enteral nutrition he is receiving, daily amount of nutrition, daily water balance, amount of bowel movements and if he has diarrhea).
* Part IV: Registry of Laxative/s and/or Prokinetic/s Treatment and its clinical evolution.
* Part V: Identification and Registration of adverse effects associated with the indicated treatment that are clinically evaluable and/or by registration in the nursing and medical record.

Stage 2

• Bundle/protocol development according to evidence-based approach

Protocol and bundle elaboration.

• Active dissemination of a constipation protocol / bundle.

Implementation strategies will be addressed using the EPOC taxonomy (Effective Practice and Organization of Care (EPOC). EPOC taxonomy. Oslo: Norwegian Knowledge Center for the Health Services; 2002). For the purpose of this work only part of the

Interventions aimed at health professionals.

A. Distribution of the protocol and bundles by email and a hard copy to all unit heads. In addition, all the professional prescribers of the unit will be given a hard copy.

B. Educational Talks: Directed to health professionals.

* Active education: Session in groups of no more than 10 people, usually carried out in medical visits, as feedback in multidisciplinary reviews of a patient between different professionals of the medical team and/or interconsultores (professionals from other disciplines and/or units other than within the ICU), in order to engage and educate the health professional about the interventions of the protoco and the bundles, and also confirm learning by the professional.
* Passive education: Sessions intended to disseminate information to the prescribing doctors of the entire unit, and to solve doubts globally.

C. Local opinion leaders:

Intervention through the participation of health professionals designated by their colleagues as "educationally influential" (health professionals staff of the ICU, nutritionist, gastroenterologist or others)

D. Reminders: any oral or visual intervention that encourages the health professional to perform a clinical action related to the protocol / bundle. The following interventions are included:

* Oral reminders (Aimed at both treating physician, medical staff, and nurse between medical visits when there is evidence of suboptimal care for patients included in the study, for example, when a patient is constipated and is not receiving treatment).
* Administrative support (graphics or reminder stickers attached to each patient's box).

Organizational Interventions:

A. Structural interventions Incorporation of the protocol and bundles in each medical record of the patients included.

Stage 3

• Implementation of the bundle/protocol in patients admitted during this period, who meet the inclusion criteria and our treating doctors accepted informed consent (if necessary).

The patients included in phase 3 of the study corresponding to the implementation of the package will be patients of the ICU, whatever the applications during the statistics, the set of exclusive controls for each service unit (previously accepted as a package) focused on the prevention of a probable episode of constipation, as long as there is no contraindication (previously described). If a patient included in the corresponding phase of the study will present constipation, the pharmacological management for said health problem will be applied, as specified in their "pharmacological management protocol for constipation" developed and validated together with the package.

These protocol / package interventions will be presented to the health team during medical rounds by both the pharmaceutical chemist responsible for the investigation and by any other professional of the patient's health team in order to comply with the adherence to the protocol / package for each patient

• Collection of patient information, adherence measurement and evaluation of the effect of the protocol / package.

Information from hospitalized patients in the ICU will be collected through a data collection form previously validated in Stage 1. In addition, the following information will be incorporated:

* Part I to Part V: Identical to the one previously validated.
* Part VI: Applicability of bundle in each of the elements.
* Part VII: Applicability of protocol.

This data will be backed up in an EXCEL (office) format file for later analysis.

Sample size

The universe and the target population will be all admitted patients that meet the inclusion criteria in the period of time in which stage 1 (observational period) and stage 3 (period of implementation and evaluation) of the study are executed

Events to evaluate

In this research paper:

The effectiveness of the analysis of the following definitions shall be understood:

• Adhesion: It will be understood as adherence to the effective fulfillment of the interventions that will be prepared for the protocol and the bundle.

• Constipation: Constipation shall be understood as the presence of "three or more consecutive days without depositions" and prolonged constipation as "six or more consecutive days without depositions". For both definitions, it will be considered as zero day without depositions from the start of enteral nutrition, at most 96 hours after admission to the ICU.

Safety shall be understood as the analysis of adverse events described in the following definitions:

• Intolerance to nutritional support: It is understood as an intolerance to enteral nutritional support to the presence of "gastric residue greater than 500mL in a measurement during the day, or to the presence of vomiting", which will be taken into account in patients who are being given enteral nutrition.

• Liquid deposition: Liquid deposition shall be understood as the presence of a "deposition of liquid consistency quantified in an amount greater than 200 milliliters". It is also synonymous with a diarrheal deposition. \*

• Mechanical fan day: A mechanical ventilator day will be considered when the patient requires mechanical ventilator support for more than 12 hours on the day of hospitalization analyzed.

Eligibility criteria: Inclusion Criteria:

* Patient admitted to the intensivo care unit.
* Hospitalization equal to or greater than 3 days.

Exclusion Criteria:

* Patient admitted after surgery for resection of the digestive tract.
* Patient with exclusive parenteral nutrition.
* Patient with total intestinal obstruction / ileus, documented during the stay at UPC.
* Patients admitted exclusively for "isolation measures".

Primary outcomes:
measure: Adherence to protocol / bundle implementation.
timeFrame: 1 mounth
Secondary outcomes:
measure: Difference in incidence of constipation between observational period group and protocol / bundle implementation period group.
timeFrame: 1 mounths.
measure: Intolerance to nutritional.
timeFrame: 1 mounths
measure: Liquid deposition.
timeFrame: 1 mounths.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: International
Study officials:
affiliation: University of Chile
name: José Ignacio JI Farías, Pharmacist
role: PRINCIPAL_INVESTIGATOR
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