Optimal nutrition by Informing and Capacitating family ... · Rupinder Dhaliwal, RD Manager, Research & Networking Clinical Evaluation Research Unit Queen’s University, Kingston,

Version: October 9th 2014

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Optimal nutrition by Informing and

Capacitating family members of best practices:

The OPTICS feasibility study

Phase 1b

Implementation Manual Intended Audience: Site Investigators/Site Dietitians


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Table of Contents GLOSSARY .......................................................................................................................................................... 2

CONTACTS ......................................................................................................................................................... 3

SITE INVESTIGATORS ................................................................................................................................................ 3 PARTICIPATING SITES ............................................................................................................................................... 3 COORDINATING CENTRE .......................................................................................................................................... 3

STUDY SYNOPSIS ................................................................................................................................................ 4

STUDY OVERVIEW .............................................................................................................................................. 6

ROLES & RESPONSIBILITIES ................................................................................................................................. 7

STUDY PREPARATION ACTIVITIES ....................................................................................................................... 8

INCLUSION CRITERIA .......................................................................................................................................... 9

EXCLUSION CRITERIA ......................................................................................................................................... 10

CONSENT AND CONFIDENTIALITY ...................................................................................................................... 11

PATIENT CONFIDENTIALITY ..................................................................................................................................... 12

STUDY INTERVENTION & PROCEDURES ............................................................................................................. 13

DATA COLLECTION ............................................................................................................................................ 22

DURATION & TYPE OF DATA COLLECTION ............................................................................................................. 22 SOURCE DOCUMENTATION ..................................................................................................................................... 22 OTHER STUDY PROCEDURES ................................................................................................................................ 22

PROTOCOL VIOLATIONS .................................................................................................................................... 23

SERIOUS ADVERSE EVENTS ................................................................................................................................ 23

Glossary APACHE Acute Physiology and Chronic Health Evaluation classification system for severity of

disease

OPTICS Optimal nutrition by informing and capacitating family members of best practices

CERU Clinical Evaluation Research Unit

ICU Intensive Care Unit

HCP Health Care Provider

CRF Case Report Form


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Contacts

Site Investigators Andrea Marshall, RN, MN, PhD, FACN Griffith University and The Gold Coast University Hospital Southport, Queensland [email protected]

Daren Heyland, MD, FRCPC Director, Clinical Evaluation Research Unit Queen’s University, Kingston, Ontario [email protected]

Rupinder Dhaliwal, RD Manager, Research & Networking Clinical Evaluation Research Unit Queen’s University, Kingston, Ontario 613-549-6666 ext 3830 [email protected]

Participating Sites Institution Site Investigator Oakville Trafalgar Memorial Hospital, Oakville, Canada

Hilda Seyler

Mount Sinai, Toronto, Canada

Kristen MacEachern

Coordinating Centre Rupinder Dhaliwal, RD Manager, Research & Networking Clinical Evaluation Research Unit Queens University, Kingston, Ontario 613-549-6666 ext 3830 [email protected]


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Study Synopsis Background: During and following critical illness, nutrition requirements are considerably increased, while at the same time, nutrition intake may be suboptimal. The problem of malnutrition and underfeeding seems to span the entire journey of critical illness starting in the intensive care unit (ICU) and extending into hospital and the community. Given the lack of continuity of care by health care professionals as patients move throughout the health care system, the only constant is the patient’s family. This raises the possibility of using family centered care to optimize nutrition. Overall Objective: This study proposes to determine the feasibility and acceptability of a family centered nutrition intervention designed to educate families about the importance of nutrition during, and following recovery from, critical illness, and to encourage families to advocate for better nutrition on behalf of their family member. We ultimately hypothesize that educating families about the importance of nutrition and having them advocate for better nutrition for their loved one in the ICU will result in better nutrition delivery during critical illness and in the recovery phase. Study Design and Setting: Given the complex sequential processes involved in the varying health care settings, we have developed the program of research into several preliminary phases, as shown on the next page. Phase 1b is a feasibility study evaluating the acceptability and feasibility of the family centered nutrition intervention in 2 Canadian sites. Each site in Phase 1b will be responsible for recruiting a total of 15 patients and their families and approximately 15 ICU health care providers from the ICU and another 15 health care providers from the floor. This phase is based on the learnings from Phase 1a, a feasibility study completed at 2 Australian sites. Study Intervention: In the Intensive Care Unit: Patients in the ICU and their family members will be recruited and upon consent, the family members will be asked to provide a short nutrition history of the patient within the first week of the patient’s admission. Family members will receive a short, focused education session on the importance of nutrition in critical illness by the ICU dietitian. This will be supplemented with a nutrition booklet provided to the families and follow up by the dietitian in the ICU. Prior to the patients discharge from the ICU, the nutrition education will be reinforced and a nutrition diary will be introduced. This diary is to be completed by the family when oral intake is resumed. In addition, a survey will be used to elicit health care providers’ perceptions of intervention acceptability and attitudes to family centered care. Lastly, data will be collected from the patient’s medical chart on the patient’s diagnosis, nutrition practices and outcomes in the ICU.

After ICU discharge (or extubation): Families will be followed by the dietitian and will be asked to keep a nutrition diary on the patient on the days they visit for 2 weeks following the patient’s extubation and resumption of oral intake. The diary includes retrospectively documenting the amount of food consumed each meal by the patient, as well as intake of any nutrition supplements. Families will be asked to interact with the patient’s nurse/dietitian to obtain information on nutrition intake,


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discuss the nutrition approach for the patient and communicate any concerns to them, thus serving as a patient-level audit and feedback mechanism. Family members and health care providers on the floor will also be asked to complete separate surveys to illicit their perceptions of the acceptability of the family centered intervention.

Future Plans: Given the complex sequential processes involved in the varying health care settings, we have developed the program of research into the following preliminary phases, as outlined below. The results of Phase 1b of the study will determine the subsequent Phase 1c and onwards. See proposed phases of the study below.


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Study Overview Below is a diagrammatic representation of the OPTICS Study Phase 1b.


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Roles & Responsibilities

The Coordinating Centre, Clinical Evaluation Research Unit (CERU) is responsible for the following:

Providing the educational booklet, nutritional diary, Mock Case Report Forms and other

study documents Providing procedures and tools for study implementation Providing training on procedures and tools Supplying a username and password for access to the Central Randomization System

(CRS) and REDCAP Providing ongoing support for research site activities Data validation and verification Distribution of data queries

Research Sites

The Site Investigator and any applicable delegates at the research site are responsible for the following:

Screening & enrolling eligible patients Informed Consent of potential research participants (family members and HCPs) Compliance with all Study Procedures Completion of Family Surveys and Health Care Provider Surveys Data collection Allowing only authorized study personnel to access the CRS/REDCAP Electronic Case Report Form (eCRF) completion on REDCAP Data query resolution on REDCap Notifying CERU of any technical difficulties or malfunctions related to the CRS/REDCAP Maintenance of local computer equipment


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Study Preparation Activities Prior to the initiation of screening activities, each site must ensure the following tasks and/or documentation has been completed, and forwarded to the CERU Project Leader: Fully-executed Site Agreement Research Ethics Board Approval Letter Documentation of attendance of Site Training on Study Procedures

o Training Logs Other essential documentation as per Good Clinical Practices is not required given the nature of the intervention (family centered care) and that the participating sites have established an understanding of nutrition research practices by participation in previous CERU quality improvement projects. In addition, A Delegation of Authority Log is not needed as the Site Investigators will be fulfilling the role of Research Coordinator/Dietitian. In the following pages, “Site Dietitian” will be used in place of Site Investigator/Research Coordinator. Following completion of site start-up training, the above referenced documentation is to be sent to the Project Leader/delegate. Patient screening can commence following confirmation of receipt of necessary documentation by the Project Leader/delegate. Training

Each member of the site research team should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial according to the protocol. (GCP 4.1.1) Training on the study procedures related to the OPTICS Study will be provided by the Project Leader/Principal Investigator/delegate to the site before the start of enrolment. It is the responsibility of the Site Dietitian to ensure that the following staff are trained on the purpose of the study and on their roles:

Other ICU and ward dietitians Bedside research nurses Attending Staff Health Care Providers


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Inclusion Criteria Since this is a feasibility study, all patients admitted to your intensive care unit should be screened consecutively to see if they meet the inclusion or exclusion criteria. You may use the Screening Logs in the Tools section of your Study Binder to help keep track of eligibility of patients screened.

Screening data for All patients meeting inclusion criteria must be entered into the Central Randomization System (CRS), these would be either of the following: patients that meet an exclusion criteria or patients that do not meet any exclusion criteria and consent is obtained (enrolled patients) or patients that do not meet any exclusion criteria and consent is not obtained (eligible but not

enrolled patients) For eligible patients where consent is obtained, the screening data must be entered onto the CRS in a timely manner. For eligible patients that refuse consent or meet exclusion criteria, the screening data can be entered onto the CRS at a later time. Refer to the Central Randomization System Manual for further instructions. The following section refers to the details around the eligibility of patients for the study. Patients must meet all five of the following criteria at the time of screening to be eligible for the study

Inclusion Criteria

Patients

1 Patients >18 years of age AND

2 Expected to remain in ICU for > 72 hrs AND Cardiac patients admitted to a mixed ICU/Cardiac Care Unit are eligible

3

a) Require mechanical ventilation in the first 48 hrs of ICU admission OR

b) Considered to have moderate or severe risk of malnutrition based on dietitian or physician clinical judgment AND

Family members

4 Family member(s) must be able to communicate in English (verbally and in writing) AND

5 Family member(s) are expected to visit regularly while their family member is in hospital. “Regularly” refers to expected to visit at least 2-3 times a week

Assessment of Patient eligibility for criteria # 2 and 3a must be made in collaboration with the attending MD/ delegate MD


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Exclusion Criteria If a patient meets any of the three exclusion criteria at the time of enrollment, they are not eligible to participate in the study. Exclusion Criteria Patients

1 In whom there is a lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated DNR acceptable)

2 Those receiving long-term tube feeding pre-admission

3 Those who are anticipated not to be able to resume oral intake because of pre-existing prolonged severe dysphagia.

When assessing eligibility, the dynamics of the family are to be considered. This is to be based on the clinical judgment made collectively by the health care team (at least 2 health care team members, i.e. MDs, RNs, RDs, Social workers, etc)


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Consent and Confidentiality “Free and informed consent refers to the dialogue, information sharing and general process through which prospective subjects choose to participate in research involving themselves.” - Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans Following confirmation of patient and family eligibility, the site must seek consent from the family member/patient to participate in the OPTICS Study before any study procedures are started.

Before you approach for consent:

Recommended Procedures for Obtaining Informed Consent The following procedures should be followed when obtaining informed consent for a potential OPTICS Study patient family member:

1. The study team member obtaining consent is qualified to do so, and is knowledgeable in the study procedures, and the clinical area being studied.

2. Review the study details with the family member in a quiet, private location.

3. Do not coerce or unduly influence the family member to participate, or continue to participate

in the study.

4. Assess the patient’s and/or the family member’s competence to consent to research, and document if you deem this individual incompetent.

5. Fully inform the family member of all pertinent aspects of research, in non-technical

language that is easy to understand.

6. Provide a copy of the Informed Consent Form (version approved by your ethics) and allow ample time to read the form and ask questions.

7. Ask the family member questions to assess their comprehension of the material reviewed.

Ensure he/she fully understands the information.

Confirm patient eligibility and appropriateness of enrollment with the attending MD/delegate Check to see if the patient has refused to participate in research in general Familiarize yourself with the patient’s history Approach bedside staff/medical staff for an update on the family’s involvement and their

degree of knowledge of the patient’s condition

Consent should be obtained within 7 days of ICU admission as the intervention is to be given within this time frame. In the event that the patient is unstable, this time frame can be extended. You may obtain consent from more than one family member


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8. Ascertain the family members’ willingness to participate. Document the decision of any family member who declines to participate on the Screening Log.

9. Have the following people sign, date & time the Informed Consent Form:

a. The family member b. The person conducting the informed consent discussions

10. Document the consent process in the patient’s medical chart. See Sample Medical Chart Entry below.

Sample Medical Chart Entry

11. Provide the family member with a copy of the signed document.

12. File the originally signed Informed Consent Form with the study-related documentation. Place a copy in the patient’s medical chart.

13. Communicate any important new information that becomes available, and that may be relevant to the patient’s/ family member’s continuing consent

14. Assess the patient through the duration of the study for competency to grant consent for him/herself, if applicable.

The research site should always follow local procedures pertaining to obtaining informed consent of patients in the ICU.

Patient Confidentiality By definition, and in the context of a trial, confidentiality refers to prevention of disclosure, to other than authorized individuals, of a Patient’s identity and of records that could identify a Patient. Care and diligence in protecting confidential Patient information must be exercised throughout the duration of the OPTICS Study. With this in mind, prior to forwarding any documentation (i.e. questionnaires) to CERU, all family/patient identifiers should be masked.

This patient is enrolled in Research Ethics Board study ID#, ‘The OPTICS feasibility study, Phase 1b” Patient met all the inclusion criteria and none of the exclusion criteria as confirmed with Dr. ____________________.

Consent obtained from _____________ (relationship to patient) on dd/mmm/yyyy at time hrs. All questions & concerns addressed with patient/family member at this time. Copy of consent was given to patient/family member.


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Study Intervention & Procedures The intervention in the study is a family centered nutrition intervention which is designed to educate families about the importance of nutrition during, and following recovery from, critical illness, and to encourage families to advocate for better nutrition on behalf of their family member.

After consent has been obtained, the Site Dietitian will proceed with the following steps: While Patient is in the ICU Nutrition History

Obtain a brief nutrition history for the patient from the family member (see Nutrition History Case Report Form and screen shot below) within 7 days of the patient’s admission to the ICU.

o In the event the patient is unstable or to accommodate the family members schedule, this timeline can be extended

Include as many family members participating in the OPTICS Study as possible when completing the nutrition history.

Communicate the data to the health care team as needed. Obtain the family member’s phone and mailing address for follow up for the Family Survey (to be done at 2 weeks post extubation or prior to hospital discharge).

Nutrition History Case Report Form


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Nutrition Education Session

Complete a nutrition education session with the family member(s) within 7 days of the patient’s admission to the ICU, preferably at the same time as the nutrition history.

o In the event the patient is unstable, this can be extended although it is preferred not to wait until ICU discharge.

All family members participating in the OPTICS Study are to be included in the nutrition education session.

Encourage the family member(s) to engage with the nursing staff in the ICU to ask questions about how much nutrition their family member is receiving and if they are meeting their nutrition goals.

Use the OPTICS Educational Booklet (see screen shot below). Leave the Booklet with the family following the education session. Ask for contact information for follow up on ward and survey.

Educational Booklet


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Site Dietitian Follow up with Family The Site Dietitian will follow up with the family members in the ICU to see if they have any questions about nutrition for the patient Data Collection

Collect data according to Mock Case Report Forms and Collect data on resources needed for future phases of the study

o Refer to OPTICS Dietitian Worksheet excel spreadsheet for details

Prior to ICU discharge* or extubation** Family Members

Provide a second education session to reinforce the education provided to families Introduce the daily nutrition diary. The diary is to be completed regardless of where

the patient is in the hospital (ICU or ward), by the family after extubation or when oral intake is resumed. The diary includes retrospectively documenting the amount of food consumed each meal by the patient, as well as intake of any nutrition supplements. When present for a meal, we also ask the family to document observed food intake, if they are able.

o The diary is to be completed for 2 weeks after the patient has been extubated and oral intake has been resumed.

o In the event the patient is receiving enteral or parenteral nutrition, the family is still expected to complete the appropriate sections of the diary.

In the event that the patient gets discharged to the floor, this reinforcement with the family can happen on the ward.

Hanover to Ward Dietitian: Handover of the following from the ICU/Site dietitian to the ward dietitian:

nutrition plan and status of nutrition education with family members and update of introduction of nutrition diary with family members.

ICU Health Care Providers (HCP): Provide Health Care Providers with the Information Letter that describes the study before asking them to complete the Health Care Provider Questionnaire (see Mock Case Report Forms, appendix B

*ICU discharge here is defined as the time the patient is “ready to be discharged” rather than “actual discharge” **Flexibility with this is allowed in order to accommodate the schedule of family members


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Consent from the HCP does not need to be obtained as completion of the questionnaire implies that they have consented (unless the local ethics board requires a signed consent form).

Health Care Providers is any health care provider who provides patient care during or following an episode of critical illness. This includes registered nurses, doctors, dietitians or other health care professionals. Every attempt must be made to involve at least one Speech Language Pathologist. Patient Assistant Liaisons are not to be considered as Health Care Providers.

Since this questionnaire asks questions about the acceptability of the intervention in general, it can be provided to the HCP any time during the study. Ideally this will be after they have had some time to review the Information letter and after they have had a chance to think about the intervention in general.

A total of 15 completed questionnaires are needed from ICU HCPs. Completed questionnaires are to be sent back to CERU (see Mock Case Report Forms,

appendix B, Health Care Provider Questionnaire for more details).

Health Care Provider Questionnaire


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On the Ward: The dietitian (ward dietitian or ICU dietitian) will

Reinforce the completion of the nutrition diary with family members. The diary is to be completed regardless of where the patient is in hospital (ICU or ward) by the family after extubation and when oral intake is resumed. The diary includes retrospectively documenting the amount of food consumed each meal by the patient, as well as intake of any oral nutrition supplements. When present for a meal, we also ask the family to document observed food intake, if they are able.

o The diary is to be completed for 2 weeks after the patient has been extubated and oral intake has been resumed

o In the event the patient is receiving enteral or parenteral nutrition, the family member is still expected to complete the appropriate sections of the diary

o Address any questions the family members have about nutrition for the patient

Nutrition Diary

At 2 weeks post extubation (or hospital discharge, whatever happens first), provide

family members the Family Survey and instruct them to complete and hand back (see Mock Case Report Forms Appendix A, Family Member Questionnaire for more details


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Family Member Survey


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Ward Health Care Providers: Provide the ward Health Care Providers with the Information Letter that describes the

study before asking them to complete the Health Care Provider Questionnaire (see Mock Case Report Forms, appendix B)

o Consent from the HCP does not need to be obtained as completion of the questionnaire implies that they have consented (unless the local ethics board requires a signed consent form).

o Health Care Providers is any health care provider who provides patient care during or following an episode of critical illness. This includes registered nurses, doctors, dietitians or other health care professionals. Every attempt must be made to involve at least one Speech Language Pathologist.

o Since this questionnaire asks questions about the acceptability of the intervention in general, it can be provided to the HCP any time during the study. Ideally this will be after they have had some time to review the Information letter and after they have had a chance to think about the intervention in general.

o A total of 15 completed questionnaires are needed from the ward HCPs. o Completed questionnaires are to be sent back to CERU (see Mock Case Report

Forms, appendix B, Health Care Provider Questionnaire for more details)

Workload Measurement: In order to determine the resources needed for future phases of the study, a record of workload measurement is needed.

o Refer to OPTICS Dietitian Worksheet excel spreadsheet for details At 2 weeks post extubation (or hospital discharge, whatever comes first)

Collect Nutrition Diaries from Family members

May offer to make a copy for the family members if requested

Batch all diaries and send to CERU (shipping details to follow)

Collect Family Member questionnaires

Remind the family member this can also be conducted by phone or can be mailed in to the Site Dietitian

Refer to Mock Case Report Forms Appendix A, Family Member Questionnaire for more details

These responses will need to be entered into REDCAP, the electronic data capture system

Collect HCP completed questionnaires

and send to CERU as per details in Mock Case Report Forms, appendix B, Health Care Provider Questionnaire

Refer to Screening and Intervention Flowsheet and Checklist on next pages


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Data Collection

Duration & Type of Data Collection The duration of data collection and frequency will vary depending upon each Mock Case Report Forms and is outlined in the instructions of these forms. Here is a brief outline of the data that needs to be collected. Collected once at baseline:

Site Details Inclusion/Exclusion (on the Central Randomization System) Pre-Enrollment/Enrollment Confirmation (on the Central Randomization System) Nutrition History Patient Baseline Baseline Nutritional Assessment

Collected daily from Study Day 1 (ICU admission) until ICU discharge or death for a maximum of 12 days from ICU admission

Daily Nutrition Data Daily Nutrition: Enteral Nutrition Daily Nutrition: Parenteral Nutrition Workload measurement (refer to excel spreadsheet)

Collected prior to ICU discharge/extubation

Health Care Provider Questionnaire (collected once for each HCP who agreed/consented) Workload measurement for stay in ICU (from ICU admission to 2 weeks post extubation or

ICU d/c whatever comes first) (refer to Dietitian Workload excel spreadsheet) Collected at 2 weeks post extubation or prior to hospital discharge

Nutrition Diaries (family members to complete) Family Member Questionnaires (for each family member that consented) Health Care Provider Questionnaire (Collected once for each HCP that participated) Workload measurement for stay on Ward (from ICU discharge to 2 weeks post

extubation d/c whatever comes first) (refer to Dietitian Workload excel spreadsheet) Collected Once at ICU discharge, hospital discharge or 60 day

Outcomes i.e. survival status, ventilation, discharge.

Source Documentation As per ICH GCP (1.51) source documents are original documents, data and records. The Site Dietitian must ensure source documents are available to verify all data collected for the OPTICS study. Other Study Procedures The Site Dietitian will follow study specific procedures related to the following:

a. Data Collection and entering into REDCAP including resolution of data queries b. Identification and reporting of Protocol Violations (see Mock Case Report Forms) c. Ethics Board submissions, renewals and communications


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Protocol Violations A Protocol violation is defined as non-compliance with the study protocol and/or procedures that may impact study participant safety, the integrity of study data and/or study participant willingness to participate in the study. For the OPTICS Study, a Protocol Violation occurs when any of the following have occurred:

1) Nutrition Education was never provided to family during the study. 2) Nutrition History of the patient was never completed with the family during the study. 3) A second, short education session which reinforces nutrition provision post extubation and

introduces the Nutrition Diary was not completed during the study. Complete the Protocol Violation Report and fax/email a copy to the Project Leader at (613) 548-2428 or [email protected] within 72 hours of becoming aware of the violation. Refer to Mock Case Report Forms for more details

Serious Adverse Events

A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that: Results in death. Is life-threatening (refers to an event in which the study participant was, in the opinion of the

site principal investigator, at risk of death from the event if medical intervention had not occurred. NOTE: This does not include an event that hypothetically had it occurred in a more serious form, might have caused death).

Results in persistent or significant disability/incapacity (i.e. a substantial disruption in an individual’s ability to conduct normal life functions).

Requires in patient hospitalization possibly related to the study intervention. Prolongs hospitalization. Is a congenital anomaly or birth defect. Is an important medical event that may jeopardize the patient and may require medical or

surgical intervention to prevent one of the outcomes listed above. Since the intervention in the OPTICS Study is a nutrition education session aimed at encouraging families to advocate for nutrition that the patients should already be receiving, there are no associated serious adverse events. In the event that a local Ethics Board requires such reporting, the Site Dietitian is to follow the institutions requirements and a copy of the reported SAE to the ethics committee should be forwarded to CERU.

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Optimal nutrition by Informing and Capacitating family ... · Rupinder Dhaliwal, RD Manager, Research & Networking Clinical Evaluation Research Unit Queen’s University, Kingston,