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ICU Doulas Providing Psychological Support

Primary Purpose

Illness, Critical, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
positive suggestion
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Illness, Critical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults (age >18) admitted to the ICU requiring intubation or vasopressors and expected to stay >48 hours.

Exclusion Criteria:

  • history of dementia, mental retardation, suicide attempt, psychotic disorders such as schizophrenia, acute alcohol/substance intoxication or withdrawal, severe metabolic encephalopathy;
  • patients on comfort care;
  • patients not expected to survive the hospital stay
  • non-English speaking, deaf or mute
  • prisoners

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICU doulas intervention

Arm Description

specially trained ICU doulas will provide critically ill intubated patients with early psychological support on a daily basis

Outcomes

Primary Outcome Measures

feasibility of integration of trained doulas into the ICU
pilot feasibility study. Feasibility defined as ICU doulas being able to perform study intervention on 30 recruited patients for at least 10 minutes daily throughout patient's ICU course.

Secondary Outcome Measures

Patient scores on Hospital Anxiety and Depression Scale
quantitative. Study patients will complete follow-up questionnaires measuring symptoms of anxiety and depression following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.
Patient scores on Impact of Events Scale - Revised
quantitative. Study patients will complete follow-up questionnaires measuring symptoms of acute stress following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.
Patient scores on Montreal Cognitive Assessment-blind
quantitative. Study patients will complete follow-up questionnaires measuring cognitive function following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.
Qualitative interviews of patients, their family members, physicians and nurses caring for the study patients
We will use an "interpretive description approach" to qualitative research, which creates an interpretive account of a clinical phenomenon for the purpose of informing clinical practice. We aim to understand the changes in experiences of critically ill patients, their family members, and providers through the interviews. This allows us to explore patient and key stakeholders' perspectives and to refine PSBPS based on the areas of highest priority, focusing on elements that are deemed by patients to be of highest acceptability. Following patient ICU discharge, interviews will be conducted on a one-on-one basis by the candidate or a trained qualitative interviewer who is not directly involved in the patient's clinical care; participants will be assured that interview transcripts will be confidential. Interviews will last approximately 15 minutes and will be conducted in person.

Full Information

First Posted
March 14, 2018
Last Updated
February 23, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03736954
Brief Title
ICU Doulas Providing Psychological Support
Official Title
Pilot Study of ICU Doulas Providing Psychological Support Based on Positive Suggestions to Mitigate Psychological and Cognitive Sequelae of Critical Illness
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
May 9, 2019 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. Research on the formation of fear and associated memories shows that if mitigating information about a traumatic event is introduced during the time between memory formation and its recall, the emotional experience of the memory can be modified in a positive manner. This means that in order to prevent mental health problems in critical illness survivors, psychological support needs to take place in parallel with medical treatment in the ICU. The Researchers hypothesize that early psychological support for the critically ill can decrease mental health morbidity in critical illness survivors. However, providing consistent psychological support intervention is a challenge for busy ICU clinicians. It is not feasible to hire behavioral medicine trained psychologists to become permanent ICU staff nationwide. Doulas, trained lay health care providers who provide emotional support to women in labor, have been identified as reliable yet affordable alternative. Given common elements of their services and our intervention, doulas are in an ideal position to administer early psychological support. The objective of this project is to refine and test a behavioral intervention to be administered in parallel with medical treatment in the ICU. This will be accomplished by training doulas in providing standardized psychological support intervention and refining the intervention based on stakeholder feedback

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Illness, Critical, Anxiety, Depression, Post Traumatic Stress Disorder, Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICU doulas intervention
Arm Type
Experimental
Arm Description
specially trained ICU doulas will provide critically ill intubated patients with early psychological support on a daily basis
Intervention Type
Behavioral
Intervention Name(s)
positive suggestion
Intervention Description
humanization of critical care experience with positive reframing of hospital course on daily basis to eligible participants
Primary Outcome Measure Information:
Title
feasibility of integration of trained doulas into the ICU
Description
pilot feasibility study. Feasibility defined as ICU doulas being able to perform study intervention on 30 recruited patients for at least 10 minutes daily throughout patient's ICU course.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient scores on Hospital Anxiety and Depression Scale
Description
quantitative. Study patients will complete follow-up questionnaires measuring symptoms of anxiety and depression following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.
Time Frame
6 months
Title
Patient scores on Impact of Events Scale - Revised
Description
quantitative. Study patients will complete follow-up questionnaires measuring symptoms of acute stress following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.
Time Frame
6 months
Title
Patient scores on Montreal Cognitive Assessment-blind
Description
quantitative. Study patients will complete follow-up questionnaires measuring cognitive function following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.
Time Frame
6 months
Title
Qualitative interviews of patients, their family members, physicians and nurses caring for the study patients
Description
We will use an "interpretive description approach" to qualitative research, which creates an interpretive account of a clinical phenomenon for the purpose of informing clinical practice. We aim to understand the changes in experiences of critically ill patients, their family members, and providers through the interviews. This allows us to explore patient and key stakeholders' perspectives and to refine PSBPS based on the areas of highest priority, focusing on elements that are deemed by patients to be of highest acceptability. Following patient ICU discharge, interviews will be conducted on a one-on-one basis by the candidate or a trained qualitative interviewer who is not directly involved in the patient's clinical care; participants will be assured that interview transcripts will be confidential. Interviews will last approximately 15 minutes and will be conducted in person.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults (age >18) admitted to the ICU requiring intubation or vasopressors and expected to stay >48 hours. Exclusion Criteria: history of dementia, mental retardation, suicide attempt, psychotic disorders such as schizophrenia, acute alcohol/substance intoxication or withdrawal, severe metabolic encephalopathy; patients on comfort care; patients not expected to survive the hospital stay non-English speaking, deaf or mute prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lioudmila V Karnatovskaia
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34930440
Citation
Karnatovskaia LV, Varga K, Niven AS, Schulte PJ, Mujic M, Gajic O, Bauer BA, Clark MM, Benzo RP, Philbrick KL. A pilot study of trained ICU doulas providing early psychological support to critically ill patients. Crit Care. 2021 Dec 20;25(1):446. doi: 10.1186/s13054-021-03856-3.
Results Reference
background
PubMed Identifier
33912833
Citation
Karnatovskaia LV, Schultz JM, Niven AS, Steele AJ, Baker BA, Philbrick KL, Del Valle KT, Johnson KR, Gajic O, Varga K. System of Psychological Support Based on Positive Suggestions to the Critically Ill Using ICU Doulas. Crit Care Explor. 2021 Apr 26;3(4):e0403. doi: 10.1097/CCE.0000000000000403. eCollection 2021 Apr.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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ICU Doulas Providing Psychological Support

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