Nurse Practitioner Led Implementation of Team Huddles in Long-Term Care Homes

May 18, 2022 updated by: Katherine McGilton, Toronto Rehabilitation Institute

Nurse Practitioner Led Implementation of Team Huddles in Long-Term Care Homes During COVID-19

A pre-experimental design to conduct a process evaluation and to compare the outcomes after implementing team huddles for the intervention and control groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Staff working in long-term care (LTC) homes during COVID-19 frequently reported lack of communication, collaboration, and teamwork, all of which are associated with staff dissatisfaction, health concerns, perceived of lack of support and moral distress. The purpose of this study was to introduced regular huddles, led by a Nurse Practitioner, to support LTC staff during COVID-19. The objectives were to evaluate the process of huddle implementation and to examine differences between staff attending and not attending the huddles on outcomes of moral distress, job satisfaction, perceived support from the Nurse Practitioner, and health and mental health. Furthermore, we hypothesize that regular huddles can lead to improvements in resident-centred care and resident outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada, N2A 1Y5
        • Long-Term Care Home
      • Sarnia, Ontario, Canada
        • Long-Term Care Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All staff working at the LTC home
  • All residents living in the home between January and December 2021

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Huddle attendees
Participants in this arm participated in huddles
Behavioral: Team Huddles
Brief multidisciplinary meeting occurring twice a week for staff working at a LTC home led by a Nurse Practitioner. Huddles focused on discussing resident-care and staff-wellbeing.
No Intervention: Huddle non-attendees
Participants in this arm did not participate in huddles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall morals distress and situations associated with COVID-19 in LTC settings contributing to moral distress were measured in the intervention and control arms using the Moral Distress in Dementia Care Instrument (Iaboni et al., 2021).
Time Frame: 20 weeks
Moral Distress in Dementia Care is a ten-item checklist, where respondents are asked to rate moral distress associated with each item on a 5-point scale ranging from none (1) to an extremely large amount (5). Higher scores represent more moral distress.
20 weeks
Overall job satisfaction with current role was measured in the intervention and control arms using a single question asking, "How satisfied are you overall with your current job in the LTC home?" (Dolbier et al., 2005)
Time Frame: 20 weeks
The single-item question was high reliability and validity (Dolbier et al., 2005) and has been used in previous studies in LTC homes (Schwendimann et al., 2016). Respondents rate job satisfaction on a 4-point scale ranging from strongly dissatisfied (1) to strongly satisfied (4), where higher scores indicate more satisfaction.
20 weeks
Overall health was measured in the intervention and control arms using a single question from Statistics Canada (2022) asking, "In general, how would you say your health is?"
Time Frame: 20 weeks
Respondents rate their health on a 5-point scale ranging from poor (0) to excellent (4), where higher scores indicate better health.
20 weeks
Mental health was measured in the intervention and control arms using a single question from Statistics Canada (2022) asking, "In general, how would you say your mental health is?"
Time Frame: 20 weeks
Respondents rate their mental health on a 5-point scale ranging from poor (0) to excellent (4), where higher scores indicate better mental health.
20 weeks
Perceived support from the nurse practitioner leading the huddles was measured in the intervention and control arms, assessed using the Supportive Supervisory Scale (McGilton 2010).
Time Frame: 20 weeks
The 5-item scale asks respondents to rate their perception of support from the nurse practitioner in 5 situations on a 5-point scale ranging from never (0) to always (5), where higher scores indicate more perceived support.
20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The duration of each huddle in minutes was recorded by the nurse practitioner using the Huddle Observation Tool (HOT) (Edbrooke-Childs et al., 2018) as part of process evaluation.
Time Frame: 15 weeks
Average and range of huddle duration were measured.
15 weeks
The attendance of different staff categories (i.e. personal support worker, registered practical nurse) at each huddle was recorded by the nurse practitioner using HOT (Edbrooke-Childs et al., 2018) as part of process evaluation.
Time Frame: 15 weeks
Attendance of categories of staff at huddles was summarized as percentage of total huddles attended.
15 weeks
The frequency of delivery of huddles by the nurse practitioner was self-reported using HOT (Edbrooke-Childs et al., 2018) as part of process evaluation.
Time Frame: 15 weeks
Data was summarized as total number of huddles delivered and number of huddles delivered per week.
15 weeks
Adherence to huddle structure was self-reported by the nurse practitioner using HOT (Edbrooke-Childs et al., 2018) as part of process evaluation.
Time Frame: 15 weeks
Data included huddle topic and aim, sharing of a positive event, maintaining a collaborative culture, and creation of a risk management plan and was summarized as number of huddles adhering to the structure.
15 weeks
Depressive symptoms of residents residing on the intervention and control units will be measured with the Depression Rating Scale before and after implementation of huddles.
Time Frame: 1 year
This is a quality indicator obtained from the Resident Assessment Instrument - Minimum Data Set (RAI-MDS) 2.0. Depression Rating Scale is based on the following items: negative statements (E1a), persistent anger (E1d), expression of unrealistic fears (E1f), repetitive health complaints (E1h), repetitive anxious complaints (E1ii), sad, pained, worried facial expression (E1l), crying, tearfulness (E1m). The score ranges from 0 to 14, where a score of 3 or more may indicate a potential or actual problem with depression.
1 year
Aggression of residents residing on the intervention and control units will be measured with the Aggressive Behaviour Scale before and after implementation of huddles.
Time Frame: 1 year
This is a quality indicator obtained from the RAI-MDS 2.0. Aggressive Behaviour Scale is based on the following items: verbally abusive (E4b), physically abusive (E4c), socially inappropriate/disruptive behaviour (E4d), resists care (E4e). Scores range from 0 to 12, where higher scores indicate higher levels of aggressive behaviour.
1 year
The cognitive status of residents on the intervention and control units will be measured with the Cognitive Performance Scale before and after implementation of huddles.
Time Frame: 1 year
This is a quality indicator obtained from the RAI-MDS 2.0. Cognitive Performance Scale is based on the following items: comatose (B1), short-term memory (B2a), cognition skills for daily decision-making (B4), expressive communication (C4), eating (G1hA). The sores range from 0 to 6, where higher scores indicate more severe cognitive impairment.
1 year
Changes in health, end-stage disease, and signs and symptoms of residents on the intervention and control units will be measured using the CHESS scale before and after implementation of huddles.
Time Frame: 1 year
This is a quality indicator obtained from the RAI-MDS 2.0. CHESS is based on the following items: decline in cognition (B6), decline in ADL (G9), dehydration (J1c), edema (J1g), shortness of breath (J1l), vomiting (J1o), end-stage disease (J5c), weight loss (K3a), leaving food uneaten (K4c). The score ranges from 0 to 5, where higher scores indicate higher levels of medical complexity and are associated with adverse outcomes.
1 year
Changes in social engagement of residents on the intervention and control units will be measured with the Index of Social Engagement (ISE) before and after implementation of huddles.
Time Frame: 1 year
This is a quality indicator obtained from the RAI-MDS 2.0. ISE is based on the following items: at ease interacting with others (F1a), at ease doing planned or structured activities (F1b), at ease doing self-initiated activities (F1c), establishes own goals (F1d), pursues involvement in the life of the facility (F1e), accepts invitations into most group activities (F1f). The scores range from 0-6, where higher scores indicate higher levels of social engagement.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Toronto Rehabilitation Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Centre for Aging and Brain Health Innovation
Canadian Foundation for Health Improvement
Walter & Maria Schroeder Institute for Brain Innovation and Recovery

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine S McGilton, KITE Research Institute - Toronto Rehabilitation Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-6298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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