Moral DistressNCT05387213
Nurse Practitioner Led Implementation of Team Huddles in Long-Term Care Homes
A study testing Team Huddles in people with Moral Distress and Job Satisfaction, run by Toronto Rehabilitation Institute at 2 sites in Canada.
Trial summary
A pre-experimental design to conduct a process evaluation and to compare the outcomes after implementing team huddles for the intervention and control groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Moral Distress, Job Satisfaction, Mental Health
- What is being tested?
- Team Huddles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesCanada
- Study dates
- 14 May 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All staff working at the LTC home
- All residents living in the home between January and December 2021
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Long-Term Care Home
Kitchener, Ontario, N2A 1Y5
Long-Term Care Home
Sarnia, Ontario
About this study
Official title: 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.
Read the 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.
- Conditions
- Moral Distress, Job Satisfaction, Mental Health, Physical Health, Support
- Being tested
- Team Huddles
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team HuddlesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Huddle attendees | Experimental | Participants in this arm participated in huddles Receives: Behavioral: Team Huddles |
| Huddle non-attendees | No intervention | Participants in this arm did not participate in huddles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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.
Measured: 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)
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.
Measured: 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?"
Respondents rate their health on a 5-point scale ranging from poor (0) to excellent (4), where higher scores indicate better health.
Measured: 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?"
Respondents rate their mental health on a 5-point scale ranging from poor (0) to excellent (4), where higher scores indicate better mental health.
Measured: 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).
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.
Measured: 20 weeks
Secondary outcomes (9)
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.
Average and range of huddle duration were measured.
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.
Attendance of categories of staff at huddles was summarized as percentage of total huddles attended.
Measured: 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.
Data was summarized as total number of huddles delivered and number of huddles delivered per week.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start14 May 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Moral DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Foundation for Health Improvement, Canadian Institutes of Health Research (CIHR), Centre for Aging and Brain Health Innovation, Walter & Maria Schroeder Institute for Brain Innovation and Recovery
- Responsible party
- Principal investigator, Katherine McGilton, Toronto Rehabilitation Institute
- Investigators
- Katherine S McGilton, Principal investigator, KITE Research Institute - Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387213
- Sponsor's protocol ID
- 20-6298
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Publications
Dolbier CL, Webster JA, McCalister KT, Mallon MW, Steinhardt MA. Reliability and validity of a single-item measure of job satisfaction. Am J Health Promot. 2005 Jan-Feb;19(3):194-8. doi: 10.4278/0890-1171-19.3.194.
PubMed 15693347Schwendimann R, Dhaini S, Ausserhofer D, Engberg S, Zuniga F. Factors associated with high job satisfaction among care workers in Swiss nursing homes - a cross sectional survey study. BMC Nurs. 2016 Jun 6;15:37. doi: 10.1186/s12912-016-0160-8. eCollection 2016.
PubMed 27274334McGilton KS. Development and psychometric testing of the Supportive Supervisory Scale. J Nurs Scholarsh. 2010 Jun;42(2):223-32. doi: 10.1111/j.1547-5069.2009.01323.x.
PubMed 20618606Iaboni A, Quirt H, Engell K, Kirkham J, Stewart S, Grigorovich A, Kontos P, McMurray J, Levy A, Bingham K, Rodrigues K, Astell A, Flint AJ, Maxwell C. Barriers and facilitators to person-centred infection prevention and control: results of a survey about the Dementia Isolation Toolkit. BMC Geriatr. 2022 Jan 25;22(1):74. doi: 10.1186/s12877-022-02759-4.
PubMed 35078424Edbrooke-Childs J, Hayes J, Sharples E, Gondek D, Stapley E, Sevdalis N, Lachman P, Deighton J. Development of the Huddle Observation Tool for structured case management discussions to improve situation awareness on inpatient clinical wards. BMJ Qual Saf. 2018 May;27(5):365-372. doi: 10.1136/bmjqs-2017-006513. Epub 2017 Sep 19.
PubMed 28928167McGilton KS, Krassikova A, Wills A, Bethell J, Boscart V, Escrig-Pinol A, Iaboni A, Vellani S, Maxwell C, Keatings M, Stewart SC, Sidani S. Nurse practitioner led implementation of huddles for staff in long term care homes during the COVID-19 pandemic. BMC Geriatr. 2023 Nov 2;23(1):713. doi: 10.1186/s12877-023-04382-3.
PubMed 37919676
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Practitioner Led Implementation of Team Huddles in Long-Term Care Homes During COVID-19
- ClinicalTrials.gov ID
- NCT05387213
- Acronym / sponsor ID
- 20-6298
- Conditions
- Moral Distress, Job Satisfaction, Mental Health, Physical Health, Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Canadian Foundation for Health Improvement, Canadian Institutes of Health Research (CIHR), Centre for Aging and Brain Health Innovation, Walter & Maria Schroeder Institute for Brain Innovation and Recovery
- Study start
- 14 May 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pre-experimental design to conduct a process evaluation and to compare the outcomes after implementing team huddles for the intervention and control groups.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huddle attendees | Experimental | Behavioral: Team HuddlesParticipants in this arm participated in huddles |
| Huddle non-attendees | No intervention | –Participants in this arm did not participate in huddles |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All staff working at the LTC home
- All residents living in the home between January and December 2021
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team HuddlesBrief 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. | Behavioural | Huddle attendees |
Primary outcome
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.
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.
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.
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.
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Background: PubMed 15693347Dolbier CL, Webster JA, McCalister KT, Mallon MW, Steinhardt MA. Reliability and validity of a single-item measure of job satisfaction. Am J Health Promot. 2005 Jan-Feb;19(3):194-8. doi: 10.4278/0890-1171-19.3.194.
- Background: PubMed 27274334Schwendimann R, Dhaini S, Ausserhofer D, Engberg S, Zuniga F. Factors associated with high job satisfaction among care workers in Swiss nursing homes - a cross sectional survey study. BMC Nurs. 2016 Jun 6;15:37. doi: 10.1186/s12912-016-0160-8. eCollection 2016.
- Background: PubMed 20618606McGilton KS. Development and psychometric testing of the Supportive Supervisory Scale. J Nurs Scholarsh. 2010 Jun;42(2):223-32. doi: 10.1111/j.1547-5069.2009.01323.x.
- Background: PubMed 35078424Iaboni A, Quirt H, Engell K, Kirkham J, Stewart S, Grigorovich A, Kontos P, McMurray J, Levy A, Bingham K, Rodrigues K, Astell A, Flint AJ, Maxwell C. Barriers and facilitators to person-centred infection prevention and control: results of a survey about the Dementia Isolation Toolkit. BMC Geriatr. 2022 Jan 25;22(1):74. doi: 10.1186/s12877-022-02759-4.
- Background: PubMed 28928167Edbrooke-Childs J, Hayes J, Sharples E, Gondek D, Stapley E, Sevdalis N, Lachman P, Deighton J. Development of the Huddle Observation Tool for structured case management discussions to improve situation awareness on inpatient clinical wards. BMJ Qual Saf. 2018 May;27(5):365-372. doi: 10.1136/bmjqs-2017-006513. Epub 2017 Sep 19.
- Derived from this study: PubMed 37919676McGilton KS, Krassikova A, Wills A, Bethell J, Boscart V, Escrig-Pinol A, Iaboni A, Vellani S, Maxwell C, Keatings M, Stewart SC, Sidani S. Nurse practitioner led implementation of huddles for staff in long term care homes during the COVID-19 pandemic. BMC Geriatr. 2023 Nov 2;23(1):713. doi: 10.1186/s12877-023-04382-3.
- Statistics Canada. Canadian Community Health Survey 2022.Link provided by the sponsor.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine S McGilton principal investigator
KITE Research Institute - Toronto Rehabilitation Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team Huddles in people with Moral Distress and Job Satisfaction, run by Toronto Rehabilitation Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05387213, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.