ResilienceNCT03874676
Exploration of Patient Ethics and Communication Excellence (PEACE) Rounds
An observational study of Resilience, run by AdventHealth at 1 site in United States.
Trial summary
A qualitative design using the thematic analysis method is proposed to answer the research question "What is the patient care provider's experience of PEACE rounds?" By establishing salient themes pertaining to the experience and identifying the most significant variables, the study results will also contribute to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resilience
- What is being tested?
- PEACE Rounds
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 13 Sep 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: An employee of AdventHealth (AH), or a physician with privileges there, who has participated in PEACE Rounds at AdventHealth. This includes nurses, technicians, chaplains, care managers, child life specialists, and other clinical staff who may provide services or treatment to patients who are the subject of PEACE Rounds.
Who may be able to join
- An employee of AdventHealth (AH), or a physician with privileges there, who has participated in PEACE Rounds at AdventHealth.
- Over the age of 18
- Able to provide informed consent
- Must speak and understand English
Who cannot join
- 1. Discernable cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of Patient Ethics and Communication Excellence (PEACE) Rounds for Patient Care Providers: A Thematic Analysis
A qualitative design using the thematic analysis method is proposed to answer the research question "What is the patient care provider's experience of PEACE rounds?" By establishing salient themes pertaining to the experience and identifying the most significant variables, the study results will also contribute to more generalizable quantitative studies. This information can be used to inform best practice in the standardization and delivery of modified PEACE Rounds.
Read the detailed description
Qualitative data about participants' experiences throughout the PEACE Rounds will be collected using semi-structured interviews and participant observation. This data will be analyzed to describe and explain the perceptions that emerge from participant experience.
Qualitative Sampling Purposive samples are identified to initiate data collection and analysis, and then are used to select participants who are likely to clarify, verify, or contradict data as it is collected. Sampling concludes when the data are "saturated," which means the coded categories are well-defined and no new significant insights are emerging from additional interviews.
Semi-structured Interviews
The study team will conduct semi-structured interviews, which will be recorded and transcribed, following a consented subject's participation in at least one PEACE round. Open-ended questions, intended to elicit participants' perspectives on their experience of PEACE Rounds, will frame the interview. These are:
"What/who do you remember most vividly?" "What was most meaningful to you? "What would you change about the experience, if you could? " "Would you do it again? Why or why not?" "What, if anything, changed after PEACE rounds?"
Observation PEACE Rounds will be observed by the PI to collect data that will provide further insight to participants' experiences. Observations of interactions and reactions in real time will be documented and the data will be coded and analyzed using thematic analysis methods. Observational data will not be integrated into interview data but will be used to confirm or contrast reported data.
Qualitative Data Analysis Qualitative methodology does not seek to verify hypotheses based on logical assumptions, as quantitative measures do, instead it is used to derive salient constructs directly from the data. This methodology allows inductive understanding of participants' perceptions of their participation in PEACE Rounds.
The qualitative data will be analyzed according to the thematic analysis method based on that of Braun and Clarke . the researcher has become familiar with the data and generated an initial list of ideas that are relevant to the research objective, codes will be generated. The codes will reflect a specific feature of the data that further explicates it. After the data has been coded, the researcher will look for how different codes can be combined to create overarching themes. When there is essentially no new information coming from the codes, the data is considered saturated and no new themes are created. At this point, the researcher will review the themes and refine them, so they can be expressed in a data map expressing how they fit together to tell the story of the data.
- Conditions
- Resilience
- Being tested
- PEACE Rounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEACE RoundsOther
PEACE Rounds are a routine process for providing self help to clinicians who care for difficult patients from the perspective of ethics and the need for cross-disciplinary communication. PEACE Rounds participants will be interviewed about how they experience the rounds and for their perspective on the effects on their own wellness and resilience.
| Study group | Role | What they receive |
|---|---|---|
| PEACE Rounds Clinicians | Nurses, physicians, care managers, chaplains, and other clinicians who attend PEACE rounds as part of their routine work in the hospital. Receives: Other: PEACE Rounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thematic Analysis of Interview Data to Describe Effects of PEACE Rounds on Burnout Relief
Analysis of data collected throughout the study, using saturation sampling and documented coding techniques, will result in thematic descriptions of the aggregated experiences of clinical staff who participate in PEACE rounds. Semi-structured interviews will measure the extent to which PEACE Rounds are an effective component on self-help for clinicians and other healthcare workers who care for patients with difficult or controversial treatment plans. Interview questions will include: "What/who do you remember most vividly?" "What was most meaningful to you?" "What would you change about the experience, if you could?" "Would you do it again? Why or why not?" "What, if anything, changed after PEACE rounds?"
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start6 Mar 2019
- Primary completion31 Jul 2019
- Study completion13 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim S. McManus, Ph.D., Principal investigator, AdventHealth Center for CREATION Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874676
- Sponsor's protocol ID
- 1398203
- Status last verified
- May 2021
- First submitted
- 6 Mar 2019
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Patient Ethics and Communication Excellence (PEACE) Rounds for Patient Care Providers: A Thematic Analysis
- ClinicalTrials.gov ID
- NCT03874676
- Acronym / sponsor ID
- 1398203
- Conditions
- Resilience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 14 Mar 2019 (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 qualitative design using the thematic analysis method is proposed to answer the research question "What is the patient care provider's experience of PEACE rounds?" By establishing salient themes pertaining to the experience and identifying the most significant variables, the study results will also contribute to more generalizable quantitative studies. This information can be used to inform best practice in the standardization and delivery of modified PEACE Rounds.
Detailed description
Qualitative data about participants' experiences throughout the PEACE Rounds will be collected using semi-structured interviews and participant observation. This data will be analyzed to describe and explain the perceptions that emerge from participant experience.
Qualitative Sampling Purposive samples are identified to initiate data collection and analysis, and then are used to select participants who are likely to clarify, verify, or contradict data as it is collected. Sampling concludes when the data are "saturated," which means the coded categories are well-defined and no new significant insights are emerging from additional interviews.
Semi-structured Interviews
The study team will conduct semi-structured interviews, which will be recorded and transcribed, following a consented subject's participation in at least one PEACE round. Open-ended questions, intended to elicit participants' perspectives on their experience of PEACE Rounds, will frame the interview. These are:
"What/who do you remember most vividly?" "What was most meaningful to you? "What would you change about the experience, if you could? " "Would you do it again? Why or why not?" "What, if anything, changed after PEACE rounds?"
Observation PEACE Rounds will be observed by the PI to collect data that will provide further insight to participants' experiences. Observations of interactions and reactions in real time will be documented and the data will be coded and analyzed using thematic analysis methods. Observational data will not be integrated into interview data but will be used to confirm or contrast reported data.
Qualitative Data Analysis Qualitative methodology does not seek to verify hypotheses based on logical assumptions, as quantitative measures do, instead it is used to derive salient constructs directly from the data. This methodology allows inductive understanding of participants' perceptions of their participation in PEACE Rounds.
The qualitative data will be analyzed according to the thematic analysis method based on that of Braun and Clarke . the researcher has become familiar with the data and generated an initial list of ideas that are relevant to the research objective, codes will be generated. The codes will reflect a specific feature of the data that further explicates it. After the data has been coded, the researcher will look for how different codes can be combined to create overarching themes. When there is essentially no new information coming from the codes, the data is considered saturated and no new themes are created. At this point, the researcher will review the themes and refine them, so they can be expressed in a data map expressing how they fit together to tell the story of the data.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEACE Rounds Clinicians | – | Other: PEACE RoundsNurses, physicians, care managers, chaplains, and other clinicians who attend PEACE rounds as part of their routine work in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An employee of AdventHealth (AH), or a physician with privileges there, who has participated in PEACE Rounds at AdventHealth. This includes nurses, technicians, chaplains, care managers, child life specialists, and other clinical staff who may provide services or treatment to patients who are the subject of PEACE Rounds.
Key inclusion criteria (4 listed)
- An employee of AdventHealth (AH), or a physician with privileges there, who has participated in PEACE Rounds at AdventHealth.
- Over the age of 18
- Able to provide informed consent
- Must speak and understand English
Key exclusion criteria (1 listed)
- 1. Discernable cognitive impairment
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 |
|---|---|---|
| PEACE RoundsPEACE Rounds are a routine process for providing self help to clinicians who care for difficult patients from the perspective of ethics and the need for cross-disciplinary communication. PEACE Rounds participants will be interviewed about how they experience the rounds and for their perspective on the effects on their own wellness and resilience. | Other | PEACE Rounds Clinicians |
Primary outcome
Thematic Analysis of Interview Data to Describe Effects of PEACE Rounds on Burnout Relief
Time frame: 6 months
Analysis of data collected throughout the study, using saturation sampling and documented coding techniques, will result in thematic descriptions of the aggregated experiences of clinical staff who participate in PEACE rounds. Semi-structured interviews will measure the extent to which PEACE Rounds are an effective component on self-help for clinicians and other healthcare workers who care for patients with difficult or controversial treatment plans. Interview questions will include: "What/who do you remember most vividly?" "What was most meaningful to you?" "What would you change about the experience, if you could?" "Would you do it again? Why or why not?" "What, if anything, changed after PEACE rounds?"
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 6 May 2021.
- Individual participant dataSharing planned: No
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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.
Kim S. McManus, Ph.D. principal investigator
AdventHealth Center for CREATION Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resilience, run by AdventHealth at 1 site in United States.
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 4 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 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Thematic Analysis of Interview Data to Describe Effects of PEACE Rounds on Burnout Relief (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2021.