Spiritual WellnessNCT03648866
A Thematic Analysis of Compassion Rounds
An observational study of Spiritual Wellness, run by AdventHealth at 1 site in United States.
Trial summary
The primary objective of this thematic analysis is to understand the experience of "Compassion Rounds" for patients, families, friends, and clinicians. The secondary objective of this study is to evaluate and interpret data to determine best practice recommendations for standardization and scalability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spiritual Wellness
- What is being tested?
- interview
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 28 Aug 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: Participants will be recruited from participants in compassion rounding, including patients, their loved ones, physicians, chaplains, social workers, nurses, and other care providers.
Who may be able to join
- An employee of Florida Hospital or Adventist Health System, or a physician with privileges there, or a patient, or a family or friend who has participated in compassion rounding at a Florida Hospital critical care unit
- Over the age of 18
- Able to provide informed consent
- Must speak and understand English
- Willing and able to provide a contact phone number
Who cannot join
- 1. Discernible cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Thematic Analysis of the Effects of Compassion Rounds on Clinicians and the Families of NICU Patients
The primary objective of this thematic analysis is to understand the experience of "Compassion Rounds" for patients, families, friends, and clinicians. The secondary objective of this study is to evaluate and interpret data to determine best practice recommendations for standardization and scalability.
Read the detailed description
This research will be conducted as a Thematic Analysis. Participants will be recruited from those who take part in compassion rounds, including patients, their loved ones, physicians, chaplains, social workers, nurses, and other care providers.
Qualitative data on participants' experiences throughout the intervention will be collected and analyzed using thematic methodology. The data will be used to explain the psychosocial processes that influence participant experience and reported outcomes.
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' social reality and perceptions of the treatment, resulting in explanations of how the treatment leads to outcomes and the identification of variables that may then be quantified for more generalizable study.
Semi-structured Interviews
Through semi-structured interviews, which will be recorded and transcribed, the researcher asks participants open-ended questions intended to elicit perspectives on their experience of compassion rounds, without limiting responses to pre-determined categories of interest. The following are examples:
"What/who do you remember most vividly?" "How would you describe your experience to a friend?" "What was most meaningful to you? "What made you feel uncomfortable?" "Would you do it again? Why or why not?" "What, if anything, changed after compassion rounding?"
Coding
The researcher codes and documents throughout data collection and analysis to lend transparency to the coding process and to keep a record of ideas to inform thematic exposition. The researcher assigns categorical codes (labels or concepts) to the transcribed responses line-by-line, analyzing patterns of relationships and using a constant comparison technique to identify similarities and differences throughout the data. The following coding techniques will be used to analyze transcriptions:
- open coding: the researcher segments the data into preliminary categories, based on similarity
- axial coding: the researcher groups the categories into themes that provide new ways of seeing and understanding the phenomenon under study
- selective coding: the researcher integrates the categories and themes to articulate a coherent theory of the phenomenon of study.
Theoretical Sampling Grounded theory research uses "theoretical sampling" to identify participants for interviews. Purposive samples are identified to initiate data collection and analysis, and to select participants who are likely to clarify, verify, or contradict data as it is collected. Sampling concludes when the data is "saturated," which occurs when coded categories are well-defined and no new significant insights are emerging from interviews.
Thematic Development and Validation
The researcher develops thematic explanations that stem from rendering participants' experiences throughout the practice of compassion rounding.
Themes are evaluated for fit and relevance and employee participants may be asked to validate the researcher's findings in follow-up interviews and focus groups.
Observation The researcher will also observe compassion rounding 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 the techniques described above. Observational data will not be integrated into interview data, but will be used to confirm or contrast reported data.
- Conditions
- Spiritual Wellness
- Being tested
- interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
Initial interview and potential follow-up interviews and focus group with Florida Hospital employees.
Interview participants in compassion rounds
| Study group | Role | What they receive |
|---|---|---|
| Physicians | interview physicians who have conducted compassion rounds Receives: Other: interview | |
| Chaplains | interview chaplains who have conducted compassion rounds Receives: Other: interview | |
| Other Healthcare Providers | interview other healthcare providers who have conducted compassion rounds Receives: Other: interview | |
| Patients | interview patients who have participated in compassion rounds Receives: Other: interview | |
| Patient family members/friends | interview patient's loved ones who have participated with the patient in compassion rounds Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated Thematic Framework to Explain the Effects of Compassion Rounding
Analysis of data collected throughout the study will result in a validated theoretical framework to understand and explain the psychosocial processes that influence participant experience and reported outcomes.
Measured: five months
Secondary outcomes (1)
Compendium of Evidence-Based Best Practices for the Implementation of Compassion Rounding
Analysis of data collected throughout the study will result in an evidence-based compendium of best practices for the implementation of compassion rounding.
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Oct 2018
- Primary completion31 Jul 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spiritual WellnessStudies 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim McManus, Ph.D., Principal investigator, FH Center for CREATION Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648866
- Sponsor's protocol ID
- 1320386
- Status last verified
- May 2021
- First submitted
- 15 Aug 2018
- 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
- A Thematic Analysis of the Effects of Compassion Rounds on Clinicians and the Families of NICU Patients
- ClinicalTrials.gov ID
- NCT03648866
- Acronym / sponsor ID
- 1320386
- Conditions
- Spiritual Wellness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 28 Aug 2018 (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.
The primary objective of this thematic analysis is to understand the experience of "Compassion Rounds" for patients, families, friends, and clinicians. The secondary objective of this study is to evaluate and interpret data to determine best practice recommendations for standardization and scalability.
Detailed description
This research will be conducted as a Thematic Analysis. Participants will be recruited from those who take part in compassion rounds, including patients, their loved ones, physicians, chaplains, social workers, nurses, and other care providers.
Qualitative data on participants' experiences throughout the intervention will be collected and analyzed using thematic methodology. The data will be used to explain the psychosocial processes that influence participant experience and reported outcomes.
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' social reality and perceptions of the treatment, resulting in explanations of how the treatment leads to outcomes and the identification of variables that may then be quantified for more generalizable study.
Semi-structured Interviews
Through semi-structured interviews, which will be recorded and transcribed, the researcher asks participants open-ended questions intended to elicit perspectives on their experience of compassion rounds, without limiting responses to pre-determined categories of interest. The following are examples:
"What/who do you remember most vividly?" "How would you describe your experience to a friend?" "What was most meaningful to you? "What made you feel uncomfortable?" "Would you do it again? Why or why not?" "What, if anything, changed after compassion rounding?"
Coding
The researcher codes and documents throughout data collection and analysis to lend transparency to the coding process and to keep a record of ideas to inform thematic exposition. The researcher assigns categorical codes (labels or concepts) to the transcribed responses line-by-line, analyzing patterns of relationships and using a constant comparison technique to identify similarities and differences throughout the data. The following coding techniques will be used to analyze transcriptions:
- open coding: the researcher segments the data into preliminary categories, based on similarity
- axial coding: the researcher groups the categories into themes that provide new ways of seeing and understanding the phenomenon under study
- selective coding: the researcher integrates the categories and themes to articulate a coherent theory of the phenomenon of study.
Theoretical Sampling Grounded theory research uses "theoretical sampling" to identify participants for interviews. Purposive samples are identified to initiate data collection and analysis, and to select participants who are likely to clarify, verify, or contradict data as it is collected. Sampling concludes when the data is "saturated," which occurs when coded categories are well-defined and no new significant insights are emerging from interviews.
Thematic Development and Validation
The researcher develops thematic explanations that stem from rendering participants' experiences throughout the practice of compassion rounding.
Themes are evaluated for fit and relevance and employee participants may be asked to validate the researcher's findings in follow-up interviews and focus groups.
Observation The researcher will also observe compassion rounding 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 the techniques described above. Observational data will not be integrated into interview data, but will be used to confirm or contrast reported data.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: interviewinterview physicians who have conducted compassion rounds |
| Chaplains | – | Other: interviewinterview chaplains who have conducted compassion rounds |
| Other Healthcare Providers | – | Other: interviewinterview other healthcare providers who have conducted compassion rounds |
| Patients | – | Other: interviewinterview patients who have participated in compassion rounds |
| Patient family members/friends | – | Other: interviewinterview patient's loved ones who have participated with the patient in compassion rounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from participants in compassion rounding, including patients, their loved ones, physicians, chaplains, social workers, nurses, and other care providers.
Key inclusion criteria (5 listed)
- An employee of Florida Hospital or Adventist Health System, or a physician with privileges there, or a patient, or a family or friend who has participated in compassion rounding at a Florida Hospital critical care unit
- Over the age of 18
- Able to provide informed consent
- Must speak and understand English
- Willing and able to provide a contact phone number
Key exclusion criteria (1 listed)
- 1. Discernible 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 |
|---|---|---|
| interviewInitial interview and potential follow-up interviews and focus group with Florida Hospital employees. Interview participants in compassion rounds | Other | Chaplains, Other Healthcare Providers, Patient family members/friends, Patients, Physicians |
Primary outcome
Validated Thematic Framework to Explain the Effects of Compassion Rounding
Time frame: five months
Analysis of data collected throughout the study will result in a validated theoretical framework to understand and explain the psychosocial processes that influence participant experience and reported outcomes.
1 secondary outcome
Compendium of Evidence-Based Best Practices for the Implementation of Compassion Rounding
Time frame: five months
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 McManus, Ph.D. principal investigator
FH Center for CREATION Health 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 Spiritual Wellness, 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 5 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?
Validated Thematic Framework to Explain the Effects of Compassion Rounding (time frame: five 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.