Difficult Decision MakingNCT00827437
Family-Staff Communication Intervention at the Time of Difficult Treatment Decision Making
A study testing Parent Interview in people with Difficult Decision Making, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The primary aim of this single site study was to assess the feasibility of implementing a staff/parent communication intervention within 72 hours of the parents making an end-of-life decision on behalf of their child. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Difficult Decision Making
- What is being tested?
- Parent Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Nov 2007
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible parents/guardian can be enrolled only one time and will be:
- 21 years of age and older.
- This study will enroll only parents/guardians who are 21 years of age and older. The investigators clinical experience is that when the parent/guardian is younger, additional adult members of the family are involved in the decision making and that asking a single person to identify him or herself as the primary parent/guardian creates difficulties for the family.
- As a result, no parent/guardian younger than age 21 will be enrolled in this study.
- English-speaking.
- Willing to give written consent to participate.
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- The parents/guardians of a child with incurable cancer or a fatal cancer-related condition who is being treated at St. Jude Children's Research Hospital
- The parents/guardians who made an end-of-life decision on behalf of the seriously ill child within the previous 72-hours.
- Eligible staff can be enrolled more than one time and will be:
- English-speaking
- Willing to give written consent to participate
Who cannot join
- Parents/guardians who meet the above criteria but are identified by their attending or social support staff member (an assigned social worker or psychologist at St. Jude Children's Research Hospital) as emotionally or mentally unable to participate in the informed consent process will not be approached about participating in the study.
- Parents who are identified by their attending or social support staff member as likely to find the study too burdensome because of their emotional or mental state.
- Parents who did not make the end-of-life decision (i.e., when the patient made the decision).
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
The primary aim of this single site study was to assess the feasibility of implementing a staff/parent communication intervention within 72 hours of the parents making an end-of-life decision on behalf of their child.
Read the detailed description
Parents/guardians of children with incurable cancer face end-of-life decisions on behalf of their child including whether or not to enroll their child in a Phase I study, whether or not to agree to a 'do not resuscitate' status, or to begin terminal care. Descriptive research to date indicates that one of the factors that most helps parents to make these decisions and to remain satisfied with the decision afterward is their perception that they decided as a 'good parent' would decide. Parents define being a 'good parent' as making a decision that is in the best interest of their child. Parents' perception of their success in being a good parent is influenced by their interactions with the child's health care providers. Health care providers who are not fully informed about the decision and the parents' rationale for the decision are likely to convey doubt about the decision to parents and to other health care providers. Parents interpret this doubt as staff questioning the parents' ability to make good decisions. Lack of adequate information also creates staff tension. This single-site feasibility study will implement and evaluate a two-part communication intervention designed to identify parents' definition of being a good parent, and to communicate this definition and the rationale for the parents' decision to staff. The intervention will be implemented in 60 to 80 end-of-life clinical care situations in which parents have made a decision on behalf of a child who is still living. The feasibility study is guided by the Pediatric Quality of Life at End of Life model. The parent/guardian intervention includes a face-to-face interview with parents regarding their definition of a 'good parent' and their basis for the decision they made. Parents/guardians will be interviewed within 72 hours after making the end of life decision and again 1 to 3 weeks after making the decision. Health care professionals assigned to the terminally ill child will receive the communication intervention within hours of the parent interview, and will evaluate its usefulness 1 to 2 weeks after receiving it.
1.1 To assess the feasibility of delivering the two-part communication intervention. The definition of feasible is that 50% of all interventions are successfully implemented.
1.1.1 To identify all three types of difficult treatment decisions within the defined time frame (thus identifying eligible parents/guardians and obtaining consent within 72 hours after the decision was made), document the study team's ability to successfully implement the intervention before the child's death (obtaining the parent/guardian information and sharing that with the defined staff such that the family achieves the definition of being fully evaluable as a study participant), and document the participation rate by tracking the number of eligible parents/guardians who agree to participate, decline to participate or withdraw from the study.
1.2: To assess staff perceptions of the impact of the communication intervention on staff 1 to 2 weeks after the intervention.
1.2.1 to measure: a) staff recall of the definition of a good parent and the rationale for the decision; b) staff perception of how this knowledge influenced their care for the family; c) staff satisfaction with the verbal and written communication intervention forms; and d) the impact of the communication intervention on team tension and team communication about the parents' decisions.
1.3: To assess the impact of the communication on parents/guardians by recording their perceptions of the positive and negative aspects of the intervention at the time of the intervention and 1 to 3 weeks after the decision making.
- Conditions
- Difficult Decision Making
- Being tested
- Parent Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent InterviewOther
To include the PI, Nursing Research Specialist,Clinical Research Associate or Clinical Nurse Specialist
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Other: Parent Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of delivering the two-part communication intervention. The definition of feasible is that 50% of all interventions are successfully implemented.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2004
- Primary completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Decision MakingStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Pamela S Hinds, PhD, RN, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827437
- Sponsor's protocol ID
- DECID4
- Status last verified
- Jun 2011
- First submitted
- 6 Aug 2008
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Staff Communication Intervention at the Time of Difficult Treatment Decision Making
- ClinicalTrials.gov ID
- NCT00827437
- Acronym / sponsor ID
- DECID4
- Conditions
- Difficult Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Nov 2007 (actual)
- First posted
- 22 Jan 2009 (estimated)
- 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 aim of this single site study was to assess the feasibility of implementing a staff/parent communication intervention within 72 hours of the parents making an end-of-life decision on behalf of their child.
Detailed description
Parents/guardians of children with incurable cancer face end-of-life decisions on behalf of their child including whether or not to enroll their child in a Phase I study, whether or not to agree to a 'do not resuscitate' status, or to begin terminal care. Descriptive research to date indicates that one of the factors that most helps parents to make these decisions and to remain satisfied with the decision afterward is their perception that they decided as a 'good parent' would decide. Parents define being a 'good parent' as making a decision that is in the best interest of their child. Parents' perception of their success in being a good parent is influenced by their interactions with the child's health care providers. Health care providers who are not fully informed about the decision and the parents' rationale for the decision are likely to convey doubt about the decision to parents and to other health care providers. Parents interpret this doubt as staff questioning the parents' ability to make good decisions. Lack of adequate information also creates staff tension. This single-site feasibility study will implement and evaluate a two-part communication intervention designed to identify parents' definition of being a good parent, and to communicate this definition and the rationale for the parents' decision to staff. The intervention will be implemented in 60 to 80 end-of-life clinical care situations in which parents have made a decision on behalf of a child who is still living. The feasibility study is guided by the Pediatric Quality of Life at End of Life model. The parent/guardian intervention includes a face-to-face interview with parents regarding their definition of a 'good parent' and their basis for the decision they made. Parents/guardians will be interviewed within 72 hours after making the end of life decision and again 1 to 3 weeks after making the decision. Health care professionals assigned to the terminally ill child will receive the communication intervention within hours of the parent interview, and will evaluate its usefulness 1 to 2 weeks after receiving it.
1.1 To assess the feasibility of delivering the two-part communication intervention. The definition of feasible is that 50% of all interventions are successfully implemented.
1.1.1 To identify all three types of difficult treatment decisions within the defined time frame (thus identifying eligible parents/guardians and obtaining consent within 72 hours after the decision was made), document the study team's ability to successfully implement the intervention before the child's death (obtaining the parent/guardian information and sharing that with the defined staff such that the family achieves the definition of being fully evaluable as a study participant), and document the participation rate by tracking the number of eligible parents/guardians who agree to participate, decline to participate or withdraw from the study.
1.2: To assess staff perceptions of the impact of the communication intervention on staff 1 to 2 weeks after the intervention.
1.2.1 to measure: a) staff recall of the definition of a good parent and the rationale for the decision; b) staff perception of how this knowledge influenced their care for the family; c) staff satisfaction with the verbal and written communication intervention forms; and d) the impact of the communication intervention on team tension and team communication about the parents' decisions.
1.3: To assess the impact of the communication on parents/guardians by recording their perceptions of the positive and negative aspects of the intervention at the time of the intervention and 1 to 3 weeks after the decision making.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Parent Interview |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Eligible parents/guardian can be enrolled only one time and will be:
- 21 years of age and older.
- This study will enroll only parents/guardians who are 21 years of age and older. The investigators clinical experience is that when the parent/guardian is younger, additional adult members of the family are involved in the decision making and that asking a single person to identify him or herself as the primary parent/guardian creates difficulties for the family.
- As a result, no parent/guardian younger than age 21 will be enrolled in this study.
- English-speaking.
Key exclusion criteria (3 listed)
- Parents/guardians who meet the above criteria but are identified by their attending or social support staff member (an assigned social worker or psychologist at St. Jude Children's Research Hospital) as emotionally or mentally unable to participate in the informed consent process will not be approached about participating in the study.
- Parents who are identified by their attending or social support staff member as likely to find the study too burdensome because of their emotional or mental state.
- Parents who did not make the end-of-life decision (i.e., when the patient made the decision).
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 |
|---|---|---|
| Parent InterviewTo include the PI, Nursing Research Specialist,Clinical Research Associate or Clinical Nurse Specialist | Other | 1 |
Primary outcome
To assess the feasibility of delivering the two-part communication intervention. The definition of feasible is that 50% of all interventions are successfully implemented.
Time frame: 22 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 23 Apr 2012.
- Related InfoLink provided by the sponsor.
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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.
Pamela S Hinds, PhD, RN principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Interview in people with Difficult Decision Making, run by St. Jude Children's Research Hospital 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 11 inclusion and 3 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 23 Apr 2012. 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?
To assess the feasibility of delivering the two-part communication intervention. The definition of feasible is that 50% of all interventions are successfully implemented. (time frame: 22 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 23 Apr 2012.