Failure to ThriveiCMPNCT02879357
Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients
A study testing Training in people with Failure to Thrive, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The hypothesis of the Serious Illness Care Program (SICP) is that adherence to the Serious Illness Conversation Guide (SICG) portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failure to Thrive
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinician Inclusion Criteria:
- Brigham and Women's Hospital or Newton Wellesley Primary Care Clinician at one of the following practices: The Phyllis Jen Center for Primary Care, Faulkner Community Physicians, Brigham and Women's Physician Group, Brigham \& Women's Primary Care Associates of Brookline, Brigham Circle Medical Associates, Faulkner
- Care for patients enrolled in Brigham and Women's Hospital integrated Care Management Program (iCMP)
Clinician Exclusion Criteria:
- Resident in Training
- Non-English Speaking Clinic (e.g. Spanish Clinic)
Patient Inclusion Criteria:
- Over 18 years of age
- English Speaker
- Patient at Brigham and Women's Hospital or Newton Wellesley Primary Care Clinician at one of the following practices: The Phyllis Jen Center for Primary Care, Faulkner Community Physicians, Brigham and Women's Physician Group, Brigham \& Women's Primary Care Associates of Brookline, Brigham Circle Medical Associates, Faulkner
- Enrolled in Brigham and Women's Hospital integrated Care Management Program
Patient Exclusion Criteria:
- Patient at Dana-Farber Cancer Institute
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
The hypothesis of the Serious Illness Care Program (SICP) is that adherence to the Serious Illness Conversation Guide (SICG) portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life.
Read the detailed description
The aim of the Serious Illness Care Program (SICP) is to provide clinicians with an evidence-based structure for eliciting and documenting vital information about preferences for patient driven care of their serious illness. It is designed to help open the door for patients, families, and clinicians to talk and reflect on end-of-life issues in an ongoing way. The hypothesis of the Serious Illness Care Program is that adherence to the conversation guide portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life. For this protocol specifically, the investigators are testing a pilot intervention of a quality improvement project; the investigators plan to train clinicians and assess the feasibility and impact of the Serious Illness Care Program, which includes patient identification, clinician training, "triggering" of clinicians to conduct the SICG conversation, and documentation, in the iCMP at the Brigham and Women's Hospital.
- Conditions
- Failure to Thrive
- Being tested
- Training
- Keywords
- Care management, end of life, advanced care planning, palliative care
- Medical subject headings
- Failure to Thrive, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
- Clinician training
- System for patient selection
- System of "triggering" and tracking conversations
- Training on how to use the Serious Illness Care Guide, a guide for patients about initiating conversations with family members about end-of-life goals and values
- Longitudinal Medical Record (LMR) documentation module to serve as a "Single source of truth" about advance care preferences in the LMR.
| Study group | Role | What they receive |
|---|---|---|
| Trained Clinicians | Experimental | Training in Serious Illness Communication Guide Receives: Behavioral: Training |
| Untrained Clinicians | No intervention | No training in Serious Illness Communication Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible patients with documented goals of care conversations
For patients whose death falls during the study period, the percentage of goals of care conversations completed and documented in the electronic medical record by clinicians in the intervention group and the control group. A completed conversation is defined by key elements being documented regarding goals of care in the patient's medical record.
Measured: from date of determination of eligibility to date of death death during the study period, assessed for up to 18 months
Secondary outcomes (2)
Median number of days before death of first documented goals of care conversation
For all patients whose death falls during the study period, the median number of days from the date of the first documented goals of care conversation to date of death in both the intervention and the control group.
Measured: from date of determination of eligibility to date of death during the study period, assessed for up to 18 months
Percentage of eligible patients with more comprehensive documentation of goals of care before death
For all patients whose death falls during the study period, the percentage of patients with more comprehensive goals of care documentation before death in both the intervention group and the control group. More comprehensive is defined as documentation of a goals of care conversation that addresses more than code status only and will be evaluated for completeness in containing more key elements of a Serious Illness Care Guide conversation.
Measured: from date of determination of eligibility to date of death during study period, assessed for up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startMar 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure to ThriveStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Partners HealthCare
- Responsible party
- Principal investigator, Bernacki, Rachelle E.,M.D., Brigham and Women's Hospital
- Investigators
- Rachelle E Bernacki, MD, Principal investigator, Dana-Farber Cancer InstituteSusan D Block, MD, Principal investigator, Dana-Farber Cancer InstituteRebecca Cunningham, MD, Principal investigator, Brigham and Women's HospitalJoshua R Lakin, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879357
- Sponsor's protocol ID
- 2014P000211
- Acronym
- iCMP
- Status last verified
- Oct 2019
- First submitted
- 7 May 2015
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients
- ClinicalTrials.gov ID
- NCT02879357
- Acronym / sponsor ID
- iCMP / 2014P000211
- Conditions
- Failure to Thrive
- Keywords
- Care management, end of life, advanced care planning, palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Partners HealthCare
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Aug 2016 (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 hypothesis of the Serious Illness Care Program (SICP) is that adherence to the Serious Illness Conversation Guide (SICG) portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life.
Detailed description
The aim of the Serious Illness Care Program (SICP) is to provide clinicians with an evidence-based structure for eliciting and documenting vital information about preferences for patient driven care of their serious illness. It is designed to help open the door for patients, families, and clinicians to talk and reflect on end-of-life issues in an ongoing way. The hypothesis of the Serious Illness Care Program is that adherence to the conversation guide portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life. For this protocol specifically, the investigators are testing a pilot intervention of a quality improvement project; the investigators plan to train clinicians and assess the feasibility and impact of the Serious Illness Care Program, which includes patient identification, clinician training, "triggering" of clinicians to conduct the SICG conversation, and documentation, in the iCMP at the Brigham and Women's Hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trained Clinicians | Experimental | Behavioral: TrainingTraining in Serious Illness Communication Guide |
| Untrained Clinicians | No intervention | –No training in Serious Illness Communication Guide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Training1. Clinician training 2. System for patient selection 3. System of "triggering" and tracking conversations 4. Training on how to use the Serious Illness Care Guide, a guide for patients about initiating conversations with family members about end-of-life goals and values 5. Longitudinal Medical Record (LMR) documentation module to serve as a "Single source of truth" about advance care preferences in the LMR. | Behavioural | Trained Clinicians |
Primary outcome
Percentage of eligible patients with documented goals of care conversations
Time frame: from date of determination of eligibility to date of death death during the study period, assessed for up to 18 months
For patients whose death falls during the study period, the percentage of goals of care conversations completed and documented in the electronic medical record by clinicians in the intervention group and the control group. A completed conversation is defined by key elements being documented regarding goals of care in the patient's medical record.
2 secondary outcomes
Median number of days before death of first documented goals of care conversation
Time frame: from date of determination of eligibility to date of death during the study period, assessed for up to 18 months
Percentage of eligible patients with more comprehensive documentation of goals of care before death
Time frame: from date of determination of eligibility to date of death during study period, assessed for up to 18 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 11 Oct 2019.
- 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.
Rachelle E Bernacki, MD principal investigator
Dana-Farber Cancer Institute
Susan D Block, MD principal investigator
Dana-Farber Cancer Institute
Rebecca Cunningham, MD principal investigator
Brigham and Women's 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 Training in people with Failure to Thrive, run by Brigham and Women's 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?
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 11 Oct 2019. 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?
Percentage of eligible patients with documented goals of care conversations (time frame: from date of determination of eligibility to date of death death during the study period, assessed for up to 18 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 11 Oct 2019.