An interventional study of Training in Failure to Thrive, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-11.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
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.
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.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's enrollment of 194 is above the median of 100 across 56 interventional studies indexed under Failure to Thrive.
Browse Failure to Thrive studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinician Inclusion Criteria:
Clinician Exclusion Criteria:
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Training in Serious Illness Communication Guide
Behavioral: Training
No training in Serious Illness Communication Guide
1. 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.
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.
Time frame: from date of determination of eligibility to date of death death during the study period, assessed for up to 18 months
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.
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
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.
Time frame: from date of determination of eligibility to date of death during study period, assessed for up to 18 months
Completion of eligible conversations
Median percentage of eligible patients with completed conversations (will report for all intervention clinicians as a whole and also on individual clinician level)
Time frame: from date of clinician training study start to study end date, assessed for up to 18 months
Length of conversation
Median length of time per conversation in the intervention group as reported by clinician survey
Time frame: from date of clinician training study start to study end date, assessed for up to 18 months
Clinician Confidence
Clinicians who are trained to use the Guide will have improved confidence in carrying out end-of-life conversations, compared to untrained clinicians. Confidence will be evaluated before training and at end of study and measured using a 22-question survey asking clinicians to quantify their confidence on a scale of 1-7. This survey was designed by study investigators based on national surveys used to evaluate a sample of medical students, residents, and attending physicians' attitudes about end-of-life care, as well as the Harvard Medical School Center for Palliative Care's national faculty development program.
Time frame: at initial clinician training and end of study (an average of 18 months)
Clinician Attitudes
Clinicians who are trained to use the Guide will have improved attitudes in carrying out end-of-life conversations, compared to untrained clinicians. Confidence will be evaluated before training and at end of study and measured using an 11-question survey asking clinicians to quantify their confidence on a scale of 1-5. This survey was designed by study investigators based on national surveys used to evaluate a sample of medical students, residents, and attending physicians' attitudes about end-of-life care, as well as the Harvard Medical School Center for Palliative Care's national faculty development program.
Time frame: at clinician training and end of study (an average of 18 months)
Utilization
Patients of clinicians who are trained to use the Guide will have higher rates of hospice usage, less health care utilization, and lower expenses near the end of life. We will measure utilization outcomes for those patients for whom we have claims data through risk contracts and the accountable care organization and will compare usage and trends between intervention and comparison patients.
Time frame: at end of study (an average of 18 months)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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