- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258594
Promoting Respect and Ongoing Safety Through Patient-centeredness, Engagement, Communication and Technology (PROSPECT)
Transforming the Acute Care Environment: BWH PROSPECT Framework
The purpose of this project is to refine, implement, and evaluate a multi-component intervention that achieves sustainable and meaningful impact on healthcare quality, safety, and costs while ensuring dignity and respect for adult oncology and intensive care patients and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this by enhancing the patient-provider relationship and introducing patient-centered approaches to multi-disciplinary communication and patient education. The PROSPECT framework is based upon a validated structured, team-work training model and novel web-based technology. The overarching goals of this project are to achieve the following:
- Optimize the overall experience of patients (including their family/care partners) by promoting dignity/respect, encouraging engagement, improving care plan concordance, and enhancing satisfaction.
- Minimize preventable harms in two environments: intensive care and acute care oncology units.
- Reduce unnecessary healthcare resource utilization and associated costs.
Study Overview
Status
Intervention / Treatment
Detailed Description
This overarching project aims are to refine, implement, and evaluate a multi-faceted intervention composed of the Patient-SatisfActive® model, developed by Drs. Ronen Rozenblum and David Bates at Brigham and Women's Hospital, and a web-based Patient-Centered Toolkit (PCTK), developed by Drs. Dykes and Dalal, on quality, safety, and cost outcomes in the intensive care and oncology units at Brigham and Women's Hospital. The specific aims of the project are as follows:
- Aim 1: To refine and implement the Patient-SatisfActive® model to promote respect, dignity, and satisfaction of patients, care partners and staff on intensive care and oncology units.
- Aim 2: To refine and implement a web-based, Patient-Centered Toolkit (PCTK), comprised of an electronic bedside communication center (eBCC) and a patient-centered microblog, to promote tailored patient and care-partner education, communication, collaboration, and engagement.
- Aim 3: To evaluate the relative impact of this intervention compared to usual care on patient reported outcome measures, adverse events (harms), post-discharge healthcare utilization, concordance in understanding the care plan, and satisfaction among care team members (patients/care partners, profession providers).
- Aim 4: To identify the barriers and facilitators of implementing this intervention to support dissemination.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18
- Any patient admitted or transferred to designated care units
- Admitted or transferred to a MICU or Oncology service
- On the designated unit for at least 24 hours
Exclusion Criteria:
- Age < 18
- Any patient admitted or transferred to designated care unit but NOT on a MICU or Oncology service
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Baseline - Usual Care
Usual Care on two Medical Intensive Care Units units Usual Care on four Oncology units |
|
Experimental: Post-Implementation - Intervention Units
PROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two MICU units PROSPECT Intervention (Web-Based Patient Centered Toolkit (PCTK) + The Patient-SatisfActive® Model) on two Oncology units |
The PCTK provides patients/care partners tailored health information regarding conditions, test results, and medications presented at a consumer health literacy level, and the ability to communicate with care team members via "patient-facing" tools accessible from bedside tablet computers.
The PCTK allows patients to post questions to their care team members via a patient-centered microblog.
The microblog facilitates development of a collaborative patient plan of care.
The "provider-facing" PCTK includes tools that engage care team members in 1) completing a safety checklist and viewing a safety dashboard; 2) viewing patient-inputted information (goals, preferences, concerns) regarding the plan of care; 3) identifying clinical problems, care team goals, and patient schedules for education and multidisciplinary communication; 4) messaging patients on the "patient thread"; and 5) discussing patient's plan of care with other providers via the "provider thread".
The Patient-SatisfActive Model is a structured, pro-active, patient-centered care model that aims at improving patient satisfaction by enhancing the degree to which patients' needs, concerns and expectations are met and by preserving dignity and respect.
The model comprises steps that enhance interpersonal communication between clinicians and patients, incorporates clinicians' efforts to ascertain, address and document patients' needs, concerns, expectations and perceptions throughout hospitalization, and includes elements that empower and engage patients in their care.
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No Intervention: Post-Implementation - Usual Care
Usual Care on two Oncology Units
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preventable Harms (Adverse Events) in the Acute Care Setting
Time Frame: Enrolled patients will be followed for the duration of hospital stay, typically ranging from 5 to 30 days.
|
Preventable adverse events in the acute care setting include medication errors, patient falls, veno-thromboembolism, hospital acquired infection, central line related bloodstream infection, ventilator associated pneumonia, catheter associated urinary tract infection, newly acquired physical harm/injury.
We will measure the rate of adverse events acquired from the time of admission to study units through hospital discharge.
Using an adaptation of the Institute for Healthcare Improvement (IHI) Global Trigger Tool, we will randomly sample charts of enrolled patients from intervention and control units during the pre-intervention and post-intervention periods to identify adverse events.
The length of hospital stay for patients admitted to medical intensive care and oncology units at our institution is variable, typically ranging from 5 to 30 days.
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Enrolled patients will be followed for the duration of hospital stay, typically ranging from 5 to 30 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Experience & Satisfaction & Engagement
Time Frame: At time of transfer/discharger from study unit and up to 45-days post-hospitalization
|
Randomly selected patients transferred from the MICU units will receive FS-ICU survey, semi-structured interviews, and 45-day post-hospitalization phone survey Randomly selected patients discharged from Oncology units will receive semi-structured interviews and 45-day post-hospitalization phone survey. Data from national patient satisfaction survey, HCAHPS, will be collected and analyzed. |
At time of transfer/discharger from study unit and up to 45-days post-hospitalization
|
Healthcare Resource Utilization
Time Frame: From time of hospital admission through 30-days post-discharge
|
Inpatient healthcare utilization measures: Total cost of hospitalization and hospital length of stay (total, ICU, and non-ICU) from administrative data for each enrolled patient. Post-discharge healthcare utilization measures: Rate of unscheduled utilization of health care resources (ambulatory/urgent care visits, emergency room visits, hospital readmissions) during the 30-day post-discharge period using the combination of administrative data and patient reports during their 30-day interview. |
From time of hospital admission through 30-days post-discharge
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Care Plan Concordance
Time Frame: Approximately 48-72 hours after admission to study unit
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Structured interviews (9-question survey) with patient/care partners, a member of the inpatient medical team (attending, resident, or intern), inpatient nurses, and one additional care team member (e.g., PCP, ambulatory specialists) will be conducted after admission to MICU or Oncology units.
Concordance for each item of survey will be rated on a 3-point scale (0, 1, 2) for each dyad.
The scores of all dyads will be summed as a global concordance score for each patient.
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Approximately 48-72 hours after admission to study unit
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Perceptions of Communication/Collaboration
Time Frame: Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
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Overall perception of collaboration and satisfaction with communication among the various members of the care team will be measured on a 5-point Likert scale via surveys administered during the baseline and intervention periods.
Scores will be dichotomized.
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Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
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Patient Safety Climate
Time Frame: Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
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The AHRQ Patient Safety Culture (PSC) survey will be used to control for differences across units and facilities that may impact incidence of adverse events (communication, leadership, teamwork, frequency of reporting, perceived patient safety score).
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Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months
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Dignity and Respect
Time Frame: At time of transfer/discharger from study unit and up to 45-days post-hospitalization
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Randomly selected patients transferred from the MICU will receive the FS-ICU survey, which contains several questions related to dignity and respect. Randomly selected patients will also receive semi-structured interviews to enhance understanding of dignity and respect. Randomly selected patients discharged from Oncology units will receive semi-structured interviews regarding perceptions of dignity and respect and a 45-day post-hospitalization phone survey. Relevant data from national patient satisfaction survey, HCAHPS, will be collected and analyzed. |
At time of transfer/discharger from study unit and up to 45-days post-hospitalization
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Patricia Dykes, RN, DNSc, Brigham and Women's Hospital
Publications and helpful links
General Publications
- Dalal AK, Dykes P, Samal L, McNally K, Mlaver E, Yoon CS, Lipsitz SR, Bates DW. Potential of an Electronic Health Record-Integrated Patient Portal for Improving Care Plan Concordance during Acute Care. Appl Clin Inform. 2019 May;10(3):358-366. doi: 10.1055/s-0039-1688831. Epub 2019 May 29.
- Gazarian PK, Morrison CRC, Lehmann LS, Tamir O, Bates DW, Rozenblum R. Patients' and Care Partners' Perspectives on Dignity and Respect During Acute Care Hospitalization. J Patient Saf. 2021 Aug 1;17(5):392-397. doi: 10.1097/PTS.0000000000000353.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013P001966
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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