NCT02258594

Brief Summary

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:

  1. 1.Optimize the overall experience of patients (including their family/care partners) by promoting dignity/respect, encouraging engagement, improving care plan concordance, and enhancing satisfaction.
  2. 2.Minimize preventable harms in two environments: intensive care and acute care oncology units.
  3. 3.Reduce unnecessary healthcare resource utilization and associated costs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

October 1, 2014

Last Update Submit

February 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Preventable Harms (Adverse Events) in the Acute Care Setting

    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.

    Enrolled patients will be followed for the duration of hospital stay, typically ranging from 5 to 30 days.

Secondary Outcomes (6)

  • Patient Experience & Satisfaction & Engagement

    At time of transfer/discharger from study unit and up to 45-days post-hospitalization

  • Healthcare Resource Utilization

    From time of hospital admission through 30-days post-discharge

  • Care Plan Concordance

    Approximately 48-72 hours after admission to study unit

  • Perceptions of Communication/Collaboration

    Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months

  • Patient Safety Climate

    Once during baseline (pre-intervention) and post-intervention periods, approximately 12 months

  • +1 more secondary outcomes

Study Arms (3)

Baseline - Usual Care

NO INTERVENTION

Usual Care on two Medical Intensive Care Units units Usual Care on four Oncology units

Post-Implementation - Intervention Units

EXPERIMENTAL

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

Other: Web-Based Patient Centered Toolkit (PCTK)Behavioral: The Patient-SatisfActive® Model

Post-Implementation - Usual Care

NO INTERVENTION

Usual Care on two Oncology Units

Interventions

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".

Post-Implementation - Intervention Units

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.

Post-Implementation - Intervention Units

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18
  • Any patient admitted or transferred to designated care unit but NOT on a MICU or Oncology service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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 Officials

  • David W Bates, MD, MSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR
  • Patricia Dykes, RN, DNSc

    Brigham and Women's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of General Medicine

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 7, 2014

Study Start

March 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 14, 2022

Record last verified: 2022-02

Locations