Anxiety, Depression
Conditions
Keywords
decision making for incapacitated patients, intensive care, surrogate decision making, patient centered care, palliative care
Brief summary
This is a stepped wedged randomized controlled trial comparing the PARTNER intervention with usual care in 5 Intensive Care Units. The overarching goal of this research project to ensure patient-centered decisions about the use of intensive treatments for patients with advanced critical illness. In a prior project, the investigators developed the PARTNER program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs, including: 1) changing care defaults to ensure clinician-family meetings within 48 hours of enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, 3) increased use of palliative care services for patients with a poor prognosis. The investigators propose to begin deployment of the PARTNER II program in the spring of 2015 enrolling 690 surrogate decision makers in 5 ICUs using a stepped wedge design. The investigators expect to achieve the following project goals: 1. To increase the patient-centeredness of end-of-life decisions, and to increase the quality of clinician-family communication. 2. To decrease the psychological burden on family members acting as surrogates. 3. To reduce total health care costs by decreasing the duration of use of burdensome, invasive treatments at the end of life.
Interventions
BEHAVIORALPARTNER II
The PARTNER intervention is a multifaceted intervention delivered by a trained PARTNER Champion who has undergone 16 hours of intense communication training, with audit and feedback, quarterly booster training, and expert implementation support. Additionally, there is academic detailing of ICU physicians and ICU bedside nurses to augment the intervention. The PARTNER Intervention deploys three strategies to improve: 1) the timeliness and frequency of clinician-family communication, 2) the emotional and decision support provided to families and 3) the appropriate involvement of palliative care specialists.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Stepped Wedge Design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Surrogate decision maker for ICU patient in one of 5 UPMC ICU's
Exclusion criteria
* Non-English Speaking * Surrogate's loved one is for organ transplantation * Not physically able to participate in family meeting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Communication (QOC) scale | At 6 months | We will assess quality of communication in family members in a telephone interview 6 months after enrollment using the validated13 item Quality of Communication Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Centeredness of Care Scale | At 6 months | We will assess Patient Centeredness of Care, using the 12-item Patient-Perceived Patient-Centeredness of Care Scale (PPPC) adapted for use by surrogates. |
| Intensive Care Unit Length of Stay | Participants will be followed for duration of ICU stay, an expected average of 21 days | We will assess the Intensive Care Unit length of stay as assessed by abstraction of this information from the medical record. |
| Impact of Events Scale | At 6 months | We will assess symptoms of post-traumatic stress in family members in a telephone interview 6 months after enrollment using the validated 22 item Impact of Events Scale. |
| Decision Regret Scale | At 6 months | We will assess Decisional Regret by family members in a telephone interview 6 months after enrollment using the validated 5 item Decision Regret Scale across treatment groups. |
| Hospital Anxiety and Depression Scale | At 6 months | We will assess symptom burden of anxiety and depression in family members in a telephone interview 6 months after enrollment using the validated 14-item Hospital Anxiety and Depression scale (HADS). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mortality | At 6 months | We will assess hospital mortality and 6-month mortality using hospital records, 6 month follow-up with surrogates, and the National Death Index in cases in which participants are lost to telephone follow up. |
| Katz Activities of Daily Living Scale | At 6 months | We will assess functional status of the patient using the validated Katz Activities of Daily Living Scale at 6 months. |
| Hospital Length of Stay | Participants will be followed for duration of hospital stay, an expected average of 4 weeks. | We will assess hospital length of stay by abstraction of this information from the medical record at hospital discharge. |
| Total Hospitalization costs | Inclusive of index hospitalization | We will measure total hospitalization costs by aggregating each patient's total service specific costs, generated from hospital administrative records. |
| 6-month health care utilization | Inclusive of index hospitalization and 6 months follow up | We will assess patient health care utilization using hospital records and through validated methods to assess utilization using standardized interviews with surrogates at 6 months. |
Countries
United States
Outcome results
None listed