Development and evaluation of an interprofessional communication intervention to improve family outcomes in the ICU

doi:10.1016/j.cct.2012.06.010

Contemporary Clinical Trials

Volume 33, Issue 6, November 2012, Pages 1245-1254

https://doi.org/10.1016/j.cct.2012.06.010 Get rights and content

Abstract

The intensive care unit (ICU), where death is common and even survivors of an ICU stay face the risk of long-term morbidity and re-admissions to the ICU, represents an important setting for improving communication about palliative and end-of-life care. Communication about the goals of care in this setting should be a high priority since studies suggest that the current quality of ICU communication is often poor and is associated with psychological distress among family members of critically ill patients. This paper describes the development and evaluation of an intervention designed to improve the quality of care in the ICU by improving communication among the ICU team and with family members of critically ill patients. We developed a multi-faceted, interprofessional intervention based on self-efficacy theory. The intervention involves a “communication facilitator” – a nurse or social worker – trained to facilitate communication among the interprofessional ICU team and with the critically ill patient's family. The facilitators are trained using three specific content areas: a) evidence-based approaches to improving clinician–family communication in the ICU, b) attachment theory allowing clinicians to adapt communication to meet individual family member's communication needs, and c) mediation to facilitate identification and resolution of conflict including clinician–family, clinician–clinician, and intra-family conflict. The outcomes assessed in this randomized trial focus on psychological distress among family members including anxiety, depression, and post-traumatic stress disorder at 3 and 6 months after the ICU stay. This manuscript also reports some of the lessons that we have learned early in this study.

Section snippets

Background

The intensive care unit (ICU) represents an important setting for improving communication about palliative and end-of-life care because death is common and because patients are at high risk for both mortality and long-term morbidity [1], [2], [3]. Palliative care issues may be raised by critical illness even for patients who survive the ICU and for their family members because of underlying chronic life-limiting illness or sequellae of their critical illness [4]. Furthermore, because the

Theoretical foundation for the intervention

This intervention was based on self-efficacy theory [24], [25], [26] which has been used to guide interventions for changing a wide range of health [27], [28] and clinician behaviors [29], [30], [31]. In this theory, the impetus for change resides in the individual's efficacy expectations, that is, his/her “confidence in his/her ability to take action and persist in action.” [25] Although primarily an individual-specific construct, self-efficacy does not arise out of the individual alone but

Overview of the study

This study is a clustered randomized trial of a “communication facilitator” intervention designed to improve communication and decision-making among physicians, nurses, and families for patients who are critically ill and in the ICU. Eligible patients are critically ill and unable to participate in clinical decision-making and are randomly assigned to either the intervention or a “usual care” control group. Communication facilitators assist families of patients in the intervention group,

Description of the intervention

The intervention uses a communication facilitator to increase families' and clinicians' self-efficacy expectations about communication in the ICU. We operationalized the three components that were conceptualized as important contributors to behavior change in the following ways: 1) the knowledge component uses a growing literature on patient–family–clinician communication techniques founded in empirical data in ICU settings and linked with positive family and patient outcomes; [32] 2) the

Training the facilitators

The facilitators are individuals with nursing or social work backgrounds. We chose these specialists because they commonly have training in communication and interpersonal skills as well as an understanding of the hospital environment upon which our facilitator training is built. In addition, by using nurses or social workers rather than individuals with psychology or mediation backgrounds, we hope to increase the generalizability of the intervention; nurses and social workers are more likely

Study design

This study is a randomized trial of an interprofessional, multi-faceted intervention of a communication facilitator. Subjects are identified from ICUs in Seattle-area hospitals, including academic and community-based sites. Eligible patients are critically ill and unable to participate in decision-making, requiring surrogate decision-making. Based on our eligibility criteria, we anticipate approximately 30–40% of the eligible patients will die in the ICU. Patients are randomly assigned to

Patients

Study staff screen ICU census daily in order to identify all ICU patients meeting the following criteria: 1) in the ICU for > 24 h; 2) older than 18; 3) mechanically ventilated at time of enrollment; 4) having a Sequential Organ Failure Assessment score ≥ to 8 or diagnostic criteria that predicts a ≥ 50% risk of hospital mortality; [65], [66] 5) a legal surrogate decision-maker to consent for patient participation, and 6) a family member able to come to the hospital.

None of the eligible patients

Patient Health Questionnaire (PHQ-9)

Families' symptoms of depression, as measured by the PHQ-9, is the primary outcome and will be assessed both at baseline and at the 3 and 6 month follow-up. This 9-item questionnaire is widely used, is appropriate for both primary care and general populations [58] and has demonstrated excellent psychometric characteristics including: internal consistency reliability (Cronbach's alpha = 0.86–0.89); test–retest reliability (r_icc = 0.81–0.96); sensitivity (ROC = 0.95); and specificity (ROC = 0.84) [67],

Surveys for family members

Family members complete a baseline survey at the time of study enrollment, which is provided to them by study staff and returned in-person or by mail to the project office. A post-intervention follow-up survey is mailed to families' homes 3 and 6 months after a patient dies in the ICU or after the patient is discharged alive from the ICU. These surveys are returned to the project office in a postage-paid return envelope or may be completed by phone with study staff.

Chart abstraction

In order to guarantee the

Overview of analytic approach

The patient is the unit of randomization and the randomization group (intervention or control) is the primary predictor of interest. Because family members are clustered under patients for many of the analyses, we need to account for the lack of independence in observations through the use of mixed-effects random-coefficient regression modeling. We will conduct the primary analyses using data from all family members who participate in the study guided by the principle that we should not

Study progress and lessons learned

The study began enrolling patients in 1/13/2009 and, as of 6/12/2012, we have enrolled 143 patients and 251 family members. We opted not to conduct any interim analyses of quantitative outcome data in order to preserve a p value of 0.05 for hypothesis testing of the primary outcome. However, we have conducted qualitative analyses of comments on returned surveys from family members randomized to the intervention. We examined all 145 such comments, of which 22 were about the facilitator. Of these

Respondent bias in an unblinded study

The nature of the intervention precludes blinding clinicians or family members. The primary outcome measure in this study addresses the hypothesis that we will reduce family symptoms of depression. Secondarily, we hope to reduce family symptoms of anxiety and PTSD as well as improve ratings on the QODD. These outcomes are inherently subjective and therefore could allow the introduction of bias if the family members who received the intervention give different ratings because they want to please

Significance and anticipated results

Given that 20% of deaths in the U.S. occur in or shortly after a stay in the ICU and that the quality of decision-making and communication for families of critically ill patients is variable and often poor, this is an important area for research [4]. There is growing evidence that an intervention that focuses on improving interprofessional communication within the ICU team and with patients' family can significantly improve the quality of palliative care for patients and their families, but to

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^☆: Funding: Funded by the National Institute of Nursing Research (R01 NR05226).

^☆☆: Trial Registration: Registered at www.clinicaltrials.gov (NCT00720200).

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Development and evaluation of an interprofessional communication intervention to improve family outcomes in the ICU☆,☆☆

Abstract

Section snippets

Background

Theoretical foundation for the intervention

Overview of the study

Description of the intervention

Training the facilitators

Study design

Patients

Patient Health Questionnaire (PHQ-9)

Surveys for family members

Chart abstraction

Overview of analytic approach

Study progress and lessons learned

Respondent bias in an unblinded study

Significance and anticipated results

Lancet

Chest

Chest

Am J Med

Gen Hosp Psychiatry

Chest

Soc Sci Med

J Crit Care

Gen Hosp Psychiatry

Behav Res Ther

J Pain Symptom Manage

J Affect Disord

J Affect Disord

Gen Hosp Psychiatry

J Affect Disord

Psychosomatics

J Anxiety Disord

Behav Res Ther

J Crit Care

Chest

J Pain Symptom Manage

Use of intensive care at the end of life in the United States: an epidemiologic study

Crit Care Med

Long-term sequelae of critical illness: memories and health-related quality of life

Crit Care

Long-term health-related quality of life in survivors of sepsis

Crit Care Med

The dying patient in the intensive care unit: making the critical difference

Clin Issues Crit Care Nurs

Saving lives and saving deaths

Ann Intern Med

Incorporating palliative care into critical care education: principles, challenges, and opportunities

Crit Care Med

Family satisfaction with care in the intensive care unit: results of a multiple center study

Crit Care Med

Patients' preferences for communication with physicians about end-of-life decisions

Ann Intern Med

A controlled trial to improve care for seriously ill hospitalized patients: the study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT)

JAMA

Improving care near the end of life: why is it so hard?

JAMA

Rethinking fundamental assumptions: SUPPORT's implications for future reform

J Am Geriatr Soc

Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: a randomized controlled trial

JAMA

A proactive approach to improve end-of-life care in a medical intensive care unit for patients with terminal dementia

Crit Care Med

A study of proactive ethics consultation for critically and terminally ill patients with extended lengths of stay

Crit Care Med

Impact of ethics consultations in the intensive care setting: a randomized, controlled trial

Crit Care Med

A communication strategy and brochure for relatives of patients dying in the ICU

N Engl J Med

Two transatlantic viewpoints on an ethical quandary

Am J Respir Crit Care Med

Risk of post-traumatic stress symptoms in family members of intensive care unit patients

Am J Respir Crit Care Med

Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity

Crit Care Med

Social Learning Theory

Self-efficacy: toward a unifying theory of behavior change

Psychol Rev

Self-efficacy mechanism in human agency