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Completed

NCT Number: NCT03702634

Chaplain Family Project Trial

Our research team has designed a chaplain delivered intervention focused on surrogate decision makers for hospitalized adults in the ICU. In this study, surrogates will complete an enrollment interview with research staff, including the completion of anxiety screening (GAD-7). Based on their score the surrogate will be put into one of two groups, and then randomized to either the control or intervention group. Control group members will receive usual care, while intervention group members will meet with our study chaplain, who will provide the SCAI (Spiritual Care Assessment and Intervention) framework.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Communication Depression Mental Disorders PTSD Personal Satisfaction Satisfaction Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Methodist Hospital, Indianapolis, Indiana, United States

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About this study

Unmet spiritual needs may have at least two negative consequences for surrogates. First, they may have high levels of spiritual distress, an important aspect of the surrogate's well-being. Second, surrogates include their religious and spiritual beliefs when making serious medical decisions . Therefore unmet spiritual needs may have a negative effect on the surrogate's ability to make good decisions for the patient, especially when facing extremely distressful decisions such as whether to continue life sustaining treatment or enroll in hospice.

The specific aims of this proposed study are:

  • To determine the effect of the spiritual care intervention on psychological well-being for family surrogates at 3 months post discharge, including anxiety (primary outcome: GAD-7), depression (PHQ-9), Posttraumatic stress (IES-R), and overall distress.
  • To determine the effect of the spiritual care intervention on spiritual well-being for family surrogates, (FACIT-SP- non-illness) and on religious coping (Brief RCOPE positive and negative).
  • To determine the effects of the spiritual care intervention on other aspects of the surrogates' experience, including satisfaction with spiritual care (Patient Satisfaction Instrument--Chaplaincy) communication (FICS), overall satisfaction with the hospital stay (Picker single item) and decision conflict (DCS).
  • To determine the effect of the intervention on treatment at the end of life (life sustaining treatments and hospice utilization) for patients who die in the hospital.
  • To determine differences in outcomes between the intervention group, who will receive our intervention, and the control group, who will receive the usual care provided by the hospital chaplaincy service.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cognitive Requirements

  • Patient is not decisional due to:
  • Intubation (other than surgery- see exclusion criteria below)
  • Sedation
  • Unresponsive
  • otherwise unable to communicate (AMS, dementia, delirium, etc.)

Decision Support Requirements

  • Patient has a qualified surrogate decision maker

Exclusion criteria

  • Intubated for surgery and expected to be extubated within 24 hours
  • Imminently dying as evidenced by patient notes
  • Patient and/or family have a care contract or other restriction due to complicated or volatile situation
  • Patient is a prisoner
  • Patient is being followed by Adult Protective Services (APS)
  • Patient meets cognitive criteria but does not have a qualified surrogate decision maker

Treatment and study plan

Spiritual Care Assessment and Intervention (SCAI) framework

Behavioral

The study chaplain will work with the surrogate, using questions in four domains of spiritual care, to assess them and tailor the visit to their specific needs. The study chaplain will then utilize a pre-determined list of spiritual care interventions, and also document observable outcomes that occur at each visit (which are also listed within the SCAI framework).

Primary outcomes

  1. Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge

    Time frame: Assessed at enrollment and again 6-8 weeks after hospital discharge

    GAD-7 (7 item inventory of anxiety)

Secondary outcomes

  1. Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge

    Time frame: Assessed at enrollment and again 6-8 weeks after hospital discharge

    PHQ-9 (9 item inventory of depression)

  2. Presence of post traumatic stress at 6-8 weeks post patient discharge

    Time frame: Assessed 6-8 weeks after hospital discharge

    IES-R (Impact of Events scale- inventory for PTSD)

  3. Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge

    Time frame: Assessed at enrollment and again 6-8 weeks after hospital discharge

    Distress thermometer (a 1-10 scale developed by our team to assess distress)

Other outcomes

  1. Change in spiritual well-being at baseline enrollment interview to 6-8 weeks post patient discharge

    Time frame: Assessed at enrollment and again 6-8 weeks after hospital discharge

    FACIT-SP- non-illness scale (a validated scale of spiritual well-being)

  2. Change in religious coping from baseline enrollment interview to 608 weeks post patient discharge

    Time frame: Assessed at enrollment and again 6-8 weeks after hospital discharge

    Brief RCOPE (a validated scale of religious coping)

  3. Satisfaction with spiritual care at 6-8 weeks post patient discharge

    Time frame: Assessed 6-8 weeks after hospital discharge

    Patient Satisfaction Instrument- Chaplaincy (an adaptation of a scale of patient satisfaction to be used with surrogates)

  4. Communication in the hospital at 6-8 weeks post patient discharge

    Time frame: Assessed 6-8 weeks after hospital discharge

    Family Inpatient Communication Survey (FICS) (A validated scale of communication

  5. Overall satisfaction with the hospital stay at 6-8 weeks post patient discharge

    Time frame: Assessed 6-8 weeks after hospital discharge

    Picker single item (1-10)

  6. Presence of decision conflict at 6-8 weeks post patient discharge

    Time frame: Assessed 6-8 weeks after hospital discharge

    Decision Conflict Scale (DCS) (a validated scale of decision conflict that is used to assess decision conflict when a person has made 1 or more major decisions for a patient in the hospital setting)

  7. Effect of the intervention on end of life care for those who die in the hospital

    Time frame: Chart abstraction to review from the date of admission to the hospital up to one year after admission

    Will use comparative statistics to determine any correlations between intervention and EOL care (life sustaining treatments received and hospice enrollment)

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health
  • Regenstrief Institute, Inc.

Registry information

Official study title

Chaplain Family Project Randomized Controlled Trial

Acronym: CFP-RCT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2018
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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