Flexible vs Restrictive Visiting in the ICU

22 November 2024 Roland Amoah Intensive Care Medicine, Summaries Leave a comment

Long-term effects of flexible visitation in the intensive care unit on family members’ mental health: 12-month results from a randomized clinical trial

JMB de Souza et al. Intensive Care Med (2024); 50:1614–1621. DOI: 10.1007/s00134-024-07577-3

Clinical Question

In family members of intensive care patients, does a flexible visiting policy, compared to a restrictive one, improve the prevalence of depression, anxiety and post-traumatic stress symptoms 12 months after discharge?

Background

Intensive care admissions present many potential challenges to relatives’ mental health. The Canadian Recover study demonstrated an association between intensive care admission of mechanically ventilated patients, and depression in their caregivers, potentially up to 12 months after discharge
Flexible visiting is one intervention which may reduce psychological stress in families, and observational studies suggest that relatives with longer visiting hours are more likely to be satisfied, and less likely to display clinical symptoms of anxiety and depression
However, evidence from randomised control trials linking flexible visiting with improved psychological outcomes in relatives is lacking

Design

Long term outcomes analysis of multicentre, cluster crossover randomised control trial (ICU Visits Study)
Intensive care units block randomised (by statistician blind to ICU characteristics) to flexible (intervention) or restrictive (control) visiting policy first. After a 30 day washout period, the ICU was switched to the opposite visiting policy. Each ICU spent equal time using flexible and restrictive visiting policies
Randomisation performed with varying block sizes, stratified by number of beds
A designated relative who randomly experienced flexible or restrictive visiting was contacted by phone 12 months post patient discharge from ICU to assess the prevalence of possible/probable anxiety/depression via Hospital Anxiety and Depression Scale (HADS) questionnaires as well as post-traumatic stress symptoms via Impact of Event Scale-6 (IES-6) scores
- Family member follow up was unplanned, and participants were consented at the 12 month follow up time point
Effect of intervention on outcomes adjusted for family members’ age, gender, previous history of anxiety or depression, and the patient’s vital status (dead or alive) 12 months post ICU discharge
- Intervention effect further analysed using subgroups by patient characteristics, including age, sex, history of anxiety or depression and ICU length of stay amongst others

Setting

36 adult intensive care units in Brazil
Patients and families enrolled between April 2017 and June 2018
Last family member follow up in May 2019

Population

Inclusion Criteria
- Not for profit adult intensive care units with at least 6 beds and patient visiting limited to less than 4.5 hours
- One family member (per patient) chosen to participate, with this member being selected by family as the “closest relative”
Exclusion Criteria
- Communication/comprehension difficulties in family members
- Inability to contact family member via telephone
- Family member refusal
- Incomplete outcome assessments by family members
Screening and attrition
- 1060 family members screened/randomised
  - 532 enrolled in flexible visiting group. 528 family members enrolled in restrictive visiting group
- 519 family members analysed. Remaining family members lost to follow up
  - 288 left in flexible visitation group
  - 231 left in restrictive visitation group
- Baseline characteristics of flexible vs restrictive visiting groups respectively:
  - Family member characteristics
    - Mean age (years): 46 vs 47
    - Female: 70% vs 72%
    - Median educational attainment (years): 11 vs 11
    - Unemployed or retired: 31% vs 30%
    - Living with the patient: 56% vs 54%
    - History of anxiety: 13% vs 14%
    - History of depression: 14% vs 13%
  - Patient characteristics
    - Mean age (years): 60 vs 61
    - Female: 45% vs 46%
    - Type of admission:
      - Medical: 37% vs 39%
      - Surgical: 51% vs 51%
    - Invasive mechanical ventilation during ICU stay: 27% vs 24%
    - Median length of ICU stay (days): 5 vs 4
    - Alive 12 months post ICU discharge: 78% vs 76%

Intervention

Flexible visiting policy
- One or two close family members allowed to visit for up to 12 hours/day (mean duration of visits during intervention was 4.5 hours/ day)
  - These members were invited to participate in a structured, in-person meetings aimed at “instructing them on the functioning of the ICU environment, common procedures, multidisciplinary teamwork, infection control, delirium management, and palliative care”
  - These members were given access to information to “help them understand the different processes and emotions associated with staying in the ICU, as well as to encourage their participation in patient care”
- Patient also allowed social visits from friends and other family members not part of the one or two above. The flexible visiting policy was not applied to these social visits

Control

Restrictive visiting policy
- Family members/friends allowed to visit as per pre-study hours (absolute maximum limit 4.5 hours; median time 1.5 hours/day; mean duration of visits during study period was 1.5 hours/day, significantly lower than flexible visiting group p< 0.001)

Management common to both groups

Family members requested to leave bedside during clinical procedures
Longer visiting (in both intervention and control groups) permitted in extraordinary situations (e.g. terminal illness or conflicts with ICU clinical team)

Outcome

Primary Outcomes: prevalence of anxiety/depression (possible or probable) and post-traumatic stress symptoms
- Significantly reduced in flexible visiting group:
  - Prevalence of post-traumatic stress symptoms (IES-6 score > 1.75)
    - 21% vs 30.5% (Adjusted prevalence ratio (APR): 0.91; 95% CI: 0.85, 0.98)
- No difference between flexible and restrictive visiting groups:
  - Prevalence of possible anxiety (HADS anxiety score > 7)
    - 28.9% vs 33.2% (APR 0.93; 95% CI 0.72, 1.21)
  - Prevalence of probable anxiety (HADS anxiety score > 10)
    - 15.4% vs 15.9% (APR 0.97; 95% CI: 0.63, 1.49)
  - Prevalence of possible depression (HADS depression score > 7)
    - 19.2% vs 25% (APR 0.78; 95% CI: 0.60, 1.02)
  - Prevalence of probable depression (HADS depression score > 10)
    - 8.2% vs 12.3% (APR 0.61; 95% CI: 0.39, 1)
- Secondary outcomes: mean IES-6, HADS-anxiety and HADS-depression scores
  - Significantly reduced in flexible visiting group:
    - IES-6 Score
      - 6.35 vs 7.76 (adjusted mean difference (AMD): – 1.36; 95% CI: – 2.22, – 0.50)
    - HADS-depression score
      - 4.48 vs 5.13 (AMD: – 0.65; 95% CI: – 1.17, – 0.13)
  - No difference between flexible and restrictive visiting groups
    - HADS-anxiety score
      - 6.02 vs 6.61 (AMD: – 0.55; 95% CI: – 1.16, 0.06)
- Sub-group analysis – family members of patients requiring ≥5 day ICU stay
  - More pronounced reduction in post-traumatic stress with flexible visitation (aPR 0.58, 95% CI 0.36-0.93)

Authors’ Conclusions

“Flexible ICU visitation, compared to the restrictive visitation, was associated with a significant reduction in the 1-year prevalence of post-traumatic stress symptoms in family members.”

Strengths

Sensible clinical question which is relevant to intensive care units around the world
Multicentre and randomised control trial design
Crossover trial design to reduce confounding effects of different intensive care units on the primary outcome
Publication of baseline characteristics of patients and their family members lost to follow up to enable detection of bias
Sensitivity analyses performed to identify methodological bias and attempt to identify effect of loss to follow up on the primary outcomes

Weaknesses

Large loss of families to follow up in intervention and control groups, with the potential to introduce attrition bias
Follow up of families at 12 months was ad-hoc and unplanned. There was no obvious power calculation and it is possible the study was underpowered in detecting differences between intervention and control groups
The intervention is multifaceted, featuring family member education as well as longer/flexible visiting hours. Are the differences between the intervention and control group therefore down to differences in visiting time allowed or due to the additional education and support offered to relatives?
It is unknown whether these results are generalisable to intensive care units outside Brazil
The study does not address how flexible visiting affects the risk of PTSD, anxiety and depression in relatives at time points before 12 months (e.g. 3 or 6 months)
The clinical course +/- treatment of family members identified to be at risk of anxiety/depression/PTSD is unknown beyond the 12 month follow-up period.
- e.g. were these family members formally diagnosed with anxiety/depression/PTSD subsequently? Did they require psychological/medical interventions?

The Bottom Line

Flexible visiting has the potential to impact the mental health of family members in the medium to long term, but this study’s results require validation in a range of ICUs internationally
Flexible visiting should be part of a wider package of care which aims to support families while patients are admitted to intensive care

External Links

Metadata

Summary author: Roland Amoah
Summary date: 04/11/2024
Peer-review editor: David Slessor

Header picture by: Khyati Trehan / Pexels

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