Family SuppleMented pAtient monitoRing afTEr suRgery: A Pilot Trial

NCT04341558 | Completed

• 1 other identifier: QMERC2019/72
• Study Type: interventional
• Target: 1,395
• Locations: 1 country
• Sites: 1

Brief Summary

To develop an intervention to train family carers to perform and document basic vital signs whilst they provide personal care to their relatives after surgery in order to supplement patient monitoring conducted by nursing staff. To evaluate the effect of this intervention on the frequency of documented vital signs for patients in the first three days after surgery in a stepped-wedge cluster trial.

Conditions

Postoperative Care; Vital Signs

Outcome Measures

Primary Outcomes (1)

• Frequency of documented vital signs for patients after surgery

  To develop a training and support intervention, in accordance with the MRC complex intervention framework, to train family carers to perform and document basic vital signs, to supplement routine monitoring of patients by nursing staff, whilst they provide personal care to their relatives after surgery and to evaluate the effect of this intervention on frequency of documented vital signs for patients in the first three days after surgery in a stepped-wedge cluster trial (explanatory outcome).

  72 hours

Secondary Outcomes (2)

• Duration of hospital stay

  30 days

• All cause mortality at 30 days

  30 days

Study Arms (2)

Baseline

NO INTERVENTION

During this baseline period, postoperative monitoring will be continued as normal by nursing and medical staff without intervention. No training of family members will take place

Intervention

ACTIVE COMPARATOR

Family carers will be trained to perform and document basic vital signs whilst they provide personal care to their relatives after surgery in order to supplement patient monitoring conducted by nursing staff.

Other: Family supplemented patient monitoring

Interventions

Family supplemented patient monitoring OTHER

Intervention training sessions will last 30 minutes and will be held twice a day over a period of six months. Carers will be welcome to attend as often as they wish. Carers will be given practical training to assess the following vital signs: heart rate, respiratory rate, conscious level (AVPU scale) and arterial oxygen saturation (SpO2) in accordance with trial standard operating procedures. An important component of the training package will be ensuring carers know how to wash their hands before and after contact with their patients. The study team will ensure that handwashing facilities are available on the ward for use by carers. Carers will record vital signs on a basic observation chart every 4 hours after surgery. They will compare results with colour posters displayed throughout each ward, providing guidance on how and when to notify nursing staff of abnormal vital signs.

Intervention

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• Patients ≥5 years of age undergoing surgery at Mbale Regional Referral Hospital, who receive post-operative care in one of four main surgical wards, with a family carer prepared to participate in the trial intervention.
• Carers:
• All carers will be included in the trial if they feel they are capable of performing and documenting the basic vital signs provided they agree to participate in the trial.
• The ability to speak English, Luganda, Lugisu, Ateso or Lugwere
• The ability to read a digital clock (to measure vital signs)
• Numeracy sufficient to write numbers on the basic observation chart

You may not qualify if:

• Patients:
• Refusal of informed consent.
• Identification of potential participant \>24hours after operative procedure has taken place
• Carers:
• Refusal of informed consent.

Sponsors & Collaborators

• Queen Mary University of London: lead
• Busitema University: collaborator

Study Sites (1)

Mbale Regional Referral Hospital

Mbale, Uganda

Location

Related Publications (1)

• Hewitt-Smith A, Bulamba F, Patel A, Nanimambi J, Adong LR, Emacu B, Kabaleta M, Khanyalano J, Maiga AH, Mugume C, Nakibuule J, Nandyose L, Sejja M, Weere W, Stephens T, Pearse RM. Family supplemented patient monitoring after surgery (SMARTER): a pilot stepped-wedge cluster-randomised trial. Br J Anaesth. 2024 Oct;133(4):846-852. doi: 10.1016/j.bja.2024.06.027. Epub 2024 Jul 27.

  PMID: 39069451 DERIVED

Study Officials

• Rupert Pearse, MD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre stepped-wedge cluster randomised trial conducted in four surgical wards over a six-month period

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: April 13, 2021
• Primary Completion: October 12, 2021
• Study Completion: November 12, 2021
• Last Updated: September 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)