NCT02401919

Brief Summary

COMMUNICATION - Feasibility and effectiveness 'Tell-us Cards' in hospital patients

  • Objective - To investigate the feasibility and effectiveness of 'Tell-us Cards' on patient participation in basic care in hospital settings.
  • Design - Cluster randomised controlled early trial design (Phase 2B, MRC Framework). Patients of two surgical and two medical wards (n=140) will be included in this study. Before and after the introduction of the intervention, assessments will take place in patients and nurses at these wards.
  • Intervention - The 'Tell-us card' is a tool to elicit patients preferences and needs in basic care. Patients are invited to write down their specific questions and concerns. The cards are handed out to patients admitted to the hospital (daily). Patients and informal caregivers are invited to use the cards to state their preferences. Nurses are instructed to use the cards as a tool in their dialogue with the patient in making care plans, during ward rounds or for discharge information sessions.
  • Comparison - Usual care
  • Primary outcome - Patient perception of participation in care (Individualized Care Scale (ICS)
  • Secondary - Use and content of the 'Tell-us Cards' actions taken by nurses as a consequence of what patients 'tell them' by means of the 'Tell-us Cards', Quality from the Patients' perspective (QPP), EQ-5D, and CQ satisfaction with communication \& care in general

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

March 11, 2015

Last Update Submit

March 24, 2015

Conditions

Keywords

NursingHospitalCommunicationPatient ParticipationIndividualised Care

Outcome Measures

Primary Outcomes (2)

  • Change in the Individualised Care Scale score

    Patients will receive a questionnaire at discharge

    For patients at baseline and 4 months after the start start of the implementation proces

  • Change in Quality of Care Scale score

    Patients will receive a questionnaire at discharge

    At baseline and 4 months after the start start of the implementation proces

Secondary Outcomes (2)

  • Process analysis 'Content of the Tell-us Card'

    3 months (after finalising implementation)

  • Process analysis 'follow-up activities on content of Tell-us Card'

    3 months (after finalising implementation)

Study Arms (2)

Tell-us Card Intervention

EXPERIMENTAL

Patients in the experimental arm will receive a Tell-us Card on a daily basis during their stay in the hospital. With this card patients are invited to state what is important to them for that day or before discharge from the ward.

Behavioral: Tell-us Card

Care as usual

NO INTERVENTION

In the control arm, patients will receive care as usual.

Interventions

Tell-us CardBEHAVIORAL

Patients will be invited on a daily basis, during their stay in the hospital, to state what is important for them at that moment or before discharge

Tell-us Card Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Speaking the Dutch language

You may not qualify if:

  • No serious cognitive impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud university medical center

Nijmegen, Gelderland, 6525EZ, Netherlands

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5223GZ, Netherlands

RECRUITING

Related Publications (3)

  • Jangland E, Carlsson M, Lundgren E, Gunningberg L. The impact of an intervention to improve patient participation in a surgical care unit: a quasi-experimental study. Int J Nurs Stud. 2012 May;49(5):528-38. doi: 10.1016/j.ijnurstu.2011.10.024. Epub 2011 Nov 20.

    PMID: 22104043BACKGROUND
  • Suhonen R, Schmidt LA, Katajisto J, Berg A, Idvall E, Kalafati M, Land L, Lemonidou C, Valimaki M, Leino-Kilpi H. Cross-cultural validity of the Individualised Care Scale - a Rasch model analysis. J Clin Nurs. 2013 Mar;22(5-6):648-60. doi: 10.1111/j.1365-2702.2012.04238.x. Epub 2012 Aug 9.

    PMID: 22882146BACKGROUND
  • Suhonen R, Gustafsson ML, Katajisto J, Valimaki M, Leino-Kilpi H. Nurses' perceptions of individualized care. J Adv Nurs. 2010 May;66(5):1035-46. doi: 10.1111/j.1365-2648.2009.05256.x. Epub 2010 Mar 9.

    PMID: 20337793BACKGROUND

MeSH Terms

Conditions

CommunicationPatient Participation

Condition Hierarchy (Ancestors)

BehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Ria Nijhuis-van der Sande, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 30, 2015

Study Start

May 1, 2014

Primary Completion

December 1, 2015

Study Completion

May 1, 2019

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations