Basic Care Revisited_Communication for Patient Participation (BCR_C)

March 24, 2015 updated by: Radboud University Medical Center

BASIC CARE REVISITED - Building the Evidence Base in Core Nursing Practice

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Feasibility and effectiveness of the 'Tell-us Card' Communication Tool on hospital patients' perception of participation and quality of Care.

The use of 'Tell-us Cards' in basic care is an intervention facilitating communication for enhanced patient participation in basic care. The effectiveness of the card is tested by Jangland et al (18) in a population of patients admitted to the hospitals surgical wards. The use of the 'Tell-us Card' in this patient group resulted in significant improvements in patients abilities to participate in decisions about their nursing and medical care. In our study we will investigate feasibility and effectiveness of the 'Tell-us cards' in three different hospital settings; patients admitted to the hospitals' surgical and medical wards and in patients attending the hospitals' emergency department.

Aim: The aim of this study is to investigate feasibility and effectiveness of 'Tell-us Cards' for patients participation in basic care in three different hospital settings. Description of the Intervention: The 'Tell-us card' (18) is a tool to elicit patients preferences and needs in basic care. Patients are invited to write down their specific questions and concerns for the day or before discharge. 'Tell-us Cards' are handed out on a daily basis to patients admitted to the hospital. Patients and their informal caregivers are invited to use the 'Tell-us Card' to state their preferences in basic care during their stay in the hospital. Nurses are instructed to use the 'Tell-us card' as a tool in their dialogue with the patient in making care plans, during ward rounds or for discharge information sessions.

Design: Feasibility and effectiveness of the 'Tell-us Card' will be tested in a controlled early trial design (Phase 2B, MRC Framework). Trained nurses will be handing out the 'Tell-us Cards' on a daily basis to patients admitted to the hospital. Baseline assessments on patient participation will be conducted at all wards in patients and nurses before the introduction of the 'Tell-us Cards'. For the baseline assessment; Nurses and patients will be asked to fill in a questionnaire. The nurses receive a questionnaire in their postbox at the ward they are working on with an envelope for returning the questionnaire to the researcher. Patients will be asked to fill in a questionnaire one week after discharge from the hospital or one week after their visit to the emergency department. Assessment of effects of the intervention in patients at T1 will start 3 months after the introduction of the 'Tell-us Cards' at the intervention wards. Nurses will be asked to fill in the questionnaire again 6 months after they filled in the first questionnaire.

Patients & Settings: Hospital patients admitted to two surgical wards and two medical wards (n=4x35=140) will be included in this study. One surgical ward, one medical ward will be randomly assigned to the intervention and control group. Baseline and follow up assessments will take place in 35 patients per assessment per ward, resulting in 165 assessments at baseline, and 165 assessments at follow-up. Outcomes: Primary outcome is patient perception of participation in individualised care. For measurement of patient participation in patients admitted to the hospital we will use the Individualized Care Scale for patients (19-23). Secondary outcomes will comprehend perception of quality of care, assessed with the Quality from the Patients' perspective (QPP) questionnaire (24, 25) as well as the use and content of the 'Tell-us Cards' and the actions taken by nurses as a consequence of what patients 'tell them' by means of the 'Tell-us Cards'. As generic tools we will use the EQ-5D for measurement of Quality of life (www.euroqol.org) and one question from the consumer Quality index for patient experience (www.centrumklantervaringindezorg). Furthermore nurses' perception of individualised care will be assessed at baseline and follow-up with the Individualized Care Scale for nurses.

Analysis: Results are clustered at ward level. We will therefore perform a random effects regression model to estimate the effects on (surgical and medical) patients' perceptions of Individualised Care for the intervention versus the usual care group at follow-up. In this analysis, ward will be entered as random effect, and covariates in the model are patients' perceptions of Individualised Care at each ward at baseline.

Descriptive analysis will reveal the topics patients regard as most important during their stay. A thorough process analysis on the use of the Card en the actions taken as a consequence of the content of the cards, will give insight in feasibility and effectiveness of the 'Tell-us Card' in daily practice.

Timeline (21 months): 1-6 (6m):Preparation time; 7-9 (3m):T0-Baseline assessment; 10-12 (3m):'Tell-us Card' Intervention Introduction; 13-15 (3m):T1-assessment; 16-21 (6m):Data analysis and study reporting

Study Type

Interventional

Enrollment (Anticipated)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525EZ
        • Recruiting
        • Radboud University Medical Center
        • Contact:
        • Sub-Investigator:
          • Frank Dillerop
        • Sub-Investigator:
          • Helga de Bie
        • Sub-Investigator:
          • Danielle Kremers
    • Noord Brabant
      • Den Bosch, Noord Brabant, Netherlands, 5223GZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Speaking the Dutch language

Exclusion Criteria:

  • No serious cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tell-us Card Intervention
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
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
No Intervention: Care as usual
In the control arm, patients will receive care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Individualised Care Scale score
Time Frame: For patients at baseline and 4 months after the start start of the implementation proces
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
Time Frame: At baseline and 4 months after the start start of the implementation proces
Patients will receive a questionnaire at discharge
At baseline and 4 months after the start start of the implementation proces

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process analysis 'Content of the Tell-us Card'
Time Frame: 3 months (after finalising implementation)
The content of what patients report to be important for them during their stay or before discharge will be inventorized
3 months (after finalising implementation)
Process analysis 'follow-up activities on content of Tell-us Card'
Time Frame: 3 months (after finalising implementation)
The follow up activities by patients or nurses or other health professionals involved in care will be inventorized as well as the number of patients receiving the card, the number of patients indicating what is important for them during their stay or before discharge,
3 months (after finalising implementation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Jeroen Bosch Ziekenhuis

Investigators

  • Principal Investigator: Ria Nijhuis-van der Sande, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

March 11, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 520002003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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