CommunicationBCR_CNCT02401919
Basic Care Revisited_Communication for Patient Participation
A study testing Tell-us Card in people with Communication and Patient Participation, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Patient Participation
- What is being tested?
- Tell-us Card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesNetherlands
- Study dates
- May 2014to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Speaking the Dutch language
Who cannot join
- No serious cognitive impairments
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5223GZ
Joost van de Mortel, jo.v.d.mortel@jbz.nl
- Recruiting
Radboud university medical center
Nijmegen, Gelderland, 6525EZ
Riny van der Ven, Riny.vanderven@Radboudumc.nl
Frank Dillerop
About this study
Official title: 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
Read the 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
- Conditions
- Communication, Patient Participation
- Being tested
- Tell-us Card
- Keywords
- Nursing, Hospital, Communication, Patient Participation, Individualised Care
- Medical subject headings
- Communication, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tell-us CardBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tell-us Card |
| Care as usual | No intervention | In the control arm, patients will receive care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Individualised Care Scale score
Patients will receive a questionnaire at discharge
Measured: 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
Measured: At baseline and 4 months after the start start of the implementation proces
Secondary outcomes (2)
Process analysis 'Content of the Tell-us Card'
The content of what patients report to be important for them during their stay or before discharge will be inventorized
Measured: 3 months (after finalising implementation)
Process analysis 'follow-up activities on content of Tell-us Card'
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,
Measured: 3 months (after finalising implementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2015 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Responsible party
- Sponsor
- Investigators
- Ria Nijhuis-van der Sande, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401919
- Sponsor's protocol ID
- 520002003
- Acronym
- BCR_C
- Status last verified
- Mar 2015
- First submitted
- 11 Mar 2015
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22104043Suhonen 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.
PubMed 22882146Suhonen 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.
PubMed 20337793
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BASIC CARE REVISITED - Building the Evidence Base in Core Nursing Practice
- ClinicalTrials.gov ID
- NCT02401919
- Acronym / sponsor ID
- BCR_C / 520002003
- Conditions
- Communication, Patient Participation
- Keywords
- Nursing, Hospital, Communication, Patient Participation, Individualised Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tell-us Card Intervention | Experimental | Behavioral: Tell-us CardPatients 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. |
| Care as usual | No intervention | –In the control arm, patients will receive care as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Speaking the Dutch language
Key exclusion criteria (1 listed)
- No serious cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tell-us CardPatients 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 | Behavioural | Tell-us Card Intervention |
Primary outcome
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
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
2 secondary outcomes
Process analysis 'Content of the Tell-us Card'
Time frame: 3 months (after finalising implementation)
Process analysis 'follow-up activities on content of Tell-us Card'
Time frame: 3 months (after finalising implementation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- Background: PubMed 22104043Jangland 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.
- Background: PubMed 22882146Suhonen 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.
- Background: PubMed 20337793Suhonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ria Nijhuis-van der Sande, PhD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tell-us Card in people with Communication and Patient Participation, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maud Heinen, PhD (+31 (0)24 3619750, Maud.Heinen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Individualised Care Scale score (time frame: For patients at baseline and 4 months after the start start of the implementation proces). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02401919, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.