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Chronic DiseaseNCT04253665

Nursing Discharge Teaching for Multimorbid Inpatients

A study testing Nursing discharge teaching in people with Chronic Disease, run by University of Lausanne at 3 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to estimate the effect size of a nursing discharge teaching intervention on multimorbid inpatients activation level, health confidence, readiness for hospital discharge, experience with discharge care and rate and time to 7-days readmission. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Chronic Disease
What is being tested?
Nursing discharge teaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
3 sitesSwitzerland
Study dates
13 Aug 2020to 30 Sep 2021
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 2 chronic diseases or more
  • Being discharged home
  • Able to speak, read and write in French

Who cannot join

  • Insufficient capacity to consent assessed with the University of California San Diego Brief Assessment of Capacity to Consent (UBACC).

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

  • Lausanne University Hospital (CHUV)

    Lausanne, 1010

  • EHC (Hôpital de Morges)

    Morges, 1110

  • eHnv (Etablissements hospitaliers du nord vaudois)

    Yverdon-les-Bains, 1318

Other trials in Switzerland

About this study

Official title: Nursing Discharge Teaching for Multimorbid Inpatients to Self-manage Their Health at Home: a Pilot Study

The objective of this study is to estimate the effect size of a nursing discharge teaching intervention on multimorbid inpatients activation level, health confidence, readiness for hospital discharge, experience with discharge care and rate and time to 7-days readmission.

Read the detailed description

Seniors returning home from hospital have to manage several chronic conditions in addition to their daily tasks. The teaching provided by nurses during hospitalization is essential care to prepare them to manage their health at home. Nevertheless, there is often a gap between professionals' belief that the teaching they have provided to patients has met their needs, and patients' perceptions of the relevance of the teaching content to their home situation. The time available to conduct this teaching is also short during the hospital stay and there is limited knowledge about how to adapt this teaching for patients who must manage multiple chronic conditions at the same time. Thus, there is a real need to develop and test a new teaching nursing intervention to prepare for the return home that takes into account the unique and complex needs and characteristics of patients with multiple chronic conditions. Tailoring teaching to seniors' life situation and level of activation (i.e., knowledge, skills and confidence in managing their health) would best meet the needs of these patients for managing their health at home. An intervention that takes these characteristics into account has been developed and will be tested in this study.

Conditions
Chronic Disease
Being tested
Nursing discharge teaching
Keywords
Discharge teaching, Nursing, Multimorbidity
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nursing discharge teachingBehavioural

    Nurses will provide multimorbid seniors inpatients with teaching related to self-management to prepare them to be discharged home. The teaching delivery will be tailored to patients' activation level and priorities. The intervention begins by determining the level of activation at which patients are and identifying priorities to address related to patients' life situation. A Discharge Teaching Guide will be used by nurses to deliver the teaching and includes six domains of self-management. For each domain, nurses first report whether a priority has been identified and what intervention they have proposed to address it. Then for each domain, teaching objectives are described and differ according to the level of patient activation. These six domains of self-management are found in the patient-oriented discharge summary, which is a document for the patient that summarizes what has been addressed in discharge teaching.

Study groups in NCT04253665
Study groupRoleWhat they receive
Usual careNo interventionDischarge teaching is usually not delivered in a systematic or consistenly way, nor by relying on a particular intervention model.
Discharge teachingExperimentalReceiving tailored discharge teaching by nurses during hospital stay.
Receives: Behavioral: Nursing discharge teaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Patient Activation Measure (PAM)

    The patient activation measure (PAM) is a 13-item self-report questionnaire to measure patient activation level. Stages of activation are distributed as follows in the PAM items: items 1-2: believing an active role is important; items 3-8: having confidence and knowledge to take action; items 9-11: taking action; and items 12-13: continuing healthy behaviors under stress. PAM raw score can be calculated by adding all of the responses to the 13 questions. This score is then converted into an activation score ranging from 0 = no activation to 100 = high activation using a calibration table. Psychometric properties of the PAM in hospitalized multimorbid patients showed a satisfying reliability (Cronbach's alpha = 0.88) and a content validity index of 0.91.

    Measured: change from hospital admission to the day of discharge and 7-10 days after discharge

Secondary outcomes (4)

  1. Change in Health Confidence Score (HCS)

    The Health Confidence Score (HCS) is an easy-to-obtain proxy measure for the patient activation construct. The HCS is a short measure (4-items) of patients' confidence to manage their health and engage with healthcare providers. Four dimensions are explored: Knowledge, Self-management, Access to help, Shared decision-making. Items have four response options (3 = strongly agree, 2 = agree, 1 = neutral, 0 = disagree). Scores are reported for each item and the higher they are, the higher the confidence is. A summary score is calculated with a 13-point scale by adding the individual items scores, with a range from 0 (4×disagree) to the ceiling 12 (4×strongly agree). This instrument has good internal consistency (Cronbach's alpha = 0.82) and construct validity.

    Measured: change from hospital admission to the day of discharge and 7-10 days after discharge

  2. Readiness for Hospital Discharge Scale-Short Form (RHDS-SF)

    Readiness for hospital discharge is an estimate by the patient of having the ability to leave the hospital, to be ready to face the realities of everyday life at home and the needs generated by their new health condition. The Readiness for Hospital Discharge Scale-Short Form (RHDS-SF) is an eight items self-reported questionnaire. Four dimensions measure personal status, knowledge to manage the post-hospital period, the ability to adapt to new health needs and the expected support. Each item is scored on a Likert scale from 0 to 10, with the highest score indicating a better perceived readiness. A mean score greater than or equal to 7 indicates that the patient is ready for hospital discharge. Content and construct validity of the RHDS-SF are missing so far. Predictive validity was tested but results showed that the patient short form of the RHDS cannot predict 30-day readmissions and emergency department visits. The RHDS has a Cronbach's alpha of 0.79.

    Measured: At the end of the hospital stay, an average of 7-10 days after admission

  3. Readmission rate and time to readmission

    7-10-day readmission rate and time to readmission retrieved from medical charts

    Measured: 7-10 days after discharge

  4. Discharge Care Experiences Survey (DICARES)

    This 11-items instrument investigates three domains: coping after discharge (4 items), adherence to treatment (3 items) and participation in discharge planning (4 items). The answer for each item ranges from 1 ("Not at all") to 5 ("To a very large extent"), with higher scores indicating more positive experience. The psychometric evaluation of the DICARES in senior patients showed an excellent test-retest reliability (ICC = 0.76, CI 95%[0.70, 0.82]), satisfactory construct validity (r = 0.54, p <0.01) and an acceptable internal consistency (Cronbach's alpha = 0.82).

    Measured: 7-10 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start13 Aug 2020
  3. Primary completion31 Aug 2021
  4. Study completion30 Sep 2021

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
2 group pre/post-intervention comparative design: 90 control patients will be recruited before the implementation of the intervention in study units. This recruitment will last approximately two months, according to the estimated turnout of patients in these units. After this control period, 30 other patients will be recruited to receive the intervention. In this sense, participants are assigned to one group or the other, depending on the phase of the study.
Masking
None (open label)
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04253665
Sponsor's protocol ID
2020_2201
Status last verified
Nov 2021
First submitted
23 Jan 2020
Last updated
8 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pellet J, Weiss M, Mabire C. Evaluation of a theory-informed implementation of a nursing discharge teaching intervention for older adults. J Adv Nurs. 2023 Aug;79(8):3147-3159. doi: 10.1111/jan.15666. Epub 2023 Apr 4.

    PubMed 37014070

  • Pellet J, Weiss M, Zuniga F, Mabire C. Implementation and preliminary testing of a theory-guided nursing discharge teaching intervention for adult inpatients aged 50 and over with multimorbidity: a pragmatic feasibility study protocol. Pilot Feasibility Stud. 2021 Mar 17;7(1):71. doi: 10.1186/s40814-021-00812-4.

    PubMed 33731212

Questions about this trial

What is this clinical trial studying?

A study testing Nursing discharge teaching in people with Chronic Disease, run by University of Lausanne at 3 sites in Switzerland.

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 3 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: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient Activation Measure (PAM) (time frame: change from hospital admission to the day of discharge and 7-10 days after discharge). 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 NCT04253665, which also lists 2 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 8 Nov 2021.

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