Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06123546 |
| Other study ID # |
PODS_2024 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 7, 2024 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
University of Lausanne |
| Contact |
Diana Eccel |
| Phone |
0041218042211 |
| Email |
diana.eccel[@]ehc.vd.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The discharge preparation is a difficult time to provide teaching, as older patients and
their caregivers are often overwhelmed by a substantial amount of information and stressed
about leaving hospital. As a result, 40-80% of patients forget or remember incorrectly the
information discussed during hospitalisation, resulting in unmet needs, poor adherence to
postdischarge care and increased use of health care services in the postdischarge period. The
Patient-Oriented Discharge Summary (PODS) is a simple, one-page tool to be completed with key
information, such as the reason for hospitalisation, warning signs to look out for, contact
information, treatment plan and upcoming medical appointments. The PODS study will assess the
effectiveness of the PODS on the quality of the transition between hospital and patients'
home and problems and unmet needs after discharge.
Description:
Full Title: The effectiveness of a patient-oriented discharge summary for older inpatients
discharged home Primary objective: To evaluate the effectiveness of a patient-oriented
discharge summary on the quality of care transition for older patients discharged home
Secondary objective: To evaluate the effectiveness of a patient-oriented discharge summary on
caregivers' perceived self-efficacy in the transition and older patients' problems and unmet
needs after hospitalization.
Hypothesis are that:
H1. Patients exposed to the PODS, compared with patients receiving usual discharge
preparation, would have improved quality of care transition H2. Patients exposed to the PODS,
compared with patients receiving usual discharge preparation, would have less problems and
unmet needs during the postdischarge period, including 7-days readmission and unplanned use
of healthcare services H3. Caregivers of patients exposed to the PODS would have improved
perceived self-efficacy in the transition compared to patients receiving usual discharge
preparation
Study design: This monocentric study has a quasi-experimental design, using a non-randomised
2 group pre/post-intervention comparative design. This design was chosen to provide
preliminary evidence on the effectiveness of the proposed intervention. As the implementation
of evidence-based interventions is a major objective of health care services, this pilot
study is prerequisite for judging the relevance and evaluate if the patient-oriented
discharge summary is likely to be effective for a future randomized clinical study. The
recruitment period is planned for 8 months. Project duration for each patient will correspond
to the duration between recruitment day and 5-7 days post-discharge.
Study intervention:
The intervention consists of three components: the patient-oriented discharge summary, the
teach-back technique and the involvement of caregivers. The healthcare team of participating
units will be trained in the intervention components.
The patient-oriented discharge summary is individualized discharge tool, containing
meaningful information for patients presented in an easy-to-understand format. This one-page
document contains six sections of information to be completed by the healthcare team: 1.)
reason for hospitalization, 2.) medications, 3.) warning signs and symptoms to watch out, 4.)
changes to daily activities and health behaviors, 5.) upcoming follow-up appointments and 6.)
contact information. The nurse responsible for hospital admission will print and give a PODS
to the participant and explain the purpose of the document. The PODS will be kept in the
participants' room during the hospital stay. In each study unit, a "PODS champion" encourage
the healthcare team to help and encourage patients to fill out the PODS over the course of
the hospitalisation as teaching content related to the six sections of information occurs.
The day of discharge, the physician responsible for participants' hospital discharge will
review and verify that the information written in the PODS correspond to the teaching content
that was discussed. Participants will take the PODS home at discharge to use it as a
reference for relevant and individualized discharge information in the post-discharge period.
The second component of the intervention is the use of the teach-back technique, as an
evidence-based approach to confirm the full comprehension of teaching content. The teach-back
consist in asking patients to repeat what they have understood in their own words. Healthcare
providers will receive a training refresher on the teach-back technique and will be reminded
to use it when they deliver discharge teaching during participants' hospital stay.
The third component is the involvement of caregivers in the discharge teaching. This will
include early identification by the healthcare provider responsible for patient admission of
a caregiver who will provide care at home, at least one teaching session during
hospitalization and the review of the PODS the day of discharge. The importance of caregiver
involvement will be emphasized to healthcare providers in the training session.
Intervention procedure:
To reduce potential performance bias, the healthcare teams of the units will attend a
one-hour training session in the intervention. The training will include and adapt the
training resources made available by the PODS developers
(https://pods-toolkit.uhnopenlab.ca/resources/#resources-train). Content of the training
session will include an introduction about the PODS, and guidance on how to fill in the tool
and use the teach-back technique. A short video clip will also be available to summarize key
information regarding the PODS. Training sessions will be conducted at the end of the control
phase to prevent contamination. A training refresher will be provided to the healthcare team
twice a month during the intervention phase. Weekly meetings will be conducted by the
investigator with the healthcare teams in the units to ensure that procedures have been
carried out correctly. If the healthcare teams have any questions during the intervention
phase, they can contact the research team at anytime.
After giving informed consent, the intervention begins by the identification by the
healthcare provider responsible for patient admission of a caregiver who will provide care at
home. Participants will receive the PODS with explanations about how it will be used during
the hospital stay. The PODS will remain in the patient's room as it will be used as a support
for the discharge teaching. The healthcare teams will provide the discharge teaching
according to the description of the intervention (see 2.4) during the hospital stay. The day
of discharge, the content of the PODS will be verified by the physician and the healthcare
provider responsible for discharge or the liaison nurse (to be defined by the units) will
inform the home care services that the participant is discharged with this summary.
Recruitment, screening and informed consent procedure:
A convenience sample of patient participants will be recruited in two participating units of
a regional Swiss hospital. Recruitment will occur upon patient admission. In each unit, 21
control patients will be recruited during the pre-implementation phase of the intervention.
This recruitment will last approximately four months. After this control period, 21 other
patients will be recruited to receive the intervention.
For the control and the intervention groups, newly admitted inpatients will be routinely
screened for eligibility in the two units by project coordinators. Project coordinators will
be healthcare professionals of the study units, responsible for the study coordination at the
hospital. They will be trained on participants inclusion criteria and inform the research
collaborator of eligible patients and caregivers. The research collaborator will be trained
by the investigator on informed consent and providing information to ensure patients'
understanding, and ethical and responsible conduct of research. The research collaborator
will approach the patient to discuss the study at the most appropriate time as deemed by them
(outside of the time for care or treatment). The research collaborator will explain to each
participant the nature of the study, its purpose, the procedures involved, the expected
duration, the potential risks and benefits and any discomfort it may entail. Participants
will be informed that the participation in the study is voluntary and that they may withdraw
from the study at any time and that withdrawal of consent will not affect their subsequent
medical assistance and treatment. Patient participants will be informed that their medical
records may be examined by authorised individuals other than their treating physician.
Eligible patients will also be invited to participate to postdischarge interviews,
additionally to the data collection with questionnaires (CTM-15). They will be informed that
interviews will be audiotaped.
All participants for the study will be provided a participant information sheet and a consent
form describing the study and providing sufficient information for participant to make an
informed decision about their participation in the study. Participants will have a 24-hour
reflection period and the investigator will remain available, including by telephone, for any
questions. The formal consent of a participant, using the approved consent form, will be
obtained before the participant is submitted to any study procedure. The consent form will be
signed and dated by the investigator or his designee at the same time as the participant
sign. A copy of the signed informed consent will be given to the study participant. The
consent form will be retained as part of the study records.
When there is an identified caregiver for the participant, the caregiver will be approached
at the most opportune time, preferably in the presence of the concerned patient. The research
collaborator will inform the caregiver of the study and its implication for the patient
participant. Caregivers who consent to participate will sign a consent form. Their
participation will consist of completing the FACT questionnaire and, as an option, taking
part in the interview 5-7 days after patients' discharge.
Data collection procedure:
A research collaborator will be responsible for collecting the data and administering the
questionnaires. The investigator will train the research collaborator on the protocol (in
particular eligibility criteria, ethical consideration related to participant information and
consent, conducting interviews, questionnaire administration, scoring and data recording to
limit the risk of measure bias. Weekly meetings will be conducted by the investigator with
the research collaborator to ensure that procedures have been carried out correctly.
After giving informed consent, the research collaborator will ask participants to complete
the baseline data form and will collect data from Electronic Health Record. During the
hospital stay, the project coordinators on sites will inform the research collaborator of
participants' planned discharge day. The day of discharge or the day before, the research
collaborator will visit the participant to plan the phone call or the home visit (according
to their preferences) 5-7 days later to collect patients and caregivers' outcomes. Interviews
with participating dyads or patients only will also be scheduled. Five to seven days after
discharge, the investigator will support participants in completing the CTM-15 and the FACT
tool. Interviews will be conducted following the interview guide and recorded. If
participants raise a major problem at home during interviews that would be necessary to be
solved for the participants' safety, the investigator will ask the agreement of participants
to notify their physician in the community.
