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Continuity of Patient CareIMPACT-careNCT06610214

IMPACT-care (Improved Medication Communication and Patient Involvement at Care Transitions)

A study testing IMPACT-care intervention in people with Continuity of Patient Care, run by Uppsala University Hospital at 1 site in Sweden.

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

Background: Transitions of care, especially at hospital discharge, pose significant risks to patient safety. The World Health Organization (WHO) identifies this as a critical area for improvement, particularly for older patients who frequently experience preventable adverse drug events (ADEs) post-discharge.These… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Continuity of Patient Care
What is being tested?
IMPACT-care intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
1 siteSweden
Study dates
16 Sep 2024to 14 Jan 2026
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Aged 65 or older
  • Manages medication independently or with assistance from a caregiver

Who cannot join

  • In the late palliative phase of care before or during the hospital stay
  • Transfer to a non-participating ward
  • Residence outside the hospital's county
  • Admission from or discharge to a nursing home or short-term care facility
  • Inability to independently receive information and give consent independently (e.g., cognitive impairment, non-contactable)
  • Death during hospital stay
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  • Inability to communicate in Swedish
  • Previous inclusion in the study
  • Relocation where another department maintains care responsibility
  • No persistent medication change post-discharge
  • Hospital stay on the study ward of fewer than 48 weekday hours (excluding holidays)

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Uppsala University Hospital

    Uppsala, Uppland, 75185

Other trials in Sweden

About this study

Background: Transitions of care, especially at hospital discharge, pose significant risks to patient safety. The World Health Organization (WHO) identifies this as a critical area for improvement, particularly for older patients who frequently experience preventable adverse drug events (ADEs) post-discharge.These risks often stem from poor communication between hospitals and subsequent care providers, and inadequate communication with patients and their informal caregivers, leading to gaps in post-discharge care. In Sweden, discharge conversations between hospital physicians and patients are standard practice but often lack structure and patient-centeredness. This can result in patients being poorly prepared for self-care, especially in managing their medications.

Aim: To improve the discharge process for older patients, making them (and/or informal caregiver) more informed and involved in their overall care, particularly in medication management.

Read more

Design: Prospective intervention study with a before-and-after design, supplemented by an Interrupted Time Series (ITS) analysis using an exploratory approach.

Setting: Two surgical and one geriatric ward in Region Uppsala.

Participants: Patients aged 65 or older, managing medication independently or with assistance from an informal caregiver.

Exclusion: Late palliative stage or transition to it during hospital stay; transfer to a non-participating ward; residence outside the hospital's county; admission from or discharge to a nursing home or short-term care facility; inability to receive information and give consent independently (e.g., cognitive impairment, non-contactable); death during hospital stay; inability to communicate in Swedish; previous inclusion in the study; relocation where another department maintains care responsibility; no persistent medication change post-discharge; hospital stay on the study ward of less than 48 weekday hours.

Interventions: 1, Information package for patient and/or informal caregiver 2, Preparation of medication-related discharge documentation; 3, Facilitation of discharge communication; 4, Post-discharge follow-up call

Primary outcome measure: Quality of medication-related discharge documentation.

Data collection and analyses: Data will be collected from patients' electronic health records (EHR), the Swedish National Board of Health and Welfare's Pharmaceutical Register, and research surveys. Analyses will follow the intention-to-treat principle, using descriptive statistics, t-tests for continuous variables, and chi-square tests for categorical variables.

Relevance: The study aims to enhance the quality of discharge documentation, improve patients adherence to medication changes, increase their sense of participation and involvement in their overall care, and reduce healthcare consumption.

Read the detailed description

Background:

The global older population is increasing, with the percentage of individuals aged 65 and older expected to rise from 10% in 2022 to 16% by 2050. Older people often suffer from multiple illnesses, doubling their risk of requiring hospital care compared to younger adults. Medication is the most common treatment for various health conditions, and the prevalence of multiple illnesses increases medication usage, heightening the risk of medication-related morbidity. Up to one in five hospital admissions among the older patients is estimated to be medication-related, with most deemed avoidable. Transitions in care, particularly when patients are discharged from the hospital, pose a significant risk to patient safety, highlighted as a a focus area for healthcare improvement by the World Health Organization (WHO). Over one-third of older patients experience adverse drug reactions (ADRs) within eight weeks post-discharge, half of which are considered preventable. These risks are often due to poor communication and coordination between hospitals and subsequent care providers, as well as inadequate communication between healthcare providers and patients/informal caregivers, leading to gaps in patient care post-discharge. Most hospitalized older patients undergo changes in their medication regimens that persist after discharge. Follow-up on these medication changes by subsequent healthcare provider relies on timely and high-quality discharge notes and referrals from hospital physicians, which is not always the case. These well-documented communication issues at discharge have also been confirmed in the Uppsala and Västmanland regions.

In Sweden, it is clinical practice for physicians to have a conversation with the patient at discharge discussing what occurred during the hospital stay. However, these conversations often lack standardized structure and patient-centeredness, appearing more as a checklist item for healthcare staff to complete before discharge. Patient-centered communication at discharge is crucial for preparing patients for self-care including medication management. Involving patients in medical decisions can be part of a patient-centered approach that improves patient satisfaction with care and clinical outcomes (e.g., better glycemic control in diabetics and improved blood pressure control in hypertensives). Challenges exist in involving older patients as they may be less willing and/or able to participate in medical decisions, linked to patient factors such as multimorbidity, cognitive impairment, and hearing loss. It is also common for older patients to express a lack of sufficient medication knowledge, trusting healthcare staff and following prescriptions to the best of their ability without further discussion. Additionally, older patients often struggle to remember medication information communicated at discharge, even when it is presented in a structured manner. Physicians also tend to adopt an authoritative role in medication communication with the patients at discharge, which can reduce the older patients' initiative to engage in their care and medication management. For older patients to be involved in their care at discharge, it is important for healthcare staff to see themselves as advocates for the patient rather than adopting a paternalistic approach in their communication. Informal caregivers also play a crucial role in involving the patient and bridging the communication gap between healthcare staff and the older patients.

With this background, the investigators have initiated the research project IMPACT-care (Improved Medication Information and Patient Involvement at Care Transitions; a strengthened chain of medication information across care boundaries). Within the project, the investigators have conducted several sub-studies exploring medication communication, both oral and written, in connection with the discharge of older patients from hospitals. Based on the results from these sub-studies and the literature, the investigators now plan to conduct the following intervention study with the overall aim of improving medication communication in the discharge process for older patients.

Aim:

To improve the discharge process for older patients, making them (and/or informal caregiver) more informed and involved in their overall care, particularly in their medication management.

Primary objectives:

  • Improved medication-related discharge communication.
  • Increased patient (and informal caregiver) involvement and confidence in their care in general and their medication management in particular.
  • Enhanced patient adherence to medication changes made during the hospital stay and that persist post-discharge.
  • Reduced unplanned healthcare utilization post-discharge.

Methods:

The study will be conducted in two surgical and one geriatric ward at the Uppsala University hospital in Region Uppsala.

The study will consist of three phases, the control phase, the training phase, and the intervention phase. Patients will be recruited by the research coordinators and the intervention will be performed by existing workforce at the wards. All healthcare staff involved, i.e., doctors, nurses, and clinical pharmacists, will be trained to perform the intervention. Based on a pilot study, the control and intervention phases will last about six months each and the training phase about four months. Follow-up of included patients will continue up to four months after discharge from the hospital.

The intervention comprises for individual intervention components:

  1. Information package for the patient and/or informal caregiver: An informational brochure, with a medication focus, and a supplementary informational video (3 minutes in length) based on the information in the brochure. The broshure will be translated into additional languages commonly spoken in Sweden and the film will have subtitles in different languages.
  2. Preparation of medication-related discharge documentation: Documentation of medication changes and follow-up plans in the patients' EHR supporting the writing of the medication report in the discharge letter and discharge summary.
  3. Facilitation of discharge communication: Prompting the patient/informal caregiver to review the informational brochure and/or video. Answering questions from patient/informal caregiver about the discharge process. Facilitating the involvement of informal caregivers in the discharge conversation.
  4. Follow-up call after discharge:

A call to review the information in the discharge letter and the medication list.

Being tested
IMPACT-care intervention
Keywords
aged, pharmacist intervention, health communication, patient centered care, medication safety, medication information, hospital discharge

What participants receive

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

  • IMPACT-care interventionOther

    1, Information package for patient and/or caregiver; 2, Preparation of medication-related discharge documentation; 3, Facilitation of discharge communication; 4, Post-discharge follow-up call

Study groups in NCT06610214
Study groupRoleWhat they receive
Control groupNo interventionNo intervention
Intervention groupExperimentalIMPACT-care intervention
Receives: Other: IMPACT-care intervention

What is being measured

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

  1. CMDD-M (Complete Medication Documentation at Discharge Measure)

    Score (0-9 points) on CMDD-M (Complete Medication Documentation at Discharge Measure). The CMDD-M tool is point-based and measures the accuracy and quality of medication reports in the discharge letter provided to the patient and in the discharge summary intended for the next health care provider. The medication-related discharge documentation is classified as complete if 9 points are achieved using the tool.

    Measured: On the 1 day of discharge

Secondary outcomes (12)
  1. PIMCH-Q (Patient Involvement in Medication Communication at Hospital discharge Questionnaire)

    Score on PIMCH-Q, a questionnaire developed by the research group, administered to patients after discharge, measuring their sense of involvement in medication communication during hospitalization and their sense of knowledge and security related to their medication treatment.

    Measured: Two weeks post discharge

  2. Quality of medication-related discharge documentation

    Prevalence of patients with maximum score (9 points) on CMDD-M (patients assessed to have complete medication-related discharge documentation).

    Measured: On the 1 day of discharge

  3. Adherence to medication changes made during hospitalization that persist post-discharge, checklist.

    • Prevalence of patients without any medication errors

    Measured: Four months post discharge

  4. Adherence to medication changes made during hospitalisation that persist post-discharge

    • Number of specific medication errors related to lasting medication changes.

    Measured: Four months post discharge

  5. Healthcare consumption

    • The prevalence of the first unplanned hospital revisit (composite measure of unplanned readmissions and emergency department visits).

    Measured: 7, 30 and 90 days post-discharge

  6. Healthcare consumption

    • The prevalence of the first unplanned readmission.

    Measured: 7, 30, and 90 days post-discharge

  7. Healthcare consumption

    • The prevalence of the first emergency department visit (visit not followed by admission).

    Measured: 7, 30, and 90 days post-discharge

  8. Healthcare consumption

    • The time to the first unplanned hospital revisit.

    Measured: 7, 30, and 90 days post-discharge

  9. Healthcare consumption

    • The time to the first unplanned readmission.

    Measured: 7, 30, and 90 days post-discharge

  10. Healthcare consumption

    • The time to the first emergency department visit.

    Measured: 7, 30, and 90 days post-discharge

  11. Healthcare consumption

    The prevalence of medication-related readmissions. The assessment of whether hospital revisits are medication-related will be conducted using the AT-HARM10 tool.

    Measured: 7, 30, and 90 days post-discharge

  12. Healthcare consumption

    • The number of unplanned contacts with hospital wards, hospital outpatient clinics, the patient's primary care centre, and the mobile care team.

    Measured: 7, 30, and 90 days post-discharge

Timeline

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

  1. First posted24 Sep 2024
  2. Study start16 Sep 2024
  3. Primary completion14 Jan 2026
  4. Study completion14 Jan 2026

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
We plan a prospective intervention study primarily with a before-and-after design. A secondary analysis using an Interrupted Time Series (ITS) design will be conducted with an exploratory approach.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06610214
Sponsor's protocol ID
UppsalaUH1
Acronym
IMPACT-care
Status last verified
Feb 2026
First submitted
5 Sep 2024
Last updated
5 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan to share individual participant data: Pseudonymised individual participant data from this trial will be made available to researchers upon reasonable request, excluding any direct identifiers. The shared dataset will include all variables relevant to the study findings. Data will be available after publication and for a period of 10 years. Access will be granted to researchers who submit a methodologically sound proposal and agree to use the data solely for scientific purposes, subject to approval by the research team and a data sharing agreement. Requests should be directed to the principal investigator.

Publications

  • Cam H, Franzon K, Ostman V, Kalvemark Sporrong S, Kempen TGH, Nielsen EI, Lindner KJ, Ekelo B, Bernsten C, Ehlin U, Lindmark S, Hadziosmanovic N, Gillespie U. Improved Medication communication and Patient involvement At Care Transitions (IMPACT-care): study protocol for a pre-post intervention trial in older hospitalised patients. BMJ Open. 2025 May 2;15(5):e099547. doi: 10.1136/bmjopen-2025-099547.

    PubMed 40316362

Questions about this trial

What is this clinical trial studying?

A study testing IMPACT-care intervention in people with Continuity of Patient Care, run by Uppsala University Hospital at 1 site in Sweden.

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 2 inclusion and 11 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. 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?

CMDD-M (Complete Medication Documentation at Discharge Measure) (time frame: On the 1 day of 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 NCT06610214, which also lists 1 linked publication.

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 5 Feb 2026.

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