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

NCT06610214 | Completed

• 1 other identifier: UppsalaUH1
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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 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. 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.

Conditions

Continuity of Patient Care

Keywords

aged; pharmacist intervention; health communication; patient centered care; medication safety; medication information; hospital discharge

Outcome Measures

Primary Outcomes (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.

  On the 1 day of discharge

Secondary Outcomes (12)

• PIMCH-Q (Patient Involvement in Medication Communication at Hospital discharge Questionnaire)

  Two weeks post discharge

• Quality of medication-related discharge documentation

  On the 1 day of discharge

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

  Four months post discharge

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

  Four months post discharge

• Healthcare consumption

  7, 30 and 90 days post-discharge

Study Arms (2)

Control group

NO INTERVENTION

No intervention

Intervention group

EXPERIMENTAL

IMPACT-care intervention

Other: IMPACT-care intervention

Interventions

IMPACT-care intervention OTHER

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

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Inability to communicate in Swedish
• 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)

Sponsors & Collaborators

• Regional Research Council Mid Sweden: collaborator
• Uppsala University: collaborator
• Uppsala University Hospital: lead
• The Kamprad Family Foundation for Entrepreneurship, Research & Charity: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppland, 75185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 40316362 DERIVED

Study Officials

• Ulrika Gillespie, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of the primary outcome measure will be blinded. The secondary outcome measure concerning drug related readmissions will be blinded. The secondary outcome measure concerning medication adherence is not possible to blind since it is dependent on the patients' discharge date, and the date will reveal the allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Pharmacist / Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 24, 2024
• Study Start: September 16, 2024
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From publication and 10 years forward.
• Access Criteria: 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.

Locations

SE (1)