A New Care Model for Patients With Complicated Multimorbidity

May 25, 2023 updated by: Slagelse Hospital

A New Care Model for Patients With Complicated Multimorbidity A Cluster-randomised Pilot Study in General Practice, Municipalities, and Hospitals

Patients with complex multimorbidity experience a high treatment burden, fragmentation of care and poor clinical outcomes. General practice is the key organizational setting in terms of offering these patients integrated, longitudinal, and patient-centered care. Therefore, we propose a new general practice based model to improve overview, patient involvement and integration of care. The new care model consist of a teaching session on multimorbidity for the health care professionals, a prolonged overview consultation for patients with complex multimorbidity with the general practitioner, resulting in an individual care plan shared with the municipalities and secondary care, access to cross-sectoral video conferences with secondary care specialists and. Control practices provide health care as usual. We evaluate the care model in a cluster-randomized non-blinded, parallel-group trial in general practice. Fourteen general practices are allocated 1:1 to either intervention or control. We evaluate the effectiveness of the intervention with patient-reported questionnaire at baseline, 6-month follow-up, and 12-month follow-up. Primary outcome measure is the Patient Assessment of Chronic Illness Care (PACIC). Secondary outcome measure includes patient-reported quality of life and the treatment burden for the patients with multimorbidity. Furthermore, the project include a process evaluation of the complex intervention with the objective to assess how the intervention is delivered and to identify important facilitators and barriers for implementing the intervention. The new model is integrated into the existing health care system structures and has the potential for a sustainable improvement in care for patients with complex multimorbidity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Anne Frølich, Professor
  • Phone Number: +45 27121622
  • Email: anfro@sund.ku.dk

Study Contact Backup

Study Locations

  • Denmark
      • Albertslund, Denmark, 2620
        • Active, not recruiting
        • Lægerne Kanaltorvet
      • Albertslund, Denmark, 2620
        • Active, not recruiting
        • Thorkil Christensen
      • Brøndby, Denmark, 2605
        • Active, not recruiting
        • Brøndbyøster Torv
      • Ishøj, Denmark, 2635
        • Active, not recruiting
        • Lægerne i Brohuset
      • Korsør, Denmark, 4220
        • Active, not recruiting
        • Lægecenter Korsør
      • Slagelse, Denmark, 4200
        • Active, not recruiting
        • Læge Depenau vej-Hansen
      • Slagelse, Denmark, 4200
        • Withdrawn
        • Læge Jørgen Larsen
      • Slagelse, Denmark, 4200
        • Recruiting
        • Læge Lene Stiggaard
        • Contact:
          • Lene Stiggaard, GP
      • Slagelse, Denmark, 4200
        • Recruiting
        • Lægerne Reventlow, Wolfhagen og Bendtsen
        • Contact:
          • Johan Reventlow, GP
      • Slagelse, Denmark, 4200
        • Active, not recruiting
        • Lægerne ved Lystskoven
      • Vallensbæk, Denmark, 2625
        • Active, not recruiting
        • Lægerne Vallensbæk Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Has more than one of the 3 common chronic diseases (diabetes, chronic obstructive pulmonary, chronic heart conditions)
  2. Has been hospitalised, or visited an outpatient clinic due to their chronic diseases during the previous year
  3. Take at least five different prescription drugs assessed from the Shared Medicine Card recording in the general practice
  4. The general practitioner or the nurse in the practice recognise the patient as a "demanding" patient with complicated multimorbidity that will benefit from an overview consultation.

Exclusion Criteria:

  • Patients who cannot speak Danish,
  • Patients who cannot give informed consent,
  • Patients who have a life expectancy of less than 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention (CIM2)
An extended overview consultation, lasting 45 minutes, with the general practitioner, the patient (and maybe a relative), and the care coordinator. An individual care plan is developed, covering planned activities in the three sectors (general practice, municipality, and hospital) that will take place within the 12-month intervention period. General practice coordinates the planned patient care between general practice, the municipality, and the hospital, and follow-up on the execution of planned healthcare activities. The individual care plan is shared electronically with the healthcare center in the municipality and with the outpatient clinics using the standard IT-communication tool provided by MedCom and a routinely used national standard in general practice, hospitals, and municipalities.
Other: Patient-centred complex intervention in complicated multimorbidity (CIM2)
CIM2 is the second version of the Patient-centred complex intervention in complicated multimorbidity
No Intervention: Usual care
Patients with a general practitioner allocated to the control group will receive usual care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 12 months
Time Frame: From baseline to 12-month follow-up
PACIC is a 20-item patient report instrument that assesses patient's receipt of clinical services and actions. Each item was scored on a 5-point scale ranging from 1 (no or never) to 5 (yes or always). Respondents rate how often they experienced the content described in each item. The scale range from 1-5 and is scored by averaging of items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. Higher scores indicate higher patient assessment delivery of high-quality care for patients with chronic diseases.
From baseline to 12-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline Patient Assessment of Chronic Illness Care (PACIC) at 6 months
Time Frame: From baseline to 6-month follow-up
PACIC is a 20-item patient report instrument that assesses patient's receipt of clinical services and actions. Each item was scored on a 5-point scale ranging from 1 (no or never) to 5 (yes or always). Respondents rate how often they experienced the content described in each item. The scale range from 1-5 and is scored by averaging of items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. Higher scores indicate higher patient assessment delivery of high-quality care for patients with chronic diseases.
From baseline to 6-month follow-up
Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 6 months
Time Frame: From baseline to 6-month follow-up
The EQ-5D-5L assess the patients' health-related quality of life. It contains two main elements: a descriptive profile comprising five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-5D visual analogue scale (EQ VAS). Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The EQ-VAS range from 0 (the worst imaginable health state) at the bottom to 100 (the best imaginable health state) on the top for respondents to rate their overall health.
From baseline to 6-month follow-up
Change from baseline EuroQol-5 Domain (EQ-5D-5L) at 12 months
Time Frame: From baseline to 12-month follow-up
The EQ-5D-5L assess the patients' health-related quality of life. It contains two main elements: a descriptive profile comprising five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-5D visual analogue scale (EQ VAS). Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The EQ-VAS range from 0 (the worst imaginable health state) at the bottom to 100 (the best imaginable health state) on the top for respondents to rate their overall health.
From baseline to 12-month follow-up
Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 6 months
Time Frame: From baseline to 6-month follow-up
The Multimorbidity Treatment Burden Questionnaire (MTBQ) is a 10-item questionnaire designed to measure treatment burden (the effort of looking after one's health) in patients with multimorbidity in primary care. Each question is scored as follows: zero (not difficult/ does not apply), one (a little difficult), two (quite difficult), three (very difficult), four (extremely difficult). To calculate a global score, each participant's average score is calculated from the questions answered and multiplied by 25 to give a score from 0-100. Higher MTBQ score indicate higher treatment burden.
From baseline to 6-month follow-up
Change from baseline Multimorbidity Treatment Burden Questionnaire (MTBQ) at 12 months
Time Frame: From baseline to 12-month follow-up
The Multimorbidity Treatment Burden Questionnaire (MTBQ) is a 10-item questionnaire designed to measure treatment burden (the effort of looking after one's health) in patients with multimorbidity in primary care. Each question is scored as follows: zero (not difficult/ does not apply), one (a little difficult), two (quite difficult), three (very difficult), four (extremely difficult). To calculate a global score, each participant's average score is calculated from the questions answered and multiplied by 25 to give a score from 0-100. Higher MTBQ score indicate higher treatment burden.
From baseline to 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Slagelse Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Anne Frølich, Professor, Innovation and Research Centre for Multimorbidity, Slagelse hospital, Region Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MM14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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