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The PAtient-Centred Team - Effectiveness and Cost-effectiveness Study (PACT)

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ClinicalTrials.gov Identifier: NCT02541474
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Gro Berntsen, University Hospital of North Norway

Brief Summary:

There is an urgent need to develop new care models for patients with long-term and complex needs. Our goal is services that are seamless, pro-active and person-oriented.

Intervention:

The Patient-centered health care team (PACT) is a service model for frail elderly patients with multiple long term conditions. PACT is a seamless and proactive health service model that aims to ensure safe early discharge and prevent hospital admissions for elderly frail patients. The four pivotal elements are are supported by theoretical and empirical underpinnings: 1) Goal-oriented person centered approach 2) Inter-disciplinary comprehensive geriatric team: 3) Pro-active care plan.

Study Objective:

1) To investigate whether the PACT model improves health-related quality of life and patient generated goals 2) carry out a health economic evaluation of PACT.

Design:

The evaluation model for complex interventions is our guiding evaluation framework. This is a non-randomized, matched control, before after study. The intervention unit, is the care organization, including four hospitals - municipality dyads. Two intervention dyads and two control dyads. Index patients from intervention hospitals will be matched age, sex and number of chronic conditions.

Intervention group: Patients with emergency admission to the UNN internal medicine department in Tromsø and Harstad who are age > 65, have three or more long-term conditions, an emergency admission within the last year, and an informed consent is given by patient or next of kin. (Approved by ethics board 07.05.2015). The exclusion criteria are: Language barriers, and less than 3 months life expectancy.

Controls: Recruited from the Nordlanssykehuset (Bodø) and UNN-Narvik internal medicine departments, matched to the index patient's sex, age, number of long-term conditions. Control patients will be subject to the same data-collection as intervention patients.

Data collections: All patient data will be collected at baseline, 6 and 12 months. Outcomes: The primary outcome is the adjusted differences in the change of Quality of Life, measured by Short Form-36 (SF-36), physical health dimension between intervention and control groups at 6 months after inclusion in study.


Condition or disease Intervention/treatment Phase
Frail Elderly w/ Multimorbidity & Functional Limitations Other: Integrated care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treatment patients
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

This is a registry based study design. The Primary outcome is extracted from routine data recorded by clinical and administrative personell who are unaware of study allocation in the electronic health care record.

The questionnaire outcome data can not be masked as the patient and study personell will be aware of treatment allocation group. To avoid preferential recording of these outcomes, study personell assist in data collection in either treatment or control groups - never both, so that they could not compare or favor one group above the other.

Primary Purpose: Health Services Research
Official Title: Effectiveness and Cost-effectiveness of Interdisciplinary Teamwork in Medical Emergencies: The PAtient-Centred Team (PACT) Service Model. Effect and Cost Effectiveness Evaluation
Study Start Date : August 15, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Integrated care
All patients fitting inclusion criteria will receive care from The Patient -centered health care team ( PACT ) which is a service model for frail elderly patients with multiple long term conditions.
Other: Integrated care
The PACT model facilitates better care by : 1) a structured person centered needs assessment , 2) individual care plans , and 3) and an inter- professional team that coordinates services across specialties and levels of care.

No Intervention: Usual care
All patients in the Control hospitals (Bodø and Narvik) that match the index patient from the intervention group, and who consents to participate in the study. Eligible patients receive an invitation to participate from the local study nurse. Included controls receive usual care in control hospital and municipalities. Data collection in intervention and control groups are the same.



Primary Outcome Measures :
  1. SF-12, physical dimension [ Time Frame: 3 months ]
    The primary outcome is the adjusted differences in the change of Quality of Life, measured by SF-12, physical health dimension between intervention and control groups at 6 months after inclusion in study.


Secondary Outcome Measures :
  1. Rates of emergency admission days in hospital [ Time Frame: 6 months ]
    # of days as inpatient in secondary care, per patient. Emergency admissions only

  2. Rates of consultations with General Practitioner outside of hours [ Time Frame: 6 months ]
    # of General practitioner consultations per patient. Emergency consultations only

  3. Rates of emergency consultations in secondary outpatient clinics [ Time Frame: 6 months ]
    # of consultations in secondary care outpatient clinics, per patient. Emergency consultations only

  4. The patient generated index (PGI), open version [ Time Frame: 6 months ]
    The patient's own health complaints at baseline and severity of these at baseline and follow-up points, using a validated and reliability tested questionnaire developed by Ruta, and adopted for norwegian conditions by Klokkerud. The PGI generates an index between 0 and 100.

  5. SF-12 [ Time Frame: 3 months ]
    Patient reported quality of life, last 4 weeks. The other dimensions of the SF-12 instrument

  6. EQ5D [ Time Frame: 3 months ]
    Patient reported health related quality of life, Today.

  7. Mortality risk [ Time Frame: 3 and 6 months ]
    Risk of death



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who either received treatment in PACT team for > 24 hours (Treat group) or an emergency admission to the UNN (Control group) in Tromsø/ Harstad/ Narvik/ Bodø. Age > 60. Have complex long-term needs.

Exclusion Criteria:

Live outside of designated municipalities. Receive < 24 hours of care from PACT team.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541474


Contacts
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Contact: Gro K Berntsen, MD, Dr Med 90518895 gro.berntsen@gmail.com
Contact: Trine Bergmo, PhD +48003565 trine.bergmo@telemed.no

Locations
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Norway
Üniversity hospital North Norway Recruiting
Tromsø, Troms, Norway, 9037
Contact: Gro KR Berntsen, MD, Dr. Med    +47 90518895    gro.berntsen@telemed.no   
Contact: Trine Bergmo, PhD    +47 480 03 565    trine.bergmo@telemed.no   
Sponsors and Collaborators
University Hospital of North Norway
The Royal Norwegian Ministry of Health
Investigators
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Principal Investigator: Gro K Berntsen, MD, Dr Med NST

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gro Berntsen, Senior Researcher, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02541474     History of Changes
Other Study ID Numbers: 2014/1707
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to data privacy legislation regarding sensitive data in Norway we are not at liberty to share original data.
Keywords provided by Gro Berntsen, University Hospital of North Norway:
Controlled trial
Matched
Before-After design
Prospective
complex interventions