The PAtient-Centred Team - Effectiveness and Cost-effectiveness Study

NCT02541474 | Unknown

• 1 other identifier: 2014/1707
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly w/ Multimorbidity & Functional Limitations

Keywords

Controlled trial; Matched; Before-After design; Prospective; complex interventions

Outcome Measures

Primary Outcomes (1)

• SF-12, physical dimension

  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.

  3 months

Secondary Outcomes (7)

• Rates of emergency admission days in hospital

  6 months

• Rates of consultations with General Practitioner outside of hours

  6 months

• Rates of emergency consultations in secondary outpatient clinics

  6 months

• The patient generated index (PGI), open version

  6 months

• SF-12

  3 months

Study Arms (2)

Integrated care

OTHER

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

Usual care

NO INTERVENTION

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.

Interventions

Integrated care OTHER

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.

Integrated care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Royal Norwegian Ministry of Health: collaborator

Study Sites (1)

Üniversity hospital North Norway

Tromsø, Troms, 9037, Norway

RECRUITING

Related Publications (2)

• Berntsen GKR, Dalbakk M, Hurley JS, Bergmo T, Solbakken B, Spansvoll L, Bellika JG, Skrovseth SO, Brattland T, Rumpsfeld M. Person-centred, integrated and pro-active care for multi-morbid elderly with advanced care needs: a propensity score-matched controlled trial. BMC Health Serv Res. 2019 Oct 3;19(1):682. doi: 10.1186/s12913-019-4397-2.

  PMID: 31581947 DERIVED

• Bergmo TS, Berntsen GK, Dalbakk M, Rumpsfeld M. The effectiveness and cost effectiveness of the PAtient-Centred Team (PACT) model: study protocol of a prospective matched control before-and-after study. BMC Geriatr. 2015 Oct 23;15:133. doi: 10.1186/s12877-015-0133-x.

  PMID: 26499256 DERIVED

MeSH Terms

Interventions

Delivery of Health Care, Integrated

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gro K Berntsen, MD, Dr Med

  NST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gro K Berntsen, MD, Dr Med

CONTACT

90518895; gro.berntsen@gmail.com

Trine Bergmo, PhD

CONTACT

+48003565; trine.bergmo@telemed.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Treatment patients

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: September 4, 2015
• Study Start: August 15, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)