The Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program

NCT02561637 | Completed

• 1 other identifier: SICAM2015
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients in fast-track programmes are required to take an active part in their treatment and rehabilitation. Spouses of older patients can often provide valued practical and emotional support, reducing stress, pain and length of stay - yet they are seldom invited to participate in a supporting role. The aim of this study is to investigate the effect of spouses' involvement in older patients fast-track treatment programs using case management as intervention. A two-group quasi-experimental design with pre-test and repeated post-test measures (protocol approved in November 2012) was used. Patients aged 65 years or older going through a fast-track programme for a total hip replacement and their spouses was recruited in dyads from one Danish orthopaedic ward for the intervention group (n=15) and for the control group (n=14). Data was collected from both groups at baseline, two weeks and three months after surgery. Outcome measures for patients include: functional status, nutrition, pain, depression and healthcare consumptions; and for spouses: caregiver satisfaction and difficulties and anxiety.

Conditions

Arthroplasty, Replacement, Hip

Keywords

Case management

Outcome Measures

Primary Outcomes (2)

• Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale

  Three months

• Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)

  Three months

Secondary Outcomes (5)

• Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)

  Three months

• Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)

  Three months

• Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)

  Three months

• Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)

  Three months

• Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale

  Three months

Study Arms (2)

Case management

EXPERIMENTAL

Before admission the spouse-patient dyads will take part in an interview with the case manager assessing the spouses' needs during admission through an individual care plan. During admission the case manager will follow-up and assess the goals and actions of the individual care plan and coordinate with other health professionals. During the discharge meeting the case manager will provide additional information to the spouse according to needs assessed in the care plan. After discharge the case manager will conduct a follow-up telephone call for the spouse 3-4 days and 10 days after the patient's discharge consisting of information similar to that provided at the discharge meeting.

Behavioral: Case management

Control group

OTHER

Spouses and patients in the control group will receive usual care and written and oral information about the fast-track program and principles in general from the nursing staff. The usual care and information is provided before admission in the out-patient facilities and during admission

Behavioral: Control group

Interventions

Case management BEHAVIORAL

Case management

Control group BEHAVIORAL

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• undergoing a total hip replacement due to arthritis
• live with their spouses
• speak, read and understand Danish without an interpreter
• have their spouses present at the mandatory pre-information meeting in the outpatient facilities.
• presence at the pre-information meeting

You may not qualify if:

• They cannot receive home care, be placed in a nursing home or be permanent users of wheelchairs
• Index score at \>24 assessed on the Mini-Mental Stats Examination (MMSE)
• Index score of \<6 assessed on the Charlson Comorbidity Index

Sponsors & Collaborators

• University of Aarhus: lead
• Lund University: collaborator

MeSH Terms

Interventions

Case Management; Control Groups

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Connie B Berthelsen, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 28, 2015
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 28, 2015

Record last verified: 2015-09