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

The SICAM-trial: Studying the Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program During and After Total Hip Replacement - A Quasi-experimental Study With a Complex Intervention

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Behavioral: Case management; Behavioral: Control group

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria: Patients

• 65 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.

Inclusion Criteria: Spouses

• presence at the pre-information meeting

Exclusion Criteria: Patients

• They cannot receive home care, be placed in a nursing home or be permanent users of wheelchairs

Exclusion criteria: Both

• Index score at >24 assessed on the Mini-Mental Stats Examination (MMSE)
• Index score of <6 assessed on the Charlson Comorbidity Index

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case management; 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
Other: Control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Lund University
• Investigators: Principal Investigator: Connie B Berthelsen, PhD, University of Aarhus

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 21, 2015
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (Estimate): September 28, 2015

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 25, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Case management
• Other Study ID Numbers: SICAM2015