The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Re-hospitalization
Study Overview
Brief Summary
This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.
Detailed Description
Included patients transition to home will be bridged through a telephone-call from a patient activation coach two days post-discharge. The patients will thereafter get motivational interviewing sessions by the same patient activation coach with the the goal that the patients are motivated to the knowledge, skills and confidence needed to manage the four main activity areas: 1) medication management; 2) adhere to care plan/ follow-up visits according to the discharge plan; 3) recognize indications (symptoms/signs) that the condition is worsening and how to respond; and 4) contact and manage relations/encounters with health care providers. Patients in control group will receive standard care, i.e. discharge and follow-up as in normal procedures. The investigators will use a randomization in permuted blocks of 10 intervention patients and 10 control patients included. To test the hypothesis that the re-hospitalizations rate is 15 % lower in the intervention group compared to the control group 242 patients (121 per group) are needed for power of 80% with the level of significance set to 5 % using two-sided chi-square.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 years or older with chronic obstructive pulmonary disease or congestive heart failure admitted at a short-term medical ward and who are living in their private home.
Exclusion Criteria
- •Diagnoses of dementia or cognitive impairment, and need of interpreter to participate in conversations.
- •The exclusion criteria are related to the patients' possibilities to participate in the motivational interviewing sessions by phone.
Arms & Interventions
sPATH
Motivational Interviewing in five sessions post hospital discharge
Intervention: Motivational Interviewing (Behavioral)
Control
Care as usual
Outcomes
Primary Outcomes
Re-hospitalization
Time Frame: 90 days
Registry data from the Swedish Register for Health Care Encounters
Secondary Outcomes
- Medication adherence(30, 90 and 180 days)
- Healthcare usage(30, 90 and 180 days)
- Health related quality of life(30, 90 and 180 days)
- Patient activation(30, 90 and 180 days)
- Depression(30, 90 and 180 days)
- Basic Psychological Needs(30, 90 and 180 days)
Investigators
Mirjam Ekstedt
Professor
Karolinska Institutet