The Supporting Patient Activation in Transition to Home Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial

Conditions
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Medication Adherence, Self-care, Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sPATH<br>Motivational Interviewing in five sessions post hospital discharge | Behavioral: Motivational Interviewing<br>* Patients will get motivational interviewing sessions by a patient activation coach (medical social workers and/or nurses trained in motivational interviewing and in the intervention) in five post hospital discharge sessions (whereof one face-to-face, four by phone) aiming to increase patient motivation to become active in self-management (medication management, care plan/follow-up, symptoms/signs of worsening condition, contacts with health care provider).<br>|
| No Intervention: Control<br>Care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-hospitalization | Registry data from the Swedish Register for Health Care Encounters | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare usage | Registry data from the Swedish Register for Health Care Encounters: re-hospitalization at 30 and 180 days. Emergency room and primary care visits at 30, 90 and 180 days | 30, 90 and 180 days | 
| Medication adherence | Patient reported data using the Morisky Medication Adherence Scale, 8 items, and registry data using medicine data from the Swedish Prescribed Drug Registry | 30, 90 and 180 days | 
| Patient activation | Patient reported data using the Patient Activation Measure, 13 item | 30, 90 and 180 days | 
| Health related quality of life | Patient reported data using the EQ-5D-5L | 30, 90 and 180 days | 
| Basic Psychological Needs | Patient reported data using the the Basic Psychological Need Satisfaction & Frustration Scale, 18 items | 30, 90 and 180 days | 
| Depression | Patient reported data using PHQ-9 (Patient Health Questionnaire) | 30, 90 and 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication management, Symptom management, Patient participation, Empowerment, Self determination theory, Motivational Interviewing