Clinical trial NCT02823795: The Supporting Patient Activation in Transition to Home Intervention
Official title: The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Self-care
Heart Failure
Chronic Obstructive Pulmonary Disease
Keywords: Patient participation
Empowerment
Medication management
Symptom management
Self determination theory
Motivational Interviewing
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Vårdalstiftelsen
name: Forte
First posted: 2016-07-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Re-hospitalization
timeFrame: 90 days
Secondary outcomes:
measure: Healthcare usage
timeFrame: 30, 90 and 180 days
measure: Medication adherence
timeFrame: 30, 90 and 180 days
measure: Patient activation
timeFrame: 30, 90 and 180 days
measure: Health related quality of life
timeFrame: 30, 90 and 180 days
measure: Basic Psychological Needs
timeFrame: 30, 90 and 180 days
measure: Depression
timeFrame: 30, 90 and 180 days
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Akutkliniken, Karolinska University Hospital
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset, Lung- Allergikliniken
Study officials:
affiliation: LIME, Karolinska Institutet
name: Mirjam Ekstedt, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandberg C, Ekstedt M, Flink M. Self-management challenges following hospital discharge for patients with multimorbidity: a longitudinal qualitative study of a motivational interviewing intervention. BMJ Open. 2021 Jul 30;11(7):e046896. doi: 10.1136/bmjopen-2020-046896.
citation: Flink M, Brandberg C, Ekstedt M. Why patients decline participation in an intervention to reduce re-hospitalization through patient activation: whom are we missing? Trials. 2019 Jan 25;20(1):82. doi: 10.1186/s13063-019-3187-9.
citation: Flink M, Lindblad M, Frykholm O, Kneck A, Nilsen P, Arestedt K, Ekstedt M. The Supporting Patient Activation in Transition to Home (sPATH) intervention: a study protocol of a randomised controlled trial using motivational interviewing to decrease re-hospitalisation for patients with COPD or heart failure. BMJ Open. 2017 Jul 10;7(7):e014178. doi: 10.1136/bmjopen-2016-014178.