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The Supporting Patient Activation in Transition to Home Intervention ([sPATH])

Primary Purpose

Medication Adherence, Self-care, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Medication Adherence focused on measuring Patient participation, Empowerment, Medication management, Symptom management, Self determination theory, Motivational Interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Akutkliniken, Karolinska University Hospital
  • Karolinska Universitetssjukhuset, Lung- Allergikliniken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

sPATH

Control

Arm Description

Motivational Interviewing in five sessions post hospital discharge

Care as usual

Outcomes

Primary Outcome Measures

Re-hospitalization
Registry data from the Swedish Register for Health Care Encounters

Secondary Outcome Measures

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
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
Patient activation
Patient reported data using the Patient Activation Measure, 13 item
Health related quality of life
Patient reported data using the EQ-5D-5L
Basic Psychological Needs
Patient reported data using the the Basic Psychological Need Satisfaction & Frustration Scale, 18 items
Depression
Patient reported data using PHQ-9 (Patient Health Questionnaire)

Full Information

First Posted
July 1, 2016
Last Updated
September 20, 2020
Sponsor
Karolinska Institutet
Collaborators
Vårdalstiftelsen, Forte
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1. Study Identification

Unique Protocol Identification Number
NCT02823795
Brief Title
The Supporting Patient Activation in Transition to Home Intervention
Acronym
[sPATH]
Official Title
The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Vårdalstiftelsen, Forte

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Self-care, Heart Failure, Chronic Obstructive Pulmonary Disease
Keywords
Patient participation, Empowerment, Medication management, Symptom management, Self determination theory, Motivational Interviewing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sPATH
Arm Type
Experimental
Arm Description
Motivational Interviewing in five sessions post hospital discharge
Arm Title
Control
Arm Type
No Intervention
Arm Description
Care as usual
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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).
Primary Outcome Measure Information:
Title
Re-hospitalization
Description
Registry data from the Swedish Register for Health Care Encounters
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Healthcare usage
Description
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
Time Frame
30, 90 and 180 days
Title
Medication adherence
Description
Patient reported data using the Morisky Medication Adherence Scale, 8 items, and registry data using medicine data from the Swedish Prescribed Drug Registry
Time Frame
30, 90 and 180 days
Title
Patient activation
Description
Patient reported data using the Patient Activation Measure, 13 item
Time Frame
30, 90 and 180 days
Title
Health related quality of life
Description
Patient reported data using the EQ-5D-5L
Time Frame
30, 90 and 180 days
Title
Basic Psychological Needs
Description
Patient reported data using the the Basic Psychological Need Satisfaction & Frustration Scale, 18 items
Time Frame
30, 90 and 180 days
Title
Depression
Description
Patient reported data using PHQ-9 (Patient Health Questionnaire)
Time Frame
30, 90 and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirjam Ekstedt, Professor
Organizational Affiliation
LIME, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akutkliniken, Karolinska University Hospital
City
Huddinge
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset, Lung- Allergikliniken
City
Huddinge
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34330857
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.
Results Reference
derived
PubMed Identifier
30683140
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.
Results Reference
derived
PubMed Identifier
28698319
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.
Results Reference
derived

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The Supporting Patient Activation in Transition to Home Intervention

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